Transcatheter Mitral Valve Repair (TMVR)

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

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

A few concerns I have are related to the need for CT surgery in person evaluation. These patients are complex and while a Heart Team discussion is warranted I do not feel that a face to face with CTS is necessary. Since surgical MVR is a class IIb recommendation for these patients, a surgical turndown is not consistent or necessary. I do think that Heart Team discussion is important but the majority of the decision should be based on HF cardiologist consistent with COAPT.

Surgical MVR volume requirements are too high to allow sustained treatment and many centers. furthermore, surgical MVR volumes have no correlation with MitraClip outcomes. Rather the requirement should focus on the success of the team in both evaluating and performing MitraClip rather than surgical MVR.

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1. The proposed requirement for new programs to have 40 mitral valve repair/surgery numbers is draconian and will deprive the community of much needed lifesaving therapy for patients who are vulnerable. This volume requirement measure will prevent access to care to large group of patients who are best taken care of in the local community. This is especially true when the program in question is an established structural heart program with a heart team which is doing high volume of structural heart procedures. I would strongly plead to reconsider the volume requirement for new programs. This would hinder busy community hospitals who provide quality care for the vulnerable patients in the community without the need for them to travel long distances to avail this life saving care.

2. Needing mandatory surgical consult for all patients with heart failure (when the COAPT trial was done without the need for surgical consultation) appears to be another unnecessary hurdle for this vulnerable population to jump through to obtain this therapy. COAPT included a heart failure specialist and interventional cardiologist and this should be the requirement consistent with trial.

3. With respect to restricting coverage to functional MR only in presence of no significant TR, will also make it impossible to take care of significant number of patient. A significant proportion of patients have improvement of TR after mitral regurgitation is addressed, as long as they don't have irreversible pulmonary HTN and severe right sided failure.

4. Mitral clip is beneficial in some patients who are on inotropic support or mechanical circulatory support who are at prohibitive risk of surgery and may be the only option for survival in this very sick and vulnerable population.

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

1. Mitral clip for FMR is part of Heart failure treatment. I am not sure the surgical volume of MR has anything to do with outcome of Mitral clip
2. Changing the requirement of MVR for 20 per year will take away patient access in many areas where patients can't travel far.
3. Many surgeons are trained in very busy programs but now practicing in community hospital setting where they perform 1 to 2 mitral surgeries a month with excellent out come. Increasing the Criteria to 40 mitral surgery per year will eliminate the Majority of centers in our country that currently have very successful structural program
4. There is no proven relationship between the number of surgical mitral repair and the mitral Clip out come.
5. Most Program of mitral clip now don't meet criteria of 25 MVR per year per Hospital
6. why do we need face to face consult with CV surgery to decide on FMR treatment knowing that there is no good surgical option FMR. Heart failure team should be qualified to make that decision.
7. most patients with severe MR have other valve issues. we are not sure why TR and AS pt should be excluded from this therapy.
8. Many Patients with severe MR have underline condition of COPD on Home O2 which might improve with fixing the MR. It will be unfortune to exclude patients with COPD from this type of heart failure therapy.

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

Data supports that these patients have improved outcomes if they are placed on optimal guideline-directed medical therapy and thus, the requirement should continue that these patients should be on documented medications and be considered for CRT, if indicated. Patients with FMR, however, are rarely good candidates for open heart, be it repair or replacement, and the guidelines support this. Thus, it should NOT be necessary for these patients to meet with a cardiac surgeon unless these patients have concomitant aortic valve disease or coronary artery disease and could otherwise benefit from surgical intervention. This decision could be made by the referring cardiologist if they believe that further intervention is necessary but does NOT require every patient to be seen face-to-face by a cardiac surgeon. In addition, requiring a center to perform 40 mitral valve surgeries should not be required, as there are multiple studies that show there is no association between MitraClip outcomes and surgery volume done at a hospital.

In addition, echocardiography is a vital component of the procedure and thus, the Interventional Echocardiographer is critical in ensuring an optimal outcome. Due to this, the echocardiographer should receive appropriate reimbursement as they are considered a key clinician.

Another issue that was discussed, especially given our current public health crisis, is placing a restriction on “face-to-face” visits, as they are deemed unsafe and should be altered to allow for telemedicine/telehealth visits to allow patients to get the care they need in these trying times.

In regards to the exclusion of performing TEER in patient with other significant valvular heart disease and/or pulmonary hypertension, there are many patients that benefit from having their primary valvular issue addressed regardless of other cardiac comorbidities. For example, many mitral regurgitation patients will have concomitant tricuspid valve disease and pulmonary hypertension. By addressing the mitral valve initially, the pulmonary hypertension and effectively, the tricuspid pathology may improve. Thus, these patients should be assessed by a cardiologist who understands the hemodynamic relationships between the associated valve/pressure issues and the mitral valve, and they will then be able to decide if they will benefit from TEER first and not consider the parallel issues prohibitive. The current NCD language would preclude this from occurring.

In the same light, patients who are on inotropic support or in shock may also benefit from TEER. Though these patients were excluded from the COAPT trial, there are patients who have significantly benefitted with TEER in the setting of cardiogenic shock and thus should be allowed on a case-by-case basis.

Thank you for your consideration.

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

I do not agree with the proposed exclusion criteria of other valve disorders as many pts with mitral valve disease often have dysfunction of other valves. This criteria would eliminate the potential of a staged approach to their structural heart disorders and even clinical trial enrollment opportunities for some patients. I would hope you would consider removing this component.

I do not agree with the ionotropic support exclusion criteria. While there isn’t a large body of evidence to support consistent success for these patients, we have had some success and I feel that the pre-op medical management in an acute setting is variable and therefore Assessment should be deferred to the local heart team.

I also support the addition of functional or secondary etiology of mitral regurgitation as an indicator for Mitraclip.

Thank you for your time and consideration.

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Dear MEDCAC Members,

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

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

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

2. Qualifications to begin a mitral valve TEER program for heart teams without mitral valve TEER experience:

3. Qualifications for hospital programs with mitral valve TEER experience:

In addition to volume requirements changes, I would also propose to eliminate exclusion criteria for coexisting aortic or tricuspid valve disease requiring surgery or transcatheter intervention and allow the heart team to tailor the individual treatment plan.

Thank you kindly for your consideration.

Respectfully,
Jasmina Katinic

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1. Excluding coverage of TEER for patients with coexisting aortic or tricuspid valve disease would prevent a large proportion of patients from receiving TEER — many patients with mitral regurgitation also have tricuspid regurgitation which can also be addressed with TEER or in a staged approach with catheter based devices designed for the tricuspid valve. There are ample publications that show success of TEER in patients with coexisting mitral regurgitation and tricuspid regurgitation and a dedicated clinical trial (TRILUMINATE trial) that has shown promising results for TEER to treat tricuspid regurgitation. Also patients frequently have aortic stenosis and mitral regurgitation and in some cases require treatment with both TAVR and subsequently TEER for persistent symptomatic mitral regurgitation after TAVR.
2. Patients with COPD requiring home oxygen therapy or chronic steroid use can still benefit from MR reduction using TEER. Although overall outcomes may be tempered in such patients, overall QoL can be improved from reducing MR. Not all patients with COPD that require home oxygen therapy or chronic steroid use are the same — in some it would be considered futile to attempt TEER, but in others it would be reasonable. Due to the heterogenity in such patients, consideration should be given to changing the NCD phrasing such that it is up to the heart team to decide in which cases TEER would be futile and in which cases there is a reasonable chance of improving QoL or mortality (similar to the heart team decision making process for TAVR).
3. There are numerous publications showing great clinical improvement after TEER in patients with hemodynamic instability requiring inotropic or mechanical support. Excluding coverage for these patients would withhold this treatment option which has been shown to be effective for such patients. It would be more favorable for the NCD to state that it is up to the heart team to decide which of these types of patients would have reasonable chance of clinical improvement with TEER — as above in #3, patients with 3-4+ MR and hemodynamic instability are hetergenous.
4. I agree with expanding coverage to patients with FMR as per the COAPT trial results.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

1. Surgery for FMR has not shown to have any survival benefit and is not the standard of care. There is very high rate of recurrence of MR in these patients following surgery. A CT Surgeon has been an integral part of any structural heart team operations, specially TAVR where both SAVR and TAVR are both excellent options. However we should get rid of this requirement of face to face evaluation with CT Surgeon before TEER can be offered to the FMR patient. This creates confusion, is un-necessary and can potentially delay timely care to these patients.

2. In real life, many of the FMR patients have co-existing severe TR as part of the disease process as the annular dilation can affect the right side of the heart as well. TEER is the ONLY major therapy that has shown mortality benefit and positive results across all the end-points including repeat hospitalizations, quality of life, etc in the very well done COAPT Trial for severe FMR patients. To exclude coverage for this potentially game changing therapy for patients with co-existing other valvular disorder, importantly TR is thus difficult to comprehend. We should absolutely get rid of this condition from coverage decision. I think it is a mistake to copy this exclusion from a COAPT trial setting to real life practice where as such we already have limited good options available which are as robust as TEER.

3. As seen in different case reports, case series and also from personal experience, salvage TEER in patients with hemodynamic instability like cardiogenic shock, inotrope support or who are on mechanical support can save lives and help them transition to recovery. Device trials will always exclude these patients from enrollment, but when it comes to coverage decision, we should allow clinical judgement of the heart team to make decisions on these patients. I think we should also allow local heart teams to make best clinical judgement to offer TEER to patients with LVEF < 20% as many of these patients have already exhausted all the options and are still symptomatic. TEER has shown to delay need for LVAD and transplant in FMR patients making this therapy even more clinically relevant in this subset of patients.

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

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

The Interventional Echocardiographer have specific training and certification to be eligible to guide interventional procedures. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. This is true for both academic and private practice centers. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:
Interventional echocardiographer:

A board-certified physician, also certified in Perioperative Transesophageal Echocardiography with professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures, as well as advanced training in those procedures.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

Again, I support the inclusion and identification of the essential role of the echocardiographer in this procedure as a key member of the heart team.

Sincerely yours,

Jeffrey C. Astbury, MD, FASA, FACC, FASE, MSBE, MSEE
Vice Chairman of Cardiovascular Services
Director of Perioperative Echocardiography
Department of Anesthesiology
Butler Health System
Clinical Assistant Professor
Lake Erie School of Osteopathic Medicine
jastbury@zoominternet.net
412-849-6105

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

I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists.

Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:
Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team

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1. Face to Face: I would propose telehealth should be allowed for an evaluation by a second physician. Patient's should not have to travel hours to see two independent physicians as this can delay the appropriate therapy.
2. TR in conjunction with FMR: The number one cause of TR in severe MR is the severe MR. TR can get better with therapy.
3. Surgical Volume >40/year: Very few new programs will be able to reach these numbers to establish a program and can restrict access to patient care.
4. Heart Failure Consult: I would propose a formal heart failure evaluation as COAPT has taught us the power of medical therapy. MR can improve on good medical therapy including: ACEI/ARB/ARNI/BiVICD.
5. Hemodynamically unstable patients can get better with treating their valvular heart disease.

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July 30, 2020

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

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

Dear Ms. Syrek Jensen,

Edwards Lifesciences (“Edwards”) thanks CMS for the opportunity to comment on the National Coverage Analysis (NCA) for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). This cover letter serves as a summary of our attached detailed comments, which review the current scientific data and our recommendations based on those data.

Edwards appreciates CMS’ commitment to ensuring patient access to new medical therapies through the current policy review. We are encouraged by elements within the draft NCD that will enable mitral valve disease patients to have improved, prompt access to therapy options.

As background, despite the excess mortality associated with mitral regurgitation (MR), a significant number of these patients are not referred for surgery, as they may be considered inoperable or at high surgical risk because of age or comorbidities. TMVR therapy addresses an unmet patient need and has saved lives and dramatically improved the quality of life of patients over the duration of the existing NCD. In addition, as this field continues to emerge, and new evidence is generated, new therapies will be incorporated into clinical practice.

Based on the additional insights gained through study and therapy development since the publication of the NCD in 2014, we believe the policy should be updated to ensure patients have timely access and high-quality outcomes through comprehensive care under the guidance of a Heart Team, with particular consideration of the following:

We believe CMS can use Coverage with Evidence Development (CED), requiring reporting of outcomes in a streamlined registry for a defined period of time, to collect real-world data that ensures high-quality care and enables patient access to new lifesaving therapies with labeled indications. We recommend continuing requirements for participation in a registry, while significantly reducing the data requirements to approximately 50 fields of the most critical information and limiting the duration of the participation to three years. We believe this will ensure high-quality procedures, allow for coverage to label for all TMVR devices and modernize the site requirements to reflect consistency with transcatheter aortic valve replacement (TAVR) site requirements.

We recommend returning Degenerative Mitral Regurgitation (DMR) coverage from Medicare Administrative Contractor (MAC) discretion back to the NCD to preserve timely patient access to current and future therapies and to allow for continued data collection to support quality patient outcomes. Deferring future coverage determinations to MACs could negatively impact patient access if some MACs choose to implement restrictive coverage policies.

Other areas for consideration include the following, which are detailed in the full comment letter that is attached:

• Allow in-person, face-to-face provisions to be satisfied with telehealth visits. During the COVID-19 global public health emergency, CMS preserved continuity of care for structural heart disease patients by allowing them to receive telehealth exams by the Heart Team cardiac surgeon and interventional cardiologist, rather than face-to-face exams. While intended as a temporary measure, we recommend incorporating permanently this provision to support aspects of eligibility evaluation.
• Removal of surgeon sign-off for eligibility. When the initial TMVR NCD was implemented, the policy was limited to the treatment of significant symptomatic DMR, a disease for which there exists a surgical treatment. This same requirement, however, is not applicable to functional mitral regurgitation (FMR) patients, where determination of surgical risk is not applicable. We believe it would be more appropriate to replace the surgeon sign-off for eligibility with a heart failure specialist to support the determination of appropriateness for transcatheter mitral therapy.
• Eliminate exclusion criteria. In the proposed decision memo, CMS provides seven different conditions for which treatment of FMR with transcatheter mitral leaflet approximation is not covered. Continuing the CED registry requirement would allow for timely and ongoing evaluation of the benefits of transcatheter mitral therapy in these sub-populations and ensure access to therapies that FDA has determined are safe and effective.
• Revise the title to reflect transcatheter mitral leaflet approximation (TMLA). It appears CMS intends to define the therapies covered by the policy to be inclusive of catheter-based therapies that approximate the edges of the anterior and posterior mitral valve leaflets at the site of regurgitation. Therefore, we recommend clarifying this intention by revising to a title that more accurately reflects all leaflet approximation therapies.

Edwards thanks CMS for its consideration of our attached TMVR clinical evidence summary and recommendations for the NCD reconsideration. We look forward to working closely with CMS throughout the NCA process and to providing any additional information that CMS may require. For further information, please contact me at 949-250-2500, or at Bernard_Zovighian@edwards.com.

Sincerely,

Bernard Zovighian
Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Edwards Lifesciences

COMMENT LETTER

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Dear Director Syrek-Jensen,

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

The Duke-Margolis Center generates and analyzes across the spectrum of health policy and supports the triple aim of better care, better health, and lower cost. A core mission of the Center is to focus on increasing the value of biomedical innovation to patients. Center experts are engaged in policy research and development efforts to improve the processes and infrastructure needed at CMS to ensure efficient access to new and innovative technologies – including challenges related to coding, coverage, and payment. Key to this work is understanding the performance of health technologies in real-world clinical care through standardized data collection on safety and outcomes.

Duke-Margolis supports the Proposed NCD’s goals to expand coverage of TEER for the treatment of functional mitral regurgitation. Duke-Margolis is, however, concerned that the proposed policies for both clinical indications, functional mitral regurgitation (FMR) indication and degenerative mitral regurgitation (DMR), do not include a formal coverage with evidence development (CED) framework. We believe CED is a valuable mechanism to address uncertainties regarding the clinical data supporting the FMR indication, and the uncertainty regarding the long-term outcomes and durability of the therapy in the DMR indication.

Our comments are guided by the following key principle: Since 2006, CMS has used its authority under Section 1862(a)(1) (A) and Section 1862(a)(1) (E) of the Social Security Act to mandate evidence development as a condition of coverage for certain medical products in the context of research conducted by the Agency for Healthcare Research and Quality.¹ Since then, CED has been a crucial tool in ensuring a wide diffusion of innovative technologies to the Medicare population when there may be uncertainty regarding long-term outcomes, on how well an intervention works in real-world practice settings, on durability, and to determine if there are important subpopulation effects.

CED allows patients to benefit from promising interventions that warrant additional evidence development. It has the potential to provide beneficiaries with more or earlier access to a treatment that is reasonable and necessary, while developing better evidence to inform optimal care decisions. By promoting continued evidence development under real world settings, it helps to address questions that are not informed through clinical trials, such as long-term outcomes and effectiveness, determining the best value for the therapy, and collecting clinical evidence across subgroups of patients or indications. While CED is not meant to be a cost containment mechanism, it helps promote the use of treatments in Medicare beneficiaries who are more likely to benefit, which can be an important tool for increasing value and avoiding unnecessary costs in Medicare.²

CMS first provided coverage for transcatheter mitral valve repair (TMVR; now proposed to be renamed to TEER) in August 2014 under the CED framework for DMR when furnished according to an approved FDA indication.³ Providers were able to fulfill CED requirements by enrolling in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry. The TVT registry was created by a collaboration between the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) and was approved by CMS to meet the registry requirements outlined in the NCDs for TMVR (NCD 20.33) in 2014 and transcatheter aortic valve replacement (TAVR) in 2012 (NCD 20.32). Data from the TVT Registry has been vital for post-market surveillance of TEER, evaluating real world effectiveness, and identifying the operator and institutional criteria that inform therapeutic benefit.

Coverage proposal for FMR
CMS’s analysis notes that evidence from the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial, observational studies, and Medicare claims indicate that TEER for FMR is a promising treatment for Medicare patients. However, CMS notes that “evidentiary gaps remain regarding patient, interventionalist, and facility characteristics that would optimize the risk/benefit balance for TEER in Medicare beneficiaries.”⁴ Further, CMS’s analysis notes that the observational studies do not reconcile discrepancies between the COAPT and Mitra-FR RCTs, and reflect “inconsistent procedures across studies, inconsistent reporting on prescribing and adherence to GDMT, incomplete follow up resulting in under-reporting of adverse events/mortality, varied procedural experience across sties, and varied time points across patients for data collection.”⁴

While CED is notably absent in the proposed coverage decision, CMS does specify specific clinical research questions that should be addressed in future evidence generation. These research questions include patient selection criteria, long term effects, and 1-year follow up of specific clinical endpoints. Although it is encouraging that CMS continues to promote evidence development, and provides guidance on specific research questions, we are concerned that absent a CED framework, CMS will find it challenging to promote voluntary data reporting and reconcile data captured across multiple studies.

Per the current NCD 20.33, all TEER procedures (for DMR) are captured in the TVT registry. However, as CMS notes, these procedures are currently received by < 1% of the Medicare population.⁴ A significantly larger percentage of Medicare beneficiaries could be appropriate for TEER for FMR under the proposed coverage criteria, which may greatly expand the number of hospitals that provide the therapy. By removing conditional coverage, it is less likely that hospitals will newly enroll into the TVT registry. Although the registry creates valuable evidence, it is costly and cumbersome for many hospitals and has limitations.⁵

These are valid concerns for hospitals. However, we believe that there is an opportunity to address operational limitations in the TVT registry by improving electronic data collection methods and streamlining data collection to enable broader patient access and lessen the burden on health care providers. If CMS continues CED under the NCD, there will be incentives for hospitals and the TVT registry to approach data collection that builds off advanced data systems for real world evidence, a less costly and a more effective alternative compared to the current registry. However, by removing the CED requirement there may be little motivation for stakeholders to make these improvements.

Additionally, individual clinical studies could resolve many of the questions that CMS identifies. However, without CED there is less incentive to do those studies, and, as CMS notes in their evidence review for TEER for FMR (CAG00438R) as well as DMR (CAG00438N), there are inherent issues in reconciling data across multiple studies. Per the 2014 NCD for TMVR, coverage under CED ensured that all Medicare patients that receive the therapy would be enrolled in a single national, auditable database. The advantages of a single national registry (or database) include:

• enabling direct comparison across all TEER devices, which will encourage technological improvements and clinical choice;
• analyzing all patients treated by different subgroups and provider types, removing any sample bias based on single institutions like centers for excellence;
• studying durability and long-term effects on a predictable timeline across all patients and subgroups;
• developing a large study population that can help identify and analyze patient, practice, and facility level variables that impact outcomes; and
• developing benchmarks for quality of care and outcomes.

As CMS notes in their analysis of the evidence for FMR, real world outcomes may not replicate those achieved in the COAPT trial, which raises questions about the generalizability of the results.⁴ CMS addresses these concerns by issuing coverage criteria to follow the inclusion criteria of the COAPT trial, however, specifying similar inclusion criteria alone may not be sufficient to replicate the same outcomes. COAPT trial was performed under a strict set of clinical trial circumstances that cannot be reproduced in the real world. The trial specified close involvement of heart failure specialists to maximize medical therapy, echocardiographic core lab adjudication on the severity of mitral regurgitation, and careful pre- and peri-procedural screening of the valve anatomy and other measures. Continued evidence development is important to identify the patient population that can benefit from TEER therapy.

Coverage proposal for DMR
CMS has proposed that TEER for the DMR indication, which has been covered under a CED framework since August 2014, will now have coverage decisions made by local MACs. CMS notes that there is now sufficient evidence to make a coverage determination and due to the low volume of procedures, MACs are better equipped to make coverage decisions based on their understanding of “local patient, physician, and institutional factors, which are especially important when overall prevalence is low.”⁴

While there has been a great deal of evidence on the effectiveness of TEER for DMR, Duke-Margolis believes that there are still questions regarding the long-term health outcomes of patients, as well as the durability of the therapy beyond five years. Continued data collection through a modernized TVT registry that obtains critical data more efficiently would address these questions. By entrusting local MACs on coverage criteria, future data collection will be limited since MACs cannot enforce CED. Even if a local MAC requires CED, the data may be inconsistent and vary among each jurisdiction. TEER needs reliable and efficient evidence development on long-term outcomes, on how well the intervention works in particular practice settings, and important subpopulation effects.²

Multiple coverage policies for different indications, enforced by multiple authorities is operationally challenging. It will be particularly cumbersome for the MACs to determine the indication for each claim and they will need guidance on standardizing across regional areas. Further, the absence of a systematic and predictable approach for coverage and approval can result in additional administrative burdens on health care providers. Finally, in the event there are differing coverage criteria across MAC jurisdictions, there will be uneven coverage for an established procedure and will be counter to goals of equal access to care.

Conclusion

Part of CMS’s charge to improve the health and quality of life of its beneficiaries is linked to ensuring adequate and equitable access to medical therapies, especially with potential transformational technologies. CED achieves this through careful and streamlined monitoring of use of the technology in the real world with the added safety and patient protections provided by expert clinicians in facilities that furnish an appropriate environment with data collection.⁵

Given the conflicting evidence of the therapeutic benefit of TEER on heart failure patients, CED is a reliable means of collecting standard, specific data across all providers. Collecting data from the entire population in a consistent, timely, and transparent manner will help with better understanding safety signals and risk factors. This will result in practice improvements, future device innovations, and improved health outcomes.

*****

The Duke-Margolis Center appreciates CMS’s consideration of our comments, and the Administration’s support for advancing high-value, affordable healthcare. We and our colleagues would be pleased to provide more information on these issues if that would be helpful.

Sincerely,
Mark McClellan – Director, Duke-Margolis Center
Beena Bhuiyan Khan – Research Associate, Duke-Margolis Center
Rebecca Ray – Senior Research Assistant, Duke-Margolis Center
Christina Silcox – Managing Associate, Duke-Margolis Center
Marianne Hamilton Lopez – Research Director, Duke-Margolis Center (marianne.hamilton.lopez@duke.edu)

References

1 Centers for Medicare and Medicaid Services. Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development. Accessed July 24, 2020. Available at: https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27

2 McClellan, M. Comments on Opportunities to Improve Coverage with Evidence Development for Medicare Beneficiaries. Coverage with Evidence Development (CED) Public Comment & Solicitation. 2012. Accessed July 30, 2020.

3 Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for Transcatheter Mitral Valve Repair (TMVR) (20.33). 2014. Accessed July 30, 2020. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=363&ncdver=1

4 Centers for Medicare and Medicaid Services. Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). 2020. Accessed July 30, 2020. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=297

5 Pappas G, Berlin J, Avilas-Tang E, et. al. Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies. BMJ Surg Interv Health Technologies 2019;1:e000003. doi:10.1136/bmjsit-2019-000003. Accessed July 25, 2020. Available at: https://sit.bmj.com/content/1/1/e000003

6 Centers for Medicare and Medicaid Services. Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438N). 2014. Accessed July 30, 2020. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=273

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; andWho is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

2- Face to face evaluation of patients by a surgeon and interventional cardiologist: while this is acceptable for DMR, it is completely unacceptable for FMR. It will increase cost and delay treatment; as there is no role for surgery in FMR, and all the studies has been randomized to medical therapy.

3- There may not be coverage for FMR patients with co-existing tricuspid valve disease requiring treatment. As you know, combined tricuspid and mitral disease is not uncommon. Excluding these patients may not allow for a staged treatment approach and clinical trial consideration. There is an evidence the in many patients, the tricuspid regurgitation improves after treating the mitral valve. It is unfair to not treat these patients.

4- Surgical volume requirements have increased for new sites to 40 mitral valve surgeons, 20 of these need to be mitral valve repairs. This is doubled from the prior requirements. There is also a new surgical volume requirement for surgeons at new sites of 20, 50% repairs. There are two publications which have shown no link between MitraClip outcomes and surgery volume in a hospital and I’d be happy to share them with you.

5- Also proposed is lack of coverage for FMR patients with hemodynamic instability – those requiring inotropic support or mechanical heart assistance. Numerous case reports and series have shown acceptable-to-good outcomes for MitraClip™ in cardiogenic shock patients. We are experienced center for mitraclip and has one of the highest heart transplant and heart failure service for years. It is very common for our heart failure cardiologist to refer those unstable patients, for Mitraclip treatment, as they have seen the dramatic response in these patients that they go home, otherwise their lives would have ended in the ICU. <.p>

6- Signficant portion of the Mitraclip are guided by interventional echocardiographer who is not TTE certfied, as the procedure doesn't require TTE skills, only TEE. If the CMS insists on the rule of only TTE certified echocardiographers to be part of the team, it is unfair for all non TTE echocardiographers who helped in the trials, and treat patients previously, and it will jeopardize patient care, as currently the reimbursement for the echo guidance for this procedure is minimal, that will difficult to find a dedicated person to perform it.

Mitraclip has proven, through many studies, and clinical experience, that it is safe, effective treatment, even in the sickest and elderly patient population. Please don't deny these patients the hope that we were fighting for years to make it commercially available.

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

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

I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. This is true for both academic and private practice centers. There are many great success examples in the literature. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used for the purpose of intra-procedural guidance. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists.

Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

Again, I support the inclusion and identification of the essential role of the echocardiographer in this procedure as a key member of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. I have been the main inerventional echocardigrapher, and our site has been the highest enroller in COAPT, with its excellent results. This NCD is not fair for all non TTE certified echocardiographers that has contributed to making the device available today for treating the patients. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

1. In the Midwestern states comprising largely rural population, people would have to travel extremely long distances to avail these therapies and most likely these patients with severe underlying comorbidities would decline this treatment option and would deprive them of a reasonable opportunity to extend their life or improve their quality of life.

2. I have seen this in my own practice and patients have declined therapy and went on hospice although a TMVR Center was only 50 miles away.

3. Quality of outcomes should remain the focus of maintaining programs rather then the volume standards alone and any of the existing NCDR/ valve metrics could be used to recertify existing programs rather then volume alone.

4. Per operator volume is a better metric to use rather then the center volume as large centers may have multiple operators with per head volume lower then some smaller centers who may have higher volumes per operator.

Therefore it is my opinion that the current standards for maintaining TMVR programs be re-evaluated and a better quality outcomes standard be used to recertify programs which will provide programs a more meaningful way to improve outcomes and provide better coverage of these procedures.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

I fully support expanding coverage of TEER to patients with functional MR. Recent data supports its use in patients that have been managed on GDMT and continue to have symptoms. Surgical intervention has not been shown to have such benefits in this patient population. TEER with the MitraClip device has been approved for use in FMR by the FDA, and as such, CMS coverage should follow suit to provide this lifesaving therapy to the patients who need it most.

The currently proposed coverage is an excellent step in the right direction, however, I believe in its current form it is too exclusive in the patients outlined in the document. While trial data were quite impressive, limiting the types of patients to trial inclusion criteria is overly restrictive and exclusive; many patients that would benefit from TEER would not be able to receive coverage if wording is left as-is. A heart team approach would be significantly more impactful. Specifically, language on coverage based on LVEF, NYHA/CHF class, and LVED is too specific and narrow, as there will certainly be patients that may not fall exactly within these guidelines that will still benefit from TEER therapy. Similarly, language on limitations based on comorbid conditions (TR, oral steroid use, hemodynamic instability, moderate RV dysfunction, PH) is too restrictive and takes over the role of the physician in charge of the patient's care. Allow doctors to make the clinical decisions for their patients.

I believe a true heart team should consist of an interventional cardiologist, a cardiac surgeon, and imaging specialist. While having a surgeon on the team is helpful, I do not think it necessary to have a F2F visit with a surgeon for a consensus to be reached with regard to optimal therapy for FMR patients. Additionally, requirement of a F2F visit with a CHF is also overly burdensome.

I fully support a coverage decision for TEER in secondary MR patients. These patients are best managed with a heart team review that is not handcuffed by narrow anatomical and clinical restrictions, but rather overall clinical judgement based on if a patient would benefit from TEER therapy or not.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

1. For FMR patients, the role of the surgeon in decision making for TEER is not quite clear. To this date, there is no convincing evidence, even in the most biased surgical literature review that surgery either by mitral valve repair or replacement has had any impact on the survival of this very sick patient population. We have learned from COAPT trial that MitraClip in a highly selected patient population whose LV diameter is not significantly out of proportion to the heart failure have survival advantage. We also learned from MITRA-FR trial that in patients who are at end-stage of HF and have significantly large ventricles even at a lower ERO, there would be no benefit of having a surgical option. Thus, the role of the surgeon to potentially operate, esp. in the absence of any evidence, even by CTSN trials continues to be questionable to our program.

2. Mechanical circulatory support systems are excellent tools to save the lives of many of these extremely sick patients. As an instance, in our hospital alone, we have saved at least 4 patients in the end-stage HF to the point that they had the MitraClip procedure and they were discharged directly to home, albeit at a longer hospital stay. Therefore, excluding these patients for the sake of having been on MCS does not suit the real life practice. We do appreciate that in the COAPT trial, these patients were excluded, however, there is always a marked difference between a real life patient population and clinical trial patient population.

3. Heart failure specialist. Although, we agree that patient with advanced HF should be under the care of the specialized HF experts, however, in real life practice well over 3 quarters, if not more, of the TEER centers have not and most likely will never have access to HF specialists. Therefore, this decision, if implemented aggressively, will permanently shut down many programs in the nation.

Furthermore, in real life practice, many of these patients will simply be potentially "mislabeled" as DMR and these centers may continue performing TEER, while the patients information will not appear in the TVT registry with the correct indication or diagnosis.

4. Concomitant valvular heart disease: In the case of severe TR, we have learned from the TVT registry that leaving patients with severe TR, even if we have successful MitraClip procedure, will lead to an annual mortality of nearly 48%. Therefore, it begs the question whether treating concomitant TriClip of these patients should be excluded, while we know that the risk of survival is almost 50%, even in the best case scenario. It is accurate that there is no available randomized controlled data to date to confirm that reduction in TR helps the survival, however, there are multiple registries and international registries that have shown that reduction in TR helps the symptoms of the patients and their HF readmission rate, which is the main driver of the Medicare and Medicaid cost, annually.

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

While I support the role of the surgeon as a valuable member of the heart team, the requirement for a face-to-face surgical consult is ill founded. There is a paucity of compelling data to support isolated surgical repair in this patient population. COAPT compared TEER in combination with GDMT to GDMT alone. This is because optimized GDMT is the standard of care for patients with functional MR, not surgery. By this logic, why would CMS require a face-to-face surgical consult when in fact surgery falls behind GDMT in the guideline recommendations (Class 2B LOE)? This is an unnecessary requirement that will only serve to prohibit access to TEER in the patient population that has preciously few treatment options.

The exclusion of patients with other valvular disease is untenable. The patient population who suffer from TR requiring intervention concomitant with MR is quite significant. This is an arbitrary exclusion criterion pulled from COAPT that was designed for the purposes of the trial to ensure that the benefits observed in the trial were a result of isolated treatment of MR via TEER. This does not mean that patients with concomitant TR/MR do not receive an incremental benefit from TEER. TAVR is not limited to treatment of AS in the absence of concomitant valve disease, why is this restriction being imposed for TEER?

CMS proposes to exclude patients with hemodynamic instability requiring inotropic support or mechanical support. This goes against a recent ACC/SCAI position statement for TEER which suggests that appropriate candidates for the therapy include, “1) inpatients with severe functional mitral regurgitation (MR) (3+/4+) who cannot be safely discharged despite optimized guideline-directed medical therapy by a heart failure specialist; 2) outpatients with severe functional MR (3+/4+) with hospitalization for CHF within 30 days despite optimized guideline-directed medical therapy by a heart failure specialist” (Shah P et. al., JACC Cardiol Intv, 2020). This point was nicely summarized by Matthew Price.

Thank you for your consideration.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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July 30, 2020

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

Dear Ms. Syrek Jensen,

Thank you for the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) for mitral valve (MV) Transcatheter Edge-to-Edge Repair (TEER). ¹ At Boston Scientific, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We develop and supply medical devices in numerous clinical areas, including cardiology, which serve the needs of many patients, including Medicare beneficiaries. Below, we have provided comments to the proposed NCD affecting access to care for patients with mitral regurgitation (MR).

Our comments below relate to:

• Indication expansion to include treatment for functional mitral regurgitation (FMR)
• Elimination of Coverage with Evidence Development (CED)
• Shifting coverage of degenerative mitral regurgitation (DMR) to local coverage by the Medicare Administrative Contractors (MACs)
• Non-coverage of certain patients based on clinical trial criteria
• Shared decision-making including heart team composition, and independent consultation requirements for clinicians
• Surgical volume requirements for new and existing hospitals
• Scope of the National Coverage Determination (NCD)

Indication expansion: Boston Scientific supports the expansion of coverage to include functional mitral regurgitation (FMR).

Based upon the available clinical evidence, Boston Scientific supports expansion of the coverage policy to include treatment of FMR. We commend CMS for its careful evaluation of the existing trials and its recognition that the totality of literature offers evidence that TEER reduces hospital readmissions and improves survival in certain patients. Boston Scientific welcomes evidence-based clinical decision-making and coverage policies in order to offer patients the most innovative technologies. We advocate for consistency in this respect when evaluating future MV therapy options.

Coverage with Evidence Development: Boston Scientific does not support eliminating Coverage with Evidence Development.

Boston Scientific strongly advocates that CMS maintain Coverage with Evidence Development (CED) for TEER, reinstating Section A5 of the TMVR decision memo describing registry requirements.² Although solid data exists to support TEER coverage for treatment of patients with DMR or FMR, ongoing data collection is extremely valuable in this rapidly evolving therapy area. We have consulted leading physicians and researchers on this topic, and they consistently express the importance of access to real world data obtained from the STS/ACC TVT registry for structural heart valve patients. Continued collaboration and linkage between registries and Medicare claims data are essential to maximize the benefit of the CED-gathered evidence.

Ongoing data collection through a CMS-approved registry is the best vehicle for enabling comparisons that are not possible within a controlled clinical trial. The aggregate real-world evidence allows researchers to identify chronological trends and patient safety issues and detect signals prompting future research. Overall this improves the therapy and further refines the appropriate patients and treatment algorithms. Availability of comprehensive real-world data is increasingly important as new innovations in transcatheter technologies emerge to treat patients with MR. As CMS acknowledges, evidentiary gaps exist regarding patient, interventionalist, and facility characteristics and more data would optimize the clinical risk/benefit decisions for Medicare beneficiaries.

High quality, real-world evidence is beneficial to this growing field of transcatheter treatment of the MV. With the lack of differentiation of type of MV regurgitation in the ICD-10-CM coding set, the registry is essential for detecting whether patient characteristics or anatomical determinants of both FMR and DMR impacts outcomes. If MV etiology does influence differences in outcomes, it will be invisible without a registry, as clinical trials are unlikely to be designed to study these kinds of questions. Eliminating CED would result in physicians not having the best information to make decisions for Medicare beneficiaries.

Boston Scientific supports policy updates that reduce administrative burden and encourage innovation, including removing the randomized clinical trial requirement for coverage for uses not expressly listed as FDA-approved indication. Rather than eliminate the acquisition of significant and important data, we suggest a collaborative effort to streamline the registry and make it more transparent and accessible; as well as to simplify collection fields and thereby reduce administrative burden.

Shifting Coverage based on Patient Indications: Boston Scientific does not support removing degenerative mitral regurgitation (DMR) from the national coverage policy.

We disagree with removing DMR from the national coverage policy and shifting to administration by the local Medicare contractors. Shifting coverage decisions regarding DMR to local MACs while keeping FMR at the national level may result in inconsistent patient access to therapy and will further contribute to healthcare disparities. Inconsistent local policies would result in variation in coverage and reduce the ability to acquire consistent, comprehensive evidence to effectively monitor outcomes for these patients. We therefore urge CMS to maintain positive coverage for DMR at the national level to ensure consistency and safeguard patient access to transcatheter MV therapy. Because there is sufficient evidence and generalizability to make reasonable and necessary coverage determinations for TEER in DMR patients, we recommend positive national coverage for TEER therapy for both FMR and DMR, with specific volume requirements maintained for FMR only, as addressed below.

Coverage criteria: Boston Scientific recommends using FDA labeling rather than clinical trial inclusion/exclusion criteria for addressing coverage criteria.

Boston Scientific commends CMS for their careful consideration of new evidence to update the coverage policy and adjust indications regarding TEER therapy. However, defining coverage based upon clinical trial inclusion/exclusion criteria is problematic. Clinical trials typically have strict patient criteria to avoid confounding variables when assessing safety and effectiveness. In clinical practice, patients with concomitant clinical needs may benefit from therapy and should not be denied access.

Boston Scientific recommends a “coverage-to-label” approach, aligning coverage with FDA indications and contraindications to balance patient safety with patient access to innovative therapy options. Evaluation of outcomes in patient populations that were not studied in IDE clinical trials would be best assessed through continuation of CED and mandated data collection in a CMS-approved registry, as previously described.

Shared Decision Making and Physician Evaluations: Boston Scientific supports a heart team approach with adjustments to proposed requirements.

Boston Scientific supports the use of shared decision-making which allows patients, with the counsel of their providers, to evaluate personal priorities and options to determine the best therapeutic options for them as individuals. We commend CMS for adding a heart failure specialist to the team, recognizing the distinctive pathway and needs of FMR patients. However, we recommend modifying the policy in accordance with the patient diagnoses and adding language to distinguish the clinical pathways for DMR and FMR, while keeping coverage for both at the national level.

For patients with DMR, clinical decision-making is based on surgical risk assessment. It is therefore appropriate for patients with a DMR diagnosis to engage in shared decision-making with a surgeon and an interventionalist. For patients with FMR, clinical decision-making is based on the adequacy of patients’ overall heart failure management. FMR patients should therefore engage in shared decision-making with a heart failure specialist and an interventionalist. Furthermore, mitral repair with TEER does not require a surgical bailout, as it does with aortic valve replacement. We therefore suggest that FMR patients do not require independent surgeon sign-off.

To facilitate patient access and minimize barriers for elderly patients, especially those in underserved areas, we also recommend that CMS clarify the requirements that shared decision-making be conducted “face-to-face” for every evaluation. We suggest that COVID-19 exceptions, as defined by Medicare telehealth visits by using telecommunication technology, should be accepted beyond the duration of the pandemic. Separate in-person evaluation increases the burden on patients and providers and can potentially limit or delay appropriate treatment.

Volume and Institutional Requirements: Boston Scientific recommends reducing proposed volume requirements for facilities and operators.

Boston Scientific advocates for adjusting volume and institutional requirements to allow for greater flexibility for hospitals and practitioners to initiate and maintain TEER programs. Two recent studies that explore the relationship between volume of MV surgeries and TEER outcomes found no correlation. ^3,4 A limited number of facilities currently perform more than 40 MV surgeries and heightening volume requirements for new programs will create unnecessary hurdles for smaller and rural hospitals and ultimately limit patient access to appropriate care. Restriction of TEER to sites performing ≥40 yearly MV surgeries disproportionately impacts the upper Midwest and Southeast, due to gaps in geographic access.⁴

We believe that while there should be standards for initiating these kinds of programs, we urge CMS to balance the requirements with the realities of provider experience, to ensure this policy is not worsening existing health disparities. Ideally, quality would be measured based upon clinical outcomes of specific quality measures. Continuation of CED and data collection in a CMS-approved registry could provide the meaningful data to inform such measures. However, until such measures have been defined and validated, we recognize the need to rely on surrogates such as the reasonable volume requirements. Under previous volume requirements, there are no indicators to signal a patient safety issue. We therefore suggest reducing the volume requirements for FMR to be the same as prior NCD levels and eliminating distinction between new and maintenance programs. As previously stated, we propose that these reduced volume requirements be applied to FMR only, and that DMR not be subject to these requirements

Scope of NCD: Boston Scientific supports future expansion of the coverage policy to accommodate a broad range of MV therapeutic options

Boston Scientific advocates for a future coverage policy that focuses on transcatheter repair options for MR, singularly accommodating a variety of technologies to address MV function. Please see the appendix for a literature review that justifies this perspective. We urge CMS to consider future transcatheter technologies that are being developed to treat a greater range of MR patients as this TEER policy is finalized. This forward-thinking approach will provide CMS with flexibility in extending coverage to more MR patients with innovative therapies, when safety and effectiveness have been established.

A comprehensive policy at the national level will provide for physician flexibility to choose devices and treatments based on patient etiology along with valve morphology and dysfunction, and will also facilitate appropriate patient access for a disease state with a historically high untreated rate.⁵ As new devices come to market for treating patients with MR, we encourage consideration of one broad MV policy that covers all transcatheter MV technology types, according to their FDA-approved indications. This “coverage to label” policy would align with goals to reduce burden and encourage innovation. This allows structural heart programs to have flexibility with how they treat patients, ensuring the best option for each patient. Establishing a single national coverage policy, albeit with appropriate distinctions for FMR and DMR patients, to address MV repair options will be advantageous in facilitating patient access and supporting evidence-based clinical decisions.

Boston Scientific welcomes the opportunity to comment on this proposed NCD. We support timely patient access to high-quality care, so that clinicians can provide appropriate therapeutic options to all people with mitral valve disease. Ongoing data collection of real-world evidence through CED improves the therapy and further refines identification of appropriate patients and treatment algorithms. We anticipate future technologies will become available to treat patients with degenerative and/or functional MR. We envision a cohesive approach that is built on the foundation of this TEER NCD - a single national coverage policy for both FMR and DMR patients that maintains coverage with evidence development.

In summary:

Thank you for this opportunity to comment and for considering our attached clinical evidence summary supporting our recommendation for future expansion of the scope of this NCD. We look forward to providing any additional information CMS may require as you work toward a final NCD for mitral regurgitation.

Sincerely,

Maria Stewart
Vice-President, Global Health Economics and Market Access

1 National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R), (accessed 7/30/20): https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=297

2 National Coverage Determination (NCD) for Transcatheter Mitral Valve Repair (TMVR) (20.33), (accessed 7/30/20): https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=363&ncdver=1&NCAId=297&TimeFrame=30&DocType=All&bc=AAAAIAAAQAAA&

3 Barker CM, Reardon MJ, Reynolds MR, Feldman TE. Association Between Institutional Mitral Valve Procedure Volume and Mitral Valve Repair Outcomes in Medicare Patients. JACC CI 2020, Vol. 13: 1137-1139.

4 Vemulapalli S, Prillinger J, Thourani V, Yey RW. Mitral Valve Surgical Volume and Transcatheter Mitral Valve Repair Outcomes: impact of a Proposed Volume Requirement on Geographic Access. J Am Heart Assoc. 2020;9:e016140.

5 Pant, S and KJ Grubb. Percutaneous Mitral Valve Technology: What is on the Horizon? Semin Thoracic Surg 2017; 29:447–450.

TMVR Literature summary BSC Appendix

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July 30, 2020

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

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

The Heart Valve Collaboratory (HVC) is a physician initiated, patient-centric consortium of multidisciplinary stakeholders established to identify and address knowledge gaps and foster initiatives in the diagnosis, prevention and treatment of valvular heart disease. Among the four mission goals of HVC is to create a vehicle for communication and relationship building among all stakeholders to advance the efficiency of regulatory policy, invention and innovation, and implementation science in valvular heart disease. As a community of stakeholders engaged in the treatment of patients with valvular heart disease, we feel that we are uniquely positioned to submit comments addressing the proposed decision memo and national coverage determination (NCD) for transcatheter mitral valve repair (TMVR), renamed TEER (transcatheter edge-to-edge repair) that may have impactful consequences, both now and in the future.

Coverage with Evidence Development (CED)

We would first like to address the absence of a requirement for participation in a national registry under coverage with evidence development (CED) which has played a critical role in new medical device innovation and post approval medical device surveillance over the past decade. When a new and innovative medical device receives regulatory approval by the US Food and Drug Administration (FDA), there are many remaining questions and evidence gaps that are not and cannot be answered in the pre-approval trials. The FDA evidentiary standard for PMA device approval is demonstration of a reasonable assurance of safety and effectiveness rather than demonstration of absolute safety and/or effectiveness. It is also important to note that safe and effective performance of a device in the real world is dependent to varying degrees on the experience, expertise and training of the implanting physician and team. This is particularly true for TEER, where the heart team is essential for choosing appropriate patients, but the team performing the procedure is interdisciplinary involving implanters, imagers, and anesthesiologists. From a patient perspective, overall performance evaluation needs to account for all of the variables associated with patient selection, implantation procedure and post procedure care to properly assess patient benefit. This differentiation was acknowledged by the FDA in 1982 when it formed the Center for Devices and Radiologic Health (CDRH) focused specifically on the unique aspects of the medical device regulatory process. The Center for Medicare and Medicaid Services (CMS) also recognized this differentiation between devices and drugs when in 2005 it introduced CED. Since that time CED has been applied to many cardiovascular and non-cardiovascular devices and has served as an important tool in providing Medicare beneficiaries, and ultimately all patients in the US, earlier access to carefully studied, lifesaving medical technology. Indeed, the presence of a robust post-market device surveillance platform enabled by CED, has allowed the FDA to reliably shift the pre-/post- market regulatory approval balance favoring an earlier time in the total product life cycle of medical devices. Another consequence of this shift has been to allow earlier access to innovative medical devices in the US including the Early Feasibility Study program. This collaboration between the two agencies of the Department of Health and Human Services, CMS and the FDA, is a prime example of how working together greatly benefits US patients.

However, implementation of CED for cardiovascular devices has not been seamless and significant concerns and dissatisfactions exist. Major concerns include the current methodology for data gathering via CED which is burdensome and expensive for industry sponsors and clinical sites and that the evidence generated is not easily accessible to the multiple stakeholders contributing to the platform. Lessons from this experience can inform a revised less-burdensome process for the future – i.e. ‘we shouldn’t throw out the baby with the bath water’.

Many of the major clinical questions regarding the care of patients with innovative medical devices cannot be routinely answered in the pivotal trials that lead to regulatory approval. The strict inclusion/exclusion criteria of these trials frequently exclude patients who may possibly benefit. Specifically, evidence for TEER is lacking for patients with FMR and concomitant severe tricuspid regurgitation, hemodynamic instability requiring inotropes, mechanical heart assistance, chronic obstructive pulmonary disease with home oxygen and pulmonary hypertension, all of whom were excluded from the trials. Without CED, knowledge as to whether these patients would benefit will be lacking. Furthermore, it is unknown if the outcomes obtained under the strict conditions of clinical trials can be generalizable to the real world where patients are treated in non-expert centers without the close monitoring, careful follow-up and optimal medical therapy experienced in trial settings. CED offers the opportunity to generate the additional evidence necessary to determine the patients who are most likely to benefit in what conditions as well as those who will not. Specific questions such as these lend themselves to be best answered by CED with the ability to sunset the CED when the questions are sufficiently answered.

The HVC, as a not-for-profit, multi-stakeholder group, is uniquely positioned to bring all groups together who would benefit from the evidence generated by CED including clinicians, patients, sponsors, regulators and payers to help design and implement a more efficient and less expensive model. In point of fact, a working group convened by the Duke Clinical Research Institute operating under the umbrella of the HVC is currently actively engaged in creating a “mitral lean case report form” of the minimal core data set to define the least amount of required data to fill the evidence gaps for TMVR defined under CED. The goal of this more practical and least burdensome approach, likely supported by industry sponsors and the FDA, would be to address the unanswered questions under CED.

National Coverage Determination for DMR

The second concern regarding the proposed NCD Decision Memo is the proposal to leave coverage decisions for degenerative mitral regurgitation (MR) to the local Medicare Administrative Contractors (MACs). Having a bifurcated coverage policy for MR is likely to create chaos in the provider community leading to variability in access to care. Leaving the decisions of whether the MR is functional (covered under the NCD) or degenerative (not covered) or “mixed”- as 15% of currently treated cases are classified (covered or not covered?) as proposed will create confusion to clinicians, patients and payers adversely affecting access to expeditious and appropriate care. Furthermore, having uniform national coverage for FMR and leaving coverage determination for DMR to 12 regional MACs is likely to create heterogeneity in coverage and access to care. It may also create unanticipated incentives for clinicians to classify patients inappropriately in order to provide what they believe to be best care. Without an NCD for DMR, there will be no national mechanism for tracking real-world appropriate use of the TEER therapy for DMR and as a result, use of the device in operable DMR patients as well as patients who may not benefit from the procedure could become widespread.

Clinical Site Procedure Volume Criteria

The third concern in the proposed decision memo is the volume criteria for both initiating and maintaining a TMVR program. Volume metrics for both institution and operators have traditionally been used as a surrogate tool to measure quality. These metrics have been used because of the difficulties in accurately assessing the quality of procedural outcomes especially in low volume institutions due to the wide confidence intervals of the measured outcomes metric. The currently proposed volume requirements in the NCD are based on professional society consensus statement guidance. However, there is uncertainty as to whether these criteria have set an appropriate or unrealistic bar to ensure excellent procedure outcomes while maintaining needed patient access to care.

Additionally, those volume requirements are likely to change over time and likely will be less restrictive as technology matures and procedure performance and experience grows. There are significant concerns by many parties that the volume requirements proposed in the NCD will significantly reduce patient access to novel new therapies. For patients with severe functional MR that have failed best guideline directed medical therapy for heart failure, the edge-to-edge approach is currently the only procedure proven to improve patient outcomes including heart failure hospitalizations and mortality. The current proposed volume requirements would limit this procedure to one in four hospitals that perform open heart surgery. Furthermore, limiting access to the top 20-25% of hospitals quite logically will increase disparity of care among the minority communities that already struggle with access to care. All stakeholders would agree that the high quality standards demonstrated in a new device pivotal clinical trial should be maintained in the real world setting. The HVC believes that transitioning to a CED represented by a minimalistic registry to track basic outcomes, would allow relaxation of strict volume requirements, thus ensuring robust patient access while still ensuring high quality patient outcomes. Over time, volume requirements can be revisited based upon real-time, real-world outcomes data. While a reduced format registry still imposes some burden on sites and industry sponsors, this can be further minimized by creating an incentive-driven tiered voluntary site participation approach. In the midst of a protracted pandemic and racial unrest, the introduction of policies which would undoubtedly reduce access to care, disproportionately affecting underserved populations, is antithetical to the espoused patient-centered goals of the FDA and CMS. By continuing a least burdensome, modified CED process CMS could provide non-bifurcated coverage via a single NCD for all types of MR, allowing us to promote quality, monitor quality and inform patients, hospital systems, payers and purchasers who will insist on quality. In parallel, however, we do recommend that changes to the current data collection requirements and mechanisms be made so as to assure a more realistic post-market registry data capture mechanism focused on primarily answering critical post-market questions in an efficient and timely manner.

At the Heart Valve Collaboratory, we greatly appreciate the willingness of CMS to be open to feedback and reconsider their coverage proposals with the overarching goal of providing the best possible balance of excellence in care delivery while still offering ready access to care to the broadest proportion of the US population. The Collaboratory is uniquely positioned and committed to working with CMS and other key stakeholders for the purpose of achieving this goal when the final NCD is published.

Respectfully submitted,

On Behalf of the Executive Committee of the Heart Valve Collaboratory
Michael J. Mack, MD
Martin B. Leon, MD

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

I would also recommend adding a heart failure specialist be involved in the "heart team" decision making for TMVr. This is especially important to help improve patient selection and avoiding putting MitraClips in patients who have significant negative remodeling with severe LV dilatation or not severe MR (proportionate to cardiomyopathy), who may benefit from advance heart failure therapies like LVAD's or heart transplants instead.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists.

Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

1) requirement of face-to-face evaluation by a cardiac surgeon is not consistent with the 2020 Focused Update of the 2017 ACC Expert Consensus Decision Pathway on the Management of Mitral Regurgitation. The document outlines a HF physician and an interventional cardiologist evaluation is recommended for FMR patients. The document goes on to clarify that individual surgeon evaluation may be considered under certain circumstances – specifically when there is a potential need for other surgical therapies. The ACC recommendation makes more sense. In real world experience, the decision is best made by the heart failure cardiologist and the interventional cardiologist. The heart failure cardiologist can make such determination better than a surgeon who should only be brought into the decision making if surgical treatment should be considered. I recommend that pre procedure evaluation be done by a heart failure cardiologist and an interventional cardiologist, with optional chart review by or verbal discussion with a cardiac surgeon.

2) Proposed non-coverage for certain patients with multi-valve disease, those requiring inotropic support or mechanical heart assistance, and other coexisting conditions. We have anecdotal experience that such patients could benefit from TMVR significantly if carefully selected. The proposed restriction could deprive these patients from this therapy which very often could be the only effective therapy short of LVAD or heart transplantation for such patients. I recommend that these patients be evaluated and approved by the local multidisciplinary valve team on case by case basis.

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

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

I wish to also provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. This is true for both academic and private practice centers. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

Again, I support the inclusion and identification of the essential role of the echocardiographer in this procedure as a key member of the heart team.

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Thank you for allowing coverage for Secondary MR patients.

We have concerns about the following:

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

*SURGEON AND IC REQUIRED FACE-TO-FACE EVALUATION FOR FUNCTIONAL MR
(This should be removed, surgeons do not manage heart failure in the outpatient setting. SMR patients don't do well with surgery according to current literature, therefore no need for evaluation by surgeon)

*NEW HEART FAILURE PHYSICIAN SPECIALIST REQUIREMENT
(Please remove. This is redundant, all ICs are capable of managing HF patients according to guidelines)

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Charles N. Kahn III
President and CEO

July 30, 2020

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

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

Dear Ms. Syrek Jensen:

The Federation of American Hospitals (FAH) is the national representative for over 1,000 leading tax-paying hospitals and health systems throughout the United States. FAH members provide patients and communities with access to high-quality, affordable care in both urban and rural America. Our members include teaching and non-teaching, acute, inpatient rehabilitation, behavioral health, and long-term care hospitals and provide a wide range of inpatient, ambulatory, post-acute, emergency, children’s, and cancer services. We appreciate the opportunity to comment to the Centers for Medicare & Medicaid Services (CMS) on the Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R).

We appreciate CMS’s recognition of the evidence and are supportive of the rationale for a Transcatheter Edge-to-Edge Repair (“TEER”) National Coverage Determination (“NCD”) revision to include patients with Functional (secondary) Mitral Regurgitation (“FMR”). We agree with the removal of Coverage with Evidence Development (“CED”) or registry requirement as there is adequate data from the FDA-approved trial which met all endpoints and showed an overwhelmingly mortality benefit1. While generally aligned, we recommend revising the NCD to simplify format, remove redundancies, and ensure adherence.

Comments on recommend revisions for consideration below:

1. Include Primary (degenerative) Mitral Regurgitation (“PMR”) in the NCD to ensure consistency:
   
   • We believe all FDA-approved indications should be covered under the purview of a single NCD. Shifting PMR to local Medicare Administrative Contractors (MACs) will cause inconsistency in the care of Medicare beneficiaries across the country.
2. Reduce volume requirements to enable adequate access for all Medicare beneficiaries and increase likelihood of program adherence.
   • As proposed, many FAH member hospitals would have difficulty meeting current mitral requirements:
   • Potentially only a limited number of FAH member hospitals’ existing TEER programs would meet qualifications for hospital programs with mitral valve TEER experience as outlined (≥ 20 transcatheter mitral valve interventions per year or ≥ 40 interventions every two years; and ≥ 20 mitral valve surgeries per year or ≥ 40 every two years)
   • Very few if any FAH member hospitals (non-TEER programs currently) would meet qualifications for hospitals without mitral valve TEER experience as outlined (≥ 40 mitral valve surgeries in the previous year prior to program initiation, at least 20 of which are mitral valve repairs)
   • Given recent publications demonstrating little relationship between mitral valve surgical volumes and transcatheter mitral valve repair outcomes for FMR^1,2,3,4, we recommend reducing mitral valve volume requirements to 20 per year rather than 40.
   • Proposed language for program with experience: ≥ 20 transcatheter mitral valve interventions per year at least 10 of which are mitral valve surgeries, or ≥ 40 interventions in two years
   • Proposed language for programs without experience: ≥ 20 mitral valve surgeries in the previous year prior to program initiation, at least 10 of which are mitral valve repairs
   • FAH recommends the ‘PCI’ volume requirement be changed to ‘cardiac interventions’ to allow for inclusion of other closely aligned procedural experience (i.e., Transcatheter Aortic Valve Replacement, Left Atrial Appendage Occlusion, Atrial Septal Defect, other structural/transeptal interventions)
3. Condense Heart Team requirements to one section to remove redundancy, reduce number of surgeons required and enhance imaging language to account for use of a cardiac anesthesiologist:
   
   • FAH recommends reducing the required number of surgeons on the heart team from two (2) to one (1), especially for evaluation of FMR where surgical treatment is not a good option^2,3.
   • Given that imaging may be performed effectively by an experienced anesthesiologist, suggest removing the requirement of having an interventional echocardiographer.
4. Remove face-to-face surgical evaluation requirement for FMR: The need for face-to-face consultation by a cardiac surgeon for all patients being considered for TEER is not necessary. It is clear PMR and FMR are different and should have different requirements. In patients with PMR, mechanical repair/replacement is the treatment of choice. Based on the literature, including the latest guidelines, surgery is standard of care for non-high surgical risk patients. It is therefore reasonable for all patients with PMR being evaluated for TEER to be seen face-to-face by a cardiac surgeon. For patients with FMR, the current guidelines suggest surgery is not necessarily a treatment option. In a recent analysis of the Society of Thoracic Surgeons (“STS”) database4, isolated mitral valve surgery for FMR constituted less 5% of all mitral valve surgeries performed in the United States. Most of these patients are treated with medical treatment by heart failure specialist3. On the other hand, mitral valve repair using TEER has shown significant improvements in morbidity and mortality. Therefore face-to-face surgery consultation for patients with FMR is not necessary in all patients, unless the heart team thinks otherwise.
5. Simplify inclusion/exclusion criteria to reduce limitations for patients who may benefit and to account for real-world clinical practice, for example:
   • Replacing ‘stable doses of maximally tolerated’ with ‘appropriate’ will allow clinicians to intervene in a timely fashion
   • Including a left ventricular ejection fraction upper limit of 50% will inadvertently limit care for those that may benefit. The clinically important limit is the lower limit of < 20%. In patients with very low ejection fractions (< 20%), the ventricular function may be so compromised, to allow any benefit from mitral valve repair. On the other hand, if a therapy benefits patients with ejection fractions of around 50%, it would definitely benefit patients with higher ejection fraction with a suitable anatomy.
   • Simplification of the initial inclusion criteria to add the word ‘symptomatic’ encompasses NYHA class and other factors without having to list all.
   • Excluding patients based on ventricle size would unnecessarily impede the care of Medicare beneficiaries.
   • Some of the contraindications were placed in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (“COAPT”) trial to avoid confounding variables which may have affected the results. However, in clinical practice, these patients could be very good candidates for this therapy who would otherwise have no other options. For example, excluding patients with a ventricle size of >70mm or those requiring inotropes would prevent these patients from receiving life-modifying and life-saving procedure would be very unreasonable. Undue restrictions may prevent clinicians from making for appropriate medical decisions².
   • Excluding patients based on coexisting Aortic or Tricuspid disease eliminates a significant subset of patients that may not be candidates for surgery but could benefit from TEER. We recommend modifying this exclusion criteria, to patients who need prior surgical/transcatheter treatment of other valvular heart disease.
   • Excluding patients simply based on prior use of home oxygen may limit those who would potentially benefit from TEER. There are many patients who are on home oxygen therapy for heart failure, who would benefit from this treatment option.

In consideration of the above comments, we recommend the NCD be revised to read as outlined below.

Revised proposed TEER NCD:

For clarity, we are replacing the term Transcatheter Mitral Valve Repair (TMVR) with mitral valve Transcatheter Edge-to-Edge Repair (TEER) to more precisely define the treatment addressed in this proposed NCD, which is applicable to TEER for the treatment of functional mitral regurgitation (MR) and degenerative MR.

A. The Centers for Medicare & Medicaid Services (CMS) proposes that coverage of Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve for the treatment of functional (secondary) mitral regurgitation (FMR) is reasonable and necessary under § 1862(a)(1)(A) of the Act under the conditions set forth below.

1. TEER of the mitral valve for the treatment of symptomatic moderate-to-severe or severe FMR when the patient remains symptomatic despite appropriate guideline-directed medical therapy (GDMT) is covered as follows:
   1. Eligible patients must also meet the following criteria:
      1. Symptomatic ischemic or non-ischemic cardiomyopathy with a left ventricular ejection fraction of ≥ 20%; and
      2. Local heart team has determined that mitral valve surgery will not be offered as a treatment option.
   2. Patients do not have any of the following conditions:
      3. Significant valvular disease requiring other surgical or transcatheter intervention; or
      4. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months; or
      5. Patients in whom existing co-morbidities would preclude the expected benefit from correction of the mitral valve.
2. TEER of the mitral valve must be furnished according to an FDA-approved indication and meet the following conditions:
   1. 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. Heart team must include:
      1. Physician specialist experienced in the care and treatment of heart failure and valvular heart disease; and
      2. Physician(s) experienced in pre, post and intra-procedural imaging:
         1. With professional experience of ≥ 10 trans-septal guidance procedures and ≥ 30 structural heart procedures; and
         2. Who is board eligible or certified in transthoracic and transesophageal echocardiography with advanced training per the American Society of Echocardiography standards; and
         3. Has device specific training as required by the manufacturer
      3. Appropriately trained implanting physicians who have appropriately trained and qualified [interventional cardiologist and surgeon] who:
         1. Independently examined the patient, evaluated the patient’s suitability for surgical mitral valve repair, TEER, GDMT, or palliative therapy; and
         2. Documented and made available to the other heart team members the rationale for their clinical judgment; and
         3. Has professional experience
            • Interventional Cardiologist: ≥ 100 career structural heart disease procedures; or ≥ 30 left-sided structural procedures per year; and has participated in ≥ 20 career trans-septal interventions including 10 as primary or co-primary operator
            • Cardiac Surgeon: 20 combined valve interventions per year/40 for two years (transcatheter and surgical)
         4. Is board eligible or certified in interventional cardiology; and
         5. Has device specific training as required by the manufacturer
      4. Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.
   2. The heart team's implanting physician must perform the mitral valve TEER. Interventional cardiologist(s) and cardiac surgeon(s) may jointly participate in the intra-operative technical aspects of TEER as appropriate.
3. Mitral valve TEERs must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:
   1. On-site heart valve surgery and interventional cardiology programs,
   2. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
   3. Appropriate volume requirements per the applicable qualifications below:

There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous mitral valve TEER experience and the second set is for those with mitral valve TEER experience.

Qualifications to begin a mitral valve TEER program for hospitals without mitral valve TEER experience:

The hospital program must have the following:

1. ≥ 20 mitral valve surgeries in the previous year prior to program initiation, of which at least 10 are mitral valve repairs; and
2. ≥ 300 cardiac interventions per year; and
3. ≥ 1 physician with cardiac surgery privileges experienced in valvular surgery (see below for details); and
4. ≥ 1 physician with interventional cardiology privileges (see below for details); and

The hospital program must maintain the following:

1. ≥ 20 transcatheter mitral valve interventions or which at least 10 are mitral valve surgeries, or ≥ 40 interventions in two years
2. ≥ 300 cardiac interventions per year; and
3. ≥ 1 physician with cardiac surgery privileges experienced in valvular surgery; and
4. ≥ 1 physician with interventional cardiology privileges; and
5. ≥ 1 physician specialist experienced in the care and treatment of heart failure and valvular heart disease; and
6. ≥ 1 physician experienced in pre, post and intra-procedural imaging.

B. CMS proposes that coverage of Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve for the treatment of degenerative (primary) mitral regurgitation (PMR) is reasonable and necessary under § 1862(a)(1)(A) of the Act under the conditions set forth below.

1. Treatment of symptomatic PMR when furnished according to an FDA-approved indication and when all of the following conditions are met:
   1. Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient and evaluated the patient's suitability for mitral valve surgery and determination of prohibitive risk; and both have documented the rationale for their clinical judgment and the rationale is available to the heart team.
   2. The patient (pre-operatively and post-operatively) 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.
   3. TMVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:
      1. On-site active valvular heart disease surgical program with ≥ 1 hospital-based cardiothoracic surgeon experienced in valvular surgery;
      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 expertise including transthoracic/transesophageal/3D echocardiography, vascular studies, and cardiac CT studies;
      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. Adequate outpatient clinical care facilities
      7. Appropriate volume requirements per the applicable qualifications below.

There are institutional and operator requirements for performing TMVR.

The hospital must have the following:

1. ≥ 20 mitral valve surgeries in the previous year prior to program initiation, of which at least 10 are mitral valve repairs; and
2. ≥ 300 cardiac interventions per year

The heart team must include:

1. An interventional cardiologist(s) who has:
   
   1. ≥ 100 career structural heart disease procedures; or ≥ 30 left-sided structural procedures per year; and has participated in ≥ 20 career trans-septal interventions including 10 as primary or co-primary operator
   2. must receive prior suitable training on the devices to be used; and,
   3. must be board-certified in interventional cardiology or board-certified/eligible in pediatric cardiology or similar boards from outside the United States
2. A Cardiac Surgeon(s) who has:
   1. 20 combined valve interventions per year/40 for two years (transcatheter and surgical)
   2. must receive prior suitable training on the devices to be used; and,
   3. must be board-certified in interventional cardiology or board-certified/eligible in pediatric cardiology or similar boards from outside the United States
   4. Additional members of the heart team, including: cardiac echocardiographers, other cardiac imaging specialists, heart valve and heart failure specialists, electrophysiologists, cardiac anesthesiologists, intensivists, nurses, nurse practitioners, physician assistants, data/research coordinators, and a dedicated administrator;
3. The heart team's interventional cardiologist or a cardiothoracic surgeon must perform the TMVR. Interventional cardiologist(s) and cardiothoracic surgeon(s) may jointly participate in the intra-operative technical aspects of TMVR as appropriate.

References:

1. Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, et al. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. New England Journal of Medicine. 2018;379(24):2307-18. https://www.nejm.org/doi/10.1056/NEJMoa1806640

2. Shah P et al, J Am Coll Cardiol Intv. Triage Considerations for Patients Referred for Structural Heart Disease Intervention During the COVID-19 Pandemic. 2020 Jun, 13 (12) 1484-1488.) https://interventions.onlinejacc.org/content/13/12/1484

3. Bonow, et al. J Am Coll Cardiol. 2020 Focused Update of the 2017 ACC Expert Consensus Decision Pathway on the Management of Mitral Regurgitation. 2020 May, 75 (17) 2236-2270 https://www.onlinejacc.org/content/75/17/2236.abstract

4. Gammie JS et al, Ann Thorac Surg. Isolated Mitral Valve Surgery: The Society of Thoracic Surgeons Adult Cardiac Surgery Database Analysis. 2018 Sep;106(3):716-727 https://pubmed.ncbi.nlm.nih.gov/30032907/

* * * * * * * *

The FAH appreciates the opportunity to comment on the proposed NCD. If you have any questions about our comments or need further information, please contact me or Steve Speil, EVP, of my staff at sspeil@fah.org or 202-624-1529.

Sincerely,

cc: Joseph Chin, MD, MS
Steven A. Farmer, MD, PhD
Melissa A. Evans, PhD, MSAE
Lori M. Ashby, MA
Andrew Ward, PhD, MPH
Patricia Bright, PhD, MSPH
Daniel A. Caños, PhD
Sarah Fulton, MHS
Kimberly Long

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Thank you for allowing coverage for Secondary MR patients.

We have concerns about the following:

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

*SURGEON AND IC REQUIRED FACE-TO-FACE EVALUATION FOR FUNCTIONAL MR
(This should be removed, surgeons do not manage heart failure in the outpatient setting. SMR patients don't do well with surgery according to current literature, therefore no need for evaluation by surgeon)

*NEW HEART FAILURE PHYSICIAN SPECIALIST REQUIREMENT
(Please remove. This is redundant, all ICs are capable of managing HF patients according to guidelines)

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

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

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

I wish to also provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. This is true for both academic and private practice centers. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

Again, I support the inclusion and identification of the essential role of the echocardiographer in this procedure as a key member of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

Sincerely,
Eveline Stock, MD

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July 30, 2020

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

Dear Ms. Syrek Jensen:

The Advanced Medical Technology Association (AdvaMed) is pleased to offer the following comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed decision memorandum for Transcatheter Mitral Valve Repair (TMVR).¹

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.

Our comments below relate to: expanding the scope of the existing National Coverage Determination (NCD) to include transcatheter mitral valve (TMV) treatment for significant symptomatic functional mitral regurgitation; surgical volume requirements for new and existing hospitals; face-to-face consultation requirement for surgeons; non-coverage of certain patients; and general comments on coverage with evidence development (CED), as well as its potential application to support beneficiary access as part of this NCD. While AdvaMed has no comment on the proposed change in terminology from transcatheter mitral valve repair (TMVR) to transcatheter edge-to-edge repair (TEER), in this comment letter, we use the term TEER for consistency.

General Comments – Indication Expansion to Functional Mitral Regurgitation
AdvaMed commends CMS on its proposal to extend Medicare coverage for TEER to Medicare beneficiaries with functional mitral regurgitation (FMR). Despite consideration of some disparate clinical trial results, the COAPT™ study demonstrated mortality, morbidity and quality-of-life benefits that should be available to Medicare beneficiaries. AdvaMed supports evidence-based clinical decision-making in order to offer patients the most innovative technologies when they are proven safe and effective.

Volume Requirements
AdvaMed is disappointed that CMS continues to rely on mitral surgical volume requirements for defining the qualifications to begin a TEER program. We also note the disparity in surgical volume requirements for existing versus new TEER hospitals without a data driven justification for this proposal. TEER therapy was first introduced in 2013 and experience with these types of transcatheter procedures has increased without any safety concerns. This clearly does not support increasing these surgical volume requirements, particularly given that surgical intervention is not the standard of care for the treatment of FMR.

It is notable that two recently published studies explored the relationship between mitral valve surgical volumes and TEER outcomes.^2,3 The results of the Barker, et al., analysis confirmed the known relationship between mitral valve surgery volumes and in-hospital mortality but did not find any statistically significant relationships between mitral valve surgery and TEER outcomes. The proposed mitral valve surgery volume requirements to begin a TEER program for hospitals without TEER experience would severely limit the number of new centers able to open in the future. In the analysis by Vemulapalli, et al., which also found no relationship between mitral valve surgery volumes and TEER outcomes, the researchers determined that increasing the threshold for a new TEER program to perform 40 or more mitral valve surgeries per year could result in approximately 30 million individuals having to travel outside of their health referral region (HRR) to undergo a TEER procedure.

As proposed in the decision memo, the increased surgical volume requirements for new TEER hospitals and surgeons will severely restrict the number of potential TEER sites and needlessly restrict patient access to treatment, especially in rural areas among historically vulnerable and marginalized populations.

AdvaMed recommends CMS consider a more flexible, hybrid or blended approach for requirements for new TEER hospitals to align with those established for the TAVR NCD. CMS thus could consider a new site requirement whereby the hospital has performed a defined number of open-heart surgeries with some small proportion of those being on the mitral valve. Adjustments also should be made to the operator requirements under which the surgeon has performed a specified number of open-heart surgeries with some proportion being mitral valve related; and the interventional cardiologist has performed at least a minimum number of career structural heart disease procedures. Aligning with some adjustments to the TAVR NCD site requirements, we believe would allow for appropriate access and site experience in surgical and interventional structural heart procedures.

Consultation Requirement for Surgeons
AdvaMed does not support the retention in the proposed NCD of the “face-to-face” consultation requirement between the TEER patient and the heart team surgeon. Mitral valve surgery is not the standard of care for the treatment of FMR, and in fact, has been shown to not extend the life of an FMR patient. The clinical community made clear its recommendation that FMR patients under consideration for TEER should undergo face-to-face consultations with the interventional cardiologist and with heart failure physician. However, it is unclear why CMS would propose such a rigid requirement for all FMR patients and the heart team surgeon when surgery is not the standard of care for these patients. Instead, AdvaMed would support a consultation between the patient and the heart failure specialist, as recommended by the physician specialty societies.⁴

Ensuring In-person “Face-to-Face” Provisions can be Fulfilled with Telehealth Alternatives
We urge CMS to weigh the value of mandating in-person, face-to-face interactions against the potential burden to patients – particularly rural patients – and health care providers. The ongoing COVID-19 public health emergency has forced a re-evaluation of the necessity for in-person face-to-face interactions between patients and their health care providers. Patients suffering from mitral valve disease are burdened with debilitating symptoms, making travel more challenging. We strongly urge CMS to take a flexible approach with the use of telehealth to assess patient eligibility and readiness for therapy. Telehealth visits should be considered appropriate and should be allowed to fulfill the consultation requirement. Allowing these patients to communicate with their health care providers through a variety of means would allow for mor efficient and less burdensome evaluation.

Non-Coverage of Certain Patients
CMS is proposing specific non-coverage criteria for beneficiaries consistent with the exclusion criteria in the COAPT™ trial referenced in the proposed NCD. Therefore, CMS proposes to exclude from coverage FMR patients with a range of conditions, including coexisting aortic or tricuspid valve disorders and advanced COPD requiring home oxygen therapy. Like any large FDA approval study, the COAPT™ trial had a highly specific target patient population. Many of the exclusion criteria were designed to eliminate intervening health factors that would have clouded the impact of the TEER therapy. AdvaMed believes that maintaining the COAPT exclusion criteria in the NCD would potentially result in an inappropriate restriction on Medicare coverage and beneficiary access. AdvaMed strongly supports the expansion of Medicare coverage in the real world beyond the prescriptive clinical trial population in studies.

We understand that CMS may want to collect additional data in order to track clinical outcomes for these excluded patient populations. AdvaMed supports coverage with evidence development as a necessary pathway for coverage when there are gaps in the existing evidence base, as for the patients that were excluded in the clinical trials. We support CMS’ encouragement of continued collection of real-world evidence and willingness to consider other ways to generate evidence that may inform future CMS decision-making.

Coverage with Evidence Development
AdvaMed has previously commented on Medicare’s use of CED in its coverage determinations. We believe that CED can serve as an appropriate pathway for coverage in cases where evidence development and data collection are essential to answer important, outstanding clinical questions. However, appropriate guardrails should apply. When Medicare coverage is contingent on the collection of additional clinical or scientific evidence (beyond FDA requirements for safety and efficacy), CMS should:

As CED generates evidence supporting the use of a new innovation or services, AdvaMed believes that Medicare’s coverage policies should reflect these outcomes and minimize additional requirements.

AdvaMed greatly appreciates the opportunity to comment on this proposed NCD. 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 cbranham@AdvaMed.org.

Sincerely,

Donald L. May
Executive Vice President
Payment & Health Care Delivery Policy

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July 30, 2020

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

Dear Administrator Verma,

Heart Valve Voice US is a nonprofit patient advocacy organization that provides a united voice for people living with heart valve disease. We advocate for early detection, meaningful support, and timely access to appropriate treatment for all people affected by heart valve disease.

We welcome the proposed National Coverage Determination (NCD) from the Centers for Medicare & Medicaid Services (CMS) recognizing that Transcatheter Edge-to-Edge Repair (TEER) for functional mitral valve regurgitation is reasonable and necessary. Mitral valve regurgitation is the most common form of valvular disease, affecting an estimated 9.3 percent of the population age 75 or over . This proposed NCD represents an important step forward for these patients.

We are generally supportive of the removal of the “Coverage with Evidence Development” designation but have some concerns about ongoing data collection, which we see as essential, as well as the future ability to cover additional conditions without supplementary evidence.

Our comments are focused on three areas: the limited nature of this NCD, both in terms of conditions covered and future application; the continued requirement for burdensome “face-to-face” appointments when telehealth has proven to be more than sufficient; and the ongoing surgical volume requirements for new and existing centers that have no scientific basis, are anti-competitive, and only serve to limit patient access.

We appreciate the Centers for Medicare & Medicaid Services’ (CMS) thoughtful consideration and adoption of recommendations from advocacy organizations representing patients and family caregivers.

Comments on Proposed National Coverage Decision

Scope of NCD

Heart Valve Voice US, along with many other concerned entities, had anticipated a broader NCD, potentially covering a range of emerging mitral valve technologies, including transcatheter mitral replacement devices. We believe such an approach would facilitate ease of access and coverage for patients, while also providing a predictable reimbursement pathway for manufacturers. Currently, according to clinicaltrials.gov, there are at least 15 trials underway in the United States for transcatheter devices to treat mitral regurgitation. Surely, CMS would not seek to undergo the NCD process for each of these devices that ultimately receives FDA approval. Such a regime limits patient access to the latest and most appropriate technologies while creating uncertainty in the medical community.

Further, under this NCD, CMS specifies seven conditions for which treatment of FMR is not covered even though the device is FDA approved for such use. The limitations will exclude coverage for TEER in FMR patients with advanced heart failure and other conditions who may not have other effective treatment options for symptom relief. While evidence on the benefit of TEER for these populations continues to develop, we are concerned that an overly restrictive NCD may not provide sufficient flexibility and will necessitate additional coverage decisions or reconsiderations to allow coverage for additional categories of FMR patients or analogous therapies.

The results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPTTM) trial, as well as most observational studies, illustrate clear improvements in hospitalization rate and mortality, especially in periods exceeding one-year post-procedure. As a result of these findings, the U.S. Food and Drug Administration (FDA) approved TEER In March 2019 for heart failure (HF) patients who have moderate-to-severe or severe FMR despite treatment with optimal medical therapy. The CMS decision supports this determination and allows Medicare patients access to TEER to treat FMR.

We strongly urge CMS to cover FDA-approved, on-label use for devices in this broader category, in a more timely manner, and consistent with the approach taken with the Transcatheter Aortic Valve Replacement (TAVR) NCD. We also encourage CMS to change the name of the NCD to encompass future therapies.

Remove “Face-to-Face” Examination Requirement

We understand the CMS definition of “face-to-face” to mean “in-person.” If this is, in fact, the meaning, we ask that the requirement either be removed entirely or the definition be clearly modified to include telehealth interactions, either through video or other means. During the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE), waivers have been provided to enable the widespread use of telehealth, including waivers for face-to-face examination before a TEER procedure. While these flexibilities are temporary and tied to the PHE, the widespread uptake and increased comfort level with telehealth by both providers and patients has created significant support for a permanent adoption of telehealth.

Requiring patients to attend multiple, in-person appointments, often brief and with limited value, imposes a tremendous burden that can be eliminated through the use of existing technologies and telemedicine. Candidates for TEER will already be under the care of an interventional cardiologist and have received an echocardiogram and other appropriate tests to ensure their suitability for the procedure. Advances in imaging, such as advanced echocardiograms and coronary computed tomography angiogram (CTA) provide the heart team with key information without necessitating an in-person visit. We also know that travel time is an important, often determining, factor in a patient’s decision to seek surgical care, and is twice as important as following a referral or hospital affiliation (Advisory Board).

Research on patients who have received Transcatheter Aortic Valve Replacement is instructive here. On average, patients make 26 physician visits and wait 216 days between diagnosis and treatment (2016, IQVIA). Surely, it is not only in the best interest of patients, but also CMS to streamline this process without compromising patient safety or outcomes. In many cases, even an initial patient assessment could be satisfactorily conducted via telemedicine. Advances in remote monitoring, such as EKG, heart rate and oxygen saturation levels can also be effectively deployed pre- and post-procedure.

Going forward, we urge CMS to weigh the value of such in-person interactions versus the potential burden to patients, especially if multiple in-person appointments are required. As we have seen both before and during the COVID-19 pandemic, telehealth offers significant advantages to patients of all types, including and especially older Americans with mobility and other age-associated health conditions. We believe telehealth is not a trend but an important tool to facilitate safe, convenient, efficient access for patients.

We realize telehealth and payment parity is a larger issue within CMS; addressing it here in the patient context is a starting point.

Volume and Program Requirements for New and Existing TEER Programs

CMS continues to rely on unrelated surgical volume requirements for both existing and potential new TEER programs. We are concerned that such requirements will discourage the initiation of new programs in areas of need. Of note, this NCD was drafted prior to the publication of two high-quality studies (one in the Journal of the American Heart Association [JAMA] and the other in the Journal of the American College of Cardiology [JACC] ) that demonstrate there is no relationship between mitral valve surgical volumes and transcatheter mitral valve repair outcomes, including survival, rehospitalization or mitral valve re-intervention. Such surgical volume requirements needlessly restrict patient access, especially in rural areas of the Midwest and Southeast and among Black and Hispanic populations. We trust that CMS will consider this emerging body of evidence to reconsider such volume requirements.

Further, the draft NCD creates barriers to access by instituting separate surgical volume requirements for existing and new TEER programs. The existing NCD for TMVR requires a surgical program to perform = 25 total mitral valve surgical (MVS) procedures for severe MR per year of which at least 10 must be mitral valve repairs. The proposed NCD introduces requirements dependent upon whether the TEER program is new (40 MVS procedures in the preceding year) or existing (20 MVS procedures per year or 40 every two years). The two studies referenced above illustrate that these distinctions are unconnected with clinical outcomes and that surgical volume minimums should be aligned at 20 procedures per year (or 40 over two years) for both new and existing TEER programs. The JACC study showed that while there was a connection between hospitals with extremely low (1-18) surgical mitral valve volume and in-hospital TEER mortality, this association dissipated for hospitals performing a moderate (19-51) volume of MVS procedures.

These results illustrate that a 40 MVS procedure minimum for new TEER programs would stifle competition and create a de facto cap on the number of providers performing TEER. Smaller, rural hospitals would be disproportionately impacted, further reducing access for these patients, and necessitating inconvenient and risky travel to receive care. Alternatively, patients may forego the procedure entirely, further compromising their health.

The new minimum surgical procedure thresholds for both new and established TEER programs are not evidence-based and should be eliminated. We urge CMS to eliminate the separate, higher mitral valve surgical requirements for new TEER programs in the final NCD.

Additional Issues

Participation in data registries

The current data registry system for transcatheter valve technologies is cumbersome, opaque, inaccessible, and of little value to patients. We understand that CMS is reluctant to continue to require reporting to a data registry without CED. However, this data is critical to evaluate and monitor the ongoing quality and safety of these technologies, as well as patient outcomes. CMS should require data reporting requirements for TEER procedures (and potentially others covered under a final NCD) as a condition of coverage. The data reported should include outcomes that can be evaluated for the influences of access, race and sex.

CMS should work with patient organizations, the TVT Registry, providers and manufacturers to streamline reporting requirements in order to reduce administrative burden while also improving the utility of the data. Ultimately, the data must be publicly accessible. Patients – and CMS – should not be limited to analyses and data published in medical journals.

If the goals of simplified reporting, increased transparency, broader access and greater utility cannot be accommodated through the current TVT Registry structure, then CMS should consider an alternative reporting mandate to a patient-centered registry.

National vs. Local Coverage Decisions

We disagree with CMS’s proposal to defer to Medicare Administrative Contractors (MACs) on coverage decisions for degenerative mitral regurgitation (DMR) within their respective jurisdictions. We are concerned that local coverage determinations (LCDs) could negatively impact access for patients with DMR if some MACs opt for more restrictive coverage policies. A patient’s access to care options should not be compromised because of the state or zip code in which they live.

While we appreciate there is a relatively limited volume of DMR patients, this should not be used as justification for transferring coverage decisions for DMR to MACs. The previous NCD for TMVR was applicable to DMR patients (under CED). Uniformity in coverage should be the goal whenever feasible. As such, we recommend that CMS include coverage of DMR in the NCD to promote consistency of access and coverage.

Composition of Heart Team

TEER is a complex procedure. We concur with the value of a collaborative, multidisciplinary heart team in coordinating the care of a patient. We appreciate CMS’ reference to shared-decision making (SDM) and the agency’s call for standardized decision aids or tools using the National Quality Forum’s (NQF) published standards. TEER is a prime example where patient preferences, along with scientific evidence, should be considered to establish the appropriate composition of the heart team.

The proposed NCD places undue emphasis on the role of a cardiac surgeon in the care of TEER patients. The standard of care for patients with advanced heart failure in need of mitral valve repair for FMR is guideline-directed medical therapy, not surgery. These patients are frequently too sick to tolerate surgery, let alone invasive open-heart surgery, which has not demonstrated a mortality or hospitalization benefit in this population. Until the recent introduction of TEER, medical therapy was the sole treatment option for these patients.

While cardiac surgeons may be included in the heart care team, we believe a requirement for a second in-person examination by a surgeon places an undue burden on patients and creates an unnecessary barrier to care. We encourage CMS to consider the proper composition of a multidisciplinary heart team to include some combination of an interventional cardiologist, radiologist, cardiac surgeon and heart failure specialist, or other specialists who may be pertinent to the patient’s case.

We encourage CMS to support the determination of appropriateness for TEER by including a heart failure specialist on the multidisciplinary heart team.

Clinical Trials

We support CMS’s use of non-randomized controlled clinical trial studies in developing the proposed NCD for TEER. In general, we believe CMS should defer to the clinical trial data used in connection with the FDA approval of a technology. However, if additional clinical trials are required, non-randomized controlled studies are the only approach that should be considered in this situation given the ethical and practical considerations.

Conclusion

Mitral regurgitation effects more than 5.2 million Americans, 1.7 million of whom are age 75 or older . This proposed national coverage decision will have a positive impact on many Medicare beneficiaries.

We thank CMS for the constructive developments included in this NCD and trust that our comments will be given full consideration to advance patient interests.

Sincerely,

John Lewis
Executive Director

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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Thank you for allowing coverage for Secondary MR patients.

We have concerns about the following:

*NEW RESTRICTIONS FOR COEXISTING CONDITIONS

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

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

(This should be removed, surgeons do not manage heart failure in the outpatient setting. SMR patients don't do well with surgery according to current literature, therefore no need for evaluation by surgeon)

*NEW HEART FAILURE PHYSICIAN SPECIALIST REQUIREMENT

(Please remove. This is redundant, all ICs are capable of managing HF patients according to guidelines)
Thank you
Vivian Maynes APRN

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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July 30, 2020

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

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

Dear Ms. Syrek-Jensen:

The Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI) appreciate this opportunity to submit comments on the proposed decision memorandum and national coverage determination (NCD) for TMVR. The societies recognize the significant time and effort that went into producing the memorandum, including evaluating the recent evidence and listening to feedback from the clinical community and a variety of stakeholders.

The societies recognize the addition of indications for functional mitral regurgitation (FMR) following approval of this new patient indication by the Food & Drug Administration (FDA) as an important advancement for patient care. The inclusion of rigorous facility and operator standards, consistent with the 2019 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Mitral Valve Intervention,¹ will bolster the likelihood of high-quality care.

However, the societies are very concerned about proposals to eliminate data collection under coverage with evidence development (CED) and to bifurcate coverage of TMVR, with FMR addressed in this NCD while degenerative mitral regurgitation (DMR) is pushed to local coverage under Medicare Administrative Contractors’ discretion. These actions do not appear to be congruent with the current evidence and CMS precedent. The societies fear that these actions may place certain FMR patients at risk of suboptimal use as significant clinical evidence gaps still exist and that knowledge of the ideal patient population to benefit from treatment is yet to be clearly defined.

The societies and many stakeholders are disappointed with the proposed NCD that has dropped evidence collection under CED for transcatheter edge-to-edge repair (TEER) for both DMR and FMR. The decision to eliminate CED for TEER in the proposed NCD has substantial, negative ramifications for the management and safety of patients with significant symptomatic MR, whether degenerative or functional, and the societies strongly urge CMS to reconsider this proposal. Importantly, data collection under CED is not linked to volume standards, which are addressed separately in these comments.

CMS indicates in the memo that it believes the existing evidence base developed under the current CED policy and other peer-reviewed publications has addressed initial concerns about both the generalizability of clinical trial results in Medicare beneficiaries treated in real-world facilities and the durability of degenerative MR improvements over longer time periods. The societies appreciate that more evidence exists now than when the initial NCD was finalized in 2014 but believe important information to ensure quality and improve care should still be collected and monitored through continued CED since a minority of patients with DMR, roughly 10,000 per year, are now treated with TEER.

Since implemented in 2004, CMS’s visionary policy on CED has allowed more rapid access for Medicare beneficiaries to new interventions, improved post-market evidence development, provided important new evidence for care decisions, and has led to clearer understanding of the risks and benefits of cardiovascular therapies for patients, providers, and payers. During the past decade, the STS/ACC Transcatheter Valve Therapy (TVT) Registry and Coordinated Registry Network supported 23 regulatory decisions and ensured evidence-based evaluation of TVT technology. This method of evidence generation creates value for manufacturers and the broader device ecosystem with significant benefits to the public health.²

CED offers the opportunity to assess uncertainty regarding long-term outcomes. It creates opportunities to fill post-market evidence gaps and better define patient benefit and risk balance with the development of validated markers of clinical outcome benefits that can be tracked in a post-market setting. Without CED to bolster post-market surveillance and studies, the societies’ understanding is that FDA would need to alter, and likely slow, their approach to device approval requiring more robust pre-market clinical studies.

Importantly, the two pivotal clinical trials for FMR with modest study populations that led to FDA approval offer divergent conclusions in terms of optimum patient selection and benefit for TEER, an area that could be very effectively answered through CED. In fact, the remaining questions present after the results of these two randomized trials with discrepant results are precisely those that can be best answered and are prime examples of why CED was initiated by CMS. Furthermore, in the coming years, TEER will have substantial device iterations that can be assessed in terms of the long-term effectiveness utilizing CED coverage.

CED is an essential vehicle to accelerate beneficiaries’ access to improved TEER therapy for both FMR and DMR that is reasonable and necessary while developing better evidence to inform care decisions. CED is particularly important, considering the relatively still developing science on the role of TEER in the management of patient with significant symptomatic MR.

The medical field has learned more about possible differences in risks and benefits in older patients or patients with multiple comorbidities who are often underrepresented in clinical trials through CED. CED allows understanding of differences in effectiveness across practice settings or providers.

With the data underpinning FDA-approval of FMR indications for the MitraClip device coming significantly from one study that enrolled 302 patients to the device intervention group, the same outcomes under CED study for DMR patients under the current NCD warrant additional data collection to evaluate generalizability and durability. Those outcomes include all-cause mortality, stroke, repeat mitral valve surgery or other mitral procedures, worsening mitral regurgitation, transient ischemic events (TIAs), major vascular events, renal complications, functional capacity, and quality of life. CED would allow access for patients that are currently subject to exclusion criteria. Importantly, this would mean CMS could offer coverage to more patients with CED maintained than under the current proposal.

Other aspects of care that could be studied are the exact types of contraindicated conditions CMS has proposed elsewhere in the memo. Data collection under CED would gather evidence on areas such as the utility of the device in patients with other comorbidities not studied in the original trials such as pulmonary hypertension, pulmonary disease, and with other coexisting valvular disease to better deploy care to patients for whom it will be most effective.

Presently there are no validated metrics for the assessment of quality of care for patients undergoing TEER for either DMR or FMR. The development of risk-adjusted validated outcome measures and their incorporation into national management guidelines should be a top priority with four distinct goals:

1. Enable programs to improve, especially with national benchmarks.
2. Facilitate public reporting.
3. Allow the eventual sunsetting of institutional volume requirements used as a surrogate for direct quality measures.
4. Allow the CMS Innovation Center to consider application of a composite outcome measure to the payment for care improvement program.

For this comprehensive approach to quality to be feasible for TEER, for both DMR and FMR, there must be a process of required data collection with an NCD with CED. The current CMS proposal will prevent the development of a quality metric for TEER and is an abandonment of CMS’s commitment to quality care for beneficiaries.

The societies are very concerned with the proposal, to eliminate national coverage for DMR as part of the new TEER policy that creates coverage for FMR. It is simply absent from the operative coverage language. The proposed decision memo notes that, “Due to the very low number of procedures, < 1 % of the Medicare population undergo TEER of the mitral valve for degenerative MR, and the published procedural volume recommendations from the professional societies, CMS believes coverage of TEER for degenerative MR is an appropriate determination made by the Medicare Administrative Contractors (MACs). The MACs are structured to be able to take into account local patient, physician and institutional factors, which are especially important when overall prevalence is very low.”

The first rationale that services provided to less than 1% of the Medicare population do not warrant the structure and consistency across the country that an NCD provides for a complicated and costly intervention to preserve and improve patients’ lives is puzzling, as many services governed by NCDs would fit that criterion while others performed more commonly are not governed by NCDs. Degenerative MR constitutes 70% of U.S. patients entered in the TVT Registry. In Europe, where FMR is approved, it still comprises 20% of TEER patients. Furthermore, treating primary MR often solves the underlying cardiac problem whereas in FMR TEER does not treat the primary condition, and though the patient symptomatically may improve, their left ventricular dysfunction remains. The impact on longitudinal outcome and readmissions remains ill-defined. As a result, TEER in the prohibitive risk DMR patient can often be a more complete solution than TEER for FMR.

The societies also struggle to understand the second rationale that published procedural volume recommendations made by professional societies eliminate a role for NCD coverage of DMR—clinical guidelines, best practices, and experience recommendations exist for many services that are covered under NCDs.

Dividing coverage in this manner is confounded by the fact that there is often significant difficulty in the medical community differentiating DMR from FMR. In fact, 15% of patients currently entered into the TVT Registry are classified as “mixed” disease. To leave these coverage decisions to local contractors would create needless confusion in determining patient coverage.

It is the societies’ experience that NCDs are deployed when disparate coverage policies across contractors exist or are expected, when complex or novel or resource-intensive services are under consideration, or when concerns about overutilization/misutilization exist. Several of these considerations apply to TEER, the most important of which is the potential to limit access to therapy due to coverage. Clinicians have long bemoaned the challenges that inconsistent and inaccurate coverage creates, requiring documentation and phone calls to navigate inconsistent policies. Sometimes patients are referred to another state where coverage is more appropriate and allows a therapy the physician and patient agree is necessary. Local factors are not irrelevant, but the societies believe in and affirm the value of having a floor for coverage for TEER for both FMR and DMR and urge CMS to revise the final NCD to include DMR coverage alongside FMR as was suggested in the original request for reconsideration.

The societies support CMS’s proposal to require certain volume standards and staffing infrastructure for facilities and clinicians as a surrogate for quality outcome measures as an important piece of the proposal. The proposed standards are essentially consistent with those delineated in the 2019 expert consensus document, and the societies support the proposed volume standards. These standards increase the likelihood of an environment with a significant care infrastructure that will produce quality outcomes and access to care. Ninety percent of the U.S. population is within a hospital referral region that has a center with the volume threshold needed for appropriate team evaluation.³ The societies recognize not all stakeholders agree with this approach, and new data or analyses may support alterations to these volume standards. Any adjustment to volume requirements should be monitored and assessed to ensure optimal outcomes.

Furthermore, the societies support the language CMS has used that parallels the expert consensus document to describe the role on the care team of a heart failure specialist experienced in care and treatment of FMR. With the early development of heart failure as a designated specialty, it is appropriate at this time to not require more specific training or board certification that would potentially bar many experienced cardiologists with significant expertise in advanced heart failure as formal education opportunities remain modest.

Finally, the societies acknowledge that excellent procedure performance must be balanced with beneficiaries’ access to care. Indeed, this equilibrium is usually a fluid and dynamic situation as technology and operator experience and expertise evolves and as more patients present for treatment. The elimination of CED precludes the ability to inform the medical community and payers as to whether the consensus standards are correct and whether they need to evolve and change over time.

The proposed NCD includes seven contraindications that appear to be exclusion criteria taken from the COAPT trial. Such criteria are not meant to eliminate the possibility of future patient care, but to better account for confounding factors in a highly controlled clinical trial. Certainly, these are all examples of complicated patients who may be less likely to benefit from intervention than others without these comorbidities. However, applying them as absolute contraindications to the NCD will prevent some patients who would benefit from TEER from receiving this important therapy. For instance, some patients prescribed inotropes on a short-term basis would also be excellent candidates for TEER. These are decisions physicians and patients are capable of making together and the societies recommend these be removed as absolute contraindications. Instead, these are the exact types of patients and questions that can be better understood and answered through CED as has been done with other therapies. The medical field can learn a great deal through the collection of real-world evidence to improve both patient selection and procedural care through this mechanism, but only if CED is reinstalled.

Conversely, the NCD includes five inclusion indications that all moderate-to-severe or severe FMR patients on guideline-directed medical therapy must meet. Left ventricular ejection fraction and left ventricular end-systolic dimension stem from the FDA approval order for the device FMR indication. Cardiomyopathy and heart failure classification status were COAPT trial inclusion criteria. These indication criteria are reasonable at the current time for the evidence base available for TEER technology.

Rather than create such an explicit list of contraindications and indications, the societies strongly recommend that CMS link coverage to use of FDA-approved devices for FDA-approved indications. This is an approach CMS has used elsewhere that allows for the flexibility of new FDA indications to be incorporated seamlessly without additional reconsiderations. It is already in place for the existing TMVR coverage, as well as other NCDs, and has worked well. It would eliminate the need for overly prescriptive coverage criteria, allow and encourage the study of real-world patients through CED, and avoid repetitive reconsiderations as technology and evidence evolve.

In the original reconsideration request, the societies expressed uncertainty about how best to avoid confusion in the field about transcatheter mitral valve repair and replacement, both often referred to as TMVR. With only one device approved for either therapy at this point, revising the title of this policy to specifically address TEER therapy seems sensible at this time. It anticipates future therapies that utilize different mechanisms of repair or replacement and suggests those will also need to be addressed through separate NCDs. However, as implied in the 2019 expert consensus document, should CMS instead wish to design an NCD that can be evergreen as discussed above, the original recommendation made in the reconsideration request for a policy that addresses the broad category of transcatheter mitral valve therapy with coverage consistent with FDA-approved indications is preferable as it would avoid the need for additional reconsiderations to add devices or indications.

The existing NCD for DMR patients includes a requirement for face-to-face evaluation by both the interventional cardiologist and the cardiac surgeon on the heart team to consider the patient’s suitability for surgical repair, TEER, medical therapy, or palliative therapy. For FMR, this requirement was incorrectly carried forward to this NCD, and the societies recommend it be removed for the reasons stated below. This should instead refer to the multidisciplinary heart team evaluation and its minimum composition of an interventional cardiologist, cardiac surgeon, and heart failure specialist, to adjudicate FDA-approved indications for FMR.

As explained in the 2019 expert consensus document, FMR patients “should first be evaluated and treated by a heart failure cardiologist who can then consider referral for MV intervention when clinically appropriate and after optimization of guideline directed medical therapy (including cardiac resynchronization therapy when indicated). Not all such HF patients with secondary MR would need to be seen individually by a cardiac surgeon, for example, unless therapy other than transcatheter edge-to-edge clip device repair (e.g., CABG surgery, tricuspid surgery, surgical AF ablation) were felt to be potentially indicated after initial MDT review.” This is in contrast to DMR patients. “Because surgical MV repair provides reduction of primary MR superior to edge-to-edge clip device repair, surgical consultation for these patients is critical to verify that operative risk is indeed high enough to warrant transcatheter intervention.”

Stated a different way, FMR and DMR are different disease processes that are treated in different ways. Surgery is not necessarily part of the clinical pathway for pure FMR patients, typically limited to scenarios in which surgery for co-existing cardiac conditions has been planned (e.g. coronary bypass) as explained in the 2020 Focused Update of the 2017 ACC Expert Consensus Decision Pathway on the Management of Mitral Regurgitation.⁴ Instead, these patients are commonly identified and managed by their primary cardiologist and/or heart failure specialist in concert with the entire heart team. Should the MDT deem that surgical options should be considered (e.g. evaluation for concomitant operations, mixed etiology patients, alternative therapies) then a face-to-face surgical consultation will be requested. This workflow inserts the MDT as the primary arbiter for FMR to adjudicate FDA-approved indications of therapy. A requirement for all FMR TEER candidates to execute an additional consult with a surgeon creates a burden to care and drains resources when surgeons are required to see these patients who would not otherwise be in their office.

Thank you for your consideration of these comments. The societies look forward to working with you and your team during the reconsideration process and are available to provide additional information or answer questions along the way. Please contact James Vavricek at jvavricek@acc.org or 202-375-6421 with any requests.

Sincerely,

Joseph A. Dearani, MD
President
The Society of Thoracic Surgeons

Cindy L. Grines, MD, MSCAI
President
Society for Cardiovascular Angiography and Interventions

Marc R. Moon, MD
President
American Association of Thoracic Surgery

Athena Poppas, MD, FACC
President
American College of Cardiology

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

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

Dear Ms. Syrek Jensen,

W.L. Gore & Associates (GORE) is pleased to submit comments on the Centers for Medicare & Medicaid Services’ (CMS) Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) for Mitral Valve Regurgitation (CAG-00438R)

For more than 40 years, W. L. Gore & Associates (GORE) has provided clinicians and patients with a wide variety of healing solutions for complex medical problems. With more than 40 million implants worldwide, our medical products offer new solutions to medical challenges, working with the body's own tissues and organs to allow less invasive procedures and restore normal functioning.

Thank you for your consideration of the following comments to the Proposed Decision Memo:

I. Proposed change in terminology from transcatheter mitral valve repair (TMVR) to transcatheter edge-to-edge repair (TEER)

GORE supports CMS’ proposal to replace the term ‘Transcatheter Mitral Valve Repair (TMVR)’ with mitral valve Transcatheter Edge-to-Edge Repair (TEER) to more precisely define the treatment addressed in this proposed NCD.

As noted and referenced within the Decision Memo, a multi-Specialty Society letter dated 04-29-2019 requesting reconsideration of the NCD 20.33 explains that, “TMVR procedures utilize emerging technologies to treat symptomatic patients with moderate to severe or severe mitral regurgitation (MR)…” The letter goes on to explain a wide variety of technologies either currently marketed or in trials. While Gore commends CMS for their approach “to more precisely define the treatment addressed in this proposed NCD”, there remains potential ambiguity regarding the specific technologies (devices) that may be employed in these treatment areas and therefore either excluded or covered under the resulting NCD. Gore believes that NCDs should be appropriately framed to address existing, not emerging, treatments and/or technologies, particularly where evidence has yet to be developed.

For these reasons, GORE requests that the technical features of therapies and their anatomical placement that will or will not fall within the parameters of the Proposed Decision Memo be defined in greater detail by CMS for clarity.

II. Coverage with Evidence Development

GORE supports CMS’ decision to remove the Registry requirements from the NCD.

CMS states that, “With the evidence developed under CED and the peer-reviewed publications of clinical trials, CMS believes the concern about generalizability has been addressed and there is sufficient evidence to make reasonable and necessary coverage determinations for TEER for degenerative MR under Section 1862(a)(1)(A) of the SSA,” and has proposed the removal of the Registry requirements. GORE agrees that once sufficient evidence has been obtained in order for CMS to make coverage determinations, continued requirements within an NCD that may place additional administrative or cost burden on the clinical community or others should be appropriately adjusted.

GORE applauds CMS’ approach to expanding coverage criteria by encouraging the continued collection of Real-World Evidence (RWE) and conveying a willingness to consider other types of evidence inclusive of RWE and that which is published in peer-reviewed literature.

CMS states within the Proposed Decision Memo that, “Because evidentiary gaps remain to optimize patient selection for TEER, CMS will carefully monitor treated patients for adherence to these criteria and will assess patient outcomes over the next four years through evidence published in the peer reviewed literature. CMS will consider modifying criteria at that time contingent upon real-world demonstration of outcomes consistent with those achieved in the COAPT trial.” GORE is in agreement that RWE is an important and valid tool for filling evidentiary gaps and is encouraged by CMS’ approach in this regard.

GORE strongly supports the expansion of Medicare coverage in the real world beyond the prescriptive clinical trial population in studies.

We note that “CMS is proposing specific coverage and non-coverage criteria for beneficiaries consistent with the inclusion and exclusion criteria in the COAPT™ trial.” Like any large FDA approval study, the COAPT™ trial referenced in the Proposed Decision Memo had a highly-specific target patient population. Many of the exclusion criteria were designed to eliminate intervening health factors that would have clouded the impact of the specific TEER therapy that was the subject of the trial.

GORE believes that maintaining exclusion criteria in NCDs under the framework reflected within the Proposed Decision Memo seems to essentially ‘close the door’ on the subsequent use of robust and valid RWE. Not only would this potentially result in an inappropriate restriction on Medicare coverage and beneficiary access, it seems in conflict with CMS’ position on the utilization of RWE for making coverage determinations as discussed above.

Thank you for your consideration of our comments to the Proposed Decision Memo, which are intended to promote Medicare beneficiary access to important medical treatment options. If you have any questions, please do not hesitate to contact me.

Sincerely,

Keely A. Scamperle
(electronically signed)

Keely A. Scamperle, MJ, CCP, CCS-P, CHC
Global Health Policy and Advocacy Leader
Medical Products Division
kscamper@wlgore.com
469-215-4628

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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Dear Ms. Syrek-Jensen,

On behalf of Baylor Scott & White Health (BSWH), I appreciate this opportunity to provide feedback to the Centers for Medicare and Medicaid Services (CMS or the Agency) on its decision memo and national coverage determination (NCD) Transcatheter Mitral Valve Repair (TMVR); for clarity, we will use the term mitral valve Transcatheter Edge-to-Edge Repair (TEER) given CMS’ adoption to avoid confusion. As CMS notes in the document, 5.7 million people have systolic heart failure, of whom approximately 15% have moderate-to-severe or severe mitral regurgitation (MR). It is the most common valve disease and prevalence increases with age especially those age 65 and older.¹ With over 10,000 people joining Medicare daily, ensuring appropriate coverage, relative to evidence base, is critical.

BSWH is the largest not-for-profit healthcare system in Texas and one of the largest in the United States (US) with over 1,100 access points. Our organization employs more than 49,000 and affiliates with more than 7,500 physicians, attending to more than 7 million patient encounters annually. As a fully-integrated delivery system, our accountable care organization (ACO) and Scott and White Health Plan cover over 900,000 lives through both public and commercial contracts. In 2018, BSWH received an exceptional performance adjustment in the inaugural year of the Quality Payment Program (QPP). It is our ambition to be a trusted leader, educator, and innovator in value-based care delivery.

BSWH provides the full care continuum of services, from prevention and early detection through primary care, specialty care and chronic disease management, to rehabilitation and end-of-life care, across clinic, hospital, home and digital settings. BSWH is active and a leading enroller in national and international cardiovascular device trials and research studies. Most notably, BSWH has extensive experience specifically with TEER with four programs performing the procedure. Our programs have performed over 250 TEER procedures for both degenerative MR (DMR) and secondary/functional MR (FMR) and two centers participated in the COAPT pivotal trial that led to recent FDA approval of TMVR for FMR.

BSWH appreciates CMS’ proposal to ensure national coverage for the treatment of FMR by TEER and who remain symptomatic despite guideline-directed medical therapy. These are aligned with the recommendations from specialty societies and the evidence base. To that end, however, we disagree with CMS’ conclusion that there is sufficient evidence to meet the reasonable and necessary threshold and that coverage with evidence determination (CED) is no longer necessary. Finally, we are also disappointed, and do not support, CMS has proposed to delegated coverage determinations for DMR to regional Medicare Administrative Contractors (MACs). We provide further feedback on the latter two issue below.

Removing TEER from CED

As noted above CMS has opted to remove TEER from CED and instead rely on voluntary data reporting into registries by health systems, hospitals, clinicians and others. CMS believes the concern about generalizability has been addressed and there is sufficient evidence generated via CED and peer-reviewed trials to make reasonable and necessary coverage determinations for TEER for degenerative MR. BSWH disagrees with this conclusion and urges CMS to continue its NCD-CED policy for TEER procedures.

While we agree that an evidence base has developed since 2019, we feel strongly that there remain substantial gaps in the evidence published in the literature and that these findings do not obviate the need for significant additional evidence. Indeed, at several points throughout its decision memorandum, CAG-00438R, CMS acknowledges evidential gaps and limitations, and broad generalizability concerns—Page 53, “CMS also acknowledges limitations in the trial/study evidence available to assist the heart team in optimal patient selection for TEER.” Moreover, much of the evidence CMS cites has substantial research design limitations—retrospective in nature, small sample sizes, and incomplete follow-up—that further restrict the conclusions that can be drawn from them. Some remaining evidence gaps include determination of evidence benefit in those patients who were excluded from the pivotal trials and are the real world outcomes congruent with the COAPT Trial outcomes which mandated optimal guide line directed medical therapy

Additionally, the two trials CMS cites as the basis for its policy for FMR offer some conflicting conclusions in terms of optimum patient selection and application for TEER, an arena that could be very effectively answered through CED. A recent invited commentary in the American Society for Artificial Internal Organs Journal indicated that appropriate management of MR is elusive and the published studies often contradict one another and many question remain unanswered.² Additionally, FMR often goes undiagnosed and untreated, and removal of the condition from NCD-CED could exacerbate the evidence needed to correct these issues.³

While we appreciate the goal of reducing provider burden where able, including reporting requirements, given the remaining uncertainty surrounding generalizability of these procedures to certain subpopulation, we do not believe it is prudent to remove the CED requirement. Additional evidence will help ensure patient access does not become an issue and that the TEER evidence base, which is relatively limited and young, can continue to grow and mature. We do however, support efforts to make CED less burdensome and less expensive to clinical sites such as our own with the evidence obtained more accessible.

Removal of DMR TEER from NCD

CMS also proposes to remove DMR TEER treatment from NCD and instead allow regional MACs to make these determinations for local coverage. Citing low volume numbers—"< 1 % of the Medicare population undergo TEER of the mitral valve for DMR”—relative to the recommended volume loads for facilities and physicians, CMS believes MACs are better positioned to determinate coverage given their familiarity with patient demand, facilities, and physicians. BSWH disagrees with CMS proposal and believes the Agency should continue to cover DMR TEER through NCD despite the low volumes.

As stated above, MR repair procedures are becoming more prevalent in older populations and with more than 10,000 people retiring into Medicare daily, MR prevalence and demand for MR repair is likely to increase. More important than growing demand, however, and connected to our reasoning above related to the evidence base for determination, is that guidelines for DMR TEER are still in development despite NCD coverage for six years, in part because of the lower volume of procedures performed to date. MACs do not have the necessary experience, expertise or tools to make these often nuanced coverage determinations. This will create a bifurcated coverage determination for FMR and DMR and likely result in inconsistent coverage across the nation, which further hinder the development of a sound evidence base and impede uniform patient access to care. This will create a potentially chaotic coverage determination decision for the individual patient which could at the minimum delay access to care or more concerning deny care to patients who would potentially benefit.

Conclusion

BSWH appreciates this opportunity to provide CMS feedback on its decision memo and NCD, and the partnerships the Agency has built with the medical community over the past decade. MR is a prevalent disease linked to high mortality and morbidity, decreased quality of life. Repair offers patients the chance to resume a normal life and “is associated with increased survival and decreased morbidity and mortality compared to MR replacement.”⁴ In order to best serve our patients, we encourage CMS to implement a single NCD for all patients with MR with a provision for inclusion of CED. Please do not hesitate to reach out to me with any questions or concerns.

Sincerely,

Kristi Sherrill
Chief Policy and Community Officer

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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Copy and paste into the Comments section:

I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.
As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

Less

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

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

Secondly, face to face meeting with CT surgeon for FMR cases is not warranted. CT surgeons do not operate on FMR patients. COAPT trial was mitra clip vs surgery not mitralclip vs mitral valve surgery. I do believe the surgeon should review the case as part of the heart team but mandating a strict meet with the surgeon is not evidence based.

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

1. A large proportion of patients with severe MR also have severe TR, and might benefit from concomitant transcatheter repair. Although there is a dedicate trial to assess the role of transcatheter valve repair for isolated TR (TRILUMINATE), this would not address patients with mixed MR/TR. There is a plethora of data on the negative impact of residual TR on long term outcomes. By penalizing physicians who treat both valves in the same setting, the coverage decision can potentially lead to less patients being treated or patients being partially treated. Hence, I propose that this decision to deny coverage when patients receive treatment for both valves simultaneously be reconsidered.

2. The heart team has played an invaluable role in the success of TAVR in the last decade and its role in the treatment of MV disease will be equally essential. However, there are no randomized data for any surgical treatment for HF patients with severe functional MR, and those patients are very infrequently undergo surgery as evident by reports from the STS database. Restricting transcatheter options only to patients who are denied surgery is not supported by evidence and unfairly places a treatment with a higher level of evidence (randomized trial) as a second line option to a treatment with a lower level of evidence (observational data).

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July 30, 2020

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

Dear Administrator Verma,

Thank you for the opportunity to provide input on the proposed NCD for mitral valve Transcatheter Edge-to-Edge Repair (TEER). I am writing as a private citizen who has led, worked for, or volunteered with several non-profit patient advocacy organizations, during my 40+ year career in the heart disease arena. My comments here are solely my own, thus I am not speaking on behalf of those organizations.

I applaud CMS' proposed adoption of certain recommendations from patient advocacy organizations, recommendations that will contribute to increased coverage and treatment of mitral regurgitation (MR). At the same time, concerns remain regarding program eligibility requirements, minimum volume requirements in order to offer TEER to those in need, and maintaining (or increasing) inequities in access and outcomes amongst minorities and in medically underserved areas. Unless these concerns are corrected in the final NCD, availability of TEER to many who can benefit will be severely restricted for non-medical reasons.

My specific comments and recommendations are as follows:

• CMS' decision to expand TEER coverage to those patients with functional MR (FMR) is a positive step.
• However, the proposed NCD specifies seven conditions in which FMR treatment is not covered, excluding TEER coverage for patients who may have no other options — and could benefit from—TEER. These restrictions will unnecessarily restrict access to TEER by significant numbers of patients who can benefit. I urge CMS to revise the NCD to cover TEER in FMR patients with advanced heart failure and similar conditions where no other effective treatment is available for symptom relief.
• Given TEER's complexity, a multidisciplinary cardiovascular team is key. However, the NCD is overly restrictive regarding the role of cardiac surgeons in TEER. Of course cardiac surgeons should be part of the heart care team, but the requirement for a second in-person surgical exam will be a major, and unnecessary, obstacle to care. Given that the risk of surgical bailout is very low, my respectful recommendation is that (a) providers should have the option of a surgical exam on a case-by-case basis, and (b) the NCD should instead support inclusion of a heart failure expert on the care team.
• Given the COVID-19 pandemic, adoption of telehealth for many examinations has grown dramatically. The final NCD should accommodate for this option (with reimbursement equal to that of in-person exams) moving forward.
• Surgical volume requirements in the NCD will be burdensome and significantly restrict access to care, without contributing to positive patient outcomes. Thus higher MVR surgical requirements for new TEER programs should be eliminated from the final NCD.
• Data registries for TEER will continue to be vital, thus post-market data collection requirements will be essential while ensuring that such requirements are cost-effective and not burdensome to providers.
• Similarly, increased transparency is key. CMS should require that the TVT Registry (and any other such registries as they arise) regularly report physician- and hospital-specific outcomes to those federal agencies involved with patient safety and efficacy efforts. As TEER volume increases, consideration should be given to broader reporting in the future.
• The local coverage determinations (LCD) approach to TEER risks restricting access based on non-medical decisions. National uniformity in coverage criteria and decision-making is warranted and will be in the best interests of Medicare patients.
• Time is of the essence: the projected 18 months between FDA's approval and finalization of this NCD can—and should—significantly be shortened. This can occur without sacrificing careful review and patient safety, while accelerating access to a technology that the data shows will be lifesaving to large numbers of patients.

Thank you again for the opportunity to present these views, and for your thoughtful consideration.

Best regards,
Norm Linsky, MPA, MA
Washington DC

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

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

- SURGEON AND IC REQUIRED FACE-TO-FACE EVALUATION FOR FUNCTIONAL MR (This should be removed, surgeons do not manage heart failure in the outpatient setting. SMR patients don't do well with surgery according to current literature, therefore no need for evaluation by surgeon)

- NEW HEART FAILURE PHYSICIAN SPECIALIST REQUIREMENT (Please remove. This is redundant, all ICs are capable of managing HF patients according to guidelines)

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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The new CMS coverage decision will greatly benefit our patients with moderate to severe or severe functional mitral regurgitation however there are a few points in the decision that could be altered to better reflect actual clinical practice. There is no proven effective surgical treatment for functional mitral regurgitation. Therefore, it is unclear why a surgeon needs to evaluate a patient for surgical appropriateness. The decision should be multidisciplinary however the team should consist of an interventional cardiologist, interventional imager and heart failure physician. In addition, many patient with functional MR have concomitant tricuspid valve disease. Many of these patient will still see benefit from transcatheter mitral valve repair. In addition, many patients would become candidates for other investigative tricuspid repair and replacement techniques if the mitral valve is repaired percutaneously first. Therefore, it would make sense to remove the exclusion of concomitant tricuspid valve disease.

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

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

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

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

Concomitant tricuspid regurgitation is prevalent in this patient population. excluding patients with coexisting Tricuspid regurgitation will result in denial of this therapy to large number of patients who would benefit form it, and may lead to higher health care cost and hospitalizations.

RV dysfunction by itself should not be an exclusion criteria, Unless patients have predominantly advanced right side heart failure, they would derive significant benefit from treating severe MR with mitral clip.

Many HF patients are on inotropes and have disproportionate mitral regurgitation, would benefit from the mitral clip and should not be excluded.

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

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

I support the inclusion and identification of the essential role of the echocardiographer in this procedure as a key member of the heart team.

I wish to also provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. This is true for both academic and private practice centers. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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July 30, 2020

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

Dear Administrator Verma,

The undersigned organizations appreciate the opportunity to provide input on the proposed national coverage decision (NCD) memo for mitral valve Transcatheter Edge-to-Edge Repair (TEER), previously referred to as Transcatheter Mitral Valve Repair (TMVR). The TEER procedure has shown promising outcomes for clinically appropriate patients and provides a minimally invasive treatment option for patients who are not candidates for surgical repair.

The undersigned coalition appreciates the Centers for Medicare & Medicaid Services’ (CMS) thoughtful consideration and adoption of recommendations from advocacy organizations representing patients, providers, and family caregivers in the proposed TEER NCD. These changes will expand coverage and advance innovative treatment for mitral regurgitation (MR) for Medicare beneficiaries. However, we are concerned about the deep-seated inequities spotlighted by the Coronavirus Disease 2019 (COVID-19) pandemic. We remain concerned about selected program eligibility requirements and the unintended consequences of imposing a minimum number of annual surgical and interventional cardiac procedures to maintain a TEER program. These policies may restrict patient access to TEER programs, further exacerbating systemic inequities in health outcomes experienced by racial and ethnic minorities and populations in underserved areas.

Comments on the Proposed National Coverage Decision

Coverage of TEER for functional mitral regurgitation

We applaud CMS’s decision to expand coverage of TEER to patients with functional mitral regurgitation (FMR). The results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial, as well as most observational studies, illustrate clear improvements in hospitalization rate and mortality, especially in periods exceeding one-year post-procedure. As a result of these findings, the U.S. Food and Drug Administration (FDA) approved TEER in March 2019 for heart failure (HF) patients who have moderate-to-severe or severe FMR despite treatment with optimal medical therapy. The CMS decision supports this determination and allows Medicare patients access to TEER to treat FMR.

In the proposed NCD, CMS provides seven conditions for which treatment of FMR is not covered. The limitations will exclude coverage for TEER in FMR patients with advanced heart failure and other conditions who may not have other effective treatment options for symptom relief. While evidence on the benefit of TEER for these populations is under development, we are concerned that the proposed restrictions may not allow sufficient flexibility. An overly restrictive NCD would require additional coverage decisions or reconsiderations to allow coverage for additional categories of FMR patients or analogous therapies. We encourage CMS to cover FDA-approved, on-label use for devices in this broader category. We also encourage CMS to change the name of the NCD and use inclusive terminology to reflect other transcatheter mitral valve repair interventions.

Multidisciplinary heart care teams and face-to-face requirements

TEER is a complex procedure. We concur with the value of a collaborative, multidisciplinary heart team in coordinating the care of a patient. We appreciate CMS’ reference to shared decision-making (SDM) and the agency’s call for standardized decision aids or tools using the National Quality Forum’s (NQF) published standards.

However, the NCD introduces several conditions of coverage that create unnecessary barriers to care. In this section, we discuss a more appropriate role for cardiac surgeons in the heart care team for TEER patients. We also address the need for flexibility in relation to the face-to-face examination requirement.

The proposed NCD places undue emphasis on the role of a cardiac surgeon in the care of TEER patients with FMR. The standard of care for patients with advanced heart failure in need of mitral valve repair for FMR is guideline-directed medical therapy, not surgery. These patients are frequently too sick to tolerate surgery, let alone invasive open-heart surgery, which has not demonstrated a mortality or hospitalization benefit in this population. Until the recent introduction of TEER, medical therapy was the sole treatment option for these patients.

In the COAPT trial, independent face-to-face visits with both an interventional cardiologist and a cardiac surgeon were required. However, that was in the context of a structured clinical trial where variables were tightly monitored to isolate the impact of the intervention. In the setting of community-based care, not all trial-based requirements are appropriate.

While cardiac surgeons should be included in the heart care team, we believe a requirement for a second in-person examination by a surgeon creates an unnecessary barrier to care. The risk of a TEER procedure requiring conversion to heart surgery (0.7 percent surgical bailout rate) is low, mitigating the need for a surgical examination requirement. While an in-person consult with a surgeon may be appropriate for selected patients, these results show that it should not be mandated for all patients. We recommend that CMS remove the requirement for a face-to-face examination with a cardiac surgeon. Instead, we encourage CMS to support the determination of appropriateness for TEER by including a heart failure specialist on the multidisciplinary heart team.

We also encourage CMS to allow a telehealth visit to satisfy the requirement for a face-to-face examination requirement. Candidates for TEER will be under the care of a multidisciplinary heart team and undergo an echocardiogram and other appropriate tests to ensure their suitability for the procedure. CMS should avoid being overly prescriptive in coverage requirements to accommodate advances in clinician practice and minimize patient burden. For example, during the COVID-19 public health emergency (PHE) waivers have been provided to enable the widespread use of telehealth, including waivers for face-to-face examinations before a TEER procedure and payment parity between telehealth and in-person visits. While these flexibilities are temporary and tied to the PHE, the widespread uptake and increased comfort level with telehealth by both providers and the public has created significant support for a permanent extension of these waivers. Some states, such as Colorado and Idaho, have already permanently eliminated restrictions on telehealth use. We encourage CMS to continue payment parity for telehealth visits after the conclusion of the COVID-19 PHE.

Volume and program requirements for new and existing TEER programs

The proposed NCD for TEER for FMR includes increased, unnecessary conditions of coverage that would require hospitals to perform a minimum number of surgical procedures. These surgical requirements have little relation to the ability of a hospital to successfully perform TEER. While thoracic specialty societies may favor volume requirements, these restrictions do not help patients with advanced heart failure in need of mitral valve repair. Two recently published studies (one in the Journal of the American Heart Association [JAHA] and the other in the Journal of the American College of Cardiology [JACC]) conclusively demonstrated there are no established connections between mitral valve surgical volume and one-year rates of survival, rehospitalization or mitral valve reintervention.

Further, the draft NCD creates barriers to access by instituting separate surgical volume requirements for existing and new TEER programs. The existing NCD for TMVR requires a surgical program to perform = 25 total mitral valve surgical (MVS) procedures for severe MR per year, of which at least 10 must be mitral valve repairs. The proposed NCD introduces requirements dependent upon whether the TEER program is new (40 MVS procedures in the preceding year) or existing (20 MVS procedures per year or 40 every two years). The two studies referenced above illustrate that these distinctions are unconnected with clinical outcomes and that surgical volume minimums should be aligned at 20 procedures per year (or 40 over two years) for both new and existing TEER programs. The JACC study showed that while there was a connection between hospitals with extremely low (1-18) surgical mitral valve volume and in-hospital TEER mortality, this association dissipated for hospitals performing a moderate (19-51) volume of MVS procedures. Further, the JAHA study showed that implementing an annual MVS procedure minimum of 40 would disproportionately limit access to TEER in the Midwest and Southeast, causing an outsized restriction on access for Black and Hispanic populations. These results illustrate that a 40 MVS procedure minimum for new TEER programs would institutionalize a protectionist policy and likely prevent the use of the procedure beyond the current base of providers. Imposing unnecessary criteria will limit access – including to smaller and rural hospitals – by barring otherwise qualified hospital heart teams from utilizing TEER for appropriate patients. The proposed minimum surgical procedure thresholds for both new and established TEER programs are not evidence-based, will limit patient access, and should be reevaluated. We urge CMS to eliminate the separate, higher mitral valve surgical requirements for new TEER programs in the final NCD.

The evolution of heart valve disease treatment to less-invasive options significantly affects the ecosystem of hospitals and specialty physicians who make a living treating these conditions. Thoracic surgeons have been saving heart valve disease patients for decades through open-heart surgery; however, interventional cardiologists perform most transcatheter procedures. Patients are stuck in the middle of a professional sea change in heart valve disease treatment involving the specialist clinician, and between major medical centers and smaller community-based and rural hospitals.

CMS’ role is not to referee these provider issues, but to adopt an evidence-based coverage decision that will most benefit Medicare beneficiaries. By lowering the minimum MVS procedure threshold and separate program requirements included in the draft decision, CMS will ensure appropriate access to TEER and avoid reinforcing disparities for minority and rural populations.

Participation in data registries

The proposed decision would allow for national coverage of TEER for FMR patients. As a result, requirements related to TEER’s prior classification under coverage with evidence development (CED) would be eliminated, including mandatory participation in the TVT Registry.

Hospitals and care providers must fulfill extensive reporting requirements (including abstraction and reporting of data) to comply with the Medicare conditions of participation, which contribute to substantial administrative expenditures. Given these requirements and the expense involved in reporting to the TVT Registry, it is unlikely that providers will provide registry data on a voluntary basis. However, the absence of a TEER data collection mandate will result in incomplete data reporting, which limits the ability to assess quality of care. Continued documentation of data on the long-term outcomes (including 30-day, one year, and post one-year) of TEER remains important and will help determine new indications. Patients and physicians should continue to be well-informed about the likely range of outcomes as TEER is performed in non-trial settings. Further, we applaud and agree with CMS that broader evidence in predicting successful outcomes is warranted, particularly around the influence of access, race, and sex.

Consequently, CMS should include post-market data collection as a coverage requirement to ensure measurement of quality outcomes and to support development or improvement of new or existing therapies. CMS has previously finalized other NCDs with continued registry reporting requirements after ending CED. CMS should also work with providers and the TVT Registry to ensure that data collection requirements are streamlined to reduce providers’ data collection burden and participation costs.

Accessibility of registry information to federal agencies and the public

The lack of transparency and availability of registry data provides barriers to evaluating outcomes. In the NCD, CMS indicates the agency will continue to “assess patient outcomes through evidence published in the peer reviewed literature.” However, CMS and FDA should have the capability to monitor safety and efficacy outcomes on an ongoing basis, as well as differentiate between procedure types. For example, current code sets for Medicare claims data do not provide a way to differentiate between degenerative mitral regurgitation (DMR) and FMR. These data and other key outcomes information are only available through the TVT Registry. Patients and federal agencies have the right to understand how devices are performing. To support this aim, CMS should require that registries provide regular reports (annually, at a minimum) to evaluate outcomes.

Further, the TVT Registry reports aggregate data only. Provider-specific information on TEER health outcomes is not publicly available. The TVT Registry website states that “Hospital-specific registry data is not publically [sic] available and the registry cannot provide data without written permission from the hospital to do so.” Presumably, data for physicians employed or contracted by the hospital would be subject to the same restriction. However, it is more valuable to understand TEER outcomes by physician, rather than by facility, in making meaningful performance distinctions between providers.

We ask that CMS correct this lack of transparency in health outcomes in the final NCD. CMS already requires physician reporting for other quality metrics under Medicare’s Quality Payment Program (QPP). In the QPP, CMS collects data through claims, registries, and provider attestations to support physician payment determinations. These data are publicly displayed on the Physician Compare site to help consumers make more informed decisions about their health care and to encourage clinical excellence. We acknowledge that public reporting may not currently be appropriate given the relatively limited volume of TEER procedures. However, federal agencies should have access to registry data for TEER patients to support safety and efficacy monitoring efforts.

Immediate reporting of these data are also already provided in New York State. Since 1989, the New York Department of Health (DOH) has published annual data on risk-adjusted mortality following coronary artery bypass surgery by hospital and surgeon. The state's Cardiac Surgery Reporting System (CSRS) was the first program in the country to produce public data on outcomes for cardiac surgery and is the nation's longest running program of its kind. DOH is advised in its activities by the Cardiac Advisory Committee (CAC), a group of independent, practicing cardiac surgeons, cardiologists, and other professionals in related fields.

The goal of DOH and the CAC is to improve the quality of care related to cardiac surgery in the state. Providing hospitals and cardiac surgeons in New York with data about their own outcomes for these procedures allows them to examine the quality of care they provide and to identify areas needing improvement. This also allows patients and family caregivers to research data on Transcatheter Aortic Valve Replacement (TAVR) mortality outcomes in local hospitals. The program operates under the general authority of the DOH commissioner. As mentioned in previous comments on TAVR, we know from the New York DOH that this level of transparency can be achieved, that providers and patients benefit significantly, and that better healthcare is the result. The TVT Registry should meet these aims.

Designation of coverage decisions for degenerative mitral regurgitation to Medicare Administrative Contractors

We disagree with CMS’s proposal to defer to Medicare Administrative Contractors (MACs) on coverage decisions for treatment of DMR within their respective jurisdictions. We are concerned that local coverage determinations (LCDs) could negatively impact access for patients with DMR if some MACs opt for more restrictive coverage policies. For example, a beneficiary in New York could be eligible for TEER, but an identical patient in New Jersey may not be covered if the MAC with jurisdiction has differing coverage criteria.

While we appreciate there is a relatively limited volume of DMR patients, this should not be used as justification for transferring coverage decisions for DMR to MACs. Uniformity in coverage should be the goal whenever feasible. Currently, there is a relative abundance of evidence regarding the safety and efficacy of TEER for DMR patients. As a result, we recommend that CMS revise the NCD to incorporate coverage for TEER for patients with DMR. In addition, we oppose re-imposition of DMR-specific volume requirements that existed in the prior TMVR NCD.

Inclusion of non-randomized controlled clinical trial study designs

We support CMS’s use of non-randomized controlled clinical trial studies in developing the proposed NCD for TEER. As mentioned in our previous comments, the prognosis among patients with heart failure and FMR on guideline-directed medical therapy alone is very poor. In the COAPT trial, approximately two-thirds of patients who had guideline-directed medical therapy alone (control group) died or were hospitalized for heart failure within 2 years. The study found that the annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year in the device group as compared with 67.9% per patient-year in the control group, and death from any cause within 24 months occurred in 29.1% of the patients in the device group as compared with 46.1% in the control group. Given the nature of the TEER intervention, it would have been unethical to blind the study.

Timeline for coverage decision

We encourage CMS to shorten the timeframe between FDA approval of new indications and reviews of coverage determinations. We acknowledge that the review process likely experienced delays due to the COVID-19 pandemic. However, after the comment review period and issuance of the final NCD for TEER, approximately 18 months will have elapsed between FDA approval and finalization of Medicare TEER coverage for FMR. Given the potential for dramatically improved FMR patient outcomes as illustrated by trial data – and the lack of an alternative to TEER with similar clinical benefits – a more rapid process to ensure appropriate coverage for Medicare patients is warranted and necessary. Patient access to therapeutics should be prioritized once the safety and efficacy of a therapy for an indication has been established.

Conclusion

We thank CMS for the many positive advances included in the proposed national coverage decision for TEER. Expanding coverage to patients with FMR and mandating shared decision-making by an interdisciplinary heart care team will ensure that TEER can be utilized for patients whom the procedure is likely to provide clinical benefit. At the same time, we ask CMS to revise the program eligibility requirements and criteria to ensure that access to high-quality TEER programs is available to the greatest number of Medicare beneficiaries.

We thank you for the opportunity to provide feedback on the proposed decision memo for TEER. If we can be of assistance in discussing these comments in greater detail, please contact us at (202) 688-1230 or mward@agingresearch.org.

Sincerely,

Alliance for Aging Research
Association of Black Cardiologists
Caregiver Action Network
HealthyWomen
Heart Valve Voice US
National Hispanic Medical Association
Mended Hearts
Men’s Health Network
RetireSafe

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I am in strong support of CMS approval for appropriate patients with secondary MR after maximal medical therapy. The mortality, symptom and hospitalization status benefits are clear from the results of COAPT, and the requirement for a HF specialist to titrate maximal medical therapy before clip consideration likely accounts for the benefit in COAPT and lack of benefit in MITRA FR. Therefore, requirement for a HF specialist on the heart team is an excellent requirement. However, since surgery has not been demonstrated to benefit functional MR in patients with cardiomyopathy, the requirement for surgical consultation and candidacy seems not to have a strong evidence base to support this requirement.

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As director of operations at the Ronald Reagan UCLA Medical Center, I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. They play a key role in providing clinical care to our patients, yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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1) Strongly recommend expanded coverage to FMR (functional mitral regurgitation) patients
2) There’s often coexisting Tricuspid regurgitation in pt’s with significant MR. studies have shown better outcomes when you treat both vs just the MR. Recommend including pt’s with concomitant Tricuspid valve disease as well.
3) some Pt’s with acute/ subacute severe MR are too sick for surgery and do need mechanical /inotropic support. Some of them have benefited from mitraclip and presence or absence of Inotropic/circulatory support should not affect the coverage for the mitraclip

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

Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

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

Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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July 30, 2020

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

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

Dear Ms. Syrek-Jensen:

On behalf of the Heart Failure Society of America (HFSA), I am writing to provide input on the Agency’s proposed decision memorandum for national coverage of Transcatheter Mitral Valve Repair (TMVR). The vision of the Heart Failure Society of America is to significantly reduce the burden of heart failure. HFSA is a multidisciplinary organization working to improve and expand heart failure care through collaboration, education, research, innovation, and advocacy. We appreciate the opportunity to comment on this National Coverage Determination (NCD).

Coverage with Evidence Development (CED)
We believe that our patients benefit from thoughtful NCDs that are based in science and provide for the advancement of new technologies and therapies. Because of this, we are concerned with the Agency’s change of course regarding coverage with evidence development (CED). We find CMS’ proposal to eliminate data collection under CED for TMVR particularly problematic given the prospect this has for limiting patient access to treatment and reducing, rather than expanding, the amount of information available for clinical decision-making. We do not believe that eliminating data collection under CED is a move toward patient-centered care and are concerned about the Agency’s proposal to eliminate it. For heart failure patients in particular, we are concerned about the negative impact that this decision will have on the infrastructure needed to follow long-term outcomes and request that the Agency reconsider its proposal.

In addition, HFSA opposes CMS’ proposal to remove CED for transcatheter edge-to-edge repair (TEER) for both DMR and FMR. Heart failure patients may have functional MR and may be adversely impacted if TEER for both DMR and FMR is not covered. HF patients would lose access to a treatment modality by this proposal,¹ and we urge the Agency to reconsider.

Approach to Coverage for Functional Mitral Regurgitation (FMR) and Degenerative Mitral Regurgitation (DMR)
In addition to CMS’ change of position on CED, the Agency proposes to bifurcate coverage approaches for TMVR whereby CMS would maintain national coverage for functional mitral regurgitation (FMR), but relegate degenerative mitral regurgitation (DMR) coverage to local coverage decisions by each individual Medicare Administrative Contractor, likely resulting in variable coverage approaches for TMVR for DMR across the country. HFSA does not believe that this best serves the interests of patients, which should be the key decision driver in developing these policies. It is difficult for us to provide additional input because CMS’ provided rationale for this proposal does not align with current evidence. Not only are we concerned about this from the patient care perspective, but we stand with our partners at the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), the Society of Thoracic Surgeons (STS), and the Society for Cardiovascular Angiography and Interventions (SCAI) in recognizing that, clinically speaking, there are significant clinical challenges in differentiating DMR from FMR. A coverage policy premised on this differentiation could lead to delays in care and administrative complications that undermine the best care for patients. We believe that a coherent and rational coverage policy for both DMR and FMR must be developed at the national level to support the science behind their treatments and best serve the patients who are need of this care.

For these reasons, we request that CMS reconsider its approach to coverage for these procedures. If we can be of any assistance, please do not hesitate to contact us at sramthun@hfsa.org.

Sincerely,

Biykem Bozkurt, MD, PhD, FHFSA
President
The Heart Failure Society of America

1 HFSA concurs with the statements made by AATS, ACC, STS, and SCAI, in their response to the proposed decision memorandum, “Importantly, the two pivotal clinical trials for FMR with modest study populations that led to FDA approval offer divergent conclusions in terms of optimum patient selection and benefit for TEER, an area that could be very effectively answered through CED. In fact, the remaining questions present after the results of these two randomized trials with discrepant results are precisely those that can be best answered and are prime examples of why CED was initiated by CMS. Furthermore, in the coming years, TEER will have substantial device iterations that can be assessed in terms of the long-term effectiveness utilizing CED coverage."

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

Therefore, I propose the qualifications to be amended to read as follows:
Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:
Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

As Director of the UCLA Mitraclip Program and having performed the MitraClip procedure in over 100 patients I have personally been impressed with the clinical improvement that various patients experience both from degenerative and functional MR. As evidenced by the COAPT trial, I have witnessed particular benefit to my patients with heart failure who have symptoms despite goal directed medical therapy. As part of our assessment in determining benefit of Mitraclip, we work closely with the Cardiomyopathy/Heart Failure service to ensure that the patients are maximally treated with medications including Entresto and SGTL2 inhibitors as well as CRT before proceeding with Mitraclip. As I am sure you are aware, pts with heart failure are very often NOT surgical candidates and therefore we do not believe that a cardiac surgeon should be considering a surgical MVR in these patients with advanced heart failure and therefore I do not think it is appropriate for the updated coverage document to require that a patient is turned down for open MVR. The concern with such a guideline would be that surgeons will be more pressured to consider high risk surgery in a patient who will clearly benefit from a lower risk procedure such as Mitraclip.

In addition, our patients with MR often have coexistent Tricuspid regurgitation- often the underlying pathology for MR drives the TR- and often reducing the MR with mitraclip will reduce the TR dramatically. By limiting the coverage of Mitraclip to patients with only MR and without TR, those patients w both MR and TR will be left untreated and continue to deteriorate without the benefit of Mitraclip. Further studies will need to be done to understand which patients will benefit from both Mitralcip and TV therapies versus those whose TR improves with reduction of MR alone. Until then, limiting coverage to those with MR alone will leave a substantial number of patients with concaminant TR untreated which will lead to more hospitalizations and worse outcomes for those patients.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:
1.With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2.Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

Dr Allan Klein

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

ASA’s comments are in respect to the qualifications of the interventional echocardiographer. The currently proposed language for qualifications of the interventional echocardiographer within the heart team are as set forth as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transthoracic and transesophageal echocardiography with advanced training per the American Society of Echocardiography standards; and
Physician anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily, yet many would be excluded with this language. As such, recommend that the qualifications be revised to read:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in either transthoracic or transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

We thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

Sincerely,

Mary Dale Peterson, MD, MSHCA, FACHE, FASA
President
American Society of Anesthesiologists

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

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

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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To: CMS

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

We disagree with no coverage for FMR patients with co-existing tricuspid valve disease. A lot of the patients have severe MR and TR and when clipping and reducing the MR we have also seen the TR reduced. We are a trial site for Trilluminate and excluding these patients may not allow for a staged treatment approach and clinical trial consideration.
Even though we are an active and busy SH program we do disagree with setting a higher surgical MV number for new sites. The rural areas should also have access to care, and we do end up training a lot of these sites throughout central region. The MitraClip procedure is the safest SH procedure we perform.

We disagree with no coverage for FMR patients with hemodynamic instability. We have treated many of these patients successfully and during our follow up they continue to do well and have good quality of life. These patients need an option and MitraClip is a safe therapy that provides immediate clinical benefit.

On behalf of the physician team, our patients and future patients, thank you for taking our comments seriously prior to the final coverage decision.

Bassem Chehab, MD

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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

In addition, it will be critical to include more proper payment for the echocardiography procedural physician.

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

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

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Regarding expanded coverage for FMR patients:

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

There is also in the initial coverage statement a proposed lack of coverage for patients that exhibit hemodynamic instability - eg. those receiving inotropic support or mechanical cardiac assistance. These are the sickest subset of patients with the most to gain from percutaneous mitral valve repair. Numerous case reports have suggested efficacy of the Mitraclip in shock patients. Thank you for allowing me to comment.

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I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with trasesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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I am a heart failure cardiologist and not an interventionalist.

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

Approval should be based on a heart failure specialist indicating that GDMT has been implemented and optimized - not on whether a surgeon thinks surgical repair is too risky. Surgery for these patients in NOT standard of care.

Approval should be given regardless of whether the tricuspid valve is also treated.

Approval should include funding for the time intensive echo imaging needed to optimally place the device.

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

As background, we started our TEER program (using Mitraclip) in March of 2015. We have performed over 200 procedures since our launch.
As an investigative site for COAPT, we saw firsthand the benefits of treating FMR and are very glad that we will now have reimbursement for treating these patients.

We are looking forward to a final NCD; however, we disagree with denial of coverage for TEER procedures for patients with functional MR and co-existing tricuspid valve disease. Many patients have severe MR and TR and after reducing the MR we have also seen the TR reduced. In addition, we are a site for trials of transcatheter tricuspid regurgitation repair and denying coverage for such patients will not allow for a staged treatment approach and clinical trial consideration.

In addition we disagree with denial of coverage for patients with functional MR and hemodynamic instability. We have treated many of these patients successfully and during our follow up they continue to do well and have good quality of life. These patients need an option and MitraClip is a safe therapy that provides immediate clinical benefit.

While we expect that the great majority of patients with functional MR undergoing TEER will be consistent with the inclusion and exclusion criteria of the COAPT trial, we feel that the restriction of coverage to only these criteria (including LV size and function parameters, COPD parameters, and RV function parameters) is too confining and that many patients outside the parameters of COAPT can benefit from TEER – the only therapy to this point proven to benefit patients with functional MR. It is our Heart Team’s experience that there are patients outside these criteria such as those described above who with careful selection and multidisciplinary discussion can derive substantial benefit. On behalf of the physician team, our patients and future patients, thank you for considering our comments prior to the final coverage decision.

Sincerely,
Adnan Chhatriwalla MD
Keith Allen MD
Kenneth Huber MD
Michael Borkon MD
John Saxon MD
Chetan Huded MD
David Skolnick MD
Anthony Magalski MD
Michael Main MD
Bethany Austin MD
David Strelow, Director, CV Business Operations
David Warren, Director, CV Services Lab

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1. The additional requirement for CT surgical consultation will add to the burden on the patient and does not add to the outcomes of the patient. For treatment of functional mitral regurgitation the surgical options remain lacking in efficacy relative to the effectiveness of the mitral clip as demonstrated in the COAPT trial. The presence and documentation of heart team collaborative case review should be sufficient.
2. There has been no correlation between institutions mitral surgical volumes and outcomes with mitral clip/transcatheter mitral repair. The volume requirements will limit the opportunity for this technology to benefit patients.
3. I disagree with the proposed exclusion of patients with con-commitment tricuspid disease. Tricuspid disease remains a challenging condition with many etiologies with minimal proven treatment modalities. Limiting the use of trans catheter mitral repair in patients with tricuspid disease will deprive a large segment of patients with severe MR the opportunity for treatment.
4. Functional MR should be covered based on compelling results of the COAPT trial. Especially in light of the absence of clinical efficacy on hard end points in prior surgical trials for functional MR.

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Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR)

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

Functional Mitral Regurgitation is a dynamic lesion. FMR is a dynamic lesion and very dependent on loading conditions, volume status, and pharmacotherapy. This characteristic makes it much more challenging for an NCD as opposed to an obstructive lesion with clear parameters (i.e. Severity of Aortic Stenosis). For clarity, the NCD proposal does not define time dependent objective parameters for severity of functional mitral regurgitation beyond the subjective description as moderate to severe (i.e. procedural TEE at baseline shows less than moderate FMR?

Atrial Functional Mitral Regurgitation and Ejection Fraction The ejection fraction (EF) limit should be reconsidered. The current document defines the range of an appropriate patient for percutaneous mitral valve repair as 50% - 20%. An increasingly recognized and undertreated population includes those with atrial FMR (EF > 50%). They have the same physiologic an anatomic pathology regarding their mitral valve as those with ventricular disease. They should not be denied this therapy. Conversely, those with an EF < 20% and severe FMR may be treated with a beneficial result. This needs to be confirmed by the continued participation in registries like the TVT (see below).

Requirements regarding candidacy for mitral valve surgery and face-to-face encounter with a surgeon. For patients with FMR, the only therapy that has been shown to be effective (in randomized trials) for improving survival and reducing hospitalizations is transcatheter mitral valve repair. As such, these 2 requirements are excessive: (1) Section 1.b.v. “Local heart team has determined that mitral valve surgery will not be offered as a treatment option.” Transcatheter mitral valve repair is the treatment of choice for these patients; whether mitral valve surgery might be offered is not relevant to whether treatment of a patient with FMR is appropriate and indicated. If this wording needs to remain, I would recommend additional verbiage that a structural interventional cardiologist or structural cardiac surgeon evaluate all patients deemed appropriate for mitral valve surgery in the setting of FMR and document why they are not a candidate for percutaneous mitral valve repair. Thus, the patient will be offered in full transparency all the available treatments and realistic expectations of outcomes. This is paramount in the era of shared decision making. Frequently and historically the non-interventional cardiologists and cardiac surgeon make the decision and recommendation to proceed with mitral valve surgery without input or consultation from a dedicated structural heart physician. (2) Section 1.c.iv. requires that a heart team cardiac surgeon independently examine the patient face-to-face. One or more cardiac surgeons will participate in the multidisciplinary team that reviews candidates for percutaneous mitral valve repair (as outlined in section 2.a.i.). Furthermore, the ideal encounter for a patient with structural heart disease, specifically FMR, frequently includes a simultaneous visit with a structural heart physician and a cardiac surgeon. The requirement that a heart team cardiac surgeon independently examine the patient face to face undermines the spirit of the heart team and defeats the objectives of shared decision-making.

Requirement for being under the care of a HF physician specialist. It is important to ensure that patients with secondary MR are optimally treated with guideline directed medical therapy. However, requiring that the patient be under the care of a HF physician specialist (and even more restrictive than that, the text specifies one who is experienced in the care and treatment of mitral valve disease) is challenging. To encourage and help ensure that robust attempts have been made to optimize guideline directed medical therapy, documentation of this by the heart team could be required. Further, as an internal check, a HF specialist should be a key member on the multidisciplinary team that would review these cases and affirm that proceeding with percutaneous mitral valve repair is reasonable and appropriate. A HF specialist could review the medical therapy and suggest that further optimization may be warranted before reassessing MR severity and proceeding.

Requirement that the patient’s suitability for surgical mitral valve repair has been considered. Section 1.c.iv.1. indicates that the interventional cardiologist and cardiac surgeon have evaluated the patient’s suitability for surgical mitral valve repair. Building on comments made above, percutaneous mitral valve repair is the treatment of choice for FMR. It is not simply appropriate if surgical mitral valve repair is less suitable or undesirable. If a patient with FMR on GDMT with residual symptoms is deemed a good candidate (anatomically and otherwise) for percutaneous mitral valve repair, then their suitability for surgical mitral valve repair is irrelevant; their suitability or lack of suitability for surgical mitral valve repair does not influence the appropriateness of percutaneous mitral valve repair. Furthermore, I would reiterate that if someone is being considered for mitral valve surgery (repair or replacement) for FMR, they should be reviewed and counseled by an interventional structural physician on why they are not a candidate for percutaneous mitral valve repair given the clinical evidence favoring this option.

TVT Registry requirement for TEER. Eliminating the requirement to participate in a registry (i.e. TVT) that collects data about the patients being treated with this therapy and their subsequent outcome is a mistake. I appreciate the theoretical rationale that this could lead to less red tape on the back end, however, as we see many times when policy is made in medicine, this can have unintended consequences. Despite the intent, this could lead to over utilization and a lack of transparency and poor outcomes. Participation in a registry like the TVT should be mandated. As healthcare has universally transitioned to electronic medical records and automation, participation in these registries is much less burdensome.

Implications for TEER for degenerative MR. I am concerned about the coverage decision for the treatment of high surgical risk patients with degenerative mitral regurgitation to be transitioned to the regional Medicare Administrative Contractor (MAC). While I appreciate the intent of simplifying the process of pre-certification, authorization, and reimbursement - a MAC could choose to be more restrictive about this therapy and not approve it, despite the evidence base and initial NCD. I have had several cases of patients with severe symptomatic degenerative mitral regurgitation, who are high risk for surgery and approved by the heart team for percutaneous mitral valve repair, who were denied by the payer as this was deemed “experimental therapy”.

Thank you very much for your time and effort designing this proposal. I am greatly appreciative to have the opportunity to provide feedback. Please feel free to contact me directly.

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

I am concerned that patients who are hemodynamically unstable patients maybe excluded. Multiple studies have shown that these patients can potentially benefit and unfortunately they often have no other suitable options. Please consider allowing the use of Mitraclip in these very challenging patients. This is an example of a paper that demonstrates the benefit. Garcia S, Alsidawi S, Bae R, et al. Percutaneous Mitral Valve Repair With MitraClip in Inoperable Patients With Severe Mitral Regurgitation Complicated by Cardiogenic Shock. J Invasive Cardiol. 2020;32(6):228-231.

The decision memo also excludes patients with concomitant aortic and tricuspid disease. Multi valvular disease is a common phenomenon and the timing of which valve should be intervene done first should be left up to the clinician. There are many patients in whom there’s significant aortic or tricuspid valve disease but they’re not suitable for surgery. This exclusion would end up withholding the therapy from many patients without good alternatives.

Although the exclusion criteria are based on a trial, there are numerous patients who do it fit perfectly into COAPT and still be good candidates for Mitraclip. The heart team should be allowed to review the case and determine which therapy would be best for an individual patient

Thank you for considering my comments

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

However, I do not agree with excluding those patients with concomitant aortic or tricuspid valve disease, oxygen dependent COPD, or those who are anticipated to need cardiac surgery in the next 12 months. The transcatheter edge-to-edge repair (TEER) procedure will be of great benefit to patients irrespective of whether they have these other comorbidities and in fact make their management easier.

Furthermore, I disagree with the plan to increase the annual surgical volume requirement from 25 to 40 mitral valve surgeries. Surgical volume does not have any bearing on the outcomes of transcatheter mitral valve therapies. Raising the surgical volume requirement will significantly limit access of care to many patients.

Finally, I do not agree with the requirement of Functional MR patients to have a face-to-face evaluation from a Cardiac Surgeon. Per the surgical data, mitral repair is not supported by the guidelines for functional MR. Also, this rule is not aligned with the consensus statement that was published in February 2020 in which a HF specialist is mentioned, not the surgeon. Moreover, the COAPT trial data provides evidence that the HF specialist is the more appropriate to assess GDMT than a surgeon.

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wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention, and is most commonly used. Therefore, I propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of ≥ 10 trans-septal guidance procedures and ≥ 30 structural heart procedures; and
2. Who is board eligible or certified in transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

As these procedures are currently performed with transesophageal echocardiography, interventional echocardiographers board eligible or certified in transesophageal echocardiography alone would include both qualified anesthesiologists and cardiologists. Thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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Re. New restrictions for coexisting conditions: Although expanding coverage for functional MR is a great step, the exclusion of coverage for patients with other valve disease, in particular tricuspid regurgitation, may be a dis-service to this patient population, as MR and TR commonly present together and may have common pathophysiologic mechanism. The pulmonary hypertension that is secondary to FMR and may be one of the contributing factors for TR would not be able to be properly managed unless the MR is corrected. If FMR is not covered, patients with concomitant TR may be left without any good therapeutic options.

Re. Requirement of face-to-face evaluation by IC and cardiac surgeon for FMR patients. Surgery is not a good treatment option for FMR, and these patients rarely require or benefit from surgical valve repair/replacement. Therefore, requiring a surgical evaluation for a non-surgical condition may only introduce delay and complexity to the management of these patients. It may be more appropriate to have evaluation by IC only, after referral and documentation of reason by another cardiologist (who could be the HF MD). The latter approach would be more in accordance with 2017 ACC Focused Update on Management of MR.

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

While overall an excellent document, there are a couple of points where improvements can be made. The restrictions for coexisting conditions are too restrictive. Treatment of functional MR with TEER is a life saving condition. There are a significant proportion of patients with coexisting functional tricuspid regurgitation. There is no data showing definitive clinical advantage to surgery or other transcatheter repair of TR at this point. Yet patient with functional MR still benefit. They should not be excluded just because of concomitant TR.

In addition, the heart team is very important to transcatheter structural interventions. While a cardiac surgeon should still be included in the discussion of all functional MR patients under consideration for TEER, why is there a requirement for a 1:1 surgical consultaiton? There is no data that surgical MV repair improves outcomes in functional MR. This is an extraneous consultation for patients and an added burden in an already long and complex process for them. Trying to sensibly minimize consultations and make the process more efficient would help streamline the process. Patients are not going to get surgery for functional MR.

Thank you

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

A second concern is no coverage for patients with multivalvular disease. Transcatheter therapy has evolved significantly to address a variety of valve lesions, and it is entirely appropriate to offer transcatheter therapy for multiple valve lesions, when each of these lesions is anatomically approachable and the patient indications have been met. This is especially true when a patient does not have other opportunities for multivalvular therapy.

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

As the world's leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life, Medtronic is committed to continual research and evidence development. Over the years, Medtronic has had the opportunity to work directly with the CMS Coverage and Analysis Group on several NCDs, including some with CED requirements. When carefully and appropriately constructed, CED can serve as an effective tool to allow beneficiary access to critical advanced medical technologies and to gather ongoing, real-world evidence about a technology’s performance in the Medicare population.

Medtronic is supportive of a well-designed CED requirement in instances when CMS concludes that additional evidence collection is necessary, and the alternative would be non-coverage of a technology. CED requirements serve as a critical mechanism to fill evidentiary gaps and address questions that remain unanswered in early clinical trials. CED also allows the evaluation of populations not studied in the original trial for specific medical technologies. The real-world evidence gathered through a CED requirement has the potential to inform both FDA and CMS decisions and promote the rapid development of innovative, safe, and effective medical technologies.

With regard to the current proposed decision memorandum for TMVR, a CED requirement is notably absent. While Medtronic shares and appreciates CMS’s expressed desire to reduce administrative burdens associated with evidence development, we note an appropriately structured CED design can effectively facilitate the development of real-world evidence in a manner that is minimally burdensome and non-duplicative.

For example, Medtronic’s recent experience with the Leadless Pacemakers NCD (CAG-00448N) has shown that innovative approaches such as longitudinal studies utilizing administrative claims data allow for the generation of real-world evidence through a minimally burdensome approach. By taking advantage of existing data sources, these analyses offer a useful source of information beyond other traditional census-based approaches (such as registries) in many instances. Therefore, as part of any potential CED requirement, CMS should recognize the important information that can be gained from a longitudinal study utilizing administrative claims data to address specific research questions. Medtronic believes novel approaches to evidence generation such as longitudinal studies utilizing administrative claims data will inform future decisions by CMS, while also being useful to the FDA, clinicians, patients and other decision makers.

Medtronic appreciates CMS’ consideration of these comments and the Coverage and Analysis Group’s commitment to ensure appropriate access the advanced medical technologies in the Medicare population.

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The response to medical therapy with severe secondary mitral regurgitation is limited. The COAPT study has demonstrated patients with secondary MR did better with MV clip then medical therapy alone. Patients who have had the MV clip with GDMT had lower mortalities, less rehospitalizations and a better quality of life then guided medical therapy alone. There are a great number of patients who await for coverage for this life saving therapy. The Heart Valve Center at NYU is hoping that the coverage for MV clip be expanded so that these pts are treated before they succumb to their worsening heart failure and become to deconditioned to benefit.

The ability to have a therapy like the MV clip to keep patients out of the hospital is critical as we continue to move forward in an environment where hospital beds may be limited.

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1. strongly agree with reimbursement based on strong clinical data and years of experience with device and therapy.
2. No need for face to face evaluation CTS
3. Would support coverage for patients with multiple valve disease and treatment should individualized, especially for patients with concomitant tricuspid disease as it often gets better after treatment of the mitral regurgitation
4. Would also include payment for patient on an individualized basis who are on support either pharmacologic or mechanical as we have many anecdotal cases of patient's receiving life saving treatment.
5. would call it TMVr

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

1) CMS proposes that local heart team must determine that mitral valve surgery will not be offered as a treatment option. Although in concept, it's valid, the need to have a CT surgeon to sign off on these patients is less than optimal given the current scenario which MV surgery for these patients isn't the standard of care, nor its performance has been shown to have adequate results. The NCD proposal does not explicitly state that the heart failure specialist should evaluate the patient’s suitability for surgical mitral valve repair. Heart failure cardiologists are actually the ones that would need to be consulted and part of this decision, since optimization of MEDICAL therapy can certainly provide many benefits including improvement of secondary MR.

2) The exclusion of patients with significant TR isn't the justification that some of these high risk patients should be getting double valve surgery. Yes, presence of significant TR is important to be addressed in these patients, and the field of transcatheter tricuspid valve interventions will continue to mature.

3) CMS proposes to exclude patients with hemodynamic instability requiring inotropic support or mechanical heart assistance. Although these patients were not studied in COAPT Trial, they exist and surgery in the setting of acute decompensation carries a substantial morbidity and mortality. In most case scenarios such patients cannot leave the ICU and multi-organ failure can quality take place which will then further complicate the picture.

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In regards to the proposed changes to the facility requirements, this would essentially exclude any hospital from ever meeting the criteria to start a TEER program, essentially ensuring a CMS partnership with only large facilities when it comes to structural heart procedures. Sharp Grossmont currently offers TAVRs and LAAO and services one of the largest catchment areas in Southern California. By drastically increasing the TMVR requirements, CMS is ensuring an under-served population will have to travel further for their procedure to a hospital that is not their community hospital. Grossmont's data as it pertains to structural heart is among the top in the county and we are within striking distance of meeting the current TMVR criteria. I formally request the requirements for TMVR not to be increased.

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

What we are NOT happy to see are the significant increases in volumes required to begin a program. This is not supported in the literature, in fact 2 recently publications show NO STATISTICALLY SIGNIFICANT relationship between Mitral Valve Surgical volume and Transcatheter Mitral Valve Repair outcomes. I believe the NCD should be based on evidence, and not driven by the desires of large centers. There is a place for a smaller program to provide needed care to their community. Our practitioner here also travels to a larger center to perform these procedures at present until we meet the current surgical numbers- but if they dramatically increase, it would eliminate us as a center and would be a great dissatisfier to our patient population who do not wish to travel to a larger center.
We have a successful TAVR and Watchman program and were looking to begin a TMVr program, but this change would cripple our ability to provide the appropriate level of care to our community. I am adamantly opposed to the volume changes.
The outcomes for TMVr are related to the skill of the implanter, not the volume of cardiac surgeries performed at that facility. The NCD should follow the evidence, not requests from select programs.

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

Two comments:

#1 While the cardiothoracic surgeon is clearly an invaluable member of the heart team, please reconsider whether a face-to-face visit is really necessary for all patients. Especially in the case of FMR, individual patients can usually be reviewed with the heart team and a determination of surgical risk can be made without a physical face-to-face meeting with the surgeon. For those patients in whom surgical mitral valve repair may be a consideration, selective consideration for a face-to-face visit is appropriate. Furthermore, the requirement for face-to-face evaluation deviates from expert consensus.

#2 Blanket exclusion of patients with certain coexisting conditions (ie. with other valvular disease or inotropes) does exclude some patients that could be successfully treated by TEER/TMVR with expected clinical outcomes that would be comparable to those observed in the COAPT trial. These patients should be carefully considered by the heart team, but not excluded outright from coverage.

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

Patients with functional MR who are being considered for mitral valve therapy typically do have some degree of co-existing tricuspid regurgitation. Many of these patients do not have the option for open heart surgery given high surgical risk and I am concerned that denying the option of therapy on the mitral valve, these patients will be without any other options and will continue to decline. There are percutaneous tricuspid devices being studied and, in select centers, MitraClip is being used off-label for tricuspid regurgitation with some success, so staged or same-setting procedures will likely be available to address tricuspid regurgitation in the future. Percutaneous therapy for severe MR should be withheld because of the presence of co-existent TR.

The same goes for somewhat unstable patients who are requiring inotropic or mechanical support. If severe MR appears to be a significant driver of a patient's decompensation and open heart surgical intervention is not an option, MitraClip should remain an option for these patients who have little else to help them at this point.

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

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

1)Independent face to face evaluation by a cardiac surgeon. As noted in the coverage decision analysis of existing data, none of the existing data from surgical RCTs suggests any hint of benefit on hard outcomes conferred by surgical intervention in the FMR population; a stark contrast to the COAPT findings of TEER. Even the existing non randomized data shows little suggestion of benefit with surgery. While the COAPT Trial required that surgical intervention not be an option, this requirement was clearly included to ensure that the observed treatment effect with TEER was due to TEER alone (and not biased by other interventions such as surgery). And while we should clearly adhere to COAPT criteria that resulted in the impressive outcomes seen (ie mandatory GDMT, optimal procedural outcomes), we shouldn’t adhere to those which were included for trial specific purposes when they may delay patient care for no clear clinical benefit. Further, FMR patients across the MITRA FR and COAPT trials were, on average, over 70, had LVEF around 30% and STS or Euroscores of 6-8; a patient population which is unlikely to be ideal for surgery, even if it were a beneficial treatment. Similar demographics are seen in real world FMR predominant registries such as TRAMI (without the surgical requirement) so it is unclear what is really being achieved by the surgical requirement. An independent face to face surgical evaluation for these high risk, elderly patients is a non trivial undertaking which may add travel, expense and time as well as delay definitive therapy in a patient population at high risk for heart failure hospitalization and mortality. Given no benefit to surgical intervention in this population, this requirement serves only to delay care without providing a meaningful benefit. The NCD's review of existing literature has been exhaustive and clearly found no evidence of benefit to surgical intervention in this population. In an era of evidence based medicine, how can these surgical evaluation requirements be justified? A multidisciplinary team should be sufficient to assess the potential benefit of surgery for these patients, particularly as none has ever been demonstrated, and the face to face evaluation by a surgeon should be removed.

2)Exclusion of coverage in the presence of comorbidities listed in section 2. TEER in FMR is a life saving therapy. The coverage decision should note the relatively few interventions in all of medicine which can make this claim before denying this life saving therapy to specific patient populations, particularly when a lack of treatment effect has never been demonstrated in any of the patient populations being excluded. In particular the exclusion for coexisting aortic or tricuspid disease would preclude this life saving therapy in patients who might in the future receive a TAVR or be enrolled in a trial of tricuspid intervention, even if these patients are not surgical candidates according to a cardiac surgeon. Is this the intention of the coverage decision? Further, can CMS really be certain that patients with COPD on chronic steroids won’t derive a meaningful benefit from this procedure? So too with the other conditions. Certainly we can understand the desire of CMS to limit “indication creep” with the use of TEER but a lack of CMS coverage puts a de facto stop on the procedure for these “no other option” patient populations without an RCT based demonstration of lack of efficacy. For a low risk procedure, should not these edge cases be left to the discretion of the treating physicians, multidisciplinary teams and the patients themselves?

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

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

This increase prohibits availability of transcatheter therapy for functional MR in smaller communities. This will disproportionately deter this therapy in rural communities which typically have a higher rate of patients with LV dysfunction.

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

2. I also disagree with restricting therapy to patients on inotropes or mechanical device support. As a referral center we often get critically ill patients and there is no option to medically stabilize them prior to Mitral valve therapy. Sometimes the only way to pull them out of the downward hemodynamic spiral is to improve mitral valve function.

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July 23, 2020

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

Henry Ford Allegiance Health, is a 475-licensed bed regional hospital located in Jackson, Michigan. The hospital is part of the Henry Ford Health System, one of the nation’s leading comprehensive integrated health systems. The Henry Ford Structural Heart Disease (SHD) Program of Henry Ford Health System includes Henry Ford Allegiance Health as one of three hospitals in the Southeastern Michigan. The SHD team is comprised of 9 Structural Interventional Cardiologists, 8 Cardiac Surgeons, 4 Interventional Imagers. The Henry Ford SHD program has performed >1800 transcatheter aortic valve replacements, >365 MV transcatheter edge-to-edge repairs, >500 left atrial appendage closures, > 500 atrial septal defect closures. >40 aortic and mitral valvuloplasties as well as an active heart transplant, LVAD, and full open-heart surgery program.

Response:

§ A.1.c. ii. “The patient is under the care of a heart failure physician specialist experienced in the care and treatment of mitral valve disease;”

Management of heart failure is a core competency for board certification in Cardiology and the practice of cardiovascular medicine. The ACC/AHA Guidelines for the management of Mitral Regurgitation specifies treatment of heart failure related to mitral valve disease is goal directed medical therapy (GDMT). Every board-certified cardiologist is credentialed in the management of heart failure and is expected to follow these guidelines.

Recommendation:

The patient is under the care of a board-certified Cardiologist, experienced in the treatment of heart failure with mitral valve disease and has indicated that guideline based maximal goal directed medical therapy has been achieved.

§ A.2.b. “The heart team's interventional cardiologist or cardiac surgeon must perform the mitral valve TEER. Interventional cardiologist(s) and cardiac surgeon(s) may jointly participate in the intra-operative technical aspects of TEER as appropriate.” The MV TEER procedures are a true “team” procedure with both an operator and imager essential. The interventional imager must assess the severity of disease prior the procedure and provide guidance for accurate trans-septal crossing, strategic device placement and repositioning, interpretation of effectiveness and assessment of outcome. As written, the proposed memo leaves out the Interventional Imager as key to the technical aspect of the procedure. The absence of this in the intra-operative sentence technical aspect of TEER, implies that a sonographer without medical background could perform the procedural guidance. It also precludes the ability of the Interventional Imager from receiving 66% of the RVU delegation like a CTS surgeon who may scrub into the case as a second operator.

Recommendation:

The heart team’s interventional cardiologist or cardiac surgeon AND the interventional imager physician must perform the mitral valve TEER.

§ A. 2.c. Qualifications to begin a mitral valve TEER program for heart teams without mitral valve TEER experience:

Regarding the specificity of the Cardiac surgeon experience: Analysis of data in the STS data base (Gammie et.al. (2018)) showed there were 1125 open heart surgery programs in the country. Only 28 centers performed over 25 isolated primary mitral valve operations per year. The high-volume mitral valve surgery centers did an average of 23 isolated mitral valve operations for degenerative MV disease. Holding surgeons to a volume count for a procedure they would likely not have offered for the valve pathology present is counter intuitive. Surgical expertise should reflect successful mitral valve operations including a high rate of valve repairs over a longer period at the institution. Additionally, the MV-TEER has been shown to be a highly safe procedure. In an analysis of 12,334 MV-TEER procedures from data in the STS/ACC TVT Registry, only 61 or 0.5% required conversion to open heart surgery to treat a mitral valve complication. Rendering the need for emergent conversion to a mitral procedure a rare occurrence.

Recommendation

Cardiovascular surgeon with:

> 50 mitral valve surgeries in the last 5 years and more than 90% repair rate in the program, and each surgeon with > 50 career mitral valve open heart surgeries;

Regarding the experience required for the interventional echocardiographer.: For interventional imaging guidance, MV-TEER requirements should focus on the safe guidance of transseptal puncture as a primary TEE operator. TEE-guidance is a high-risk skillset and should require a minimum number of “primary” operator cases. The language used implies a fellow could observe 10 cases during training and meet the programmatic requirements. The memo calls for an Interventional echocardiographer to be part of the heart team but does not specify this to be the operator in the procedure. The term echocardiographer does not necessarily denote a cardiologist or cardiac anesthesiologist but instead is a generic term sometimes used to refer to a sonographer.

Recommendation:

The Interventional Imaging Physician:
With professional experience of =25 trans-septal guidance procedures with =10 as primary TEE operator.

Regarding the hospital program requirements for maintenance of an MV-TEER program: for programs with interventional imaging procedures specification of team composition should include a TEE Imaging physician experienced in transcatheter interventions and should be codified in this document. There is no

Recommendation: add for MV-TEER program maintenance:
=1 physician with interventional imaging privileges for transcatheter intervention guidance and analysis.

Regarding qualifications to begin a mitral valve TEER program for hospitals without mitral valve TEER experience. The 2020 Focused Update of the 2017 ACC Expert Consensus document on the Management of Mitral Regurgitation and the results of the COAPT trial, raise concerns re: the surgical criteria for hospitals to establish new programs. The proposed- Decision Memo for MV-TEER increases the number of surgical procedure from 25/year (current NCD) to 40/year without justification for this increase. he Gammie et.al. (2018) analysis, previously referenced indicates there would not be enough access to MV-TEER programs requiring patients to travel significant distances to find treatment, passing by high-quality open-heart surgery and transcatheter structural heart programs. Our concern is patients would choose to forego treatment. Additionally, there is a concern that the higher number will result in closure of currently existing MV-TEER programs that will be unable to maintain this higher number. The ultimate determinate of success for a new MV-TEER program could come through participation in an MV-TEER Registry

A key issue in post-operative patient outcomes is the institutional capability to provide appropriate pre-operative and post-operative care.

Recommendations:

Qualifications for hospitals without mitral valve TEER experience the hospital program must have the following:
a. = 50 open heart surgeries in the previous year prior to TAVR program initiation, and;
b. = 20 mitral valve related procedures in the 2 years prior to MV-TEER program initiation.
c. Participation in a prospective, national, audited registry.

Qualifications for hospital programs with MV-TEER experience the hospital program must maintain the following:
a. = 30 mitral valve interventions per year including =15 MV-TEER in the prior year or = 60 mitral valve interventions every two years; including = 30 MV-TEER procedures.
b. = 10 mitral valve surgeries per year or = 20 every two years;
c. Participation in a prospective, national, audited registry.

Regarding exclusion criteria for coverage. In the real world most patients with mitral regurgitation are a complex mix of comorbidities and multivalvular disease that require staged treatment strategies, frequently beginning with addressing the valve first.

Given the results of the COAPT trial and our experience in treating affected patients since the COAPT presentation/publication, we welcome the change in NCD for TMVr to now include FMR patients. Although an exclusion for COAPT trial was tricuspid valve disease requiring surgery or transcatheter intervention, including this new NCD exclusion may limit the application of this technology to symptomatic patients. There is data to support that one quarter of patients have tricuspid regurgitation regression after placement of a MitraClip. The postulated mechanism includes reduction in mitral regurgitation, reduction in pulmonary arterial pressures, and subsequent reverse remodeling within the right side of the heart. In addition to the growth of technologies in the tricuspid valve space that are currently in trial, leaflet plication therapy for the mitral valve may be the only option given a patients surgical risk. Nonetheless, more data is clearly need in this space and therapeutic decisions should be made as a heart team approach (IC, surgeon, echocardiographer, patient’s general cardiologist) shared with the patient without this limitation.

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

2. With respect to restricting coverage to functional MR only in presence of no significant TR, will also make it impossible to take care of significant majority of these patient. As we know in most of these patients TR improves after addressing MR, as long as they don't have irreversible pulmonary HTN and severe right sided failure.

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The decision to increase the mitral valve surgery requirement to develop a mitral clip program (TMVR) will place a great constraint on the ability for hospitals to provide comprehensive cardiac care to residents in their service area. Many patients in our region will have to travel well outside the region to receive their care. Due to the complexity of the procedure, this will place a tremendous burden on the patient and their families to travel for physician visits, procedural visits and the required registry follow up visit. For facilities, this will result in out-migration of care to tertiary facilities and place a financial burden on the referring centers and physicians. More so, patients desire to receive care in their own community.

Literature has demonstrated no relationship in mitral clip outcomes when comparing high and low surgical volume programs. In conclusion, I oppose the new surgical MVR requirements for facilities/surgeons developing a TMVR program and propose the current requirement of 25 surgical mitral valve procedures remain in place.

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COAPT has clearly shown benefit of Mitral clip in improving rate of readmission and mortality benefit in appropriately selected patients with functional MR. All surgical repairs never had shown any mortality benefit and expose patient to unnecessary procedure. Would strongly recommend adding consult in heart team from a heart failure physician or noninvasive cardiologist (from a different group if possible) with strong interest in valvular disease management as necessary prerequisite for approval to prevent potential misuse. However surgical consult prior to CLIP evaluation is unnecessary. CT surgeon remains one of bedrocks of heart team but will not add value before TMVR (for functional MR) by consult thus saving money to CMS and avoid delay to treatment of patients.

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

1. The need for face-to-face evaluation with the CT surgeon. While surgical evaluation is necessary and essential in determining the appropriateness of DMR patients. Current evidence does not support surgical intervention in FMR patients. In fact, TMVr is the first line of therapy in patients needing intervention in FMR patients (https://www.onlinejacc.org/content/75/17/2236). Hence, this requirement should be excluded.

2. Co-existing tricuspid valve disease - In our practice, we often see severe tricuspid regurgitation co-existing with severe FMR, however, most often the RV annulus is not dilated over 4.0 cm to qualify them for TV intervention. These patients are still likely to get significant benefit from a TMVr. This wording needs to be modified to improve the qualification rates in these populations as this therapy can offer a great benefit to these patients.

3. Agree with the volume requirements as it keeps the quality of the procedures high which is essential.

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We have a busy cardiovascular and particularly MitraClip program and treat thousands of heart failure patients each year at UNC REX hospital in Raleigh. We have a dedicated heart failure program here. I applaud the decision to cover functional mitral regurgitation patients as per the COAPT trial as this constitutes a large porportion of patients with CHF. However, I disagree with the decision not to include coverage for patients with co-existing tricuspid regurgitation. This is a common co-morbidity with these MR patients and excluding these patients will mean excluding a significant number of patients that would benefit from a MitraClip. Also, I would recommend covering patients with hemodynamic instability and functional MR as the Clip can be beneficial in these patients as well. Thank you for your consideration.

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CMS is to be commended by taking action to create a national coverage decision for the percutaneous management of functional MR (FMR), based upon the clinical beneifts that were seen in the COAPT study. This has the potential to deliver these benefits to the many patients who suffer from congestive heart failure despite adequate medical treatment, who have superimposed FMR. It does appear to be short-sighted that the NCD is not structured to accommodate future percutaneous therapies for this condition, which may also show substantial clinical benefits and achieve FDA approval. The process would be simplified and shorter if a more broadly defined NCD were to allow for such future therapies.

The currently structured NCD document incorporates many aspects of the COAPT study which probably should not be included in such a document. Certain components of the COAPT research study were designed to facilitate the ability to achieve the research goals. One important example is the requirement for surgical evaluation and exclusion as part of that study. That aspect was not done to remove good surgical candidates, as the role for surgery for FMR remains cloudy, lacking in validation and guideline support. However, the COAPT study was a non-blinded study, and the investigators had concerns that the control population might drop out to undergo surgical treatment after they realized they would not be receiving the procedure being evaluated. This had the potential to confound the study, so the study required patients to be excluded as surgical candidates prior to being enrolled. Unlike the surgical management of aortic stenosis, which represented a true gold standard as a mature and well-established primary treatment modality, surgery for FMR is not validated nor widely performed unless the patient is undergoing simultaneous CABG. Given the lack of recognized benefit to surgery for FMR, all aspects of the NCD which require a surgical role should be removed, other than the inclusion of heart surgeons as part of the heart team. Surgical volume requirements, face-to-face surgical evaluations, the requirements for two surgeons on staff at a hospital would preferably be removed from the document.

Another artifact of the research requirements for COAPT was the need to establish a level ground for the two groups being evaluated. To this end, the patients need to be maximally medically treated with guideline directed medical therapy. To ensure this was done to the utmost, the study required the use of heart failure specialists. Whereas the role for aggressive medical management for CHF, and the use of guideline directed medical therapy needs to be encouraged, many patients with congestive heart failure are treated in hospitals who do not necessarily have individuals who limit themselves to heart failure management. The phrasing “The heart team also includes a heart failure physician specialist experienced in the care and treatment of mitral valve disease” is vague on many levels. Is a heart failure physician specialist” limited to cardiologists who have trained in heart failure fellowships? What defines “experienced in the care and treatment of mitral valve disease”. The concern would be that this language not be used to limit access to care unnecessarily. This language could be used to limit mitral therapies to only the largest hospitals, which may not be optimal, by limiting access to care.

Another aspect which touches upon the artifact of the research study being incorporated into the NCD is the exclusion of patients with severe tricuspid regurgitation and COPD. Again, these were largely included to avoid the confounding by including these patients. Given the current positive direction of percutaneous treatment for tricuspid regurgitation (TR) it would be disappointing if these highly symptomatic patients with FMR and TR could not receive the benefits of having their FMR being treated.

This NCD as it is written unfortunately is perpetuating the mistakes of the TAVR NCD, by including hospital PCI volumes as a requirement for having a program treating FMR with percutaneous therapy. Although there were many protests of this volume requirement for the TAVR NCD, the requirement for 300 PCI’s/year was nevertheless included. Subsequent to the publication of that document, data has been provided from Massachusetts General Hospital confirming the lack of relationship between PCI volume and TAVR as well as mitral valve percutaneous therapies (Butala et al., JAMA Cardiology 2020). It would be unfortunate and perplexing if CMS insisted upon including this antiquated and invalidated requirement in this document, possibly perpetuating this requirement for future documents as well. This volume requirement would create an impediment for otherwise capable hospitals to provide care for their patients – limiting access to care.

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1. I am concerned by the use of the terminology "heart failure specialist experienced in the care and treatment of mitral valve disease." Is this implying that the heart team must consist of a board certified, subspecialty trained heart failure specialist? While this was a requirement in the trial, the vast majority of heart failure care in this country is delivered by general cardiologists, interventional cardiologists with an interest in structural/valvular heart disease, and advanced cardiac imagers. Most board certified heart failure specialists deal primarily with advanced heart failure, inotropes, LVAD, and transplant. In fact, by your own requirements, stage D heart failure patients (those often managed by heart failure specialists) are explicitly excluded from coverage. I worry this terminology would restrict care in areas without advanced heart failure/transplant centers and would require patients who by definition are quite ill to see up to 4 different cardiovascular specialists (their own cardiologist, structural interventionist, advanced heart failure specialist, and cardiac surgeon). I think it is reasonable to require documentation of GDMT, however this point needs clarification.

2. I believe that it is premature to prospectively limit patients with other valvular heart disease from coverage as it has not been conclusively demonstrated that a patient with severe tricuspid regurgitation (which may or may not require surgical intervention) from being a candidate from TEER.

3. Blanket limitations on COPD patients on home oxygen. I think a far better limitation would be, "patient with a life expectancy of <12 months from other severe medical conditions." This is addressed in a subsequent point, but I don't believe that all patients with COPD on home O2 will die within 12 months.

4. I disagree very strongly with the assertion that the patient must be considered non-operative by a surgeon to be offered TEER as a therapeutic alternative. Open mitral valve surgery for functional mitral regurgitation has never been shown to have a mortality benefit while TEER has (albeit in high/prohibitive risk patients). I think for intermediate to high risk patients who have a desire to avoid surgery they should at least be offered this option.

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

- Expanded coverage for FMR patients gives more options for patients, but we have definitely seen a more substantial improvement in those on true maximal medical therapy which is in line with the COAPT-cohort. Even those with atrial FMR or truly disproportionate LV cavity dilation on maximal medical therapy improved, but not to the same degree and it is more likely that other LVplasty devices will play more of a role here. This will need very careful patient selection to chose who would be best suited for one or a combination of devices. Some individuals have pure annular dilation and may benefit from only a LVplasty device, but after so much annular perturbation there may be a degenerative component that may need to be addressed. The simple hemodyanmics and turbulent flow across the mitral valve can cause cavity dilation, so addressing the valve may be all that is necessary. This provision of coverage expansion allows for flexibility to treat patients in whatever way is deemed appropriate and can offer individualized treatment approaches.

- It is always important to have the entire Heart Team, including the CTS team, weigh in on candidacy for a mitral procedure ..but in these situations of FMR, it is more of a discussion of bailout options and willingness, or more frequently the lack thereof. A face to face encounter with a surgeon is likely overkill, but believe that this should be a discussion that is had with the entire Heart Team at valve conference, to ensure that everyone is involved and can agree on the decisions moving forward. If a surgeon disagrees and wants to discuss the potential for an open procedure, then that can be arranged. I personally do not think that this will add anything to patient care or decision making but only lead to more delays in treatment.

- I do not agree with the fact that simultaneous tricuspid disease knocks you away from being a candidate for a MitraClip. If a patient is going to undergo a MitraClip, they have already been deemed high risk or inoperable for open surgery, so why would a worsening tricuspid valve that needs repair change that scenario? Even though it does not significant increase procedure time or significantly complicate procedures, addressing the tricuspid valve at the time of open surgery will not make the high or inoperable patient more of a surgical candidate. I am assuming that this discussion would apply only to the DMR category only because surgery is rarely (if ever) performed for FMR patients. While dedicated percutaneous tricuspid repair devices are being explored, treatment of MR can result in significant improvement in QOL measures and treat the reversible components of pulmonary hypertension and reduce right heart strain.

- I think that given new stratification and algorithms to treat patients with coexisting aortic and mitral valve disease, the aortic valve should be addressed first and then attention turned to the mitral valve after further medical therapy is attempted. Given the lability of MR based on LVEDP, hemodynamics, tolerance of medical therapy, etc, this is a reasonable approach that will likely pay off for most patients.

- Personally, I do not believe that the numbers to certify a site for MitraClip based on surgical mitral procedures should be increased, as this 1) has never been shown to improve outcomes, 2) would severely limit access to a potentially beneficial procedure in rural or community-based facilities that are fighting for accessibility for our patients with limited resources, transportation concerns. This disproportionately affects facilities outside of major cities or academic centers and seems to truly only benefit these types of institutions in an effort to drive patients away from the very capable facilities in their own towns. As long as collaborative, multi-disciplinary approach is taken that encompasses CTS, Interventional Cardiology, Cardiac Imaging, Heart Failure, and Cardiac Anesthesia, there is no reason that this therapy cannot be offered on a wider scale.

- The proposed exclusion for the COPD patients on HOT seems unreasonable, but brings up some good points. We are trying to define success by symptom improvement but it can be VERY hard to define that in this group given irreversibility of primary lung disease. This population, in my opinion, is undefined and if you can prove the stability of lung disease and that the patient has objective evidence of hemodynamically significant, unstable mitral valve disease (elevated LVEDP and LAP and PCWP) while on maximal medical therapy, these patients should be deemed appropriate for TEER. Clear expectations of improvement need to be expressed to the patient by the Heart Team, but again should be individualized and the clip be left as an option for patients.

- It certainly seems reasonable to be more selective regarding those patients with severe pulmonary hypertension, with the onus on the operator to prove that there is a reversible component driven by primary valvular pathology. This is where an in depth hemodynamic assessment is important to try and predict benefit. Those with objective evidence of RV dysfunction are more concerning and typically would signal more severe longstanding disease, so there may be a point to draw a line. But given the plasticity of the right ventricle, there may be some improvement and there have been a handful of articles that have demonstrated improvements in TAPSE, tricuspid valve regurgitation, and other right heart parameters at one month and one year follow up. Also, there is some data that early access to clip can can prevent right heart changes and decompensating, so instead of shying people away from it we should be embracing the technology early in their treatment course.

- I have seen mixed results for patients with hemodynamic instability and shock in the context of some catastrophic development of severe MR (degenerative, flail leaflet, papillary muscle rupture). I certainly think there is a role for aggressive therapy, especially in those with multi-organ dysfunction that are "too sick for surgery," but saying that it is an exclusion robs the patient of a potentially stabilizing treatment option. If the valve is not fixed in these situations, the patient will die...plain and simple. It is true that many of these patients manifest all of the terrible end organ manifestations of shock, which in and of themselves have terrible morality attached, so this population needs to be studied further as it pertains to up front management strategies (delay in diagnosis, early use of HD and mechanical support) and more importantly the optimal timing of mitral intervention. I think of it like a post-infarction VSD, the longer you wait to fix it, the more likely that person is to die. The ones who survive to receive a surgical intervention were probably the least sick in the first place and could have been addressed early (selection bias). Personally, I think it should be something to explore further and not take it off the table and should be left to the Heart Team and the patient.

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

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

I do not think that face to face evaluation of patients by a surgeon is necessary because of lack of any surgical interventions available for these patients. Also we will need a heart team approach which will include a HF specialist. Also the annual requirement for mitral surgery for new or established centers possibly should be decreased as well.

It will be very difficult to deal with FMR patients with co-existing tricuspid valve disease requiring treatment if not covered by CMS proposed decision memo. many patients with FMR do have coexisting tricuspid regargitation. I would request not to exclude these patients.

Thank you very much for your consideration.

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

Section 1.b. i. EF<50% is too low. Many patients with severe MR, some with acute MR not surgical candidates have hyper dynamic LVEF due to maximally reduced after load from the regurgitant lesion.

Section 1.c.ii. What defines a “heart failure specialist”

It is wrong to exclude COPD patients on oxygen from the coverage decision. Many patients have overlap of two diseases and many patients who are on some oxygen chronically will live > 1 year and if they have co-existant severe MR related heart failure, their chance at symptom improvement should not be arbitrarily excluded

Regarding the exclusion of patients with PASP >70. Many patients have PASP >70 due to combined pre/post capillary pulmonary hypertension due to severe MR and it is not possible to give them pulmonary vasodilator therapy due to left heart chronic congestion that can be refractory. Further as you know, we have learned from the congenital heart population and transplant population that PVR is not a fixed value and can decline in patients who achieve euvolemia for long periods of time post operatively. It would be wrong and harmful to patients to use this stipulation as an exclusion criteria.

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

However, it may be more appropriate for a heart failure specialist to determine eligibility for TMVR in secondary MR rather than a cardiac surgeon, as experts in guideline directed medical therapy in heart failure. Furthermore, I support maintaining requirement for reporting follow-up outcomes in the STS/ACC TVT registry, as currently mandated for TMVR in primary mitral valve regurgitation.

Thank you for your consideration and coverage decision.

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July 25. 2020

Dear Committee Members,

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

Our functional mitral regurgitant patients are very complex, more complex than those in the COAPT trial, and many are not good operative candidates due to multiple comorbidities. The MitraClip can offer this large group of patients a much better quality of life and reduced hospitalizations.

Several exclusions are proposed which I think will severely limit the potential benefit to our patients. They are as follows:

1. Coexisting aortic and tricuspid disease should not be an exclusion. These valvular abnormalities are common in the elderly. Sometimes the MR improves after TAVR but sometimes it does not. Many of our TAVR patients are left with significant MR. They were not candidates for a surgical aortic valve, and therefore they are not candidates for an open MV repair/replacement either. Many of our MR patients have significant TR but the TR almost always improves after MV repair/replacement. We have done several patients with severe pulmonary hypertension and they have benefited.

2. Lung disease and oxygen use is common in heart failure especially with worsening valve disease. I live in Kentucky. More than ¾ of my patients are former or current smokers and have COPD, many on home oxygen. This is one of the greatest reasons why they are not good operative candidates. The additional burden of functional MR drives additional hospitalizations. TEER would be beneficial for many of these patients. Many of my functional patients that came to me on oxygen no longer need oxygen at all.

3. Heart failure patients should definitely be covered. Those in the later stages of heart failure, C and D, are likely to benefit most. More heart failure patients are living longer due to better medical therapy and ICDs/BiVICDs. We need an option to treat their MR and reduce hospitalizations.

4. Hemodynamic instability requiring inotropic support or mechanical heart assistance due to MR should be covered. In my experience this is not common, however about 2 months ago we had a patient who died of just that. Had we been able to place a MitraClip we could have prevented her subsequent multisystem organ failure.

5. The proposed requirements for hospitals with mitral valve TEER experience need to be adjusted. As we become more proficient at TEER, the surgical mitral valve procedures will decline. I think that 20 MitraClip procedures are reasonable once the functional patients are approved. I think that surgical mitral valve procedures should be 10 per year or 20 per 2 years as many of the previous surgical patients will now be MitraClip patients.

Thank you for allowing me to comment on this very important decision.

Paula W. Hollingsworth, MD, FACC
Interventional Cardiologist
Baptist Health Lexington
Lexington, KY 40503

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

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

thank you for your consideration.

Juhana Karha MD
interventional cardiology
medical director / heart valve clinic at the heart hospital of austin / Austin TX

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

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

2. In patients with functional mitral regurgitation, the trial was designed with mitral clip versus guideline directed medical therapy. There was no surgical intervention because it was a IIb recommendation and not standard of care. To include a surgical visit will delay care and likely subject patients to higher risk procedure which has not been shown to be of significant benefit.

3. Including tricuspid valve requirements in functional mitral regurgitation will only make it less likely these patients are treated as it will not be able to be reimbursed. Many of these patients are even sicker and will not get treatment that could be beneficial

Overall I believe though well intended, the guidelines create more confusion and less access to care.

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

1. The benefits of TEER in functional MR patients in the COAPT trial were consistent across numerous subgroups, including patients who had ischemic and nonischemic cardiomyopathy and those who were and were not at high risk for surgery-related complications or death, and the benefits were independent of the left ventricular volume and function at baseline. The prognosis among patients with heart failure and secondary mitral regurgitation is very poor; in the trial, approximately two thirds of such patients died or were hospitalized for heart failure within 2 years. Transcatheter mitral-leaflet approximation led to a decrease in the severity of secondary mitral regurgitation; this is presumably the mechanism behind the improvements in prognosis,
All enrolled patients were symptomatic (NYHA class II, III, or IVa , despite the use of maximal doses of guideline-directed medical therapy and had moderate-to-severe or severe mitral regurgitation, a left ventricular ejection fraction of 20 to 50%, and frequent coexisting conditions.
Whether the device would have similar benefits in patients who are more critically ill was not answered by the COAPT trial specifically. A similar trial in this subgroup is unlikely to be done in the foreseeable future. Based on the reduction of MR being mechanistically the reason for reduction of mortality and rehospitalization across all spectrum of heart failure it is conceivable even the sicker cohort would benefit. In fact many of us have indeed shown benefit in patients with cardiogenic shock, inotropic support and on MCS.To exclude this group for the only therapy which has the potential to help, is unfortunate.

2. Placing an ICD in a patient listed for heart transplant is a Class1 indication - with the same reasoning a TEER procedure to bridge a patient to transplant allowing to reduce rehospitalizations and improve QOL while waiting in uncertainty should be covered ( The proposal in its current form excludes patients who need any cardiac surgery in 1 year).

3. In the COAPT trial, among surviving patients in the device group, the mitral regurgitation grade at 2 years was 3+ or higher in only 0.9% and was 2+ or higher in only 22.8%. In contrast, a previous randomized trial evaluated the effectiveness of a downsized annuloplasty ring in patients who had secondary ischemic mitral regurgitation of similar severity to that seen in this trial; among surviving patients who were treated with the downsized annuloplasty ring, the mitral regurgitation grade at 2 years was 3+ or higher in 14.0% and was 2+ or higher in 58.8%. Surgical repair has never been shown to be of benefit in functional MR.In view of this a “face to face” CV surgery consult adds an avoidable burden for patients - especially when logistics of frequent visits for “ consultations” is a major inconvenience for patients coming from far and wide.

4. Patients with heart failure and severe MR often have severe Tricuspid regurgitation - although in many the later goes down in severity after Mitral TEER , some continue to have burdensome TR. Many operators have demonstrated significant benefit of Tricuspid TEER , especially patients with cardiorenal syndromes due to high venous pressures. To exclude these from coverage will be a disservice to them.

Thank you

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

Currently there is NO Class I indication for mitral valve surgery due to lack of positive data. In patients undergoing surgical aortic valve replacement or CABG, it is considered class IIa indication to repair mitral valve for significant MR. While there is no standard of care in terms of mitral valve surgery for functional MR in patients with reduced ejection fraction, what is the point of having a CV surgery evaluate these patients unless they have concomitant coronary disease and/or aortic valve disease. The requirement to be seen face-to-face by a cardiac surgeon should be removed as it will only create obstacles while offering this powerful lifesaving therapy to the patients with no surgical alternative.

GDMT is imperative before undergoing TEER (as evidenced from COAPT trial). While the term ‘heart failure specialist’ is loose, it needs further clarification. Most of the interventional cardiologist performing TEER go through at least 7 years of intensive training, majority of which is spent on taking care of HF patients. Thus they are able to effectively manage HF. In most centers, the patients are only referred to advanced heart failure teams if they need mechanical therapy or heart transplant. As referral to HF team before offering TEER will delay the necessary care, this requirement should be removed. Appropriate documentation of GDMT and failure of such is reasonable to expect. The structural heart interventionalist should be able to do that. On the other hand, some centers performing TEER do not have ‘HF specialists’ – what is the alternative for them?

Some technical exclusions such as pulmonary hypertension with PASP > 70 mmHg, concomitant severe TR, patients requiring ionotropic support etc. are good for clinical trial when they are trying to select pristine ‘pure’ MR patients. But in reality, the patients with these high-risk features get better after TEER as MR is the reason for their TR, Pulm HTN etc. They should be removed.

Lastly, intra-procedural echocardiography is a critical component of TEER and the physician performing it should be reimbursed appropriately. With current model, it is not the case. More involvement from ‘echo experts’ will not only achieve better/optimal results but will also decrease the procedural time.

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I am pleased to see that there will be CMS coverage for SMR patients soon. After reviewing CMS's proposed NCD I'd like to share some of my concerns. MR patients may require additional inotropic or mechanical support prior to, during or after TMVr therapy so I don't agree with excluding these patients from access to MitraClip therapy. Furthermore, I referred a patient with MR and TR to a program that offered tricuspid thearpy in a trial in addition to MitraClip. It was thought that the patient may need tricuspid repair but after fixing the MR the TR resolved with additional medical therapy post MitraClip. The heart team should be able to decide the path for staged procedures that could benefit the patient.

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

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

2. Recurrence of functional MR in patients who undergo surgical mitral valve repair is close to 50-60% indicating poor efficacy of the open surgical procedure, raising concerns on the validity of surgical MV repair as the gold standard in functional MR. With recent COAPT trial data suggesting overwhelming benefit of MitraClip in terms of mortality, CHF readmissions and symptom relief, one could consider MitraClip as the new gold standard for functional MR. 

Patients already suffer long waiting times to see a general cardiologist and an interventional cardiologist specializing in mitraClip. A surgical face-to-face consult needs to be removed as a mandatory requirement especially given the high recurrence rate of functional MR after surgical MV repair. The Valve team can consider surgical candidacy based on STS score, PFTs etc in the conference rather than yet another face to face consultation.

3. CMS requirements for pts to have face-to-face consults with an interventional cardiologist, CT surgeon and potentially another CHF specialist is highly cumbersome for the patients. This must be simplified to a face-to-face consultation with an interventional cardiologist and a general cardiologist. General cardiologists or interventional cardiologists whose practices comprise a significant CHF population could easily determine the adequacy of medical therapy before proceeding with mitraclip than a dedicated CHF specialist appointment.

4. Reimbursements for MitraClip in larger centers amidst an urban population are higher compared to rural hospitals which de-incentivises the rural hospitals to perform these procedures given the financial constraints caused by lower reimbursements for the same procedure at urban centers. By de-incentivising the rural hospitals, healthcare disparities will only get worse in rural America.

5. Reimbursements for intraprocedural TEE must improve to incentivize non-invasive physicians who are crucial to the procedure.

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The Society of Cardiovascular Anesthesiologists (SCA) wishes to respond with the following comments with respect to the Centers for Medicare & Medicaid Services proposed revision to current national coverage determination (NCD) 20.33 for patients with mitral regurgitation undergoing treatment with Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve. It is our understanding that CMS is proposing that coverage determinations under section 1862(a)(1)(A) of the Act for on-labeled uses of FDA approved devices for these patients will be made by Medicare Administrative Contractors (MACs). In particular, the SCA is providing comments with respect to the qualifications of the interventional echocardiographer. The currently proposed language for qualifications of the interventional echocardiographer within the heart team are as set forth as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in transthoracic and transesophageal echocardiography with advanced training per the American Society of Echocardiography standards; and

Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily, yet many would be excluded with this language. We propose the qualifications to be amended to read as follows:

Interventional echocardiographer:

1. With professional experience of = 10 trans-septal guidance procedures and = 30 structural heart procedures; and
2. Who is board eligible or certified in either transthoracic or transesophageal echocardiography with advanced training that qualifies the individual to be credentialed at the facility performing the procedure.

We thank you for this consideration of including qualified anesthesiologists to serve this patient population, as integral members of the heart team.

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To Whom It May Concern:

We have been offering mitral clip therapy for high STS risk or prohibitive risk for mitral valve surgery. We have treated degenerative MR, functional MR with significant improvement in symptoms, quality of life. Being an advanced heart failure center, and transplant center, we do get referred a lot of patients with cardiogenic shock, that have no other options to treat mitral regurgitation except mitral clip therapy. So far we have performed mitral clip therapy on these shock patients with advanced CHF, on inotropes, and other support devices with great results.
I emphasize again, these patients have no other options. Some of these patients live long enough, leave hospital and come for follow up. There is significant improvement noted.
Therefore I feel that such patients should not be denied this therapy option, which can be performed with minimal risk, and great outcomes.

Thank you for considering our thoughts

Imran Arif MD
Rishi Sukhija MD
University of Cincinnati Medical Center

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

The lack of coverage for the treatment of functional MR with concurrent aortic or tricuspid valve disease would exclude a significant number of patients that would potentially benefit from the technology and avoid the high re-hospitalization rate present in this patient population.

The exclusion of patients with pulmonary hypertension and hemodynamic instability also will take away a potential life saving therapy in a patient population that has no other option.

The excellent peri-procedural results and outstanding safety profile with the current utilization of TMVR is a great example of technology being utilized in the real-world based on best clinical judgement.

The current document will limit significantly the practice of medicine with regards to TMVR. Would suggest a revision of criteria that would allow for the clinician to offer full benefit of TMVR in this very sick patient population.

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July 17,2020

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

Henry Ford Hospital is an 877-licensed bed tertiary, quaternary care hospital, education and research center located in Detroit. The hospital is recognized for clinical excellence in the fields of cardiology and cardiovascular surgery, neurology and neurosurgery, orthopedics and sports medicine, transplant, and cancer. It is the flagship hospital of Henry Ford Health System, one of the nation’s leading comprehensive integrated health systems. The hospital is staffed by the Henry Ford Medical Group, one of the nation’s largest group practices, with over 1,900 physicians and researchers in over 40 specialties who staff Henry Ford Hospital and 28 Henry Ford medical centers in southeast Michigan.

The Structural Heart Disease (SHD) Program of Henry Ford Health System includes three hospitals in the Southeastern Michigan. The SHD team is comprised of 9 Structural Interventional Cardiologists, 8 Cardiac Surgeons, 4 Interventional Imagers. Since its inception in 2012, we have performed >1800 transcatheter aortic valve replacements, >365 MV transcatheter edge-to-edge repairs, >500 left atrial appendage closures, > 500 atrial septal defect closures. >40 aortic and mitral valvuloplasty’s as well as an active heart transplant, LVAD, and full open-heart surgery program.

Our comments:

§ A.1.c. ii. “The patient is under the care of a heart failure physician specialist experienced in the care and treatment of mitral valve disease;”
Management of heart failure is a core competency for board certification in Cardiology and the practice of cardiovascular medicine. The ACC/AHA Guidelines for the management of Mitral Regurgitation specifies treatment of heart failure related to mitral valve disease is goal directed medical therapy (GDMT). Every board-certified cardiologist is credentialed in the management of heart failure and is expected to follow these guidelines.

Recommendation:

The patient is under the care of a board-certified Cardiologist, experienced in the treatment of heart failure with mitral valve disease and has indicated that guideline based maximal goal directed medical therapy has been achieved.

§ A.2.b. “The heart team's interventional cardiologist or cardiac surgeon must perform the mitral valve TEER. Interventional cardiologist(s) and cardiac surgeon(s) may jointly participate in the intra-operative technical aspects of TEER as appropriate.”

The MV TEER procedures are a true “team” procedure with both an operator and imager essential. The interventional imager must assess the severity of disease prior the procedure and provide guidance for accurate trans-septal crossing, strategic device placement and repositioning, interpretation of effectiveness and assessment of outcome. As written, the proposed memo leaves out the Interventional Imager as key to the technical aspect of the procedure. The absence of this in the intra-operative sentence technical aspect of TEER, implies that a sonographer without medical background could perform the procedural guidance. It also precludes the ability of the Interventional Imager from receiving 66% of the RVU delegation like a CTS surgeon who may scrub into the case as a second operator.

Recommendation:

The heart team’s interventional cardiologist or cardiac surgeon AND the interventional imager physician must perform the mitral valve TEER.

§ A. 2.c. Qualifications to begin a mitral valve TEER program for heart teams without mitral valve TEER experience:,

“Regarding the specificity of the Cardiac surgeon experience”: Analysis of data in the STS data base (Gammie et.al. (2018)) showed there were 1125 open heart surgery programs in the country. Only 28 centers performed over 25 isolated primary mitral valve operations per year. The high-volume mitral valve surgery centers did an average of 23 isolated mitral valve operations for degenerative MV disease. Holding surgeons to a volume count for a procedure they would likely not have offered for the valve pathology present is counter intuitive. Surgical expertise should reflect successful mitral valve operations including a high rate of valve repairs over a longer period at the institution. Additionally, the MV-TEER has been shown to be a highly safe procedure. In an analysis of 12,334 MV-TEER procedures from data in the STS/ACC TVT Registry, only 61 or 0.5% required conversion to open heart surgery to treat a mitral valve complication. Rendering the need for emergent conversion to a mitral procedure a rare occurrence.

Recommendation
Cardiovascular surgeon with: > 50 mitral valve surgeries in the last 5 years and more than 90% repair rate in the program, and each surgeon with > 50 career mitral valve open heart surgeries;

“Regarding the experience required for the interventional echocardiographer.”: For interventional imaging guidance, MV-TEER requirements should focus on the safe guidance of transseptal puncture as a primary TEE operator. TEE-guidance is a high-risk skillset and should require a minimum number of “primary” operator cases. The language used implies a fellow could observe 10 cases during training and meet the programmatic requirements. The memo calls for an Interventional echocardiographer to be part of the heart team but does not specify this to be the operator in the procedure. The term echocardiographer does not necessarily denote a cardiologist or cardiac anesthesiologist but instead is a generic term sometimes used to refer to a sonographer.

Recommendation:

The Interventional Imaging Physician:
With professional experience of =25 trans-septal guidance procedures with =10 as primary TEE operator.

“Regarding the hospital program requirements for maintenance of an MV-TEER program”: for programs with interventional imaging procedures specification of team composition should include a TEE Imaging physician experienced in transcatheter interventions and should be codified in this document. There is no Recommendation: add for MV-TEER program maintenance: =1 physician with interventional imaging privileges for transcatheter intervention guidance and analysis.

§ A.2.c. Qualifications to begin a mitral valve TEER program for hospitals without mitral valve TEER experience. ———————

The 2020 Focused Update of the 2017 ACC Expert Consensus document on the Management of Mitral Regurgitation and the results of the COAPT trial, raise concerns re: the surgical criteria for hospitals to establish new programs. The proposed- Decision Memo for MV-TEER increases the number of surgical procedure from 25/year (current NCD) to 40/year without justification for this increase.

The Gammie et.al. (2018) analysis, previously referenced indicates there would not be enough access to MV-TEER programs requiring patients to travel significant distances to find treatment, passing by high-quality open-heart surgery and transcatheter structural heart programs. Our concern is patients would choose to forego treatment. Additionally, there is a concern that the higher number will result in closure of currently existing MV-TEER programs that will be unable to maintain this higher number. The ultimate determinate of success for a new MV-TEER program could come through participation in an MV-TEER Registry

A key issue in post-operative patient outcomes is the institutional capability to provide appropriate pre-operative and post-operative care.

Recommendations:

Qualifications for hospitals without mitral valve TEER experience the hospital program must have the following:

a. = 50 open heart surgeries in the previous year prior to TAVR program initiation, and;
b. = 20 mitral valve related procedures in the 2 years prior to MV-TEER program initiation.
c. Participation in a prospective, national, audited registry.

Qualifications for hospital programs with MV-TEER experience the hospital program must maintain the following:

a. = 30 mitral valve interventions per year including =15 MV-TEER in the prior year or = 60 mitral valve interventions every two years; including = 30 MV-TEER procedures.
b. = 10 mitral valve surgeries per year or = 20 every two years;
c. Participation in a prospective, national, audited registry.

§ A.2.c – Regarding exclusion criteria for coverage

In the real world most patients with mitral regurgitation are a complex mix of comorbidities and multivalvular disease that require staged treatment strategies, frequently beginning with addressing the valve first.

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

My concerns are mainly in excluding coverage in patients with concomitant valvular disease and dismantling the heart team. It would be an obvious disservice to apply strict study inclusion exclusion criteria to the general population thereby limiting access to a therapy with significant benefit to a large commercial cohort. Patients with additional valvular disease is the norm and moving forward we may have to be creative and treat the valve that is driving the patients symptoms-thus breaking from traditional surgical approaches to valvular disease. We need this flexibility as care providers to provide potential staged procedures and achieve optimal outcomes.

Moreover, the patients benefit with the current heart team model and in this particular patient population, I would advocate for heart failure and EP cardiologist involvement. The inclusion of these providers ultimately lead to the groundbreaking results and they need to be replicated moving forward. Like many who have commented, could we do this and other structural heart procedures as a single operator? Of course. The technologies have become simplistic, however the outcomes would not be equivalent as the patients benefit from the combined knowledge of the multidisciplinary team. Further, with the plethora of emerging technologies, it will be of great value to obtain key stakeholders opinions regarding which therapy best fits certain patient subgroups. Conversations we are already starting to have current day based on small patient numbers but with some serious lessons learned.

Lastly, as I read the comments I am struck by the different cultures/infrastructure of the participants and it is a tribute to the technology to have such incredible success in a heterogenous group of facilities. Ultimately, my advocacy lies in my initial skepticism of the technology which was abolished by repeated excellent patient outcomes transforming me into a current high adopter-even as a surgeon.

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A summary of this document:

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

Let me be more specific about my criticism of this NCD document.
As always, the concern should be first and foremost patient safety.
This document discusses:
1. Practitioner requirements
2. Institutional requirements
3. Various physician requirements and sign off and verbiage requirements
4. The narrow window in which this treatment can be provided

1. Practitioner requirements

The safety of this procedure is dependent on the experience of the interventionalist or surgeon with the TEER procedure. The only study to date on this subject was by Chhatriwalla AK et al (Operator experience and procedural results of transcatheter mitral valve repair in the United States. JACC 2019). In the TVT registry, “greater experience was associated with shorter procedure, improved procedure success, and fewer in hospital complications (TCT MD 2019).” Improvements flattened out after 50 implants but continued to improve in those implanters with over 200 implants. The NCD requirements do not even come close to this level of experience. Again, the NCD proposes, 100 life time “structural heart” procedures and experience with trans septal puncture in at least 20 cases.

Cardiac surgery requirements appear to be reasonable on the surface. But why can the cardiac surgeons do mitral valve repairs in centers without structural cardiology expertise in mitral valve percutaneous repair? Especially when this NCD addresses functional mitral insufficiency? The overwhelming set of data does not support a surgical role. The data for surgery is present for degenerative mitral disease NOT functional mitral disease in cardiomyopathy. Also “Interventional” echocardiography training is not board recognized by the ABIM.

2. Institutional requirements

Reasonable:
Greater than 20 TEER procedures per year

Unreasonable:
The number of PCIs per year (relation to functional MR?). I believe the intent is to restrict the procedure to only large academic hospitals.

3. Various physician requirements and sign offs and verbiage requirement

This is simply UNPRECEDENTED. This effectively is a policing mechanism on the TEER procedure and not on the DISEASE. If you are truly worried about policing, then the DISEASE should be policed and ALL its TREATMENTS including cardiac surgery for functional MR, which we know has no mortality benefit. The NCD specifies the exact language and rationale that should be used. Including sign off by heart failure physicians and other practitioners (which are alluded to but not specified). If you are so concerned, apply it to all of functional MR including SURGERY or MEDICAL THERAPY. Ergo, DO NOT PAY for SURGICAL THERAPY for this disease. Let’s agree to be logically consistent.

4. Finally, the narrow window of patient characteristics

The document implies that we should never use clinic judgement in cases in which we will never have trial information. The goal of trial inclusion/exclusion is to get FDA approval for the device:

Lack of data is not equal to lack of efficacy.

If you have put faith in a heart team approach, then each patient is different and should be managed by that team. If the pulmonary pressure is 75 mmHg, why is that forbidden (data for 70 mmHg?)? The pulmonary vascular resistance data is meaningless. All WHO Group II pulmonary hypertension is reversible over time if the left atrial pressure normalizes. LVAD therapy has proven this. The NCD should not be the repeat of a clinical trial. We successfully saved a patient with severe MR in a LVAD with a TEER procedure. Repeat surgery involved a 5th sternotomy with a patient in heart failure despite his LVAD. This case would be prohibited and the patient would be dead. This is not patient safety.

No reason exists for a heart team if the NCD has decided all the guidelines. Yet again, this document is not logically consistent.

This is a deeply flawed document that sounds like an agenda driven by an interest group. I hope that reason and sensibility prevails.

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

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

3. FMR payment supoort for MitraClip is necessary and much needed to bring this procedure to properly evaluated patients

4. MitraClip is a non surgical procedure performed mostly by non-surgeons. Surgical volumes should not impact a center and program. Outcomes and TVT like Registry for performance is appropriate. This can be seen in the evolution of PTCA/PCI that today does not mandate an in house Surgical program.

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

Oftentimes patients who have severe symptomatic MR from a functional etiology also have severely reduced LV function/associated co-morbid issues which would make them obvious surgically prohibitive patients. Streamlining the process for these patients to be seen by the treating IC to facilitate decision making (rather than forcing a mandatory surgical consult) would allow these patients to be treated in a timely and effective fashion.

Additionally, these patients also commonly present with tricuspid valve regurgitation. Repairing the functional mitral valve disorder oftentimes brings clinical improvement, irrespective of the underlying TR, and the presence of TR should not be used to exclude patients in this cohort from receiving this therapy.

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I agree with the proposed change to reimburse MitraClip for SMR. The coverage decision should not mimic the COAPT trial exclusively. There are many patient subgroups that would have been excluded from COAPT that have shown to benefit from MitraClip therapy. To exclude reimbursement for patients that require mechanical circulatory or inotropic support may limit the availability of a potentially life saving treatment option. Excluding reimbursement for patients with multi-valve disease negatively impacts patient care because it excludes staged procedures as you often see simultaneous mitral and tricuspid disease. While treating severe MR can often reduce the severity of TR, it may persist despite the reduction of MR and therefore the patient may need tricuspid intervention. The proposed coverage decision would preclude the option of a staged procedure that could benefit the patient.

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

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

The coverage limitations placed on this high-risk population limits access for many patients who may otherwise be ideal Mitraclip TEER candidates as this population frequently has other comorbidities listed in the exclusion criteria that would deny them proper care. Many patient outcomes could progressively worsen with increased morbidity and mortality without access to Mitraclip TEER therapy.

Regarding face-to-face evaluations with an interventional cardiologist and cardiothoracic surgeon, we do propose CMS align with the multi-society statement of evaluation by a heart failure physician and interventional cardiologist for the functional patient population. Our patients with advanced heart failure and valvular disease struggle with the complexities of scheduling multiple visits and procedures as they are evaluated for these advanced therapies. Aligning this statement can assist in alleviating some of that burden.

We recommend re-evaluation of the exclusion criteria of co-existing tricuspid valve disease as this is often present concurrently with mitral regurgitation. Sometimes tricuspid regurgitation can improve post TEER, sometimes it does not. Furthermore, there is not currently transcatheter based therapy FDA approved in the United States for the tricuspid valve. That, coupled with the understanding that the functional MR patient population is often a prohibitive surgical risk for surgical repair or replacement, renders this population helpless if they are not candidates for Mitraclip TEER.

The final concern we would like to voice is that of excluding the patient population that requires home oxygen therapy or pressor therapy prior to intervention. Often, moderate to severe mitral regurgitation is a primary contributor of these advanced therapy requirements and these are a specific patient population that can benefit significantly from Mitraclip TEER therapy. We have seen successful outcomes of decreased oxygen demands as well as removal of pressor support following Mitraclip TEER therapy.

We thank you for your time and review of our comments regarding this complex and extraordinary patient population. We look forward to the opportunity to provide effective and life-changing therapy to those that will benefit.

Thank you,

Samer Garas, MD
George Pilcher, MD
Mariano Mikulic, MD
Mark Mostovych, MD
Raymond Lee, MD
Clay Burnett, MD
Richard Proia, MD
Bethany Bell, APRN

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The volume requirements (baseline and ongoing) for cardiac surgeon mitral valve surgeries is excessive and will severely limit the availability/access to this therapy for patients. Also the in person evaluation by a cardiac surgeon seems that it is unnecessary and burdensome for the patient/institution. Chart review including imaging +/- telehealth visit should suffice for purposes of surgeon evaluation. Also the PCI numbers for interventional cardiology do not seem necessary as the skill set required for a structural cardiologist are not necessarily related to PCI skills (although most structuralists) will have those.
And finally changing the name/acronym to TEER is serves no purpose in my mind as the technology has already become well known as TMVR.

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

1) Given the COVID19 pandemic and future public health crises, I would suggest addition of telemedicine encounter as an alternative to "face to face" encounter with the Heart Team members given hospital policies may preclude such a face-to-face encounter.

2) The exclusion of other valvular heart disease (aortic, tricuspid) would limit the utilization of TEER in FMR patients. Many patients we see at clinic have multivalve diseases (e.g. aortic stenosis (AS), tricuspid regurgitation(TR)) and we need to tailor the staged valve intervention based on the appropriate patient. Some of these patients may benefit from TEER first. Many of these patients have concomitant mitral and tricuspid disease and current practice has always recommended treating the mitral disease first before tricuspid. Current NCD language would preclude us from treating these patients with TEER if they have both mitral and tricuspid disease.

3) Similarly, patients on inotropic support or shock may benefit from TEER in select cases, as demonstrated during COVID19 pandemic where ICU resources are extremely limited and the goal is to stabilize the patient to get them to an de-escalated level of care to bridge them to recovery or something more definitive once they have been stabilized. Precluding these patients from TEER, even though they were excluded from the COAPT trial, would limit access to care in these patients in the context of an ongoing pandemic or those would clinically benefit.

4) Echocardiography is a critical component of TEER and the echocardiographer doing the imaging during the procedure should be considered as an key physician for the procedure and should be reimbursed appropriately. Right now it is not the case.

5) The role of the surgeon here is not to determine surgical risk. Rather, it is to provide a balanced discussion within the Heart Team on the optimal management of these patients, who often do not have just isolated FMR disease. A young patient with severe mitral and tricuspid disease may be considered for double valve surgery if appropriate over TEER alone. Although the critical role of a heart failure specialist in managing these patients and deeming them appropriate for TEER is undeniable, some of these patients may benefit from advanced heart failure therapies and a surgeon specialized in this area would also be able to provide valuable input in managing these patients. This is similar to the multidisciplinary model in treating advanced heart failure patients being evaluated for LVAD/transplant. Now that TEER is an important therapeutic addition among these patients, interventional cardiologists need to be added to this team already consisting of heart failure specialists and surgeons to jointly make the best management decision for these patients.

6) A heart failure specialist has to be the one evaluating patients with FMR. a general cardiologist managing heart failure and FMR patients cannot qualify as a heart failure specialist. This is a critical point that needs to be emphasized.

7) Participation of sites performing TEER in FMR in the STS/ACC TVT registry should be mandatory, as is the case for TAVR and TEER in degenerative MR and transcatheter mitral valve-in-valve replacement. This needs to be included in the NCD.

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

With that being said, I have several concerns regarding several of the proposed criteria outlined in this proposed decision memo. First, in section A1, subsection b, item ii, it is being proposed that eligible patients for Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve for the treatment of functional mitral regurgitation (FMR) have a left ventricular ejection fraction (LVEF) of 20-50%. I would propose that while the low LVEF threshold is reasonable, the higher LVEF should be removed. The rationale surrounding this is that LVEF is oftentimes “overestimated” (and rarely, if ever, underestimated) in the setting of severe mitral regurgitation due to the low-pressure/afterload relief offered by significant MR. After reduction in MR, the “true” LVEF is typically revealed and is abnormal. Thus, a patient with moderate to severe or greater FMR may have a visualized LVEF of 60%, but in reality, the patient’s “true” LVEF (in the absence of significant FMR) is likely more in the range of 40-50% or less. It is difficult to determine the true LVEF in the setting of FMR, which is why I strongly feel that the upper threshold of LVEF should be removed.

In Section A2, subsection c, I have particular concerns regarding the proposed hospital and operator qualifications for hospital programs WITH mitral valve TEER experience. I believe that the proposed requirement of >/= 20 transcatheter mitral valve interventions per year (or >/40 interventions every 2 years) is quite high and there are likely very few existing TEER programs in the nation that would meet this benchmark currently. Furthermore, the proposed requirement of >/= 20 mitral valve surgeries per year (or >/= 40 mitral valve surgeries over 2 years) is exceedingly high, especially when factoring in that given expanded indications for TEER and potential introduction of newer transcatheter mitral valve repair and replacement therapies over the next 5+ years, the volume of mitral valve surgeries will continue to decline. I would instead propose that CMS take a similar approach to TEER as was recently done with the updated NCD for TAVR where the TOTAL number of mitral valve interventions (inclusive of both transcatheter and open surgical procedures) be used as the volume benchmark – in this light, I would propose that a “fair” number given the contemporary practice of mitral valve therapy (with limited commercially approved devices and indications currently) would be >/= 25 mitral valve procedures (again inclusive of both transcatheter and surgical valve interventions) per year, or >/= 50 mitral valve procedures over 2 years.

In addition to the above volume criteria, I would propose that the requirement for >/= 300 PCI procedures per year be eliminated as there is little data to show any correlation between and absolute volume of PCI’s performed per year relative to valve procedure outcomes.

My biggest concerns regarding the proposed CMS decision for TEER, however, revolve around the stated criteria for which TEER for FME would NOT be covered. I fundamentally disagree with the proposed criteria of i, ii, iv, and vi, specifically. First, the VAST majority of patients with FMR demonstrate concomitant aortic and/or tricuspid valve disease of some degree. To simply deny a patient treatment because they have concomitant valve disease is unreasonable with little to no data to support the mandate. Perhaps the assumption by the authors is that if concomitant valve disease is present that the patient would be better served with surgery. This statement, however, directly contradicts language even present in this proposed NCD update where TEER will be covered in situations where the local heart team has determined that mitral valve surgery will not be offered as a treatment option. For those of us that see and manage these patients on a regular basis, we know that many are not optimal surgical candidates from a risk profile perspective and adding in concomitant surgery on a second valve at the time of MVR only increase surgical risk further. Furthermore, surgical MV repair and replacement has never shown to be beneficial inpatients with FMR, and if it has been shown that TEER should be the treatment of choice in these patients, why would the therapy NOT be covered just because concomitant valve therapy is present (especially if the local heart team has already determined that surgery for FMR is not an option)? This seems very counterintuitive to me. Lastly, we also know that tricuspid valve disease often goes hand-in-hand with mitral valve disease (due in part of pulmonary HTN in the setting of long-standing MR with diastolic or systolic heart failure) which is oftentimes more easily managed once MR is adequately treated. Under the proposed mandate, a large percentage of patients with significant symptomatic FMR would not be covered for potential lifesaving TEER therapy. Whether a patient with multi-valvular disease would benefit from TEER should be left to the discretion of the Heart Team who is managing and caring for the patient.

On a similar note, I also fundamentally disagree that patients with COPD on continuous home O2, chronic outpatient oral steroid use, significant pulmonary HTN, or RV congestive heart failure be blanket excluded from coverage for TEER. Although said patients may not receive 100% benefit from TEER therapy for significant FMR, in the properly selected cases, these patients can still receive a significant incremental benefit in quality of life with TEER for FMR. Whether a patient with significant lung disease could “truly” benefit from TEER for FMR should really be left at the discretion of the Heart Team who is managing the patient.

Thank you for your consideration of these comments on the proposed NCD for TMVR/TEER. If you have any questions, please do not hesitate to reach out to me directly.

Sincerely,

Michael S. Kim, MD, FACC, FSCAI
Director | Structural Heart Services
Penrose-St. Francis Health Services
Centura Health
Colorado Springs, CO
MichaelKim@centura.org

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

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

https://www.ahajournals.org/doi/10.1161/JAHA.119.016140
https://www.onlinejacc.org/content/75/11_Supplement_1/1320

2. Co-morbid condition exclusions: The exclusion of patients with COPD on O2/oral steroids and co-existing tricupsid valve disease is too restrictive. Anecdotally many patients with COPD or TR are successfully treated with mitraclip achieving significant symptom reduction and reduced HF hospitalizations. In many cases TR improves after mitraclip therapy or at least becomes easier to treat medically without the co-existing MR. Finally, we are already talking about patients who are not surgical candidates with no commercially available tricuspid valve devices; so these patients really don’t have an option to treat the TR at this time.

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

I strongly support expanding coverage of TEER to patients with functional MR. COAPT has shown substantial benefit of TEER for survival, prevention of HF hospitalization, and QOL. There are a substantial number of patients who may benefit from treatment and, after exhausting GDMT, there are no other treatment alternatives. While some patients may be able to undergo surgical repair or replacement many if not most patients are not healthy enough to safely undergo surgery. Additionally, the data to support surgery in secondary MR is now not as strong as for TEER and has not shown mortality benefit.
TEER with MitraClip is now FDA approved for functional MR and without consequent CMS coverage a significant number of patients who could benefit may be denied life saving care.

While I applaud the proposed coverage decision I believe the proposed wording in overly prescriptive and restrictive. Limiting coverage only to patients who would fit the COAPT clinical trial undercuts care teams ability to take very specific clinical trial data and generalize it to the larger population. While Mitra-Fr showed patients with end stage LV function and less than severe MR do not on average benefit from TEER, and importantly were not hurt either, there are patients who don't fit either clinical trial that may benefit.

Restricting coverage to very specific sub-populations functionally restricts access because FDA approval without CMS coverage of this expensive technology means TEER will less likely be available to patients who could potentially benefit. Restrictive CMS coverage has become the de facto secondary FDA because FDA approval without coverage means the same limited access to patients prior to FDA approval. Because a patient does not fit neatly into COAPT inclusion criteria does not mean that patient will not benefit from therapy. What if COAPT had never been performed and only Mitra-Fr had been published? Most patients would not fit into either trial. We can not study every patient care scenario and the absence of data does not assure the absence of benefit.

I strongly support the concept of Heart Team management of this complex patient population. Allow Heart Teams to evaluate the available evidence from clinical trials and clinical experience and make tailored decisions for their individual patients. CMS covers cardiac surgery for functional MR with far less restriction and far less evidence of benefit. Should we not start to treat coverage for surgical and endovascular procedures similarly?

Complex restrictive approval simply allows RAC auditors "Gotcha" moments punishing care teams for decisions made in good faith weighing the totality of evidence for patients that almost never neatly fit clinical trial entry criteria. Please allow multi-disciplinary Heart Teams to make decision for their patients and avoid overly prescriptive coverage language to create overly simple protocolization of all care. I would remove language on coverage based on EF, CHF class, and LVED. There may be circumstances where an individual falling outside these boundaries may still benefit.

For instance patients with Carpentier 1 disease may have an EF of 60% but still benefit (and remains yet unstudied and likely will never be subjected to a RCT). Patients with EF <20% may not enjoy survival benefit from TEER but may enjoy symptoms improvement and be able to get home from inpatient status. Patients without severe symptoms but severely depressed EF (and inactive) may benefit from therapy and delay until symptoms may result in LV depression outside of coverage or progression to end stage LV beyond recovery.

Similarly other comorbidity restrictions (TR, oral steroid use, hemodynamic instability, moderate RV d/f, pulmonary HTN) hand cuff care teams from making decisions specific to an individual situation. No one wants to offer therapy to patients where they believe their is no benefit and bad actors will find ways to document around restrictions anyway. Allow care teams to make tailored decisions in good faith. Preserve physician judgment and don't over regulate. Additionally, cardiac surgery is not the standard of care for secondary MR and is only a Class 2B guideline recommendation. While it is important for a surgeon to be part of the team, with current evidence and unlike for primary MR, surgery should not be the default for "acceptable" surgical risk patients. Functional Heart Teams should include an IC, Surgeon, and Imager. Forcing a HF specialist to see a patient F2F for coverage is too burdensome. Most practices don't have Heart Failure Specialists as was part of COAPT yet appropriately make decisions (including referral for another mechanical CHF therapy CRT) for their patients. Having CHF specialist sign off in COAPT was more about ensuring a clean trial. If CMS so lacks trust in Heart Teams to judge OMT at least allow non-F2F chart review sign off.

Shared decision making statements discoverable in the EMR are again another opportunity for RAC "gotcha" situations. The presence of a shared decision making statement in the EMR does not mean that it occurred and the absence of such a statement does not mean it did not occur. It is just another bureaucratic step for nurse coordinators to check off. Ethical team always provide shared decision making regardless of the documentation of such. Unethical team will document it whether it occurred on not. Requiring documentation just wastes time and creates a RAC "gotcha" opportunity.

Additionally, surgical volume requirements in this proposed NCD are too high. In my experience there is a balance between volume and access to care. If TEER is not offered locally then most patients will not be offered therapy at all particularly if the travel distance is too far. I have personally observed this in my clinical practice. Where I would receive occasional referrals from outside programs, when those programs started offering therapy far more patients were treated overall. When restricting coverage only to ultra high volume programs therapy awareness is more limited and patient acceptance to travel and navigate unfamiliar systems is often an unsurmountable barrier to care. While volume of mitral surgery is a marker of program size, quality, and sophistication there is a balance between volume and access.

I would suggest for program initiation 20 mitral surgeries in the last year. Having a different number for entry and maintenance does not make sense. Additionally there are few programs in the US that do 40 mitral surgeries a year and for a smaller program to be doing 40 mitral surgeries a year they are likely performing a significant number of functional MR surgeries which may not be appropriate nor should be encouraged.

Finally, while this coverage decision is for institutional reimbursement, when physician coverage is revisited I would strongly recommend the imaging physician receive RVU's equivalent to the operator. They are providing the same amount of time and expertise to the procedure and current reimbursement grossly undervalues the imagers contribution. This dissuades imager involvement in the procedure which reduces commitment to developing skills and reduces the quality of the procedure. Thus this is not just about fairness but also about quality. This must change.

In summary I applaud a coverage decision to support TEER in secondary MR. Remove restrictions for specific clinical scenarios and trust Heart Teams to make the best decisions for their patients based on all the available data. Strike a less restrictive balance on program volume to improve therapy access. Let individual programs decide how to assure GDMT has been met. Create parity in coverage been surgical MVR and TEER. Remove bureaucratic documentation requirements such as shared decision making statements. Provide equal valuation of the imager and operator for the procedure.

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

     As a community hospital that serves a vast population of cardiovascular disease, we have found that in one year of opening a structural heart clinic, that our referrals are quite robust. We have had close to 100 referrals in that time frame, with about 15% being mitral valve in origin. The proposed change of 20 to 40 mitral valve procedures per year for new centers is detrimental to many patients who do not qualify for open surgery. It creates a burden on older patients to travel and obtain care elsewhere. In times of Covid=19, this would be frowned upon, and frankly dangerous for their health.

     Our interventional cardiologist already has experience with this procedure and we would like to bring TMVR/TEER to our new hybrid cath lab and hybrid OR (under construction). We were on track to meet the current requirements which are much more reasonable.

     The proposed coverage restrictions also are quite stringent, especially coming from a background where I have seen many patients thrive with the co morbid conditions that are now becoming exclusion criteria.

     Concomitant respiratory failure is quite common in a generation of patients who did not understand the risks of tobacco use. COPD is managed much more effectively today and would actually be a reason to perform a minimally invasive procedure over a much more invasive procedure with high mortality risk.

     Inotropic agents are used much more readily today to manage patients with heart failure. Identifying the cause of the patients’ heart failure and providing a service to improve quality of life ,in regards to heart failure, only makes sense for the patient’s quality of life. Often times, patients are able to avoid readmission ,if their mitral valve disease is addressed and they have exhausted their medical management options.

     Patients with tricuspid and mitral valve disease are common. Eliminating TMVr/TEER for these patients is restrictive and will lead to higher health care costs and hospitalizations.

Please consider these comments as you move forward. Offering services in the community that patients reside is more important than ever, especially in current pandemic times. It also allows hospitals to expand needed services and tighten up on health care spending.

Thank you for your consideration,

Renee Tierney ACNP, MSN,CCRN

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

1. While the importance of achieving maximally tolerated GDMT demonstrated in the COAPT Trial is fundamental to the care of these patients I don't feel that a heart failure physician is mandatory to achieve this outcome. Most programs, including ours do not have a cardiologist with formal advanced training in heart failure. As a cardiologist who happens to be an interventionist I am well versed in recognizing and implementing maximally tolerated GDMT. Most of my referring cardiologists are also very familiar with this concept and are educated as to the specific importance of this as it relates to functional MR patients.

2. The requirement of a cardiac surgeon seeing these patients is unnecessary since there is no good data to support the use of surgery for functional MR. Also, the term "face to face" should be removed in the era of telemedicine.

3. While the exclusion criteria for the COAPT Trial were understandable to get a clear picture of the role of TEER in most functional MR patients excluding ALL patients with coexisting aortic and tricuspid valve disease, advanced COPD or need for inotropic or mechanical support should be reconsidered. There are select patients in these categories that may still benefit from the procedure that a competent heart team can recognize.

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When surgical mitral valve repair is considered for mitral regurgitation (MR), it is ubiquitous to see concomitant tricuspid regurgitation (TR). 15.7% of mitral valve surgeries require concomitant tricuspid repair from the STS database. Mitral regurgitation and tricuspid regurgitation are linked condition, but oftentimes MR is the cause of TR. It does not make sense to recommend treating TR first, when it is the consequence of MR. We understand that the COAPT trial did not include concomitant severe valvular disease, but as a clinical transcatheter surgeon, it is critical to include the concomitant valvular condition in the NCD. The high-risk patients with MR & TR will likely benefit from the treatment of MR by edge-to-edge technique, followed by treatment of the tricuspid disease both medically and procedurally.

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

1. The CMS proposal for a face-to-face encounter with a heart surgeon seems unreasonable, since NO PATIENT IN THE COAPT TRIAL UNDERWENT MITRAL VALVE SURGERY AS AN INITIAL THERAPY, and approximately 1/3 of patients enrolled were not high surgical risk. MITRACLIP THERAPY (NOT SURGERY) IS NOW THE STANDARD OF CARE FOR PATIENTS WITH ISOLATED SECONDARY MR MEETING THE COAPT PATIENT CHARACTERISTICS. GIVEN HOW BUSY CARDIAC SURGEONS ARE WITH THEIR MULTIPLE HEART TEAM ROLES AND WITH THEIR OWN BUSY PRACTICES, IT WOULD SEEM MORE REASONABLE THAT THE CARDIAC SURGEON EVALUATION SHOULD BE BASED ON A CHART REVIEW RATHER THAN FACE TO FACE. The reality is that these patient are managed primarily by heart failure cardiologists, not cardiac surgeons.

2. THE CMS PROPOSAL TO EXCLUDE PATIENTS WITH TRICUSPID VALVE DISEASE REQUIRING INTERVENTION IS VAGUE AND POTENTIALLY HARMFUL in that it may exclude many patient who would benefit. The reality is that tricuspid valve disease is dynamic and can improve after correction of MR. THE DECISION SHOULD BE LEFT TO THE HEART TO TEAM TO DECIDE THAT MITRACLIP IS APPROPRIATE AND THAT CONCOMITANT TRICUSPID AND/OR AORTIC VALVE DISEASE WOULD NOT PRECLUDE CLINICAL BENEFIT.

3. The CMS proposal to exclude patients with hemodynamic instability requiring inotropic support or mechanical heart assistance is overreaching. Many patient with secondary MR have a dynamic clinical course with periods of decompensation. When these patients are hospitalized they often require low-dose dobutamine to aid diuresis and achieve euvolemia. In many cases in may be safer to treat patient with a low-dose inotrope after the MitraClip procedure and this practice was not excluded by the COAPT protocol. THE DECISION TO TREAT PATIENTS WITH HEMODYNAMIC INSTABILITY SHOULD BE LEFT TO THE HEART TEAM TO DECIDE IF MITRACLIP THERAPY IS APPROPRIATE AND THAT THE PATIENT WILL DERIVE CLINICAL BENEFIT.

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

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

I also recommend the inclusion of patients with COPD on supplemental O2 or chronic steroids, as mitral regurgitation on top of their lung disease can appreciably affect their symptoms, utilization of medical resources, and survival.

I lastly would recommend the removal of the exclusion of patients with moderate right ventricular dysfunction as assessed by echocardiography, as echocardiography is a very poor test for determination of RV function.

Thank you.

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

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

I disagree with many of the comments regarding the value that a cardiac surgeon brings to the discussion involving the treatment of complex valvular heart problems. The fact that isolated mitral valve surgery for FMR is relatively rare compared to other mitral valve operations, does not translate into it not being useful or beneficial for the patient. 4.3% of nearly 90,000 patients still means that several thousand patients still underwent and potentially benefitted from mitral valve surgery, during the same time period quoted by Dr. Price. The benefit of any intervention is determined by studying the long term outcomes (freedom of readmission/reintervention, survival, quality of life, etc). The overall relative volume of any particular procedure is rather irrelevant.

To take that one step further and state that “a cardiac surgeon is not necessary for the heart team to determine that cardiac surgery will not be offered” is not only ridiculous, it is irresponsible. Who else would be better qualified to determine whether cardiac surgery is to be offered than a cardiac surgeon? That’s like saying the decision to offer PCI can be made without consulting with an interventional cardiologist. The decision to offer any intervention has to take into account a variety of different things – access, approach, individual anatomy, calcification, patient’s comorbidities, patient’s functional status, etc. The proceduralist doing that particular procedure has to be involved in making the decision whether the procedure/intervention is appropriate and whether it can/should be done. A non-proceduralist does not have the knowledge or experience to make those decisions.

Similar discussions were made when CMS invited comments to their TAVR protocols. What was decided then remains true today, and that is that a multidisciplinary team has to be involved in these decisions. Valvular heart disease is a very complex disease process. For mitral valve disease, the pathology does not rest in only leaflet disease. The annulus, chords, left ventricular geometry, function, volumes, pressures, etc – all have to taken into account to determine the best treatment option for the patient. Surgery may be able to offer things that percutaneous options don’t, and vice versa. A surgeon’s viewpoint in this is priceless, as is the viewpoint of the other team members. We each look at the same disease process but from different perspectives. It is only after having such a multidisciplinary evaluation, that a proper treatment option, CENTERED AROUND THE PATIENT, NOT THE PROCEDURE, can be offered to the patient. That’s the only way the patient can truly make an INFORMED decision. This will also hold true for many of the other percutaneous/hybrid valve procedures that are in development today. This is precisely why CMS, the other payors, as well as our professional societies require multidisciplinary involvement. To dissuade such collaboration or blindly discount the benefit of a multidisciplinary discussion certainly would bring more harm to a patient than any theoretical nuisance/delay in having the patient see one more doctor.

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

1. The statement requiring a cardiac surgeon evaluation prior to TEER is not in line with the current knowledge on the subject and should be removed. Open mitral valve replacement or repair has not been shown to improve outcomes for patients with functional mitral regurgitation and therefore current guidelines appropriately give cardiac surgery only a class IIb recommendation. Heart surgery is not the first line therapy for these patients, and having patients undergo this unnecessary step would not only delay their care, increase costs, but for some patients may led to unnecessary high risk heart surgery. Evaluation by a non-interventional cardiologist with expertise in heart failure is reasonable.

2. The proposed minimum number of mitral valve surgeries per year is too high. For example, less than 15% of hospitals in the country perform >10 isolated MV surgeries for DMR per year (Gammie JS, Chikwe J, Badhwar V, et al. Isolated mitral valve surgery: the Society of Thoracic Surgeons Adult Cardiac Surgery Database analysis. Ann Thorac Surg. 2018). The vast majority of institutions in the country perform less than half the proposed minimum number, and will prohibit most institutions from offering TEER, which would severity limit the access to patients.

3. Several proposed exclusion criteria are no restrictive. PASP > 70 mmHg, severe tricuspid regurgitation, LVEF >25%, and cardiogenic shock. TEER is still beneficial in all these patients when selected appropriately. Rather than a list of exclusion criteria, the memo should state TEER should be done after the heart team (in this case interventional cardiology and non-interventional cardiology with expertise in heart failure) determines the patient is a good candidate after review of comorbidities and clinical status.

4. TEER cases should be reported to the TVT registry to track its outcomes.

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

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

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1-I support the decision to include FMR coverage

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

3-Disagree lack of coverage for FMR with hemodynamic instability. There are no studies that would ever include these patient in a clinical trial. We have extensive experience in our Institution and have a cohort of 10-12 patients on inotropic support that have been bridge to a successful mitral clip. This restriction would limit the choices for patients already at very high risk for surgical intervention. A percutaneous mitral clip may be their only choice. As a disclosure, I have been a speaker for Abbott in the past.

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

Dear Ms. Syrek Jensen:

Cardiac Dimensions Pty Ltd is pleased to submit comments regarding the Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R) to expand Medicare coverage to include treatment of symptomatic functional mitral regurgitation (FMR). Cardiac Dimensions strongly supports national Medicare coverage for treatments for patients with FMR when furnished pursuant to an FDA-approved indication for FMR obtained through FDA premarket approval (PMA). However, the definition of Transcatheter Edge-to-Edge Repair (TEER) should be clarified to include all transcatheter mitral valve repair devices that act through leaflet coaptation as the primary result of the repair procedure.

Company Background
Cardiac Dimensions is a medical device manufacturer focused on the development of innovative, minimally invasive treatments for FMR in patients with heart failure and related cardiovascular conditions. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia and Germany.

The Carillon System
Cardiac Dimensions is the manufacturer of the Carillon® Mitral Contour System® (the Carillon System), a right-heart transcatheter mitral valve repair device designed to treat the primary cause of FMR in patients with mitral regurgitation in grades 2+, 3+ and 4+. The Carillon System is CE-marked (0344) and has been implanted in over 1,200 total patients in the U.S., Europe, Australia, Turkey and the Middle East. The Carillon System is approved for investigational use in the United States.

The Carillon System offers a simple right heart approach to transcatheter mitral valve repair designed to reduce FMR by reshaping the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to reduce the dimension of the mitral annulus with the result of increasing the coaptation of the leaflet edges of the mitral apparatus to reduce mitral regurgitation without compromising the valve or future treatment options.

REDUCE FMR Clinical Trial
The Carillon System is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling as well as trends toward improvement in functional capacity and quality of life in a prospective, multi-center, double-blinded, randomized, sham-controlled clinical trial of percutaneous valve therapy in patients with heart failure and moderate to severe functional mitral regurgitation (the REDUCE FMR Trial). Key inclusion criteria were MR grade 2+ to 4+, NYHA class II–IV and LVEF ≤50%. The trial met the primary endpoint of significant reduction in RV at 12 months and showed an improvement in LVEDV and LVESV at 6 and 12 months, indicating LV reverse remodeling.

Pivotal Trial - The CARILLON Trial
Cardiac Dimensions is currently conducting its pivotal trial in support of a PMA submission for the Carillon System, the CARILLON Trial, which is designed to evaluate the Carillon System for the treatment of FMR associated with heart failure as compared to a randomized control group treated with optimal medical management according to established heart failure guidelines. The multi-center, double-blinded, randomized controlled trial is expected to randomize 352 subjects at up to 75 centers in North America and Europe. The trial will evaluate the primary safety and efficacy endpoints at 12 and 24 months and will follow the randomized subjects out to five years to document long-term safety and clinical status.

Primary Safety Objective:
The primary safety objective is to demonstrate that freedom from a composite of pre-specified adverse events that are clinically meaningful in the intervention group at 12 months is greater than performance goal of 90%. A composite of the following adverse events will comprise the primary measure of safety:

• Device Embolization
• Vessel Erosion, requiring percutaneous or surgical intervention
• Cardiac Perforation, requiring percutaneous or surgical intervention
• Occurrence of cardiac surgery or percutaneous coronary intervention associated with device failure

Primary Efficacy Objectives:
The primary efficacy objective is to demonstrate that the CARILLON Mitral Contour System (Intervention) group is superior to the Control group at 24 months (analyzed when the last subject completes their 12-month follow-up visit) on the hierarchical composite endpoint of:

• Death,
• Transplant or Left Ventricular Assist Device (LVAD),
• Percutaneous or surgical mitral valve intervention,
• Heart failure hospitalization(s), and
• Improvement in six-minute walk distance at twelve (12) months

Cardiac Dimensions Recommendations
Cardiac Dimensions supports the request for reconsideration dated April 29, 2019 submitted by the Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI). Specifically, Cardiac Dimensions believes that CMS should revise the NCD for TMVR to grant national Medicare coverage for transcatheter mitral valve repair treatments for symptomatic patients with FMR when furnished pursuant to an FDA-approved indication for FMR obtained through a PMA. The Carillon System, and other pipeline treatments that reduce FMR by reshaping the mitral annulus for symptomatic patients with FMR, upon FDA approval through a PMA, should be covered by Medicare.

Cardiac Dimensions Request for Clarification
CMS Comment: “[W]e are replacing the term Transcatheter Mitral Valve Repair (TMVR) with mitral valve Transcatheter Edge-to-Edge Repair (TEER) to more precisely define the treatment addressed in this proposed NCD, which is applicable to TEER for the treatment of functional mitral regurgitation (MR) and degenerative MR.”

Cardiac Dimensions Response: We are unclear how CMS defines the term mitral valve “Transcatheter Edge-to-Edge Repair (TEER)” and whether or not this term will include the CARILLON System which is designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus, improving leaflet coaptation, and directly reduce functional mitral regurgitation shown above. We request that the term TEER be defined and that if it does not include the CARILLON System that a different, more inclusive term be used in its place.

Summary of Cardiac Dimensions Comments

1. Cardiac Dimensions supports the request for reconsideration dated April 29, 2019 submitted by the STS), ACC, AATS and SCAI.
2. Cardiac Dimensions believes that CMS should revise the NCD for TMVR to grant national Medicare coverage for treatments for symptomatic patients with FMR when furnished pursuant to an FDA-approved indication for FMR obtained through a PMA.
3. We request that the term TEER be defined and that if it does not include the CARILLON System that a different, a more inclusive term be used in its place.

Thank you for the opportunity to provide comments on the reconsideration of the proposed NCD for TMVR. Please let us know if you have questions or require additional information.

Sincerely,
Steven Goldberg, MD
Chief Medical Officer

Matthew Stark, PhD
VP Clinical and Regulatory

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

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

i.Coexisting aortic or tricuspid valve disease requiring surgery or transcatheter intervention; or
ii.COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use; or"
iv.Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg as assessed by echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization laboratory is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with a v wave less than twice the mean of the pulmonary capillary wedge pressure (PCWP); or
v.Hemodynamic instability requiring inotropic support or mechanical heart assistance; or
vi.Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction; or

Comment: Many patients with severe MR HAVE co-existing aortic and/or tricuspid disease as well as severe COPD, requiring home oxygen therapy. Some of those patients have severe pulmonary HTN with PASP of >70mmHg and some are HD unstable due to their severe MR. This is why most of them are consider prohibitive risk for surgery but they are mostly doing very well with TMVr which is a life saving procedure for them.

In most of those cases TR will improve, PASP will decrease significantly, RV function will improve and HD will stabilize following TMVr. Obviously if heart failure is too advanced and left ventricle is too dilated they would not make good candidates. Those above conditions should not be the barrier for these sick patients to receive this safe and life saving procedure.

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

Requirements regarding candidacy for mitral valve surgery and face-to-face encounter with a surgeon. For patients with secondary MR, the only therapy that has been shown to be effective (in randomized trials) for improving survival and reducing hospitalizations is TEER. As such, these 2 requirements are unnecessary:
(1) Section 1.b.v. “Local heart team has determined that mitral valve surgery will not be offered as a treatment option.” TEER is the treatment of choice for these patients; whether mitral valve surgery might be offered is not relevant to whether performance of TEER in a patient with secondary MR is appropriate and indicated.
(2) Section 1.c.iv. requires that a heart team cardiac surgeon independently examine the patient face-to-face.

Why is this necessary? One or more cardiac surgeons will participate in the multidisciplinary team that reviews candidates for TEER (as outlined in section 2.a.i.), but why would a cardiac surgeon be required to have a clinic visit with a patient with secondary MR before they are treated with the only therapy shown to be effective for secondary MR (TEER)? That is an additional step that simply adds unnecessary burden and costs to the healthcare system and patient experience. While a face-to-face encounter with both a cardiologist and surgeon to discuss treatment options for secondary MR may be optimal and may be performed at many centers, requiring it for this patient population and treatment is not necessary.

Requirement for being under the care of a HF physician specialist. While it is important to ensure that patients with secondary MR are optimally treated with guideline directed medical therapy, requiring that the patient be under the care of a HF physician specialist (and even more restrictive than that, the text specifies one who is experienced in the care and treatment of mitral valve disease) is problematic for several reasons:
(1) many areas of the country will have less access to physician specialists board-certified in heart failure and transplant (which the proposed text implies is required);
(2) even more problematic, many of these HF physician specialists are not experienced in the care and treatment of mitral valve disease;
(3) requiring that a patient be under the care of a HF physician specialist in addition to (presumably) their ongoing care by a general cardiologist along with the requirement to see both an interventional cardiologist and cardiac surgeon before performing edge-to-edge repair for secondary MR is costly, logistically challenging to coordinate, and burdensome; and
(4) cardiologists and advanced practice providers who are not boarded certified HF specialists are capable of optimizing medical therapy for heart failure and referring patients for cardiac resynchronization therapy as appropriate.

Collectively, while well-meaning, this requirement is unnecessary, would place undue and unrealistic burden on patients, increase costs, be logistically challenging to coordinate in a timely manner, and undoubtedly lead to delays in therapy. To encourage and help ensure that robust attempts have been made to optimize guideline directed medical therapy, documentation of this by the primary cardiologist, interventional echocardiographer, interventional cardiologist, or advanced practice provider (nurse practitioner or physician assistant) could be required.

Further, as an internal check, it is reasonable (and included in the proposed decision memo) to include a HF specialist on the multidisciplinary team that would review these cases and affirm that proceeding with TEER is reasonable and appropriate; in this manner, a HF specialist could review the medical therapy a patient is on and suggest/indicate that further optimization and up-titration may be warranted before reassessing MR severity and proceeding with TEER. This reflects what was operationally done in the COAPT trial. Accordingly, 1.c.ii. as currently proposed should be deleted and replaced with: “Documentation that the patient is on maximally tolerated guideline-directed medical therapy.” Since there is a relatively small number nationally of the specific individual outlined in 1.c.iii, that condition could be revised to read: “The heart team also includes a heart failure physician specialist.”

Face-to-face physician encounters prior to mitral valve TEER. Section 1.c.iv. requires that the heart team cardiac surgeon AND interventional cardiologist have independently examined the patient face-to-face… and documented and made available to the other heart team members the rationale for their clinical judgment. Above, I commented on why a face-to-face encounter with a cardiac surgeon should not be required, even if it is desirable and optimal. Here, I will make the additional point that the heart team interventional echocardiographer can provide every bit as thorough of an evaluation of these patients as an interventional cardiologist or cardiac surgeon, providing the patient with a detailed explanation of their disease process and what to expect from an edge-to-edge repair procedure. The interventional echocardiographer is also very capable of assessing candidacy for TEER, optimization of medical therapy, candidacy for cardiac resynchronization therapy, and appropriateness of palliative care. Since in the vast majority of TEER cases, the interventional cardiologist and interventional echocardiographer will be performing the TEER procedure jointly (and usually not the cardiac surgeon), 1.c.iv. should be revised to read: “The heart team interventional cardiologist OR interventional echocardiographer OR cardiac surgeon (if the cardiac surgeon is to perform the TEER procedure) have independently examined the patient face-to-face…”

Remove the requirement that the patient’s suitability for surgical mitral valve repair has been considered. Section 1.c.iv.1. indicates that the interventional cardiologist and cardiac surgeon have evaluated the patient’s suitability for surgical mitral valve repair. Building on comments made above, TEER is the treatment of choice for secondary MR. It is not simply appropriate if surgical mitral valve repair is less suitable or undesirable. Based on evidence to date, it is the preferred therapy for secondary MR. As such, if a patient with secondary MR on GDMT with residual symptoms is deemed a good candidate (anatomically and otherwise) for TEER, then their suitability for surgical mitral valve repair is beside the point; their suitability or lack of suitability for surgical mitral valve repair does not influence the appropriateness of TEER.

TVT Registry requirement for TEER. Will participation in the TVT registry be required for patients treated with TEER? If so, it did not appear to be included in the proposed decision language. To ensure quality and for eventual public reporting of outcomes, including all patients with TEER in a national registry should be required. It is required for TAVR, which now has a far larger evidence base than TEER.

Implications for TEER for degenerative MR unclear. It is somewhat unclear what the coverage for TEER for degenerative MR will be if this decision memo is implemented. Will TEER for degenerative MR (for high/prohibitive risk surgical candidates) still be approved? It should be.

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

1. There is data that suggests mitral open surgery volume is NOT predictive of procedural success for MitraClip. Increasing open surgical procedural requirements for centers would benefit high-volume surgical centers, likely in large urban cities, at the expense of patients who do not live close to these areas.
2. There is data that describes how the current recommendations would indeed LIMIT ACCESS to this life-saving procedure to certain minority populations.
3. My current practice is in Cincinnati, and many of my patients reside in some of the rural outreach sites in Ohio and eastern Indiana. We had hoped to open a MitraClip program to serve these patients (in Fairfield, OH) at our hospital with a very successful TAVR program. The new proposed guidelines would indeed restrict the care, not expand it, to my patients.

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In reviewing the NCD on TEERS there are several points that need to be addressed The hospital program must have the following:
= 40 mitral valve surgeries in the previous year prior to program initiation, at least 20 of which are mitral valve repairs; from 2000 through 2009. Only 9% of hospitals performed more than 40 mitral operations per year. In 2019 a report noted in a study looking at mitral surgery Median annual procedural volume was 23 at the hospital level (11 for repairs only) and 12 at the surgeon level (5 for repairs only) this arbitrarily selected number based on no data potentially limits access to life saving technology to many referral centers. In maintaining a TEER center, no data supports that any number of mitral valve surgeries in anyway offers a better outcome to those patients undergoing TEER. The number of TEER does and maintaining that number makes sense.

Requiring = 300 percutaneous coronary interventions (PCI) per year are obvious selected to seek centers that have an active program. However as the number PCI numbers continue to decline across the US because of better stents and delivery methods this number too is arbitrary with no data. Local heart team has determined that mitral valve surgery will not be offered as a treatment option. Although this was an important parameter in COAPT, there has been no data to support mitral valve surgery is better then TEER in secondary MR. This outcome can not be extrapolated from EVEREST and primary MR.

Not being able to treat patients with coexisting aortic or tricuspid valve disease requiring surgery or transcatheter intervention is again an arbitrary point from COAPT. Concomitant valvular disease is common place and frequently encountered in the real-world. TAVR has not been restricted to isolated AS, neither should TEER for "isolated MR" Many patients with concomitant secondary MR and TR would have a prohibitive surgical risk, offering only repeat heart failure admits to the patients if TEER was not an option.

Although limiting TEER to patients COPD requiring continuous home oxygen therapy may make sense in some patients with a limited prognosis, what about the patient with 2-3 HF admits, secondary MR and stable lung pathology again limiting TEER to this group, where COAPT noted a significant reduction in hospital admits makes no sense. Also chronic outpatient oral steroid use can be seen in several other disease states and stole not be a factor in deciding TEER

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I wish to comment on the proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). My qualifications are as follows. I am a board certified interventional cardiologist and medical director of the Cardiac Catheterization Laboratory at the Houston Methodist Hospital, Houston TX. I have been involved in structural heart interventions since 2009 and am director of our structural interventional fellowship training program. I have been a principal investigator in approximately a dozen trials of TAVR, having performed approximately 1,000 TAVR procedures, and have been a high enrolling principal investigator in the COAPT trial. I am currently a MitraClip implanter and CLASP TEER investigator as well. I have also served a term on the research and publications committee of the TVT registry. I wish to make several comments/suggestions concerning the Proposed Decision Memo.

1. The proposed Memo requires a patient interview and examination b y a cardiovascular surgeon. While this requirement is perfectly fitting for both TAVR and TEER treatment of primary (degenerative) mitral regurgitation, situations where open surgery is an extremely successful and established (Class I treatment), it isn’t rational for treatment of secondary mitral regurgitation and would in some cases create an extra burden on health systems and on ill patients. As the Memo notes, open surgical valve repair/replacement is performed uncommonly in this situation, is not regarded as a first line therapy, and is given only a Class IIb recommendation by our professional societies. Unlike TAVR and TEER for primary mitral regurgitation, there is rarely equipoise regarding TEER or open surgery for secondary mitral regurgitation. Rather the equipoise is between TEER and more aggressive heart failure management, including more vigorous GDMT titration, ventricular assist device, or heart transplantation. Accordingly, a more fitting requirement a more fitting requirement would be evaluation by an advanced heart failure specialist.

2. The statement that TEER is a single operator procedure is only partially correct. Although a single experienced operator can manipulate both the delivery system (including guide) and clip, the procedure imposes an equal time requirement on the part of a second operator to perform transesophageal echocardiography to guide accurate puncture of the interatrial septum at the correct location as well as appropriate placement of the clip itself and evaluation of residual mitral regurgitation. We are often biased by the fact that one operator must be scrubbed in order to perform punctures and to manipulate the clip, however the second operator has an equivalent time commitment and must be equally adroit at manipulating the echo probe and interpreting the echo and Doppler images. Accordingly, it makes sense that the echocardiographer be reimbursed as a second operator for the procedure, as skilled TEER as studied in the clinical trials cited in the Memo would not be technically possible without that individual’s contribution.

3. Several technical exclusions are too restrictive. While these features appropriately excluded patients from the COAPT trial, the reason for doing so was to allow precise definition of a severely ill group of patients. Broadening the trial beyond the exclusion criteria would have led to the inclusion of a less poorly defined cohort whose inclusion in the trial may have confounded results. Nonetheless, in clinical practice many such patients might be expected to benefit from successful TEER:

4. I do not see in the Memo a continued requirement for participation in the TVT registry. Participation in this registry has been mandatory to obtain CMS reimbursement for TAVR and thus far for TEER for primary mitral regurgitation, so unlike enrollment in randomized trials, site and patient selection factors are eliminated. As a result, findings reported from the TVT registry can confidently be generalized to the TAVR population at large. In the nearly ten years since TAVR has been approved, the TVT registry is continuing to provide important lessons about TAVR. Similarly, we have learned a good deal about TEER from this registry. Mitral valve regurgitation is a more complex disease than aortic stenosis, and its treatment is accordingly more complex. It is almost certain that if uniform participation in the registry is continued the learning and improvement in patient selection and procedure performance of TEER will even exceed the clinically critical insights that we have obtained about TAVR. Understandably, the resources required of a site to participate in the registry are costly. However, the failure to continue to refine TEER would prove far more costly in the long run. If resource allocation is an issue, it would be much preferable to simplify the data elements included in the registry (which would reduce the effort required to participate) than to eliminate the registry entirely.

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

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

2. Not all institutions that have access to TEER have a fellowship trained heart failure specialist. This requirement would place an undue hardship on the institutions and patients to get seen out of town by a heart failure specialist.

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

This is a life-saving technique in qualified hands and can reverse hemodynamic instability immediately in properly selected patients. I believe that the heart valve team clinicians can be empowered to do this.

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I have two comments regarding the exclusion list:

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

2-It seems arbitrary and harmful to exclude O2 dependent patients with COPD. If the patient is in stable condition on their O2, they have the chance to feel much improved with mitral valve treatment. Often it is their mitral disease causing a large amount of the shortness of breath and not the COPD.

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I support the expanded coverage for FMR patients for TEER

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

*CMS should consider striking specificity of "face-to-face" in NCD entirely to permit options such as telemedicine.

*we frequently assess patients with concomitant valve disease (tricuspid and mitral valve disease). Sometimes tricuspid regurgitation resolves once MR is treated. Excluding coverage for patients with combined MR and TR may not allow for a staged treatment approach and clinical trial consideration.

* In numerous case reports and case series have shown acceptable-to-good outcomes for MitraClip in cardiogenic shock patients. Therefore patients with hemodynamic instability requiring inotropic support or mechanical heart assistance should not be excluded from coverage.

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

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

3.Patients with co-existing valve conditions such as Tricuspid regurgitation or aortic disease will not improve after valve surgery. Percutaneous valve therapies allow these patients to garner tremendous clinical benefit without the extreme surgical risk associated with multi-valvular open heart surgery.

4. Functional mitral regurgitation is a tremendous clinical problem. These patients represent a large percentage of recurrent CHF admissions. Treatment of functional mitral regurgitation has been proven to reduce mortally, hospital readmission, and improve quaintly of life. Any patients that meets clinical criteria based on the COAPT Trial should be teated with this therapy. Withholding this therapy would be considered below the standard of care in current CHF therapy. Cardiac surgeons know that the treatment of functional mitral regurgitation with mitral valve surgery is ineffective and increases mortality. It is most appropriate for FMR patients to have a thorogh assessment from a heart failure specialist prior to TEER, as appose to a cardiac surgeon.

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

1) Coverage deferred to MACS for degenerative MR: This therapy (TEER) has already been proven very effective to improve quality of life and reduce hospitalizations of CHF for degenerative MR. I am concerned if deferred to MACS, certain areas of the country will be able to get TEER for their patients, where others will not. We have seen this with other therapies (Cardiomems for one) and it ends up being especially frustrating since the only determination of coverage becomes the patient's zip code. I don't see why this revision would be in there. The only people to lose from this revision are the patients.

2) The only FDA-approved intervention we have for tricuspid valve disease is surgery. Many of these patients also have concomitant severe tricuspid valve regurgitation. It would be unfair and wrong to withhold therapy that we know lowers mortality and improves symptoms/quality of life because they also have a severely leaky tricuspid valve. Also, often times the tricuspid valve leaks less after TEER therapy.

3) Similarly, I have seen many patients labeled with "COPD on home o2" when in fact they have severe MR and CHF. I fear many patients would get turned away from TEER therapy because they have a listed COPD diagnosis and they are on home oxygen.

4) Last comment is about the annual volume requirement—specifically >20 per year. This doesn't take in to account physicians who trained in high volume centers. Currently do maybe 10-15 per year but I still believe we deliver good quality procedures. I think one procedure per month ought to keep someone facile with the procedure.

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1) The use and success of MitraClip for appropriate FMR patients was recently shown in the COAPT trial. I want to reiterate the importance of this therapy remaining covered and being available for these important patients.
2) Severe TR is associated with high mortality and is often present in patients with moderate-severe/severe MR. It is vital that we be able to percutaneously repair the MR in patients with concomitant severe TR, as our surgical colleagues would do in operable patients. This would allow for the best possible outcome for Mitraclip treated patients with significant severe TR.
3) Severe MR with cardiogenic Shock is a known entity and for patients who cannot go to surgery we should be able to repair the MV with a percutaneous therapy like MitraClip while also supporting their circulation with a mechanical circulatory assist device (such as Impella, IABP, ECMO, etc) if needed. We need to have the coverage and option to approach these patients percutaneously I’m the same way a surgeon would surgically.

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CMS proposes that the heart team must include a cardiac surgeon, and that the surgeon Independently examine the patient face-to-face, evaluate the patient’s suitability for surgical mitral valve repair, TEER, maximally tolerated GDMT, or palliative therapy. Furthermore, CMS proposes that local heart team must determine that mitral valve surgery will not be offered as a treatment option. Although this wording mimics the COAPT trial, the absolute requirement for a cardiac surgeon to be involved in the heart team in FMR does not comport to current clinical standards and places an undue hurdle that will delay or limit care and may harm patients. Cardiac surgery in the treatment of functional MR is not accepted in the general clinical community, despite its Class IIB recommendation in Society guidelines. Of the 87,214 patients in the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database undergoing isolated mitral valve operations between 2011 and 2016, only 4.3% of patients had functional MR (Gammie JS et al, Ann Thorac Surg. 2018 Sep;106(3):716-727).

Therefore, a cardiac surgeon is not necessary for the heart team to determine that cardiac surgery will not be offered, particularly since the patient is required to be managed by a heart failure specialist. The requirement for a cardiac surgical evaluation will inevitably result in treatment delays; since the treatment effect of TEER on heart failure hospitalizations was observed soon after randomization, delays may likely also result in heart failure hospitalizations, with their associated costs and morbidity, that could have been prevented. The decision to seek a face-to-face evaluation with a cardiac surgeon on a case-by-case basis should be left to the discretion of the heart failure specialist.

Of note, the NCD proposal does not explicitly state that the heart failure specialist should evaluate the patient’s suitability for surgical mitral valve repair, TEER, maximally tolerated GDMT, or palliative therapy. Rather, the NCD proposal leaves this assessment to the cardiac surgeon and the interventional cardiologist, who may not have the tools to fully assess maximally tolerated GDMT and the role of palliate therapy.

CMS proposes to exclude patients with hemodynamic instability requiring inotropic support or mechanical heart assistance. Although these patients were not studied in COAPT, TEER has an important role in selected patients with decompensated heart failure and/or those on inotropic support or mechanical heart assistance. A recent ACC/SCAI Position Statement states that groups of patients who should be considered for TEER during the COVID-19 pandemic include (1) patients with severe functional MR (3+/4+) who cannot be safely discharged despite optimized guideline-directed medical therapy by a heart failure specialist and (2) patients with severe functional MR who are in low-output, decompensated heart failure requiring ICU-level care for whom edge-to-edge device implantation might improve hemodynamic status for extubation and/or transfer out of the ICU setting. (Shah P et al, J Am Coll Cardiol Intv. 2020 Jun, 13 (12) 1484-1488.) The ACC/SCAI support for TEER in this population even within the midst of the COVID-19 pandemic underscores the importance of having this therapy clinically available to this patient population.

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Dear Sir or Madam,

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

Cardiac surgery has an extremely limited role in the treatment of functional mitral regurgitation (FMR). This is in stark contrast to the role of cardiac surgery in the treatment of degenerative mitral regurgitation (DMR), where surgery is first-line therapy. There are data to support the superiority of surgery over TEER in DMR. Therefore, it makes sense for DMR patients to see a surgeon face-to-face before undergoing TEER. There are no data to support the superiority of surgery over TEER in FMR. Actually, surgery has never been shown convincingly to reduce mortality in FMR. Unlike surgery, TEER actually has been shown convincingly to reduce mortality in FMR (COAPT trial). Therefore, it does not make sense for all FMR patients to see a surgeon face-to-face before TEER can be offered. It may make more sense for all FMR patients to see a TEER operator (interventional cardiologist or cardiac surgeon) before surgical valve repair can be offered. Mandating that FMR patients see a surgeon face-to-face before undergoing TEER will increase costs and represent a barrier to care. In the vast majority of cases it will be a waste of the patient’s time, a waste of the surgeon’s time, and a waste of Medicare dollars. FMR patients do not need to see cardiac surgeon before undergoing TEER.

There should be no surgical volume requirements for active TEER programs to remain active. Surgical volumes have little to do with TEER outcomes, especially in established TEER programs. Surgical volumes are no more relevant to TEER outcomes in established TEER programs than TEER volumes are to surgical outcomes in established surgical programs. Should TEER volume requirements be established for existing surgical programs?

TEER should be covered in patients with comorbid tricuspid valve disease. These patients often have an improvement in pulmonary pressures and tricuspid regurgitation after TEER, and withholding TEER from them will cause harm. Furthermore, TEER may be combined with transcatheter tricuspid valve repair (either as a concomitant or staged procedure), effectively treating the tricuspid valve disease along with the mitral valve disease.

TEER should be covered in hemodynamically unstable patients when it believed that the hemodynamic instability is due in significant part to the mitral regurgitation and that treatment of the mitral regurgitation will resolve the hemodynamic instability.

TEER should be covered in patients similar to those enrolled in the COAPT trial, which is already supported by the proposed National Coverage Decision. This coverage is essential, and it will improve the quality and quantity of life for many Americans with FMR.

Thank you for your thoughtful consideration.

Sincerely,
Robert A. Leonardi, FACC, FSCAI

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

II. New proposal call for exclusion of co-existing conditions such as: a) aortic and tricuspid valve disease requiring intervention, b) need for cardiac surgery within 12 months, c) copd requiring home oxygen.
Response: TR severity should not be an exclusion criteria. TR is dynamic condition, that may be influenced by MR severity and RV pressure overload. I have seen many patient's TR improve following successful Mitraclip.

III. Surgical volume increase for new programs to 40 with 20 being MV repairs…??
Response: This is represents a steep increase and even busy surgical programs will have difficulty meeting the 20 MV repair goal.

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

For managing FMR patients and MitraClip procedure evaluation, I do understand need for optimal medical therapy, heart failure management but I do not understand a need to meet with a surgeon. Surgeons are not trained to medically manage heart failure and COAPT study did not require a surgical consultation for enrollment into the trial. None of the trials have ever shown any surgical benefit in FMR patients. Decision for face-to-face evaluation with surgeon is unnecessary burden on these sick patients and should be avoided.

Excluding coexisting Tricuspid regurgitation will result in denial of clinical care and intervention to really sick and deserving patients in whom such intervention will impact morbidity and possibly mortality.

With a collaborative effort from all tertiary care centers in Arizona we just submitted a cohort registry analysis evaluating outcomes of MitraClip patients with cariogenic shock requiring percutaneous support devices. We found high rate of MitraClip procedural success (100%), survival to hospital discharge was 92% and 88% survival at 30 days. This data is very impressive and compelling given all patients were in cardiogenic shock at time of procedure.

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

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

MANDATING THAT 3 SEPARATE CV SPECIALISTS EVALUATE PATIENTS FOR CANDIDACY FOR A CARDIAC PROCEDURE IS UNPRECEDENTED AND OVERLY ONEROUS FOR THE PATIENT. Such a requirement does not exist with coronary angioplasty, coronary bypass, or any open valve surgery. While both an interventional cardiologist (IC) and CT surgeon (CTS) independently evaluate possible TAVR patients, a third CV specialist is not mandated, and should not be mandated for FMR. Historically, FMR has not been in the domain of surgical treatment and the procedural risk of conversion to an open chest operation is exceedingly rare. IN THE DEVICE ARM OF COAPT, “the 30-day rates of death and stroke were 2.3% and 0.7%, respectively, and NO PATIENTS UNDERWENT MITRAL-VALVE SURGERY.” (N Engl J Med 2018; 379:2307-2318.) Therefore, the need for a surgeon to be ‘on standby’ is unjustified.

If the CTS is the operator who will be performing the TEER, then the CTS and heart failure (HF) specialists would comprise the heart team pre and post op. Otherwise it should be the IC and HF specialists.

I STRONGLY SUGGEST THAT THE MEMO BE CHANGED TO SAY “INTERVENTIONAL CARDIOLOGIST OR CARDIAC SURGEON”. In particular, section A, c, iv should be changed to: “The heart team cardiac surgeon OR interventional cardiologist… have independently examined… and documented…” and section 2, a, i and ii changed to “cardiac surgeon or interventional cardiologist;…”

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Two points:

The statement made in the proposed document - "COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use" was listed as a criteria to disqualify a patient from Mitral TEER from an NCD perspective. This exclusionary clinical criteria needs to be considered in the setting of other clinical conditions (RV failure, dilated RV, PHTN with fixed pulmonary vascular resistance) that would suggest a more advanced pulmonary condition where MV intervention may lead to clinical deterioration over improvement. Simply excluding a patient because a hx of COPD on 2L NC O2 may indirectly classify patients as "surgical-only" which I think is an un-intended consequence of this statement and a poor clinical decision overall. This leads to my second point I would like for the committee to consider.

If specific exclusion criterion are going to be made for mitral TEER, why is the committee not doing the same for surgical mitral valve (SMVR) candidacy? These same statements do not exist for SMVR. Quoting general mitral valve guideline statements (as done in the document) is an inappropriate comparison, especially since this statement is one of "last resort" if medical therapy fails to improve symptoms. These statements were made prior to mitral TEER was even an option. There needs to be better equipoise with surgical mitral valve surgery, if specific exclusion criterion are to be used for mitral TEER for an NCD. This is especially important since outcomes in a surgical subset have not been shown to be better than medical therapy for FMR. If you are going to limit/outline the indications/exclusions for mitral TEER, please do the same for SMVR from an NCD perspective. Back SMVR indications for FMR with the data to support it please, just as the document is doing for mitral TEER.

Thank you for the opportunity to comment.

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• I support expanded coverage for FMR patients due to the COAPT™ results.
• Please consider coverage for FMR patients with co-existing tricuspid valve disease requiring treatment. Combined tricuspid and mitral disease is not uncommon. Excluding these patients may not allow for a staged treatment approach and clinical trial consideration.
• Please consider keeping volume requirement as before. There are two publications which have shown no link between MitraClip™ outcomes and surgery volume in a hospital.
• Please consider coverage for FMR patients with hemodynamic instability – those requiring inotropic support or mechanical heart assistance. Numerous case reports and series have shown acceptable-to-good outcomes for MitraClip™ in cardiogenic shock patients.

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

This surgical evaluation is a deviation from the 2020 expert consensus ACC guidelines on MR and will slow down patients getting this important treatement.

These patients are complex patients, often times with mixed valvular disease. Putting in specific instructions on who can and cannot receive the therapy interferes with the clinicians ability to decide the best options for treatment for individual patients. Therefore, I would suggest removing the language around multi-valvular disease relating to reimbursement.

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• I am glad CMS is considering expanded coverage to FMR patients due to the COAPT results. This is going to be beneficial to a large segment of patients.
• Face to face evaluation of patients should be limited to the operator/interventional cardiologist. A surgeon should be part of multidisciplinary evaluation team but face to face with a surgeon should not be a requirement. This is a roadblock to efficient patient care.
• There should be coverage for FMR patients with co-existing tricuspid valve disease requiring treatment. Combined tricuspid and mitral disease is very common.
• Surgical volume requirements should be kept at prior levels. Current data shows no link between MitraClip outcomes and surgery volume in a hospital.
• I am disappointed at lack of coverage for FMR patients with hemodynamic instability – those requiring inotropic support or mechanical heart assistance. Current data shows acceptable-to-good outcomes for MitraClip in cardiogenic shock patients.

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

Additionally, this would effectively disqualify many patients from the Triluminate trial which is poised to add significantly to the body of literature regarding TR treatment.

Finally, TR is much better tolerated clinically than MR. It can often be managed medically for years if not indefinitely. This decision would essentially precipitate premature treatment of TR in cases that have severe MR and severe TR at the time of evaluation for trans catheter mitral valve repair. Thank you.

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

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

3rd I also have concerns with the exclusion of pts requiring inotropic or other forms of hemodynamic support. These are the very patients that often benefit the most from this type of therapy.

And lastly, I have concerns with the requirements of Face to Face meeting with CV Surgery. Surgery has very little to offer Functional MR pts. I don't see this improving care, but rather this could reduce a patients access to this proven therapy.

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To whom it may concern:

My name is Adam Pick [PHI Redacted].

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

Thanks to HVS, I have been fortunate to see and to participate in the success stories of all different types of patients who struggle with mitral, aortic, tricuspid and pulmonary valve disorders. Watching their physical and emotional transformations, from sickness to health, has been wonderful and inspiring.

Specific to the use of External TEER (Transcatheter Edge-to-Edge Repair) for severe degenerative mitral regurgitation (MR), I have known many patients, including [PHI Redacted], whom have experienced fantastic results and a renewed quality of life thanks to External TEER. If you like, you can see several patient success stories at https://www.heart-valve-surgery.com/mitraclip/.

Through HVS, I have also had a special opportunity to meet with and help patients who struggled with functional MR. More specifically, I know two patients who were nearing the end of their lives prior to participating in the COAPT trial and receiving External TEER. One patient was in the hospital waiting for a heart transplant. The other patient, who suffered from multiple heart attacks, found it difficult to do just about anything considering he was perpetually short-of-breath.

Today, after receiving External TEER procedures, one patient is camping again and the other patient is dancing again!!! Again, please visit this webpage to learn about these wonderful patient success stories - https://www.heart-valve-surgery.com/mitraclip/.

For these reasons, I became very interested in the proposed changes to CMS coverage of External TEER for patients with functional MR. That interest led me to read and consider the “Proposed Decision Memo for Transcatheter Mitral Valve Repair” (the “Memo”).

Upon review of the Decision Summary of the Memo, I had a few comments that I wanted to share with your team:

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

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

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

I also would support a review of the policy that a cardiac anesthesiologist cannot bill for the 93355 (interventional TEE) code and provide anesthesia at the same time. In practice, many large heart centers use cardiac anesthesiologists to provide both the anesthetic (with or without a resident or CRNA) and provide intraoperative guidance with TEE simultaneously. Such a model encourages the most efficient use of personnel. This model should be encouraged. The alternative is a much less efficient use of resources: The utilization of not only an anesthesiologist to deliver the anesthetic, but an additional cardiologist and an echo tech (that cardiac anesthesiologists generally don’t use). The alternative to a cardiac anesthesiologist providing the imaging is more people in the room being exposed to the radiation and more people that need to be paid while not doing anything to increase the quality of the outcome.

Cardiac anesthesiologists providing the anesthetic and the imaging is the most efficient model to facilitate interventional procedures. As evidenced by its widespread adoption in several major heart centers, it is also a successful model in the view of leading practitioners around the country. It should be duly noted and appropriately incentivized.

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

There should not be a requirement to have face to face evaluation by surgeon for functional mitral regurgitation prior to MitraClip, given these patients are rarely good candidates for open surgery. Heart failure specialist consult would be more appropriate to ensure heart failure therapy has been optimized.

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Our Structural Heart Physicians have concerns regarding the following statements:

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

Comment: In most centers with a long track record and high volume of TEER procedures GDMT is standard of care and a pre-requisite for consideration of TEER procedures in their patients. Many patients with severe functional MR are seen by our team in referral who are not on GDMT. We then escalate their medical therapy for heart failure according to guidelines and re-evaluate them after 30 days of optimal treatment. No board-certified Heart Failure Specialists are involved in this process, as they would not do anything differently for these patients. Approximately 30% of the patients referred for TEER have significant symptomatic improvement with aggressive medical therapy and are returned to the care of their referring physicians for ongoing care without TEER. During the COAPT trial, once patients were referred to the Heart Failure Specialists in our center they were frequently lost to follow-up by us and were not entered into the trial, unfortunately. Additionally, our referring physicians became alienated due to poor communication from the heart failure specialists.

The requirement for Heart failure specialist consultation represents a major barrier to this life saving therapy and it should be removed. Requiring documentation of failure of GDMT is reasonable, however.

2. “TEER of the mitral valve for the treatment of functional MR is not covered for patients with any of the following conditions:
Coexisting aortic or tricuspid valve disease requiring surgery or transcatheter intervention;
Hemodynamic instability requiring inotropic support or mechanical heart assistance; or”

Comment: Patients with severe functional MR frequently have significant TR, which often Improves with successful TEER. Similarly, Hemodynamic instability frequently is resolved after TEER.

The above restrictions should be removed.

The remainder of the requirements stated in the document seem reasonable. Thanks very much for the opportunity to provide feedback regarding this important and lifesaving procedure.

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