Transcatheter Mitral Valve Repair (TMVR)

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 procedures and those performed in clinical trials.

My comments regarding this joint participation requirement are informed by the experience of being one of the original 7 operators in this procedure, and having performed over a decade's worth of percutaneous MitraClip repairs. The procedure requires 3 essential physician personnel: an anesthesiologist to administer general anesthesia, an echocardiographer to provide imaging guide the placement of the clip, and a single operator who controls the device -which has only one handle with multiple controls that must be maneuvered in concert and not separately. A second set of hands is not required and could actually be detrimental since the actions at the controls need to be coordinated. In my experence, a surgeon has never been present or required, and the data on the safety of the procedure bears this out.

While CMS appears to have replicated this surgical requirement from the TAVR NCD, in fact these procedures are quite different. TAVR is an arterial procedure using larger bore catheters which then must transit the aorta. The aortic valve itself can embolize, can result in annular rupture, etc. These life-threatening outcomes are not present in the trans-venous TMVR MitraClip.

Therefore, based on both my experience, the dissimilarities with the TAVR procedure, and the data on the safety profile of the MitraClip procedure, the requirement to have a surgeon present during the procedure should be removed. The surgeon involvement in the multidisciplinary deliberation and selection of the high sugical risk candidate for the commercial use of the MitraClip remains important and is supported.

CMS also proposes to limit coverage of TMVR when performed outside of approved indications to “FDA-approved randomized clinical trials.” I am concerned that a requirement of randomization as a condition of trial coverage could inappropriately limit the scope of clinical trials that could be performed in the future to investigate new indications for TMVR, or to further characterize the procedure. As an example, future TMVR research, the FDA might approve a randomized trial that is supplemented by a registry of non-randomized patients.

CMS’s recommendation that trials also must be FDA approved would not allow consideration of coverage for investigator or society sponsored studies to evaluate the evidence for TMVR within discrete sub-patient populations with mitral regurgitation, which could further inform which groups experience the greatest benefit from TMVR.

For these reasons, CMS should modify the proposed clinical trial coverage language so it is consistent with the final TAVR NCD as follows: “TMVR is covered for uses that are not expressly listed as an FDA approved indication when performed within a clinical trial that fulfills all of the following…”

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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 evaluated by both interventional cardiology and cardiac surgery to determine possible and appropriate care pathways. As such, we support the provisions that a patient should be under the care of a heart team and evaluated independently by a cardiac surgeon.

We do not support the proposal to require both an interventional cardiologist and cardiac surgeon in the procedure. Our experience, both in commercial & research, has been single operator with exceptional patient outcomes. Inclusion of 2 operators only serves to impact the overall cost to deliver and ability to schedule procedures. Both would negatively impact the patients who could be served by MitraClip therapy.

Thank you for the opportunity to share our experience and thoughts on the delivery of this impactful therapy.

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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 to the Centers for Medicare & Medicaid Services(CMS) proposal for a national coverage determination for transcatheter mitral valve repair(TMVR) for appropriate patients, who are in need for this procedure (CAG-00438N). We are pleased to know that the CMS has recognized the importance of this life saving and life enhancing therapy. The comments provided by me are in response to some of the criteria that have been proposed by CMS.

Cedars Sinai Medical Center is a lead enrolling center for transcatheter aortic and mitral valve procedures. We have the largest experience of transcatheter mitral valve repair in the America, and one of the largest experiences in the World. We were the lead enrollers of the EVEREST clinical trial and the REALISM registry, and are the lead enrolling center in the ongoing COAPT study. We have performed over 200 successful MitraClip procedures, with 95% procedural success rate, 0% in hospital mortality, and no instance of requirement of urgent open heart surgery. I also serve as an international proctor of this procedure and have had the opportunity to train physicians in US and abroad. Based on this large experience, I feel qualified to voice my comments and concerns about the proposal of national coverage for TMVR procedure.

I definitely endorse the CMS decision to provide coverage for the TMVR procedure for patients with significant primary mitral regurgitation, who are at high risk for surgery or not surgical candidates. This is consistent with CMS decision to provide coverage with other life-saving transcatheter valve procedures.

The TMVR procedure is a unique procedure that involves placement of one or more clips on the mitral valve to help reduce or eliminate mitral valve regurgitation. The procedure is performed in the catheterization laboratory, and requires the expertise of an interventional cardiologist well trained in trans-septal procedures. The procedure is guided by real time trans-esophageal echocardiography, and therefore requires a skilled echocardiographer to be present during the entire procedure. The procedure is complex and often takes a lot of time, however unlike transcatheter aortic valve replacement (TAVR), the patients are very stable, and there has been NO CASE INSTANCE of requirement of urgent cardiac surgery.

We have a well -defined heart team approach, with a great collaboration, between interventional cardiologists, cardiac surgeons, echocardiographers, anesthesiologists, and heart failure specialists. In addition we have dedicated physician assistants and research personnel for this procedure. The Chief of Cardiac surgery, Prof Trento, is extremely proficient in mitral valve surgery, and serves an integral role within the heart team at our center. I have examined the institutional requirements and agree with most of the proposals. In general, they seem consistent with the recent guidelines published jointly by the SCAI, AATS, ACC, STS societies

I completely disagree, however, with the requirement that the interventional cardiologists and cardiac surgeon must JOINTLY participate in the intra-operative aspects of the TMVR. This provision is not consistent with the guidelines published by the professional societies. In the US the MitraClip is the only TMVR procedure approved by the FDA. The procedure UNLIKE TAVR, is a single operator procedure, with need of a qualified echocardiographer to guide the procedure. In certain instances, it is helpful to have assistance from another qualified interventional cardiologist or a cardiac surgeon. In our institution we have NEVER required official standby for cardiac surgery, and never required a pump oxygenator to be in the room. In contrast, we have a pump oxygenator and cardiac surgeon in all cases of TAVR. The clinical trials did not require a Cardiac surgeon to serve as co-operator in this procedure. Prof Trento sometimes assists in the TMVR procedures , but his presence is not due to institutional or research requirements. The critical role of the cardiac surgeon has been to assess the patients prior to procedure, or perform surgery in patients who are not suitable for TMVR or in patients who have had recurrence of mitral regurgitation following a TMVR procedure. Most cardiac surgeons will not want to stand for hours during a procedure. They can be more productive by performing cardiac surgery during that time. In most institutions in the US and overseas, the procedure is performed by an interventional cardiologist, often assisted by a fellow cardiologist or fellow and some instances a cardiac surgeon, proficient in the procedure. On a personal note, during some difficult cases, I sometimes seek the assistance of my fellow interventional colleague proficient in trans-septal procedures. This co-operator requirement proposed by CMS will create an undue burden for hospitals and physicians, which is not warranted by TMVR clinical experience and the joint society consensus statement. In summary, it should be left to the institution and not CMS to decide who has the proficiency in performance of these procedures. I therefore proposed that section 4 be modified to read as follows:

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

In conclusion, I support the CMS proposal for national coverage of the TMVR procedure, and I agree with most of the requirements. I strongly oppose the proposed mandate for a cardiac surgeon to be present during the actual interventional procedure. We feel instead that the physician skilled in echocardiography is vital and essential to assist the interventionalist during the procedure. They should be therefore appropriately reimbursed for their effort.

Thank you,

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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 a great benefit for patients with severe mitral regurgitation and who are in extreme high risk population for surgical repair. As a person who has been intensively involved in this procedure and witnessed its dramatic benefit in many patients who would die otherwise and now return to normal life, I wholeheartedly support CMS proposal to provide coverage of MitraClip procedure in patient who meets criteria of FDA-approved indication.

I would like to make one comment regarding section 4 in decision summary.

This section should reflect a statement from recnelty published guideline (SCAI/AATS/ACC/STS Operator & Institutional Requirements for Transcatheter Valve Repair and Replacement, Part II–Mitral Valve)

Accoding to this guideline, simultaneous presence of both interventional cardiologist and cardiac surgeon during the procedure is not needed.

As an interventional cardiologist who performs primary assistant role in setting that cardiac surgeon is not available, I feel presence of cardiac surgeon is not always necessary.

If any particular cardiac surgeon is interested into participating the procedure, he/she must undergo appropriate training of invasive/interventional cardiology that potentially requires few more years of training.

My view of the MitaClip is more like transcatheter procedure that has to be handled by highly skilled operator who is an expert to perform complex transcathater procedure including site-specific transseptal puncture and handling of large caliber catheter as well as catheter based treatment of potential associated complications.

In fact, in some difficult cases, it would be beneficial to involve second interventional cardiologist who is also skilled in transcatheter valvular intervention as a primary assistant.

Therefore, the section 4 should be modified as follows;
A quailfied operator should primarily perform the MitraClip procedure and either second interventional cardiologist or cardiac surgeon may jointly participate in the intra-operative technical aspects of TMVR.

Additionally, since MitraClip procedure is performed under the TEE guidance, presence of expert echocardiographer (cardiologist or cardiac anesthesiologist who is skilled on TEE and familiar with the procedure) should be mandated for the procedure.

Lastly, those who are activity involved in the procedure as a qualified echocardiographer or qualified primary assistant (second interventional cardiologist or cardiac surgeon) must be eligible to claim financial reimbursement for their expert service.

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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 unrealistic. It should be 25 procedures/yr at the maximum

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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 patient.
2. A CT surgeon is not necessary to be present at the table, since, unlike TAVR, TMVR does not need conversion to open surgery. The worst complication that can occur is pericardial effusion, which the cath lab is very well equipped to handle (pericardiocentesis).
3. There is no requirement for 2 operators in any of the consensus documents and guidelines for TMVR from ACC, STS or any other medical society.
4. In ALL trials of TMVR, the procedure was done by a single operator, not two.
5. The second operator would not be reimbursed, placing a further burden on the hospitals and operators that offer this procedure. This is essentially an unfunded mandate, which would severely restrict patient access to this new technology, in cases where patients are suffering significantly and there is currently no medical solution for their problem.

Again, unlike TAVR, TMVR does not need a CT surgeon present, since there is no need for emergent CT surgery (unless the surgeon is also the primary operator for TMVR).

Therefore, I propose that the requirement for 2 operators should be removed from the proposed coverage decision.

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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

Dear Ms. Syrek Jensen:

The Advanced Medical Technology Association is pleased to offer the following comments on the Centers for Medicare & Medicaid Services’ (CMS) Proposed Coverage Decision Memorandum for Transcatheter Mitral Valve Repair (TMVR). Our comments below relate to (1) the requirement for randomized clinical trials in studies for unlabeled uses of TMVR, and (2) the proposed operator and institutional requirements.

AdvaMed’s member companies produce the life-saving and life-enhancing medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

AdvaMed supports the use of sound evidence to inform medical practice. In general, we view Coverage with Evidence Development (CED) as a means to generate additional evidence in cases where the available evidence regarding a promising medical technology or procedure is not sufficient to support national coverage. In such circumstances, coverage that is contingent on the development of additional evidence can enable beneficiary access to state-of-the art medical treatments, particularly when the alternative would be non-coverage.

In the proposed decision memorandum, CMS proposes to cover TMVR under Coverage with Evidence Development (CED) when certain conditions are met. The proposed coverage decision is similar in structure to CMS’ coverage determination for Transcatheter Aortic Valve Replacement (TAVR) in 2012. We appreciate CMS thoughtful approach and application of learning from the TAVR NCD experience, which we understand contributed to certain elements of the proposed TMVR draft NCD. In particular, the proposed determination provides coverage when specific conditions are met, including:

• Procedure uses TMVR system that is FDA-approved (PMA) for that system’s FDA-approved indication and other conditions:
• Two physicians have examined the patient and documented the need (cardiac surgeon and cardiologist),
• Patient is under the care of a multi-disciplinary heart team,
• Hospital meets certain conditions, and
• Hospital and heart team participate in a national registry.

Further, CMS proposes to cover TMVR for uses that are not expressly listed as an FDA approved indication when it is performed within an FDA-approved randomized clinical trial (RCT) that fulfills certain requirements.

RCT and FDA Approval Requirements

Our primary concern relates to CMS’ proposal that coverage, in the case of an unlabeled use of TMVR, be permitted only in a randomized clinical trial. AdvaMed previously has commented that CED allows CMS to provide coverage within the context of studies that conform to standards spelled out in Medicare’s Clinical Trial Policy; and research meeting these standards can include a range of studies, from randomized clinical trials to observational research. CMS has relied on a range of research approaches in its various applications of CED.

For the purpose of FDA approval, the trial design should be under the purview of the FDA; and therefore, CMS need not prescribe a particular trial design or methodological approach.

In addition we are concerned that only FDA-approved trials would be considered for coverage. This requirement would exclude coverage for future physician-sponsored or society-sponsored studies that could further inform which patient groups experience the greatest benefit from TMVR.

This language is consistent with the language that was included in the NCD for Transcatheter Aortic Valve Replacement (TAVR) in 2012.

Proposed Operator and Institutional Requirements

We agree that operator and facility criteria are important and need definition, and we appreciate the complexity of the procedure and the importance of maximizing a beneficiary’s chance for improved health outcomes. However, we are concerned about CMS proposal to require the heart team’s interventional cardiologist(s) and cardiac surgeon(s) to “jointly participate in the intra-operative technical aspects of TMVR.” We believe this proposed requirement is inconsistent with guidelines that were recently issued by a group of four medical societies. The consensus paper, entitled "Operator & Institutional Requirements for Transcatheter Valve Repair and Replacement, Part II – Mitral Valve," was developed jointly by the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC) and The Society of Thoracic Surgeons (STS), and it specifically addresses this issue.

The joint societies’ recommendations state that the MitraClip procedure can be performed as a single physician procedure and in other cases with two operators (which may include either two interventional cardiologists, or an interventionalist and a cardiothoracic surgeon). The guideline indicates that the surgeon may provide direct intra-procedural support in some cases, or may act as the operator in the intervention. The recommendations do not require a co-surgeon for all TMVR procedures but rather cite it as a possible scenario for promoting the heart team approach.

CMS’ proposed operator and facility requirements are generally aligned with the joint societies’ recommendations. Additionally, the proposed NCD emphasizes the importance of the multi-disciplinary heart team in the effective management of TMVR patients from the pre-procedure patient selection, intra-procedure management, through post-procedure management and discharge. However, we believe CMS’ proposal to require that “the heart team’s interventional -cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TMVR” is inconsistent with the societies’ recommendations.

AdvaMed greatly appreciates the opportunity to comment on these issues, which we believe to be relevant not only within the context of the TMVR coverage decision, but can have broader implications with respect to future CMS coverage determinations.

If you have questions regarding these comments or if you require additional information, please contact Chandra Branham, JD, Vice President, Payment and Health Care Delivery Policy, at (202) 434-7219 or cbranham@AdvaMed.org.

Sincerely,

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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 been very pleased with the effectiveness and safety of the procedure. This procedure fills a large treatment gap for patients who usually have no other reasonable treatment options.

However, I am very disturbed by the proposed requirement to have a cardiothoracic surgeon present during the mitraclip procedure. This is a cath lab based procedure done with TEE guidance and no need for a surgeon to be present. It usually takes 2-3 hours to complete. The surgeon does plays an integral and crucial part in assessing the patient prior to the procedure and deciding on suitability. However, once the procedure is being done in the cath lab, there is no role for the surgeon at that time. Requiring that our cardiothoracic surgeons be present during the procedure would be akin to preventing our program from performing this procedure. It is clear that this would not be feasible, nor is it logical or necessary for the care of the patient. This would be similar to requiring a surgeon to be present during a balloon mitral valvuloplasty or a coronary stent procedure. It makes absolutely no real sense to me. Furthermore, how would the surgeon be compensated for his/her time? I cannot overemphasize how inappropriate I feel is this requirement. Keeping it in the coverage decision would essentially prevent a good therapy from being available to patients. As we serve a large catchment area in North Florida and South Georgia, this would be doing a disservice to large group of patients who are referred to our valve program. I can only hope that logic will prevail and this requirement for the surgeon to be present will be removed from the coverage decision.

With regards to the procedure itself, this is a technically challenging procedure which demands a high level of skill and catheter based and echo skills. It takes an average 2-4 hours of procedure time and cannot be rushed. I would hope that the reimbursement will eventually reflect that complexity of the this procedure as well. This procedure is every bit as challenging as TAVR but does not require a surgeon at all in the cath lab. Our surgeons have NO interest in being present for this as they clearly feel that their skills are better used in other surgical procedures.

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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 with the National Coverage Decision and reimbursement determination by CMS. We strongly support the CMS proposal to provide coverage for the MitraClip procedure when provided with an FDA approved system for current and future FDA approved indications, subject to quality requirements for hospitals performing the procedure and participation in a prospective national audited registry under Coverage with Evidence Development (CED). We also support the proposal to allow coverage for Medicare beneficiaries participating in ongoing and future clinical trials for non-FDA approved indications. The additional clinical data collected under the Coverage with Evidence Development program will help to supplement existing clinical trial data and evaluate the safety and effectiveness of the therapy in a real world clinical setting. More generally, we believe that both the May 2012 transcatheter aortic valve replacement (TAVR) national coverage determination (NCD) and the proposed coverage decision memorandum for MitraClip represent an innovative approach to providing patient access to promising new therapies and provide a framework for coverage that could be applied to future technologies. We also appreciate that CMS has taken a collaborative approach to the coverage process involving all stakeholders.

We appreciate this opportunity to share our collective opinion regarding these outstanding issues that were raised in the analysis of TMVR with the MitraClip System.

1. Clarification of complexity involved with mitral valve repair versus mitral valve replacement

For patients eligible for mitral valve surgery, clinical practice guidelines from the AHA/ACC and ESC/EACTS support the use of mitral valve repair over mitral valve replacement despite the absence of randomized comparisons between these two options.^1,3 When compared with mitral valve replacement, observational studies and global registries have shown mitral valve repair has a lower perioperative mortality, improved survival, better preservation of postoperative LV function, and lower long-term morbidity.³ In addition, the use of mitral valve repair has been shown to reduce the need for antiplatelet therapy and preserve annular-papillary muscle continuity.^1,3

There is further evidence to support the correlation between TMVR and surgical mitral valve repair based on the 2014 Guidelines for the Management of Patients with Valvular Heart Disease issued by the American Heart Association [AHA] and American College of Cardiology [ACC] on Transcatheter Therapies for Mitral Regurgitation which is issued jointly by the American College of Cardiology, American Association of Thoracic Surgery, Society for Cardiovascular Angiography and Interventions Foundation, and the Society of Thoracic Surgeons.^1,2 Within the guidelines it is stated that:

“TMVR may be considered for severely symptomatic patients (NYHA class III to IV) with chronic severe primary MR (stage D) who have favorable anatomy for the repair procedure and a reasonable life expectancy but who have a prohibitive surgical risk because of severe comorbidities and remain severely symptomatic despite optimal GDMT for HF.”¹

2. Need for two operators to perform the MitraClip procedure, in which one is required to be a cardiac surgeon

It is imperative to have the cardiac surgeon as an essential part of the Heart Team for patient selection and pre-procedural evaluation as well for intraoperative assessment when necessary. The primary operator may be either a cardiothoracic surgeon or an interventional cardiologist and this must be preserved in the current recommendations. We would like to further clarity the surgeon’s role during TMVR with the MitraClip or future technologies that require trans-venous access for primary device delivery. There is recognition of the importance of the cardiothoracic surgeon in being immediately available if emergency surgery is required. Given the surgeon’s intricate knowledge of the valve anatomy and various pathologies that can pose technical challenges their presence can be extremely valuable in complex cases. Additionally, surgeons are very familiar with the use of echocardiography in intraoperative assessment of the mitral valve. However, mandating that the cardiothoracic surgeon participate in the intraoperative technical aspects of TMVR for MitraClip when there is another primary operator is inconsistent with the societies’ recommendations. Recommendations do not advocate that a co-surgeon requirement must be mandated for TMVR for MitraClip but rather cite it as a mechanism for promoting the heart team approach. The recommendations also state that the MitraClip procedure can be performed either with a single or two operators depending on the complexity of the case. The two operators may include either two interventional cardiologists or an interventional cardiologist and a cardiothoracic surgeon. The following are clarifying recommendations on procedural operators:

If the TMVR procedure involves trans-venous access as the primary vessel for device delivery, as is the case for the MitraClip, then we recommend:

1. The Cardiothoracic Surgeon or Interventional Cardiologist may serve as primary operator.
2. If the primary operator is an interventional cardiologist, the Cardiothoracic Surgeon may serve as a co-operator.
3. If the Cardiothoracic Surgeon is the primary operator, the Interventional Cardiologist may serve as the co-operator.
4. If the primary operator is an Interventional Cardiologist, the Cardiothoracic Surgeon must be immediately available for intraoperative consultation and familiar with the patient and the procedure, but the surgeon is not mandated to scrub during the procedural component.
5. If the primary operator is a Cardiothoracic Surgeon, the Interventional Cardiologist must be immediately available for intraoperative consultation and familiar with the patient and the procedure, but the Interventional Cardiologist is not mandated to scrub during the procedural component.

If the TMVR procedure involves ventricular access or open major vascular exposure for access as the primary or secondary vessel for device delivery or manipulation, then we recommend:

1. The Cardiothoracic Surgeon or Interventional Cardiologist may serve as primary operator.
2. If the primary operator is an interventional cardiologist, the Cardiothoracic Surgeon must serve as a co-operator.
3. If the primary operator is a Cardiothoracic Surgeon, the Interventional Cardiologist must serve as a co-operator.

We appreciate this opportunity to share our recommendations and hope this memo addresses these outstanding issues associated with the TMVR with MitraClip and future technologies involving transcatheter solutions for mitral valve disease. As leaders in our respective fields involved in mitral valve disease, we recognize the importance of this process so that this therapy will become a successful part of the armamentarium for treating valvular heart disease and facilitate optimum quality during the delivery of this therapy to patients of prohibitive risk for conventional surgery for mitral valve disease.

Sincerely,

References:

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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 Heart Failure Patients with Functional Mitral Regurgitation (the COAPT trial),we would like to submit the following comments for the proposed decision memorandum for transcatheter mitral valve repair (TMVR) procedures.

COAPT (NCT01626079), performed under an FDA Investigational Device Exemption (IDE), is the ongoing, pivotal prospective multicenter randomized trial evaluating TMVR with MitraClip in symptomatic heart failure patients with functional mitral regurgitation. Eligible patients are enrolled in the study based on evaluation by the site’s local heart team as not being appropriate candidates for mitral valve surgery and are randomized 1:1 between the MitraClip group and the control group (standard of care including optimal medical management). COAPT was designed by 2 principal investigators, consisting of an interventional cardiologist (Gregg W. Stone, MD, from Columbia University Medical Center) and a cardiac surgeon (Michael Mack, MD, from Baylor Health Care); 2 heart failure co-principal investigators (William Abraham, MD from Ohio State University and JoAnn Lindenfeld, MD from the University of Colorado),and a 24 physician multidisciplinary advisory committee consisting of mitral valve surgeons, interventionalists, heart failure specialists and echocardiographers, and the sponsor Abbott Vascular. Currently, 62 US sites are enrolling patients in COAPT. Trials such as COAPT are essential to establish the appropriate role of new therapies for US patients, and COAPT represents one of the largest randomized trials performed to date for mitral valve therapies.

The COAPT physician leadership and participants support CMS’s recommendations to establish a national coverage policy for TMVR procedures under the Coverage with Evidence Development (CED) provision for FDA approved indications and subject to facility and operator requirements. This proposal provides a framework to ensure that the therapy is available to appropriate Medicare beneficiaries at qualified institutions with multi-disciplinary teams that have sufficient experience in the assessment and management of patients with mitral regurgitation.

However, we respectfully but strongly request three important revisions to the proposed national coverage policy in order to both enable appropriate patient access for FDA-approved indications of TMVR and to sustain invaluable clinical research to determine whether TMVR procedures do indeed improve health outcomes in Medicare beneficiaries.

Thank you for your careful consideration of these recommendations on finalization of a national Medicare policy, which will enable appropriate Medicare beneficiary access of TMVR for approved indications and as part of clinical studies.

Sincerely,

Michael J. Mack, MD
COAPT Surgery Principal Investigator

Gregg W. Stone, MD
COAPT Interventional Cardiology Principal Investigator

William Abraham, MD
COAPT Heart Failure Co-Principal Investigator

JoAnn Lindenfeld, MD
COAPT Heart Failure Co-Principal Investigator

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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) procedures. Abbott Vascular is the manufacturer of the MitraClip® System, which consists of the Steerable Guide Catheter and the MitraClip Clip Delivery System which includes the MitraClip device implant. Abbott received FDA approval on October 24, 2013 for MitraClip, a first-of-a-kind transcatheter mitral valve repair system for the treatment of significant symptomatic degenerative mitral regurgitation (DMR) in patients who are at prohibitive risk for mitral valve surgery. Abbott is also sponsoring an ongoing investigational device exemption (IDE) trial in the US (COAPT) to evaluate the use of MitraClip for the treatment of clinically significant functional mitral regurgitation in symptomatic heart failure subjects who have been determined by the site’s local heart team as not appropriate for mitral valve surgery. Abbott expects data to be available within the next five years to support an FDA indication and Medicare coverage for this population.

Abbott strongly supports the CMS proposal to provide national Medicare coverage for TMVR procedures when performed using an FDA-approved system in accordance with an FDA approved indication, subject to quality requirements for hospitals performing the procedure and participation in a prospective national audited registry under Coverage with Evidence Development (CED). We also support the proposal to allow coverage for Medicare beneficiaries participating in ongoing and future clinical trials for non-FDA approved indications. The additional clinical data collected under the CED program will help to supplement existing clinical trial data and evaluate the safety and effectiveness of the therapy in a real world clinical setting. More generally, we believe that this proposed coverage decision for TMVR represents an important step to provide patients with limited treatment options access to transformational new transcatheter valve therapies in the US. We appreciate the collaborative approach to the coverage process involving all stakeholders including CMS, FDA, national societies, clinical investigators, academic centers and industry.

Our comments below address the following issues:

• Title of the National Coverage Analysis (NCA)
• Evidence Supporting CED
• Qualification Requirements for Hospitals and Operators
• Randomization and FDA Approval Requirements for Clinical Trial Coverage

We request that CMS update the title of the NCA to say 'Transcatheter Mitral Valve Repair with Implant' so that it is clear that the assessment scope is focused on transcatheter mitral valve repair procedures with implants and does not address transcatheter mitral valve replacement procedures or mitral balloon valvuloplasty or commissurotomy procedures which have been in use for three decades.

Abbott agrees with CMS that the clinical evidence supports coverage for MitraClip under CED. As detailed in the proposed decision memorandum, clinical trials worldwide have demonstrated consistent effectiveness of MitraClip across numerous clinically important endpoints, including:

• MR Reduction
• Left Ventricular Reverse Remodeling
• Improvement in acute hemodynamics
• Improved NYHA functional class
• Improved quality of life
• Reduction in heart failure hospitalizations

MitraClip clinical evidence supports coverage for the FDA approved indication for patients with significant symptomatic DMR at prohibitive risk for surgical intervention, as demonstrated by multiple studies including the results below of the DMR cohort study on transcatheter mitral valve repair for the DMR prohibitive risk population¹:

• Reduction in MR to ≤ 2+ in 82% of patients that was sustained at one year.
• Reductions in left ventricular volumes and dimensions at 12 months, consistent with reverse remodeling.
• Clinically important improvements in functional status to NYHA Class I or II and improved quality of life at 12 months.
• 73% reduction in the heart failure hospitalization rate at 1 year compared to the one year prior to MitraClip.

It is particularly important that CMS provide coverage for the MitraClip therapy because it offers the only option to correct mitral regurgitation in prohibitive risk DMR patients. These patients are unable to undergo surgery and medical management such as beta blockers and ACE inhibitors at best can only reduce symptoms. Many patients with untreated significant mitral regurgitation subsequently develop heart failure requiring palliative care and leading to death.

The attached systematic literature review provides a more detailed review of published clinical evidence documenting the safety and effectiveness of the MitraClip therapy to address the unmet clinical needs of DMR patients at prohibitive risk for surgery.

We also agree that the evidence supports coverage under CED for Medicare beneficiaries participating in clinical trials for non FDA-approved uses. The evidence generated by such trials will inform future FDA approvals and CMS coverage of additional indications for TMVR therapies without the need for CMS to reopen the national coverage decision. This will avoid lengthy delays in Medicare beneficiary access to new and expanding indications for TMVR as technology and clinical evidence evolve over time.

Abbott supports the establishment of qualification requirements for hospital surgical programs performing the MitraClip procedure in order to assure high quality care and clinical outcomes. In this regard, we fully support the adoption of coverage requirements consistent with the Operator & Institutional Requirements for Transcatheter Valve Repair and Replacement, Part II– Mitral Valve published by the Society for Cardiac Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), and the Society of Thoracic Surgeons (STS).² Theserecommendations for operator and institutional requirements were developed based on extensive collaboration and review between major national specialty societies representing physicians with expertise treating mitral valve disease patients.

While the proposed CMS requirements generally are in line with the published society recommendations, we note one inconsistency whereby CMS has proposed that “the heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TMVR.” This proposal would apply to both FDA and non-FDA approved indications. In contrast, the joint society guidelines state the following:

These society recommendations emphasize the role of the multi-disciplinary heart team in the safe and effective application of TMVR to appropriate candidates from the pre-procedure patient selection and case evaluation to intra-procedure technical issues to post-procedure management including discharge. They recommend that a cardiac surgeon and interventional cardiologist must evaluate every case. They also note the importance of the role of the cardiac surgeon in acting as “back up” in case of the need for emergency surgery. The guidelines indicate that the surgeon may provide direct intra-procedural support in some cases, or may act as the operator in the intervention. This is an important aspect of the approach to these patients given they are high risk surgical candidates who may have complex disease pathology that is familiar to surgeons well experienced in mitral valve surgery. However, the recommendations do not state that a co-surgeon requirement should be mandated for all TMVR procedures but rather cite it as a possible option and mechanism for promoting the heart team approach. The recommendations specifically state that the MitraClip procedure can be performed as a single physician procedure and in other cases with two operators (which may include either two interventional cardiologists or an interventional cardiologist and a cardiothoracic surgeon). Clinical experience with the MitraClip demonstrates that placement of the clip(s) is typically controlled, where the patient does not require cardiopulmonary bypass and is in a hemodynamically stable condition. Therefore the controlled state of both the patient and the technical elements of the intervention do not warrant that two operators always be present in the intraoperative aspects. Given the clinical community consensus that 2 operators are not always required to perform the MitraClip procedure, we request that the requirement in Section I A, bullet 4 be revised in the final decision memo to be consistent with clinical practice as follows:

We also believe that this requirement for dual operators should be removed from the coverage requirements for clinical trials of non-FDA approved indications (Section I B, bullet 1). For example, the ongoing COAPT IDE trial was designed with extensive input from the FDA and clinical investigators and does not require involvement of both an interventional cardiologist and a surgeon as co-operators. In addition, it is not clear whether future TMVR technologies will require two physician operators.

We note that CMS is requesting comments on operator and facility requirements specifically as they apply to clinical trials. Abbott requests that CMS provide flexibility to clinical trial sponsors and the FDA to determine appropriate criteria for physicians performing the intraoperative procedure in clinical trials during the trial design and protocol development phase.

CMS is proposing that clinical trials for non-FDA approved indications only be covered when performed within an FDA approved randomized clinical trial. We note that the TAVR national coverage decision does not require that trials be FDA approved or randomized in order to be considered for coverage and do not believe that there is an appropriate policy rationale to apply different coverage criteria for TMVR trials of non FDA-approved uses. The requirement for randomization would inappropriately limit consideration of coverage for potentially valuable trials in the future. While the ongoing COAPT trial is a randomized controlled trial and many future FDA approved IDE trials for TMVR are also likely to be randomized, it is possible that there may be a need for non-randomized trials. For example, a randomized controlled trial may be supplemented by a registry for non-randomized patients with no alternative treatment options. In addition, future physician or society-sponsored studies may not always be randomized especially if studies are conducted to evaluate utility in discrete patient subpopulations that could further inform which groups experience the greatest benefit from TMVR. Meaningful clinical evidence stems from a range of appropriate clinical research study designs, which is not limited to randomized trials, and we believe that non-randomized trials should be considered by CMS for coverage based on their merits. The proposed requirement that all clinical trials be FDA approved would not allow consideration of coverage for important investigator sponsored studies under the approval of central or local investigational review boards (IRBs).

Accordingly, we request that the beginning of section B be amended to state that:

“TMVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that fulfills all of the following...""/p>

This would provide consistency with the TAVR coverage decision on this requirement.

Abbott commends CMS for its collaboration with a broad range of stakeholders to establish a national framework for coverage of transformational TMVR technologies. Abbott supports this coverage framework for TMVR and believes that the clinical evidence demonstrates that the MitraClip procedure is reasonable and necessary when performed in accordance with the FDA-approved indication subject to the coverage conditions proposed by CMS. Future FDA approved indications should be covered, as proposed, upon FDA approval to assure immediate patient access and avoid the need for frequent updates to the NCD. In order to support the generation of additional evidence for MitraClip and other TMVR technologies, we support the CMS proposal to provide coverage for qualifying clinical trials of non-FDA approved indications. That said, we request that CMS make specific changes in the final decision relating to dual surgeon and cardiologist involvement in intraoperative technical aspects of TMVR and the type of clinical trials of non-FDA approved indications that can be considered for coverage as outlined above.

Abbott looks forward to working with CMS, physician specialty societies and other stakeholders during the finalization of the TMVR coverage process, with the goal of providing access for Medicare beneficiaries to these highly needed treatments.

Thank you for considering our comments. Please let us know if you have any questions or require additional information.

Sincerely,

/s/
Barbara Calvert
Director, Medical Products Reimbursement

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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 and practice of mitral valve repair and transcatheter aortic valve replacement. My early exposure in the mitral space was research and development of percutaneous mitral repair with Mitralife and later with Ample Medical. I have also been involved in the research and development of the Direct Flow Medical next generation TAVR with repositioning and retrieval capabilities.

We have been involved with MitraClip since 2006, participating in the clinical trials and we have also edited a textbook-atlas on the procedure. I have had the good fortune of working with several outstanding surgeons who have been committed to mitral valve repair with excellent results. The experience with patients who had degenerative mitral regurgitation was excellent with good acute and durable results. The functional mitral regurgitation results were good acutely but not durable in our experience and enthusiasm for surgery in these patients waned.

I strongly support the CMS proposal to provide national coverage for FDA approved indications of MitraClip and other transcatheter mitral repair therapies.

Our clinical experience with MitraClip therapy has been extremely positive with a high procedural success rate and impressive hemodynamic, echo-doppler and clinical symptom improvement. The clinical benefit is definitely under estimated by the echo results. Our excitement with this technology resulted in our Textbook-Atlas of MitraClip Therapy so that we could share what we learned.

Importantly, advances in trans-esophageal echo have contributed to improved results in a more timely manner. Additionally, the ability to use more that 1 clip and significantly improved the outcomes. The hemodynamic stability of the patient during the procedure and the ability to position and reposition the clip to obtain an excellent result contributes to the excellent clinical outcomes.

While I completely embrace the "Heart Team" concept in the evaluation and management of valvular heart disease patients, the MitraClip procedure has been performed predominately by cardiologist. We have introduced one of our surgeons and involved him in some procedures, all agree that their participation is not important or essential as it is with TAVR.

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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 Southwestern encompasses 3 campuses, the Dallas Veteran's Administration, Parkland (the county hospital), and the University Hospital. Collectively, our interventional practice far exceeds the suggested annualized institutional volume of 400 PCI cases per year. However, based upon the current CMS guidelines, UTSW would be excluded from reimbursement for the MitraClip procedure. Thus, it is our strong opinion that the volume criteria will have little relation to both quality of care and the safe implementation of the MitraClip program for inoperable patients with severe mitral regurgitation at our institution. Moreover, it must be recognized that institutional volume is at best a modest surrogate for quality. We have many ongoing interventional programs and our ability to provide these services in a safe, effective manner is evidence that we would be successful in rolling out the MitraClip program. For example, we have developed the institutional infrastructure, experience and technical expertise in caring for many complex patient populations. We have a number of complex clinical care programs including heart transplantation, left ventricular assist devices, mitral valve repair, transaortic valve replacement , structural and congenital heart disease interventional programs. We believe that our participation in the national registries, such as STS/ACC TVT registry and ACC NCDR Cath PCI Registry is foundational in our approach to quality improvement. These registries afford us the opportunity to benchmark our outcomes to national rates and adjust process of care appropriately.

We would therefore urge CMS to reconsider the suggested annualized institutional PCI volume criteria. This could be implemented in a number of ways including exemption for academic and teaching institutions where the collective “institutional” volume and experience is distributed to multiple clinical sites, or an easing of quantitative volume criteria in lieu of hitting national outcome and quality benchmarks as measured in the national registries. We appreciate the opportunity to share our concerns and do hope you seriously consider these comments.

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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 1000 open heart procedures including a large number of aortic and mitral valve surgeries. In addition we have a program in advanced heart failure therapy that includes cardiac transplantation and the use of ventricular assist devices.

Our structural heart program includes the performance of aortic and mitral valvuloplasties, atrial septal defect closure and PFO closure. We have performed TAVR beginning shortly after the approval of the Edwards Sapien valve and have participated in the Medtronic core valve clinical trials. We have established and utilize a multidisciplinary heart team approach to the care of these patients.

We have treated a number of patients with heart failure related to mitral regurgitation. Many of these patients are not candidates for conventional mitral valve replacement or repair and therefore have ongoing symptoms of heart failure. They become a challenge to the health care system as they may require frequent hospital admissions.

We have had some experience with the MitraClip device. Our experience has been limited and the initiation of our program was delayed by the lack of specific reimbursement for the procedure. Despite the fact that this treatment has been shown in clinical trails to provide important clinical benefit and has been approved by the FDA, the cost of this technology has been a burden to the hospital. Our institution like many others has been only willing to support this procedure to a limited extent.

However we have seen examples of substantial clinical benefit in that patients have had a dramatic reduction in mitral regurgitation and improvement in their symptoms as a result of the MitraClip procedure.

I support the concept that patients must be evaluated and cared for by a multidisciplinary heart team as is done with the TAVR population.
However I would object to the proposal that the interventional cardiologist and cardiac surgeon must jointly participate in the intra-operative aspect of TMVR with the MitraClip. The SCAI/AATS/ACC/STS Operator and Institutional Requirements for Transcatheter Valve Repair and Replacement,Part II-Mital Valve document published earlier this year states that with regard to the MitraClip the "procedure itself is commonly performed by a single physician. This physician may be either an interventional cardiologist or a cardiothoracic surgeon; however, for some patients, the expertise of two physicians (either two interventional cardiologists, or an interventional cardiologist and a cardiothoracic surgeon) could be required, I believe that the policy should emphasize the operator should have the appropriate interventional training and skills. It is possible as the above referenced document indicates that other future mitral valve therapies may be best performed by a team of interventional cardiologists and cardiac surgeons.

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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 decided on the best treatment strategy for patients with severe mitral regurgitation.

In the US, I direct the transcatheter aortic valve program and have enjoyed performing these high risk procedures side by side with our CT surgeons. However, my experience with the mitral procedures is quite different in that those cases tend to be much longer while the patients remain incredibly stable throuhgout the procedure with very rare need for acute surgical intervention.

As our volume continues to grow we are increasingly running into road blocks getting procedures scheduled due to the number of physicians involved (echo, anesthesia, CT surgery, 1+ interventional cardiologists). We are at a point where having both a surgeon and an interventional cardiolgist mandated to be present for a 1-4 hour procedure becomes not only inconvenient but cost prohibitive.

I am very pleased with the overall structure of the CMS coverage decision, but would ask that you consider changing the mandate for both a surgeon and cardiologist to be present for the procedures.

Sincerely,

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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 expertise in mitral repair and replacement but some patients are not surgical candidates.

The MitraClip allows us to consider treating these patients that would otherwise fall through the proverbial cracks. We have a well integrated heart team doing TAVR's and anticipate the same model with modifications for mitral interventions.

Specifically, I support the NCD for Mitraclip but disagree with the requirement for a cardiothoracic surgeon present during the procedure as it is basically a cath lab intervention and not open hybrid surgery like a TAVR. The surgeon is critical in the selection process to decide which patients merit surgery and which are best served with percutaneous repair.

The other issue is that the number of trans-septals should be reduced to 25 yearly. Alternatively, the trans-septals that are performed for afib ablations etc could be counted but volume of transseptals in not required for other procedures such as percutaneous VAD (TandemHeart) so there is no reason to include it for MitraClip

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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 Cardiovascular Angiography and Interventions (SCAI), appreciate this opportunity to comment on the proposed decision memo. We support CMS’ decision to approach transcatheter mitral valve repair (TMVR) as a technology that warrants further study and agree that utilizing coverage with evidence development (CED) is appropriate.  Further, we agree that TMVR should be available for use by expert heart teams in valve centers of excellence for the treatment of select, appropriate patients who can benefit optimally from its use.  We support the general direction of the conditions of coverage outlined in the attached proposed decision memorandum. (Attachment 1)  However, we are concerned the following requirement may be unnecessarily restrictive. 

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

We also note other specific edits we believe would improve the coverage decision related to specific staffing requirements and clinical trials.

Guiding Principles

In these comments,the societies are guided by the following principles:

• Care of TMVR patients should be guided by the multidisciplinary heart team.
• The physicians who care for these patients are capable of determining which patients will need joint intraoperative care and should be allowed to do so based upon the clinical needs of the patient.
• Coverage should benefit patients now with the technology that currently exists while remaining flexible enough to accommodate any future developments.
• Patient access should not be delayed by a requirement for joint intraoperative care when the procedure can be successfully completed by one operator, as determined by the heart team.
• We fear hospitals may be less inclined to offer repair through use of the Mitral Valve Clip (or comparable device) if a federal mandate for joint intraoperative care is universally imposed and increases costs to an unsustainable level.

Recommendations Summary

Clinical trials and practice indicate that TMVR using current technology is nearly universally performed by a single physician. We make the following recommendations for changes to the proposed decision memorandum:

1. We recommend CMS revise condition four which would establish a universal requirement for joint intraoperative participation. 
2. We recommend CMS explicitly provide coverage and payment for both physicians in cases where a patient’s clinical condition might warrant joint intraoperative participation by an interventional cardiologist and cardiac surgeon.
3. We recommend CMS cover TMVR for uses not expressly listed as an FDA approved indication when performed within an FDA-approved clinical study.
4. We specify revisions to the composition of the heart team that are more realistic for clinical practice.
5. We request CMS work with ACC and relevant societies to update decisions as required by the introduction of new technology.

Supporting Information

Coverage and Payment Should Provide the Option for Joint Intraoperative Participation

Current and future technologies for TMVR may warrant joint intra-operative participation by both a cardiologist and surgeon. We agree coverage and payment should reflect the work of both physicians in situations where a patient’s clinical condition might require joint intraoperative participation.  We recommend CMS assign relevant TMVR codes co-surgery indicator 2 in the physician fee schedule that allows cosurgery “if two specialty requirements are met.”

Clinical Trials on the Mitral Clip Do Not Support a Mandate for Joint Intraoperative Participation

The only device currently approved by FDA for TMVR, Abbott’s MitraClip, proceeded through clinical trials and FDA-approval without any indication that joint intraoperative participation is required for procedural success.  FDA’s post-approval study does not require two operators.  Lastly, a dual-operator requirement was not part of trial protocols or discussed in journal articles for the COAPT, RESHASPE-HF, EVEREST II, EVEREST HRR, or REALISM trials. It is not included as part of FDA’s labeling, indications, or Abbott’s instructions for use.

Additionally, the recently published competency document indicates the importance of collaboration by the heart team and the possibility that the expertise of two physicians could be required.  It also explicitly states “the procedure is commonly performed by a single physician.”

CPT and RUC

Throughout the CPT and RUC process it was made clear that TMVR, performed with the device currently approved by the FDA, is typically performed by a single operator.  While that does not prohibit the use of an appropriate modifier for two operators, surgical team, assistant surgeon, or minimum assistant surgeon, it speaks to the fact that at no point during the process was the prospect of a dual-operator requirement supported by evidence or involved stakeholders. 

We recommend revision of the requirement for joint participation in the intra-operative technical aspects of transcatheter deployment of mitral valve clips by the heart team’s interventional cardiologist and cardiac surgeon.  We propose CMS revise the fourth condition of coverage to confirm that coverage expressly includes, but does not require, joint participation in the intra-operative technical aspects of TMVR when appropriately provided and documented. We also propose to revise the second condition of coverage to provide that both physicians will agree and document whether a patient would be expected to require joint intraoperative participation.  We are happy to work with CMS to explore additional viable solutions to this problem. An attempt to execute the suggested revision is presented in redline below.

2. Both a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face-to-face and evaluated the patient’s suitability for mitral valve surgery and determination of prohibitive risk; and both physicians have documented the rationale for their clinical judgment and the rationale is available to the heart team.  This documentation indicates that both physicians agree joint participation is or is not anticipated for the service.

4. The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must may jointly participate in the intra-operative technical aspects of TMVR.  CMS covers services designated by two operators or assistant operator or surgical team modifiers when appropriately provided and documented.

These recommendations extend to condition number one in the clinical trial coverage section.

Heart Team Composition

Some of the specific requirements are misaligned with the way cardiac care is provided.   For example, the requirement that the hospital have congenital heart disease specialists and surgeons at the institution is very restrictive. If a hospital is near a pediatric hospital, for example, that is where the expertise resides for congenital heart surgeons and that is the facility to which such patients are referred. It is unnecessary to demand that the adult hospital have such congenital specialists and surgeons on staff.  A TMVR procedure would almost never require such expertise. We recommend the following edits to the staff requirements in item f.4.

Coverage in a Clinical Trial

We support CMS’ proposal to cover services for non-FDA-approved indications in clinical trials to ensure TMVR technology evolves in a safe and effective manner. However, we strongly urge CMS to reconsider its proposal to limit research coverage to randomized clinical trials which will unnecessarily hamper research into off-label uses in the U.S.

Specifically, a requirement for randomized clinical trials would limit exactly the sort of observational, registry studies CMS is encouraging through the proposed CED. We recommend the following language: “TMVR is covered for uses that are not expressly listed as an FDA approved indication when performed within an FDA-approved randomized clinical trial clinical study…”

Thank you for your careful consideration of these comments and your continued work on this complex issue.  Please contact James Vavricek, ACC Associate Director of Medicare Payment & Coverage at jvavricek@acc.org, Courtney Yohe, STS Director of Government Relations at cyohe@sts.org, or Dawn Hopkins, SCAI Director of Reimbursement & Regulatory Affairs at dhopkins@scai.org  you have questions or need additional information.

Sincerely,
/s/
Patrick T. O’Gara, MD, FACC
ACC President

/s/
David A. Fullerton, MD
STS President

/s/
Charles E. Chambers, MD, FSCAI
SCAI President

Attachment

cc: Kathy Bryant, Director of Practitioner Services

Attachment 1: CMS’ Proposed Conditions of Coverage

The Centers for Medicare & Medicaid Services (CMS) proposes to cover transcatheter mitral valve repair (TMVR) under Coverage with Evidence Development (CED) with the following conditions:

A. TMVR is covered for the treatment of significant symptomatic mitral regurgitation when furnished according to an FDA approved indication and when all of the following conditions are met.

1. The procedure is furnished with a complete transcatheter mitral valve repair system that has received FDA premarket approval (PMA) for that system’s FDA approved indication.


2. Both a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face-to-face and evaluated the patient’s suitability for mitral valve surgery and determination of prohibitive risk; and both physicians have documented the rationale for their clinical judgment and the rationale is available to the heart team.


3. The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care.

   TMVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:

   1. On-site heart valve surgery program,
   2. Cardiac catheterization lab or hybrid operating room/catheterization lab equipped with a fixed radiographic imaging system with flat-panel fluoroscopy offering catheterization laboratory-quality imaging,
   3. Non-invasive imaging including expertise in transthoracic and transesophageal echocardiography,
   4. Sufficient space, in a sterile environment, to accommodate necessary equipment for cases with and without complications,
   5. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
   6. Appropriate volume requirements per the applicable qualifications below.

      Outlined below are qualification requirements for hospital surgical programs wishing to perform TMVR procedures.

      The hospital surgical program must have the following:

      1. 25 total mitral valve procedures in the previous year of which at least 10 must be mitral valve repairs;
      2. ≥1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year;
      3. Interventionalist with: ≥ 50 structural procedures per year including atrial septal defects (ASD) and patent foramen ovale (PFO) and trans-septal punctures; and
      4. Additional members of the heart team including echocardiographers, other imaging specialists, heart valve and heart failure specialists, electrophysiologists, cardiac anesthesiologists, intensive care and cardiac imaging departments, congenital heart disease specialists and surgeons, nurse practitioners, data/research coordinators and a dedicated administrator; and device-specific training as required by the manufacturer.


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


5. The heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TMVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and 4) complies with relevant regulations relating to protecting human research subjects, including 45 CFR Part 46 and 21 CFR Parts 50 & 56. The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes:
   1. Quality of Life (QoL);
   2. Functional capacity
   3. Stroke;
   4. All-cause mortality;
   5. Transient ischemic events (TIAs);
   6. Major vascular events;
   7. Renal complications;
   8. Repeat mitral valve surgery or other mitral procedures;
   9. Worsening mitral regurgitation.

The registry should collect all data necessary and have a written executable analysis plan in place to address the following questions (to appropriately address some questions, Medicare claims or other outside data may be necessary):

• When performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clinical studies?
• How do outcomes and adverse events in subpopulations compare to patients in the pivotal clinical studies?
• What is the long term (≥ 5 year) durability of the device?
• What are the long term (≥ 5 year) outcomes and adverse events?
• How do the demographics of registry patients compare to the pivotal studies?

Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.

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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, I have found that this novel technology provides criticical symptom relief in patients that have no other treatment option. I do believe, although it has not been documented in the current literature to date, that use of this novel technology will provide a mortality benefit in critically ill patients with degenerative mitral regurgitation that are deferred from surgical intervention because of prohibitive risk.

Despite current recommendations from the US FDA, introduction of the MitraClip has been hindered in my hospital because of lack of appropriate reimbursement from CMS. In the time course of the approval process that has been needed to convince my hospital administration to allow for MitraClip use, numerous elderly patients with severe degenerative mitral regurgitation have suffered and died.

As an interventional cardiologist that has initiated a multidisciplinary program for the use of Transcatheter Aortic Valve Replacement at my hospital. I strongly feel that all patients being evaluated for use of the MitraClip must be thoroughly reviewed by experienced Cardiac Surgeons skilled in mitral valve repair and replacement. The use of the MitraClip in any patient must be approved by a combined team consisting of Cardiac Surgery, Interventional and Clinical Cardiology, Echocardiography, Anesthesiology and Radiology, with the appropriate use of current risk stratification methods to determine risk for open heart surgery. I do not feel, however, that use of the MitraClip in the cardiac catheterization requires participation of both a Cardiac Surgeon and an Interventional Cardiologist during the actual procedure. Effective participation of a Cardiac Surgeon requires extensive training in transseptal catheterization and other complex catheter/guidewire techniques that far exceeds the expected "skill set" of any Cardiac Surgeon, and unnecessarily increases the need for CMS reimbursement.

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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, we are particularly well-suited to provide CMS with input regarding the proposed coverage policy.

We, the Interventionalists/Structuralists from Morristown Medical Center, have read the proposed regulatory requirements and would like to make the following comments and recommendations:

We do not believe that TMVR procedures using the MitraClip system must be done in a hybrid OR and that it is suitable to be done in the Cath Lab suite with appropriate imaging and sterility.

While we agree that the surgeon and interventionalist must be involved in pre and postoperative screening and evaluation. However, we strongly disagree with CMS’ proposal that an interventional cardiologist and a surgeon jointly participate in the intra-operative technical aspects of TMVR. Such a requirement places a significant burden on the heart team’s surgeon. Rather than providing necessary services, the surgeon would be relegated to ‘stand-by’ role during TMVR procedures. While such a requirement may be appropriate for a percutaneous valve replacement, should one or more such devices receive FDA approval, we do not believe mandating such surgeon participation is necessary for TMVR using the MitraClip system. We do believe participation of a cardiac surgeon may be necessary in some TMVR cases, as discussed in the recent multi-society guidelines and credentialing requirements. Therefore, we recommend that co-surgeon and assistant surgeon modifiers be permitted, but not required, for TMVR with MitraClip procedures.

Because of the critical role of intraprocedural echocardiographic and fluoroscopic guidance, we strongly recommend that the echocardiographer on the Heart Team has particular interest and experience in structural interventions. In addition, we recommend the echocardiographer be required to have at least 25 structural cases per year, including but not limited to PFO, ASD, TAVR, Mitral Valvuloplasty and TMVR.

Respectfully submitted

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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 medical care and will negate the potential clinical benefits seen in clinical trials. Higher costs associated with this newer technology would seem to warrant, at least tempoarily, a higher DRG base and New Technology Add-on Payment.

Thank you for seeking input.

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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 (CED). The proposal outlines a logical set of conditions to ensure maximum patient safety during TMV procedures using either currently FDA approved devices or devices in development that may become available for patient use in the future. The document appears well balanced and keeps the wellbeing of individual patients as the ultimate goal during the introduction and long-term application of novel, but potentially dangerous technologies to treat serious cardiac conditions. The proposal as written delineates appropriate criteria to ensure maximum patient safety and is consistent with previous NCDs that reinforce the importance of the heart team in the development of new transcatheter valve therapies. Again, we applaud CMS and strongly agree with their intentions to keep patient safety as the primary driver as new transcatheter devices are developed in the future that while potentially beneficial, will remain dangerous if not applied appropriately.

Thank you very much for the opportunity to express our views on behalf of the AATS. With our very best personal regards,

* Note: The American Association for Thoracic Surgery (AATS) is the oldest association in the world dedicated to cardiothoracic surgery. The AATS has played a major role in developing opinion statements about all novel forms of transcatheter aortic and mitral valve therapies.

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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, we are particularly well-suited to provide CMS with input regarding the proposed coverage policy.

We, the Interventionalists/Structuralists from Morristown Medical Center, have read the proposed regulatory requirements and would like to make the following comments and recommendations:
We do not believe that TMVR procedures using the MitraClip system must be done in a hybrid OR and that it is suitable to be done in the Cath Lab suite with appropriate imaging and sterility.
While we agree that the surgeon and interventionalist must be involved in pre and postoperative screening and evaluation. However, we strongly disagree with CMS’ proposal that an interventional cardiologist and a surgeon jointly participate in the intra-operative technical aspects of TMVR. Such a requirement places a significant burden on the heart team’s surgeon. Rather than providing necessary services, the surgeon would be relegated to ‘stand-by’ role during TMVR procedures. While such a requirement may be appropriate for a percutaneous valve replacement, should one or more such devices receive FDA approval, we do not believe mandating such surgeon participation is necessary for TMVR using the MitraClip system. We do believe participation of a cardiac surgeon may be necessary in some TMVR cases, as discussed in the recent multi-society guidelines and credentialing requirements. Therefore, we recommend that co-surgeon and assistant surgeon modifiers be permitted, but not required, for TMVR with MitraClip procedures.

Because of the critical role of intraprocedural echocardiographic and fluoroscopic guidance, we strongly recommend that the echocardiographer on the Heart Team has particular interest and experience in structural interventions. In addition, we recommend the echocardiographer be required to have at least 25 structural cases per year, including but not limited to PFO, ASD, TAVR, Mitral Valvuloplasty and TMVR.

Respectfully submitted

Barry M Cohen MD FSCAI
Medical Director, Cardiac Cath Lab
Gagnon Cardiovascular Institute
Morristown Medical Center
100 Madison Avenue, Box 5
Morristown , NJ 07962
Telephone 973-971-8858
Fax 973-290-7457

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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 treatment of structural heart disease since the mid-80s. At that time, we started an aortic and mitral valvuloplasty program which has continued through the years and to those procedures we added percutaneous repair of atrial septal defects, ventricular septal defects, patent ductus arteriosis and patent foramen ovale (under research protocol).

Additionally, we have been involved in both research and commercial aspects of E-valve mitraclip therapy since 2006 and were one of the leading enrollers in the EVEREST II trial. We enrolled 53 patients in EVEREST I, II and REALISM and subsequently have treated 7 patients under the commercial availability of the mitraclip. The success rate is 90% overall and, excluding the initial roll-in patients, 99% in terms of successfully delivering clips in patients who were considered candidates for the therapy. We have had only one 30-day mortality in a patient presenting with multisystem failure from a referring out-of-state institution in a compassionate use situation. The patient died of multi-organ failure pre-existant to the clip implantation. It is of note that the mitraclip eliminated his mitral regurgitation and his liver, renal and lung impairment were the primary causes of death.

Many of our patients were referred needing oxygen therapy and were limited to a wheelchair existence due to their extreme dyspnea on exertion. With rare exceptions, all have returned to a virtually normal life. It is also worth pointing out that many of the patients that were randomized in the EVEREST II trial were younger patients with no significant comorbidities with degenerative mitral regurgitation. All of these younger patients, otherwise considered surgical candidates, have done exceedingly well with trivial mitral regurgitation and complete restoration of normal cardiac function. In addition to our E-valve mitraclip program, we began a TAVR program in late Fall 2011 implanting the first commercial transvascular aortic valve in Texas. At that time, we also initiated our PARTNER II enrollment and have treated over 320 patients with transvascular aortic valve replacement since the late Fall 2011. We’re also one of the leading enrolling sites for the PARTNER II Sapien 3 trial.

We would like to clearly state that we strongly support the CMS proposal to provide national coverage for FDA approved indications of mitraclip and other transcatheter mitral valve therapies when available.

As stated above, we have had a very favorable experience with E-valve mitraclip and received referrals from, literally, all over the country for their therapy. The mitraclip has returned numerous patients to a normal life when they previously had limited mobility and frequently required continuous oxygen therapy. To illustrate this more in depth, I have taken the liberty of attaching a patient’s story describing the travail of a young woman from New Mexico who really had a limited existence secondary to her severe mitral regurgitation and was clearly deemed inoperable by numerous surgeons both in New Mexico and in Texas. In fact, she was referred to us for the E-valve mitraclip by a very well-known surgeon at the Texas Heart Institute.

“Cardiologists use commercially approved MitraClip® for repair
HOUSTON – (May 27, 2014) – [PHI Redacted], had already survived two open heart surgeries. She carried a pacemaker in her chest and was on continuous oxygen. So when it became apparent that she needed a repair for a leaky mitral valve, which was allowing blood to flow dangerously from the heart back into her lungs instead of forward into the body, cardiovascular surgeons advised again open heart surgery. Instead, she was referred to Richard Smalling, M.D., Ph.D., of The University of Texas Health Science Center at Houston (UTHealth) Medical School for a procedure that had just been commercially approved by the Food and Drug Administration: the transcatheter MitraClip® procedure.

In the normal heart, blood is pumped forward by the left ventricle – the main pumping chamber of the heart – into the aorta and the rest of the body. The normal mitral valve does not allow backflow into the left atrium and lungs. In severe mitral regurgitation, the mitral valve leaflets do not work properly and the leaking valve allows blood from the left ventricle to flow back into the left atrium and then into the lungs. Mitral regurgitation can lead to stroke, heart enlargement and failure and sudden death. It affects approximately 4 million Americans and symptoms include shortness of breath, irregular heartbeat, lightheadedness, fatigue, and chest pain.

Prior to the MitraClip® procedure, open heart surgery was the only treatment. Smalling, the James D. Woods Distinguished Chair in Cardiovascular Medicine and director of interventional cardiovascular medicine in the Division of Cardiology at UTHealth and the Memorial Hermann Heart & Vascular Institute-Texas Medical Center, was a principal investigator of the EVEREST II trial, which studied the MitraClip® procedure in patients with mitral regurgitation. Results from that study led to approval of the device for use in patients with degenerative mitral regurgitation who are at high risk for open heart surgery.

“It took us nine months to get approval from our insurance company,” said [PHI Redacted], who lives in New Mexico. “They said Dr. Smalling was out-of-network and kept asking if there was anyone else who could do it. The answer was ‘no.’ Dr. Smalling was the best and we wanted the best.”

The wait was hard on [PHI Redacted], who had to quit her job teaching pre-school kids because of her low oxygen levels. “I was on oxygen 24-7 and I’m a very active person. My quality of life was minimal, like 40 percent. We couldn’t go camping. We love to do mission trips through our church and we couldn’t do any of them,” [PHI Redacted] said. [PHI Redacted] was finally scheduled for her procedure in late February at the Memorial Hermann Heart & Vascular Institute-Texas Medical Center. During the procedure, the interventional cardiologist works closely with a cardiologist who specializes in transesophageal echocardiography. A flexible ultrasonic probe is placed into the patient’s esophagus and stomach to capture high resolution images of the heart continuously throughout the procedure. These images allow the interventional cardiologist to position the MitraClip® delivery system precisely between the valve’s two leaflets and clip the valve across the leaking area. Once deployed, the clip still allows blood to be pushed out of the heart, but backward flow is now restricted.

Dr. Catalin Loghin, associate professor of cardiovascular medicine and an interventional echocardiographer specially trained in E-Valve mitral valve repair, helped direct the optimal positioning of the clip placement. Loghin was a co-investigator on the earlier MitraClip® clinical trial. “We know once the valve is repaired with this technique, the outcome is usually very good,” Smalling said. “The deterioration stops and they get better and the heart function gets better. Over time, the heart actually shrinks.” [PHI Redacted]’s procedure took just 35 minutes and a month later, she said her quality of life was up to 75 percent. Two months later, she said she has 95 percent of her quality back and she is looking forward to returning to her classroom in the fall. She uses oxygen only at night and said she will be retested soon to see if she can stop using it altogether. “I actually sang in the choir on Easter morning for the first time in years,” she said. “I am so excited!”

UTHealth has begun a second trial for the MitraClip®, this one testing its efficacy for functional mitral regurgitation, which is caused by enlargement of the heart due to heart attack or heart failure. The commercially approved MitraClip® is for degenerative mitral regurgitation, caused by damage to the leaflets. For more information, call 713-500-UTCV. Link: https://www.uth.edu/media/story.htm?id=73ae5e45-7731-40c6-b960-1f9c7f6b5d48 ”

Comments Continued
While I support the majority of the points in the coverage proposal, I would like to comment specifically on sections A3 and A4.
Section A3-c. “Non-invasive imaging including expertise in transthoracic and transesophageal echocardiography,”:
At the present time, percutaneous mitral valve therapy requires the collaboration of an interventional cardiologist and what we term an interventional echocardiographer. This obviously also requires an experienced cardiac anesthesiologist. These procedures frequently take longer than 2 hours and sometimes much longer than that in order to achieve an optimal result. The results obtained are highly dependent on the skill of the echocardiographer and his/her ability to communicate optimal positioning strategies to the interventionalist who is manipulating the mitral clip delivery system. This time commitment for the interventional echocardiographer is not currently compensated in the current reimbursement scheme for echocardiography. A typical transthoracic echo CPT code reimburses the physician less than $100 when he/she must be involved in the E-Valve procedure for long periods of time clearly exceeding their ability to be reimbursed appropriately. Commensurate with the coverage for the procedure CMS should consider carefully an additional reimbursement code for the interventional echocardiographer. Without his/her appropriate compensation, it is feared that the skilled individual will lose interest in the procedure and that will jeopardize the institution’s and valve team’s ability to successfully treat these critical patients.

Section A3 – b. “The hospital surgical program must have the following:
= 1000 catheterizations per year including =400 percutaneous coronary interventions (PCIs) per year”:
The number of coronary interventions per year has little impact on the ability of an institution to support structural heart interventionalists and associated specialties. Additionally, there is no published literature describing the interaction of PCI expertise on structural heart expertise, and I respectfully suggest that this requirement be either modified or eliminated.

c. “Interventionalist with =50 structural procedures per year including atrial septal defects (ASD) and patent foramen ovale (PFO) and trans-septal punctures”:
This is a relatively stringent requirement which also is somewhat arbitrary without documented evidence. Despite this stringent requirement in our large institution, we have 4 operators who would meet these criteria while only one of these has any E-valve experience. I would suggest that this requirement perhaps be halved in order to allow institutions with an intermediate experience develop expertise in this life-saving procedure. Parenthetically, it also needs to be stated that percutaneous mitral valve interventions are the most technically challenging procedure a structural heart interventionalist performs. Not only is an extreme level of skill necessary regarding complex manipulations of a delivery system of almost 4 feet away from mitral valve, but also taking into consideration the high degree of collaboration and communication necessary with the interventional echocardiographer to achieve successful outcomes. The reimbursement for the interventionalist also needs to reflect the high level of skill and long period of procedural time, which in most cases eclipses any procedure currently being performed in the catheterization laboratory.

Section A4. “The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TMVR”:
There is no clear reason for this particular requirement since surgeons, as a rule, do not perform TMVR. The procedure requires a trans-septal puncture and transesophageal echo guidance, in addition to complex catheter manipulations, which happen in the left atrium, which clearly is outside the realm of expertise for the typical cardiovascular surgeon. Although the procedures are very complex and tend to be somewhat prolonged, the patients typically remain very stable during the procedures and the incidence of hemodynamic challenges, arrhythmic instability and electrical instability are very rare and handled by an experienced cardiac catheterization team, in collaboration with a cardiac anesthesiologist. The main potential risk is cardiac perforation, typically during the trans-septal portion of the procedure which can occur with any trans-septal procedure. In the E-valve cases, however, this part of the procedure is probably safer than in the majority of the other trans-septal procedures being performed in the catheterization laboratory, either by interventional structural heart operators or cardiac electrophysiologists. This is due to the fact that the trans-septal puncture is meticulously guided by the transesophageal echo and the interventional echocardiographer. Thus, the probability of trans-septal complications is very low. The requirement for a cardiac surgeon to be in the room during the procedure is unnecessary and there is no clinical evidence for such a requirement.

I appreciate the opportunity to provide comments regarding this very important lifesaving modality. I would be happy to comment further should you have any questions regarding the above information.

Sincerely,

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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 involved in the decision making and discussion about this patients best treatment plan. However, the Mitral Clip procedures themselves require 2-4 hours to perform and do not require the skill set of a cardiothoracic surgeon. I have performed this procedure multiple times and have not found myself needing or wanting a cardiothoracic surgeon input. They will become frustrated at the time commitment for these lenghty procedures and quickly recognize they provide no significant value in actually performing the procedure. This dual physician requirement will increase health care costs unnecessarily and limit the availability of this procedure to patients who are generally frail and elderly. I strongly encourage CMS to revise this component of the recommendation. I would be willing to discuss this further if requested.

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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 been outstanding and the value to patients has been significant. The device and the therapy regularly benefits individuals who have exhausted all their other therapeutic options.

I compliment CMS on moving forward with a plan for national coverage of the MitraClip. It is a unique device which deserving patients clearly benefit from having access to. Both its remarkable safety and efficacy have been well documented in the US and globally. The CMS proposal sets impressively stringent requirements for operators and facilities to utilize the technology and under the proposed guidelines will be used in a limited number of high volume institutions, potentially dramatically limiting access to deserving patients. To date we have learned that the procedure is not difficult to perform. It requires a an interventionalist with a mastery of catheter skills and cardiac imaging. Our surgical colleagues have been supportive in helping us to decide in which patients the technology is most effectively applied but they have had no role in the performing the procedure. As compared to TAVR where surgeons provide support in both arterial access and in the situation when complications arise requiring surgical support, these situations do not occure with the MitraClip procedure. The MitraClip can be performed by a single interventional operator and requiring a cardiac surgeon to jointly participate or provide surgical backup is unnecessary and is an inappropriate and inefficient use of resources.

In summary, I strongly support the CMS proposal to provide national coverage for FDA approved indications for this unique, highly beneficial, therapy for the treatment of mitral regurgitation

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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 cardiologists.

This procedure does not require the skill set of a cardiac surgeon. Unlike TAVR, access for the Mitraclip procedure is obtained percutaneously via the femoral vein, with all subsequent maneuvers conducted by catheter. These maneuvers are entirely within the domain of the interventional cardiologist. Mandating a surgeon's presence would lead to an extravagant waste of resources, relegating the surgeon to an observational role in a procedure that does not require surgical skills.

Two additional issues in the proposal require comment. The proposal rightfully requires appropriate sites for these procedures to have cardiac cath labs, hybrid ORs, and ICUs. While our hospital meets these requirements, we conduct our MitraClip procedures in a cardiac cath lab and care for our patients post-procedure in an Interventional Cardiology Unit, not an ICU. We have had great success with this approach and find that it an appropriate use of resources. The wording of the proposal was unclear to me regarding whether CMS would require these procedures to be conducted in a hybrid OR with post-procedure care taking place in an ICU. I hope that is not the case.

Thank you for the opportunity to respond to this very important proposal for CMS coverage.

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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.

General Comments

AHIP and its member health plans believe that a strong evidence base developed through rigorous research on the safety, effectiveness, and value of new technologies, biologics, and pharmacological products, is critical to ensuring that patients receive the most effective and appropriate treatments. According to the Proposed Decision Memo dated May 15, 2014, CMS is proposing to cover the transcatheter mitral valve repair (TMVR) procedure for the FDA-approved indication when the evidence is collected in a registry; and is further proposing to cover off-label indications under Coverage with Evidence Development (CED), in the setting of a well-designed, qualified clinical trial, as defined in CMS’s Clinical Trial Policy. Our member health plans believe that both on-label and off-label indications should only be covered under CED, in the setting of a qualified clinical trial as defined in the CMS Clinical Trial Policy, and do not believe that a registry is considered sufficient evidence development for labeled indications.

Currently, the U.S. Food and Drug Administration has only approved one TMV device/procedure. The evidence on this procedure is promising, but requires validation and further study. A coverage policy that supports CED in the setting of a qualified clinical trial will help generate the evidence necessary to further define and refine the appropriate indications going forward.

Thank you for the opportunity to comment on this important issue.

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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 during the cases. This also helps in continuity of care as I have seen the patient before hand which helps in making the right judgement in the OR. I not only provide expertise but also am active in technical and hands on support during the procedure. Since my interventional colleague does his own tee during the case I often end up navigating the clip and capturing the leaflets which helps for the procedure to go much more smoothly and benefits the patient.

I therefore strongly feel that just like TAVR reimbursement the surgeon should be reimbursed for their time if they choose to scrub in the case at an equal level as interventional colleagues. This will not only help the patient but also make the heart team stronger.

Thank you for your consideration.

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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 facilties and operators. These volume ensure the centers have significant mitral valve surgery, percutaneous and structural heart experience.

It is clear that forming a heart team (interventional and cardiac surgeon) is essential for the success of a MV program. This heart team is especially important in the evaluation of the candidacy of the patients for either open MVRepair/Replacement or TMVR. Both should concur on which therapy should be offered to the patient.

I do not agree with the CMS proposal of requiring BOTH an interventional cardiologist and a CT surgeon during the intraoperative technical aspects of the procedure. It should require TWO trained and experience operators at the procedure, whether they are both cardiologists or both cardiac surgeons. The procedure requires two operators doing different part in coordination with each other. It is much more important to work as a team than to have two specialty presence.

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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 multidisciplinary valve team, experienced mitral valve surgeons and the volume requirements for surgeries, cardiac catheterizations, PCIs and structural heart interventions.

I do not agree with the proposal to require both a interventional cardiologist AND a cardiac surgeon to be present during all procedures. The FDA approval does require the determination of eligibility to be done by a heart team that includes an experienced mitral valve surgeon, but it does not require that the surgeon scrub in on the cases. In our own hospital, two of our surgeons, Drs. Michael Mack and Rob Smith, do scrub in on the cases. While this is our own practice, there are many other centers wherein the interventional cardiologist does these cases without a surgeon present. There is no evidence that outcomes or complications are different whether a surgeon, interventional cardiologist, or both are scrubbed in. Making this a requirement will only make the procedure more expensive and may create scheduling delays that harm the patient. Given that neither the FDA nor the cardiovascular societies have requested dual presence during the procedure itself, I would respectfully ask that this requirement be removed.

I also disagree with the language that coverage for future research would be limited to RCTs. "Coverage with Evidence Development" correctly assumes that further clinical research needs to be done. Recent data from the TAVR TVT registry suggests that outcomes are very poor in renal failure patients and patients with severe COPD on home oxygen therapy. Such data is enormously useful in teaching us which patients should not undergo the procedure. Such data is unlikely to come from RCTs, but from registries. So, FDA sponsored registry and single-arm studies should also be covered.

I wish to express my gratitude and support for the CMS decision and hope my proposed refinements will be adopted.

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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 mitraclip procedures with 12 being done since the commercial availability of the mitraclip following FDA approval. Our experience is one of the largest in the New York City metropolitan area.

In general I support the CMS proposal to provide national coverage. The mitraclip, while not as effective as surgery in terms of quantiative MR reduction can provide very meaningful clinical results in patients for whom surgical correction is high risk. We have treated several patients with degenerative MR in the last 6 months who were confined to the ICU on hemodynamic pharmacologic support and turned down for surgery. These patients were successfully treated with the mitraclip,discharged and have returned for follow up leading active, productive lives. It is a very important addition to our treatment options for therapy of MR.

I have no problem with the reporting of these cases to a national data base and believe this is a good idea. I also feel the facilities requirements are appropriate. I disagree, however, with the requirement that the procedures be done jointly with a cardiac surgeon and interventionalist. Unlike TAVR where alternative access routes are often necessary and the surgeon's skill set indispensible TMVR is done via a transvenous approach utiliziing a transeptal puncture. The positioning and clipping of the valve is done via interaction between the echocardiographer and interventionalist and no surgical skills are required. TMVR is a very safe procedure and in the world wide experience of close to 8000 patients has required emergent surgical intervention on extremely rare occasions. Our surgeons would find this requirement unacceptable and generally have no interest in the procedure except to refer patients for it who they believe are poor surgical candidates. I strongly urger CMS to remove this requirement from the national coverage proposal.

That being said I strongly believe the decision to perform TMVR should be a joint decision between an experinced mitral valve surgeon and a mitraclip trained interventionalist. The performance of the procedure, howver, only requires one trained operator, which is usually an interventional cardiologist.
Thank you.

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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 hopefully innovate in this area.

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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 institution (NorthShore University HealthSystem) that is very active in the performance of these procedures. As such, I have been a referring physician for these procedures and as an interventional cardiologist, chair of the writing committee, and colleague of those performing these procedures, I am intimately aware of the procedures being performed and patient outcomes nationally and at our institution. It is my opinion that in the group of patients that have undergone TMVR that there is significant clinical and symptomatic improvement in these patients who are at high risk for surgical mitral valve therapy.

I understand that CMS has proposed to create a new DRG called “Endovascular Cardiac Valve Replacement” to include transcatheter aortic, pulmonary and unspecified valve replacement procedures, but not repair procedures like MitraClip. The rationale is that transcatheter replacement and repair procedures are not “clinically coherent” and therefore should not be grouped in the same DRG family. I believe it is inappropriate for CMS to group TMVR with balloon valvuloplasty and coronary angioplasty and TMVR should be more appropriately grouped with TAVR for payment purposes. The underfunding of this procedure will make it more difficult for patients to have access to this procedure which has shown clinical and symptomatic improvement in patients at high risk for surgical mitral valve procedures. This will cause an excess mortality in patients with mitral regurgitation, either by treatment only with medical therapy or by high risk surgical procedures.

Additionally, I am not sure how to interpret the term “clinical coherence.” If it is the difference between repair and replacement, then how can CMS place surgical mitral valve repair and replacement in the same DRG family? If it is in terms of procedural intensity, I can assure CMS that the TMVR with MitraClip is a much more intensive procedure than TAVR.

The other issue I would like to comment on is the CMS comment that “Interventional cardiologist and cardiac surgeon must jointly participate in the intra-operative technical aspects of TMVR.” In the above referenced manuscript1 it is clearly stated that “the procedure itself is commonly performed by a single physician. This physician may be either an interventional cardiologist or a cardiothoracic surgeon; however, for some patients, the expertise of two physicians (either two interventional cardiologists, or an interventional cardiologist and a cardiothoracic surgeon) could be required.” This was based on the comment language in FDA’s approval of the MitraClip, and in the manufacturer’s labeling and was language agreed upon by the four societies that endorsed the manuscript1 of which two were surgical and two cardiology societies.

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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 for symptomatic mitral regurgitation). We have performed about 100 TMVR procedures, in addition to other percutaneous valve procedures like 400 TAVR and 400 percutaneous balloon mitral valvuloplasties. We have participated in the EVEREST trials and registries and participate in the COAPT trial. I personally served as national surgical co-PI in the EVEREST trials.

Without CMS coverage, few if any hospitals can afford to offer TMVR therapy, and the device will essentially disappear from practice in the U.S. as has occurred with other prior unreimbursed technologies.

I have personally seen at least 100 patients before and after TMVR therapy, along with several hundred more potential candidates. There is no doubt in my mind that the data correctly show significant improvement in symptoms, less hospitalization, less costly outpatient care, and less pressure to consider other heroic interventions like surgery in high risk patients.

1. Although a surgeon should be involved in preprocedure patient selection as a condition for institutional reimbursement coverage (as with TAVR because of similar alternatives of percutaneous versus surgical options), the TMVR procedure itself is distinctly different from TAVR and does NOT require surgeon presence during the procedure (unlike TAVR). There are essentially NO surgeons on this planet who do transeptal puncture or who regularly perform TMVR insertion. TMVR procedures already tend to require the full time presence of 3 MDs, namely the interventional cardiologist, and anesthesiologist, and an experienced transesophageal echocardiographer. The presence of a surgeon during the procedure would only be a distraction and an additional cost.

2. At my institution and every other participating institution that I am aware of in the U.S., the cost of TMVR is very, very close to that of TAVR and not at all like percutaneous balloon mitral valvuloplasty (PBMV) for mitral stenosis. One big difference from PBMV and similarity with TAVR is that TMVR involves a significant cost of an implanted device that has been $12,000-$18,000 per case. The cost of the TMVR devices is in fact very similar to the costs of current TAVR devices which have also run from $12,000-$18,000 per implant. The cost of an Inoue balloon for PBMV is 100X less, and PBMV involves NO implanted device. THEREFORE, the final CMS DRG for TMVR should either be that of TAVR or else a new, separate DRG reimbursed at a rate similar to that for TAVR.

De feel free to contact me if I can be of any assistance

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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 integrated and collaborative heart team. Our cardiovascular surgeons have always evaluated our MitraClip candidates and have on occasion participated in our MitraClip procedures. They are always invited and welcome in these procedures. I support all of the proposed CMS guidelines with the exception of required surgeons participating in the MitraClip procedure. As there is no clinical need for a surgeon in these procedures, the requirement for surgical participation suggests policing. This is contrary to the spirit of mutual trust and collaboration which drives best patient care.

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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 procedures.

The MitraClip procedure is a significant advance to the care of patients with symptomatic mitral valve disease. For many patients who are poor conventional surgical candidates due to comorbidities MitraClip offers realistically their only option for both improved quality and quantity of life. Medical therapy for degenerative mitral insufficiency is palliative as it does not address the underlying mechanical problem. While MitraClip does not consistently reduce MR as effectively as surgery it does so in an overwhelming majority of cases and clinical trial results (EVEREST 2) have shown similar patient centered outcomes including heart failure class, freedom form CHF admission, quality of life, and survival. From the patients standpoint MitraClip achieves the same outcomes and those outcomes are substantially superior to medical therapy which is the baseline therapy for all patients. The therapy is a substantial advance and is meaningfully impactful for patients in a way similar to surgery. Lack of coverage will deny patients not suitable for conventional surgery an important option. I have personally observed this benefit in clinical practice with application of the MitraClip procedure saving lives and restoring quality to those lives.

I am concerned about two proposed stipulations to coverage. My first concern is for the requirement that a cardiac surgeon participate in the procedure. Unlike TAVR, which currently requires two operators and where a surgeon is an important part of the implanting team, MitraClip is a single operator procedure. It is performed in the cath lab not the OR and no operative incisions are required. A requirement that the surgeon be present during the procedure would provide a significant barrier to clinical implementation of this procedure. Surgeons have decision rights as two what patients are best suited for a non-operative percutaneous repair approach but have no role in the implant. To have a surgeon stand in the room during this procedure which typically take two to four hours would be a substantial waste of the surgeons time. In my institution our surgeon, Dr. Eric Skipper, has long been a strong supporter of the technology but has no interest in participating in the procedure. No surgeon that I know would want to be required to stand in the room without a significant role. It is a single operator procedure and does not require a surgeons expertise. That said I do believe that reimbursement should be provided for both the implanting interventional cardiologist and the imaging cardiologist. The imaging cardiologist is critical to implant and is as important to the procedure as the implanter. Currently there is essentially no reimbursement for the imager who guides the procedure with continuous TEE throughout the procedure.

The second concern I have is the proposed mandate that future clinical trials on MitraClip covered by CME be only randomized control trials. While RCTs are important they are not the only form of clinical investigation that has value. I believe that decision with regard to coverage of clinical trials remain between investigators and the FDA. I believe that CMS is required to cover FDA approved clinical trials. If CMS puts stipulation on the types of trials it will cover it will set precedent and effectively usurp oversight of clinical trials from the FDA. I do not think this is appropriate or productive.

Third, a requirement of 50 structural heart procedures is too high for the operator. Structural heart as a field is advancing but realistic volumes should be closer to 25. TAVR most certainly should be counted in the number and essentially any procedure that requires trans-septal catheterization such as LAA closure and balloon mitral valvuloplasty should count as well.Setting the bar too high runs the risk of encouraging operators to keep their number high through cases where the clinical benefit may be lacking.

The pathway for MitraClip approval and reimbursement has been a complex decade long journey. I am excited as a clinician and investigator to finally be able to offer this important technology to patients. Hopefully well intended but misguided caveats national coverage will not be implemented. We need a strong coverage decision the supports realistic national implementation for the benefit of patients

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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 selected patients the Mitraclip is an excellent therapy and should be made available as a treatment option. Although I understand the inclination to model Mitraclip rules on those applied to TAVR, the procedures are entirely different. I am involved with both a know first hand how important the team approach is for TAVR. Mitraclip procedures require catheter based skills. Cardiac surgeons are not trained in these skills much like I am not trained to do surgical procedures. To mandate their presence is waste of their time and skills.

Finally, it is generally accepted that the more of a given procedure you perform the better the outcomes. I would hope that other structural procedures like TAVR would count towards the minimal number required to maintain accreditation. If other procedures are not considered, it will incentivize structural heart specialist to perform procedures that currently have little application in clinical medicine.

I am very proud of our pMVR program at the Maine Medical Center. This program has developed with much work from a diverse group of professionals in public and private positions. My hope is that the rules CMS finalize foster the careful growth of this technology.

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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 cardiologists.

This procedure does not require the skill set of a cardiac surgeon. Unlike TAVR, access for the Mitraclip procedure is obtained percutaneously via the femoral vein, with all subsequent maneuvers conducted by catheter. These maneuvers are entirely within the domain of the interventional cardiologist. Mandating a surgeon's presence would lead to an extravagant waste of resources, relegating the surgeon to an observational role in a procedure that does not require surgical skills.

Two additional issues in the proposal require comment. The proposal rightfully requires appropriate sites for these procedures to have cardiac cath labs, hybrid ORs, and ICUs. While our hospital meets these requirements, we conduct our MitraClip procedures in a cardiac cath lab and care for our patients post-procedure in an Interventional Cardiology Unit, not an ICU. We have had great success with this approach and find that it an appropriate use of resources. The wording of the proposal was unclear to me regarding whether CMS would require these procedures to be conducted in a hybrid OR with post-procedure care taking place in an ICU. I hope that is not the case.
Thank you for the opportunity to respond to this very important proposal for CMS coverage.

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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 research in the surgical and medical treatment of valvular heart disease. The Providence Valve Center is currently actively enrolling patients in the PARTNER II and COAPT clinical trials.

CMS coverage for FDA-approved indication of MitraClip and other transcatheter mitral valve repair therapies is imperative. Our experience with the MitraClip technology has been nothing short of awesome with clear life changing benefits for the great majority of the patients we have treated to date. However without CMS coverage, we are currently performing the MitraClip procedure at a significant deficit of ~ $18,000 per case, and we do not see a sustainable financial or programmatic model that will allow treatment of all Medicare beneficiaries who need this new technology.

Regarding Items A4 and B1,
“The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TMVR.”:

The proposed requirement of active participation of a cardiac surgeon in the MitraClip procedure is misguided and unnecessary. In our experience, it does not make sense and is a waste of valuable physician resources to require procedural participation of our surgeons who may have personally referred a patient for MitraClip , have participated in the team decision and have deemed a patient high risk or non-operable. It is a reasonable requirement that a cardiac surgeon, experienced in mitral valve surgery be part of the heart team and participate in the heart team evaluation and decision process. The procedure must be performed by interventional cardiologists and cardiac surgeons who are experienced in percutaneous transseptal and structural heart therapies. Cardiac surgeons that are qualified and interested should be included in the technical aspect of the procedure. However, the literature has shown that the incidence of emergency surgical intervention is very low.

Regarding Item B,
“B. TMVR is covered for uses that are not expressly listed as an FDA approved indication when performed within a FDA-approved randomized clinical trial that fulfills all of the following:”:

The word, “randomized” should be stricken from the language. The NCD proposal should rightly require all covered clinical trials be approved by the FDA.

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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 single operator procedure and has never been performed routinely conjointly by a cardiac surgeon and interventional cardiologist together. Of course, if a cardiac surgeon OR an interventional cardiologist wich to perform the procedure that is appropriate but is NOT appropriate to mandate that both physicians be present TOGETHER for the entire procedure.

Other data to support this position include:

1. Need for urgent MV surgery is exceedingly uncommon, at 0.3% in the pooled analysis of currently available published data on MC outcomes (n=3198). (In press, Philip et al, Catheterization and Cardiovascular Interventions) This is similar to many other procedures performed in catheterization laboratory.
2. Current approval is for “prohibitive surgical risk patients” – by definition, these patients are not going to benefit from any surgical intervention.
3. This will add to the cost of the procedure with no documented benefit.
4. The requirement is not based on any prior published study protocol or investigational study results.
5. Echocardiographer is very important and should get reimbursed rather than a surgeon who will not add any procedural value. Evaluation by surgeon prior to procedure is essential but procedural involvement is not necessary.
6. Multi-society document recommends single interventional operator with crucial involvement of echocardiographer.

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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 hospitalizations. The requirement for submission to national data base is reasonable. We have been performing this procedure after patients are evaluated in a multidisciplinary heart team system with an experienced mitral valve cardiac surgeon. That requirement for evaluation is essential. The volume requirements are to stringent. This procedure has been well studied in large multicenter trials which led to the FDA approval. In no trial was a cardiac surgeon mandated to jointly participate in the intraoperative procedure. There is no evidence that this would improve outcomes. This was clearly based on the transcatheter aortic valve replacement coverage decisions. I jointly with a cardiac surgeon perform transcatheter aortic valve replacement regularly. That procedure is technically much different and the studies that led to approval required joint interventional cardiology and surgical intraoperative collaboration. for transcatheter mitral valve repair the collaboration is between the interventional cardiology and a trained cardiac echocardiographer. He is a joint procedure between these 2 specialties and I would recommend co-surgeon reimbursement for the interventional cardiologist and the cardiac echocardiographer.

Thank you,

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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 clinical results are more impressive. After the MitraClip, patients that were unable to walk down the hall without stopping are able to return to more normal activities without breathlessness and fatigue. This in a category of patients without many remaining options.

I strongly support coverage of the MitraClip procedure. We currently perform these procedures at a significant financial loss to the hospital and our heart and vascular institute. This is not a sustainable arrangement.

Finally, I would like to express disagreement with the coverage requirement that a surgeon jointly participate in the procedure. At the Providence Valve Center we have an exemplary multidisciplinary collaboration with cardiac surgeons, interventional cardiologists, noninvasive cardiologists, palliative care physicians, cardiac anesthesiologists, nurses, echo sonographers, and others. We see patients side-by-side in valve clinic and review all cases with images in a weekly conference, often multiple times. I find the cardiac surgeons' input in conference and patient selection to be invaluable, and they are a primary referral source. I trust their judgement immensely. However, I do not think that it is appropriate for cardiac surgeons to be required to participate in the actual procedure, as is stated in the current CMS proposal. The skill set required for MitraClip is fully within the capacity of an interventional cardiologist. I feel that there is little to be gained within the case by the addition of a cardiac surgeon, since their skill set is quite different. Currently our MitraClip procedures are performed with two interventional cardiologists, another cardiologist performing the transesophageal echocardiogram, an anesthesiologist, an echo sonographer, and a cardiac cath lab scrub tech, and others. With this rather large contingent, we have never felt the need for input or technical assistance from a cardiac surgeon during the case itself.

Thank you for your consideration of my comment, and please do not hesitate to contact me for further information.

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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 done by the interventionalist in conjuction with the imaging provider (usually a cardiologist doing TEE). The surgeon would literally just be standing in the room doing nothing. There should always be a surgeon available for some unforeseen emergency, but they would not be helpful at all during the procedure and it would add needless complexity and would tie up a surgeon for 3-4 hours without affecting patient outcomes.

2) I think there should be better support for physicians who provide imaging services during these cases. When I do a 4 hour TEE for this procedure, I bill the same code as I do for a 15 minute routine TEE, despite the obvious differences. There should be additional support for non-interventional cardiologists who give of their time to participate in these important structural interventions.

c) The 400 PCI cutoff for institutions is unnecessarily stringent. I would suggest a lower cutoff of perhaps 300-350 PCIs/year.

Thank you for your consideration.

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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 eliminated. We believe that sufficient evaluation of the patient may be done jointly and by careful review of appropriate testing and records.

Additionally, it appears that much of the proposed decision memo for mitra clip has simply been copied from TAVR. We trust the final NCD will be corrected.

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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 inoperable patients with severe functional mitral regurgitation and CHF. Our site has recently been performing mitraClip for patients with severe degenerative mitral regurgitation, CHF and are inoperable.

I support the CMS proposal to provide national coverage for FDA-approved indications of MitraClip and other transcatheter mitral valve therapies.

My experience with MitraClip has been personal and through review of the clinical data. The clinical data supports the use of MitraClip for appropriate patients - it decreases mitral regurgitation, reduces repeat hospitalizations for CHF, decreases left ventricular size and improves quality of life. My personal experience has been even more impressive. The quality of life improvement has been nothing short of phenomenal, as well as the decrease in mitral regurgitation. As a clinician, this improvement has been most important to me. The procedure has been very safe and very well tolerated, although it takes much in the way of resources (2 interventional cardiologists, an echocardiographer with excellent TEE skills, anesthesiologist) and lengthy procedures.

Evaluation of the patient prior to the procedure are evaluated by a surgeon, interventional cardiologist and heart failure specialist. All must agree the patient is appropriate for the procedure. The procedure is performed by one or two interventional cardiologists. This procedure does not need a cardiothoracic surgeon to perform the procedure.

Thank you for hearing my opinions.

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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 catheterizations at all.

2)AF ablations should be included in the structural heart procedures as it is the most useful procedure for MV Clip and LA work. The number 50 seems excessive, especially for procedures that really do not work in the atria. If 50 is a number chosen, I would consider lead extraction as well. This also is a difficult skill more on par with that required of a mitralclip, rather than a valvuloplasty.

3)It seems that much of this has been a duplicate of the trans-catheter AV requirements. This is a shame, as it give the appearance of only restricting the transcatheter mitral reibursement to those centers already performing transcatheter aortic valves. The skills required and the patient populations are very different. I would recommend that the requirements be distinct.

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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 risk for surgery. Similarly, I am strongly in favor of the CMS proposal to provide national coverage for FDA-approved

Without this payment, we are hamstrung by the onerous financial situation surrounding treating these high risk patients. My personal experience with the MitraClip device and my familiarity with the literature has me convinced that the device, used in appropriately selected patients, will improve clinical outcomes in the form of quality of life, re-admissions and the like. If reimbursement changes are instituted, I am convinced that this group of patients, albeit small in number, will benefit and I look forward to offering this treatment to them. As it stand now, however, it is very difficult to make this a tenable option for our institution given the lack of meaningful reimbursement for device and procedure.

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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 based on data or trial design. This will simply put unnecessary barriers and logistic hurdles in place, not to mention increase costs for all concerned - patients, CMS, practices and hospitals. This is a completely percutaneous procedure and can be performed by a skilled and appropriately trained structural interventionalist (whether from a cardiogy or surgery background).

Similarly, hospitals will not provide this therapy if they experience negative margins. The therapy is mitral valve repair and should be reimbursed accordingly, however since resource consumption is less than open MV repair it is equally reasonable that reimbursement is somewhat less. Again, the focus should be on providing value to our patients.

Thank you for the opportunity to comment.

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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 from his procedure and continues not only to survive, but thrive. His experience mirrors the outcome for the vast majority of the >65 pts we have treated with MitraClip.

It is therefore with great anticipation that I review CMS' proposed support of MitraClip technology, as I believe firmly that this policy could extend its lifesaving benefits to a greater number of patients.

In reviewing the proposal, I appreciate that CMS recognizes that the technical skill essential to successfully utilize Mitraclip technology requires a highly experienced team. Accordingly, the procedural volumes and specific experiences of the program and operators outlined in the proposal are appropriate, with one exception: unlike TAVR, TMVR does not require an interventional cardiologist and a cardiac surgeon for implantation. In support of this view, recent joint medical society guidelines have stated that MitraClip may be performed by a single operator. Indeed, this has been our institutional experience for the past 7+ years.

Unlike TAVR, MitraClip requires (1) an implanting physician (either an interventional cardiologist OR cardiac surgeon) + (2) an echocardiographer. Although in general TMVR has parallels to TAVR in teams of composition of the heart team, TMVR with Mitraclip is fundamentally dependent on continuous, real-time, intraprocedural transesophageal echo assessment for deployment. The integral role of the imager in this procedure should be recognized and reflected in the language of the coverage decision.

In sum, I respectfully propose that the CMS' coverage decision proposal remove the requirement of joint participation of a cardiac surgeon and an interventional cardiologist in the MitraClip procedure. In addition, I would strongly advocate that the proposal highlight the crucial role of the echocardiographer in the application of this technology.

One additional point: I would recommend that TAVR be specifically cited in the qualifying list of the >50 structural procedures the heart team must perform per annum.

Thank you for your consideration of my perspective.

Sincerely,

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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. Being placed in a valvuloplasty code, seemed more as a matter of convenience then of actual thought. This procedure is nothing like a valvuloplasty, other then you're re intervening on the mitral valve. I think institutions need to be able to offer this technology to those appropriate patients without fear of hemorrhaging for the lack of reimbursement. The need for an institution to be a mitral center is also onerous. There are many very good interventional practices that are referred mitral valve cases from CT surgeons that felt the patient was too high of a surgical risk for conventional mitral valve surgery. Referring that patient to a “mitral valve surgeon” is fraught with many political nightmares. I understand that there needs to be some control over the procedure so that it is done in the appropriate patients in the appropriate way, but to have a mitral valve surgeon sign off (which there are very few) is more an issue with CT surgery and not the Mitral clip procedure

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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 rehospitalization.

Though, I support strongly team work, requiring a cardiac surgeon in the intra-opertive aspect of TMVR is not necessary and should not be a must but preferable.

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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 prohibitive surgical risk.

I strongly recommend the CMS proposal to provide national coverage for the FDA approved indications of using MitraClip device and all other transcatheter mitral valve therapies. I have two recommendations:
first, the volume required for the interventionalist can be lower than 50 PFO/ASD/Trans-septal punctures in one year. It is more reasonable to consider 25 per year.

Second, the procedure is a single operator procedure that has been done in the trials by interventional cardiologist who is best equipped and trained to perform trans-septal puncture and is trained on various catheter techniques.

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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 support the CMS proposal to provide national coverage for FDA-approved indications of MitraClip and other transcatheter mitral valve repair therapies.
In our early experience with the Mitraclip, we have had remarkable outcomes. Patients have had rapid recovery times and at 30days, all have significant improvement in functional status and quality of life. It will be essential to have this option for patients who are suffering, yet are too high risk for surgical repair or replacement.

One issue that needs to be modified is the requirement of an interventional cardiologist and a cardiac surgeon to participate in the intra-operative technical aspect. TMVR is a much different procedure than TAVR, and therefore, the recommendations for each procedure must be unique and tailored to the needs. TMVR has been extremely successful and safe in trials and commercial applications outside the U.S. as a single operator procedure that can be done in a cardiac catheterization lab. Requiring 2 physicians to participate in the procedure will conflict with TMVR data that already exists. Furthermore, this would increase cost, decrease efficiency and limit access to care for the patients. I would strongly encourage this condition of the proposed coverage be removed.

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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 an integral part of a heart valve treatment program and should be covered by CMS as are other therapies for valvular heart disease.

Our institutional experience with MitraClip therapy has been nothing short of groundbreaking in the sense that patients who previously had no hope of survival or had severely limited quality of life have been treated successfully with the MitraClip. These patients are not offered surgery and without MitraClip would have no other option. These patients gain back quality and years of life at a decreased risk as compared to surgical therapies.

I support the use of a heart team to evaluate these patients for TMVR therapy. I would also like to emphasize that the complexity of screening, managing, and treating patients with complex mitral valve disease with TMVR is generally as involved and as complex as treating patients surgically, and is also on a par with the complexity of a TAVR procedure.

CMS coverage of the MitraClip procedure and TMVR is essential for many worthy patients to receive this therapy which has for years been available only to those outside the US. CMS coverage will bring the United States up to speed with the European and global community.

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