Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

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

RE: CAG-00468N Transcatheter Tricuspid Edge-to-Edge Repair (T-TEER)

Dear Ms. Syrek Jensen:

Abbott welcomes the opportunity to comment on the Proposed National Coverage Determination (NCD) for T-TEER, CAG-00468N.

Abbott believes establishing a national coverage policy for T-TEER with the TriClip™ TEER System will ensure predictable and consistent coverage for all Medicare beneficiaries to this FDA-designated Breakthrough Device. Abbott has worked collaboratively with CMS to best define the evidentiary requirements to support a National Coverage Determination (NCD) for T-TEER with the TriClip TEER System through the FDA-CMS Parallel Review Program and as a Transitional Coverage of Emerging Technology (TCET) pilot. While there are now multiple FDA-Approved therapies to treat tricuspid regurgitation (TR), each therapy has distinct considerations when evaluating appropriate requirements for care delivery.

Abbott is committed to transcatheter therapies for structural valve disease including FDA-Approved solutions in transcatheter aortic valve implantation (TAVI)[1], mitral transcatheter edge-to-edge repair (M-TEER)[2], and tricuspid transcatheter edge-to-edge repair (T-TEER)[3]. In addition, we are advancing multiple mitral and tricuspid replacement devices in various stages of product development and clinical trials. Abbott believes establishing a national coverage policy for T-TEER will ensure predictable and consistent coverage for all Medicare beneficiaries.

Our comments are summarized here and discussed in detail below.

Comment Summary

Numerous TriClip results publications have been released since CMS’s evidence review that Abbott believes should be included in the National Coverage Analysis and may impact CED requirements. These publications are discussed in detail below.
Abbott is overall very supportive of CMS’s proposal to cover T-TEER procedures. Specifically, Abbott supports CMS’s proposal to:

Establish coverage for all FDA-Approved indications, and

Adopt only evidence-driven coverage requirements

Abbott also provides the following recommended edits to the T-TEER coverage proposal:

Remove proposed requirement for Electrophysiologist inclusion on the Heart Team : As Electrophysiologist (EP) inclusion on the heart team for T-TEER is not supported by evidence, we recommend that the heart team requirement be updated to specify that EP evaluation is at the discretion of the Heart Team members .

Clarify proposed requirement for Multi-Modality Imaging Specialist[s] on the Heart Team .

Refer to updated FDA labeling for the TriClip System, which does not suggest implantation in a facility with immediate access to surgery.

These recommendations are discussed in detail below.

Newly Published Evidence on T-TEER
Abbott reviewed the reference table in Appendix B as well as the discussion of evidence. Here we provide newly published evidence on the TriClip TEER System for consideration and inclusion by CMS.

TRILUMINATE Pivotal publications
Described here are four new, significant publications of the TRILUMINATE Pivotal trial results:

Tang et al. [4] “Tricuspid Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: 1-Year Outcomes From the TRILUMINATE Randomized Cohort.” This analysis found that TriClip was safe and effective at one year in the full randomized trial population (n=572) – including significant TR reduction and improvements in 6-minute walk distance and health status.

Kar et al. [5] “Two-year Outcomes of Transcatheter Edge-to-edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Trial.” These are the first randomized results reporting transcatheter tricuspid intervention outcomes at two years. Importantly, this analysis showed that TriClip decreased rates of heart failure hospitalizations compared with medical therapy.

Naik et al. [6] “Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial.” This study found there were no differences in mortality, heart failure hospitalization, or need for TV surgery or intervention between patients who had transvalvular CIED leads and those who did not.

Vemulapalli et al. [7] “How Procedural Volume Prerequisites Could Impact Access to Tricuspid Transcatheter Edge-to-Edge Repair.” This analysis looked at the potential impact of procedural volume restrictions on patient access to T-TEER. It also compared results from the TRILUMINATE Pivotal trial showing that there was no difference in outcomes between sites that meet suggested procedural volume thresholds and those that do not.

The two-year results by Kar et al. show a decrease in the rate of heart failure hospitalizations with the TriClip TEER System compared to medical therapy, and the results reported in Naik et al. provide evidence that the TriClip System does not impact the function of pre-existing CIED leads. The findings by Vemulapalli et al. reinforce the appropriateness of CMS’s proposal to defer setting strict procedural volume requirements until robust clinical evidence has been generated through the coverage with evidence development (CED) process.

Tri.Fr Study
In addition to the TRILUMINATE Pivotal randomized controlled trial (RCT), a second RCT has published results comparing the TriClip TEER System to optimized medical therapy. Donal et al. [8] reported results from the Tri.Fr trial in late 2024. This trial (n=300) also found that TriClip improved patient outcomes at one year. Improved outcomes were driven primarily by improvement in patient-reported outcome measures, which align with the one-year outcomes seen in TRILUMINATE Pivotal.

bRIGHT Study
Goebel et al. [9] examined outcomes for patients with endocardial leads in the bRIGHT study population. The analysis found that T-TEER using the TriClip system was safe and effective in patients that had an endocardial lead across the tricuspid valve. Consistent with the TRILUMINATE Pivotal study, this study showed similar safety and effectiveness in patients with and without endocardial leads.

Establish coverage for all FDA-Approved Indications
Abbott supports CMS’s proposal to establish T-TEER coverage for current and potential future FDA-Approved indications, similar to how the TAVR NCD 20.32 and M-TEER NCD 20.33 are structured. This will ensure beneficiaries have access to the therapy without the need for CMS to reopen and revise the NCD. Avoiding the unnecessary burden to CMS, providers, and beneficiaries of reopening and revising the NCD aligns with the government’s efficiency goals. As the NCD policy for T-TEER is proposed under coverage with evidence development (CED), there is a framework to gather additional evidence for both current and potential future indications.

Adopt Only Evidence-driven Coverage Requirements
T-TEER is a promising new therapy for patients with TR. Abbott agrees that it would not be appropriate to establish operator and/or institutional experience requirements at this time and supports deferring inclusion of coverage requirements to when CED data are available to inform the decision. Any potential operator and/or institutional requirements must also be considered in the context of beneficiary access, with a particular focus on underserved populations.

Specifically, Abbott agrees with CMS’s statements from the Proposed Decision Memo, including:

“Treatment conditions that provide an appropriate balance of satisfactory health outcomes and optimal patient access are currently unknown for this technology.”

“We anticipate that CED with pre-specified analyses of the impact of operator and facility characteristics on outcomes, will help to guide future decisions relative to treatment conditions for T-TEER.”

T-TEER has many years of commercial experience in Europe, with an excellent safety record. The real-world experience of TriClip in Europe showed a very low number of adverse events at 30-day follow-up, including 0.8% cardiovascular mortality, 0.4% stroke, 0.2% non-elective cardiac surgery for device related adverse events, and 0% new pacemaker implantation [10]. The strong safety record for T-TEER supports allowing the CED framework to collect evidence to discern what factors reliably and significantly impact patient outcomes.

Evidence continues to be generated on whether volume-outcome relationships exist within and across heart valve procedures. Analyses have focused on both intra-therapy volume-outcome relationships (i.e., is there a learning curve?) and inter-therapy volume-outcome relationships (i.e., do higher volume centers have better outcomes across different procedures?). During this and other NCAs, many articles have been provided with varied conclusions. Abbott is providing below additional articles that we have not seen referenced in other comments or discussion.

Vemulapalli et al. [11] “Mitral Valve Surgical Volume and Transcatheter Mitral Valve Repair Outcomes: Impact of a Proposed Volume Requirement on Geographic Access.” This paper concluded there is no relationship between mitral valve surgical volumes and mitral TEER (M-TEER) outcomes. It also found that including higher surgical volume requirements for M-TEER providers would disproportionately impact patient access in the Midwest and Southeast.

Barker et al. [12] “Association Between Institutional Mitral Valve Procedure Volume and Mitral Valve Repair Outcomes in Medicare Patients.” Results from this analysis found no relationship between mitral valve surgery volumes and M-TEER outcomes.

Kumbhani et al. [13] “National Variation in Hospital MTEER Outcomes and Correlation With TAVR Outcomes: STS/ACC TVT Registry Analysis.” This registry-based analysis found low correlation of inter-therapy outcomes between TAVI and M-TEER. The authors noted that factors influencing “centers of excellence” may differ between procedures.

Regarding intra-therapy volume-outcome relationships, Abbott supports the CED framework as an appropriate way to collect data on the T-TEER learning curve to identify if there is evidence to support coverage restrictions for new programs.

Regarding inter-therapy volume-outcome relationships, there are numerous published analyses on volume-outcome relationships that come to different conclusions. The highly variable nature of inter-therapy volume-outcome relationships reported across different therapies further justifies using the CED framework to inform whether non-T-TEER procedural volumes significantly impact T-TEER patient outcomes in the commercial, real-world setting. It is worth restating that the first T-TEER system was approved by the FDA in April 2024, and studies analyzing U.S. patients prior to this date are assessing either clinical trial cases, off-label use of products approved for M-TEER, or miscoded procedures.

Restrictive requirements imposed on hospitals as a condition of coverage can limit the availability of safe, medically necessary care and unintentionally hinder equitable patient access to innovative technologies. For example, the difficulty of traveling to an eligible hospital impacts not only the patient, but also their caregivers and families, often necessitating overnight stays and time off work. Abbott appreciates and agrees with CMS’s proposal to defer specific care management coverage requirements until sufficient evidence is available through the CED framework to inform and appropriately balance site / operator restrictions with equitable patient access. Through this robust evidence development, the community will be better equipped to understand which procedural volume-outcome relationships reliably predict T-TEER outcomes. In particular, Abbott supports:

Focusing coverage requirements on those specifically related to T-TEER patient safety.

Prioritizing patient access when developing coverage requirements related to anticipated procedural success, particularly if there is high variability or uncertainty in the relationship between requirements and patient outcomes.

Embracing diverse and emerging modalities for intraprocedural imaging.

Allowing for patient management and care guided by the site care team rather than prescriptive requirements.

Remove Proposed Requirement for Electrophysiologist Inclusion on the Heart Team
It is unclear what evidence on T-TEER was used to propose an Electrophysiologist (EP) to be required on the Heart Team for T-TEER. Unlike alternative treatment options for tricuspid regurgitation (TTVR, TV surgery), T-TEER has been shown to have a low risk of causing conduction disturbances . T-TEER reduces TR by grasping and coapting the tricuspid valve leaflets resulting in fixed approximation of the tricuspid leaflets throughout the cardiac cycle, whereas TTVR or surgical TV replacement implant a prosthetic valve within the native tricuspid valve. The replacement valve fits inside the tricuspid annulus and is in direct contact with the atrial and ventricular walls which are in close proximity to the cardiac conduction system (atrioventricular node and bundle of His). The replacement valve often interacts with the conduction system, leading to heart block in approximately 15-25% of patients [14,15,16]. Unlike replacement valves, the mechanism of action for T-TEER (leaflet coaptation) does not impact the conduction system and therefore has shown minimal risk of heart block [5,17] .

Abbott appreciates that CMS clarified that the scope of this NCA is T-TEER. While Transcatheter Tricuspid Valve Replacement (TTVR) has evidence demonstrating a significant impact of existing pacemaker leads and a need for new pacemaker implants after TTVR [18], that evidence does not extend to T-TEER. As referenced above, studies have shown both in clinical trial [6] and real-world [9] populations that T-TEER outcomes were good amongst patients that had existing transvalvular CIED leads. Pacemaker implantation after tricuspid intervention is a significant adverse event for TTVR: 24.7% at 30-days for patients without a pre-existing pacemaker [18], but not for T-TEER: 0.6% [17].

Abbott believes that published evidence supports that EP participation in the heart team should not be a condition of coverage. The core Heart Team members (Interventional Cardiologist, Cardiac Surgeon, and Echocardiographer) may call on additional specialists, such as an EP, when necessary.

CMS refers to the TRILUMINATE Pivotal trial exclusion and TriClip G4 instructions for use that indicate pacemakers or cardiac leads may prevent appropriate placement of the TriClip Clip. This exclusion / instruction was not assessed in the trial by an EP, but by the implanting physician to determine whether the device can be successfully implanted. Said simply, it is not a clinical question about the impact to the electrophysiologic treatment or interference (which would be assessed by an EP), but a question about TriClip procedural success (which would be assessed by the implanter). The implanting physician can request evaluation from an EP in specific cases, if needed, however clinical experience to date does not suggest an EP is required on the heart team to evaluate likelihood of procedural success. Additionally, the evidence does not support requiring rapid access to an EP during T-TEER procedures.

Abbott requests that CMS continue to focus solely on T-TEER and with that scope, evidence does not suggest an EP is required on the Heart Team.

Clarify Proposed Requirement for Multi-Modality Imaging Specialists on the Heart Team
CMS describes Multi-modality Imaging Specialists as integral to the diagnosis, prognosis, and management of valvular heart disease. After reading the Proposed Decision Memo , Abbott is not clear if the Multi-modality Imaging Specialist requirement can be satisfied by the same individual who serves as the Interventional Echocardiographer on the Heart Team. This clarification is important since T-TEER does not require CT imaging for patient screening or pre-procedural planning, whereas other tricuspid therapies such as TTVR do. Tomlinson, et al. [19] state “CT is requisite in all TTVI planning, excluding TEER,” which is reinforced by the EVOQUE [20] and TriClip [21] instructions for use. In order to ensure the coverage policy requirements are clear, Abbott suggests simplifying the two imaging-centric Heart Team requirements into a single requirement:

- Imaging specialist(s) with sufficient expertise to diagnose and provide interventional guidance (this requirement can be met by a single individual or by multiple individuals on the heart team)

This suggested alternate wording will ensure heart teams can incorporate imaging modalities as appropriate for both TR diagnosis and intervention.

Refer to Updated FDA Labeling
The TriClip G5 System has been approved by the FDA and includes updated labeling. The quote included in the Proposed NCD Memo, “The TriClip G4 System should be implanted … in a facility with immediate access to cardiovascular surgery” is not present in the TriClip G5 System labeling [21]. Abbott provided data to the FDA supporting an update to both MitraClip and TriClip G5 IFUs to remove the statement requiring on-site cardiovascular surgery and instead ask for a plan to be put in place if surgical intervention is required: “Facilities implanting the TriClip™ G5 Implant need to maintain a plan for treating the patient if cardiovascular surgical intervention is required.” The evidence provided to justify this change came from landmark trials, contemporary registries, and commercial complaint data, demonstrating that the MitraClip and TriClip devices are safe and have very low rates of conversion to emergency cardiovascular surgery.

Conclusion
Abbott thanks CMS for its dedication and development of this proposed coverage policy for T-TEER, ensuring Medicare beneficiaries can access and benefit from this important advancement in cardiac care.

Thank you for your consideration of our comments.

Sincerely,
Arthi Chandran
DVP Health Economics and Reimbursement
Abbott Medical Devices

References
[1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190023S002
[2] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p100009
[3] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230007
[4] Tang GHL, Hahn RT, Whisenant BK, et al. Tricuspid Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: 1-Year Outcomes From the TRILUMINATE Randomized Cohort. Journal of the American College of Cardiology, 85(3), 235–246. https://doi.org/10.1016/j.jacc.2024.10.086
[5] Kar S, Makkar RR, Whisenant BK, et al. Two-year Outcomes of Transcatheter Edge-to-edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Trial. Circulation. Originally published 30 March 2025. https://doi.org/10.1161/CIRCULATIONAHA.125.074536
[6] Naik H, Price MJ, Kapadia S, et al. Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial. JACC Clin Electrophysiol. 2025 Jan 20:S2405-500X(25)00010-6. doi: 10.1016/j.jacep.2025.01.001. Epub ahead of print. PMID: 39903153.
[7] Vemulapalli S, Prillinger JB, Adams DH. How Procedural Volume Prerequisites Could Impact Access to Tricuspid Transcatheter Edge-to-Edge Repair, JACC: Cardiovascular Interventions, 2025, ISSN 1936-8798, https://doi.org/10.1016/j.jcin.2025.01.444
[8] Donal E, Dreyfus J, Leurent G, et al. Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial. JAMA. 2025;333(2):124–132. doi:10.1001/jama.2024.21189
[9] Goebel B, Lurz P, Schmitz T, et al. Outcomes of tricuspid transcatheter edge-to-edge repair in subjects with endocardial leads. EuroIntervention. 2025 Mar 3;21(5):e253-e261. doi: 10.4244/EIJ-D-23-01033. PMID: 40028727; PMCID: PMC11849534.
[10] Lurz P, Besler C, Schmitz T. et al. Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice. JACC. 2023 Jul, 82 (4) 281–291. https://doi.org/10.1016/j.jacc.2023.05.008
[11] Vemulapalli S, Prillinger J, Thourani V, Yeh 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 Jun 2;9(11):e016140. doi: 10.1161/JAHA.119.016140. Epub 2020 May 27. Erratum in: J Am Heart Assoc. 2020 Jul 7;9(13):e014560. doi: 10.1161/JAHA.119.014560. PMID: 32456507; PMCID: PMC7429011.
[12] Barker CM, Reardon MJ, Reynolds MR, Feldman TE. Association Between Institutional Mitral Valve Procedure Volume and Mitral Valve Repair Outcomes in Medicare Patients, JACC: Cardiovascular Interventions, Volume 13, Issue 9, 2020, Pages 1137-1139, ISSN 1936-8798, https://doi.org/10.1016/j.jcin.2020.01.212.
[13] Kumbhani DJ, Manandhar P, Bavry AA, Chhatriwalla AK, Giri J, Mack M, Carroll J, Pandey A, Kosinski A, Peterson ED, Kaneko T, de Lemos JA, Vemulapalli S. National Variation in Hospital MTEER Outcomes and Correlation With TAVR Outcomes: STS/ACC TVT Registry Analysis. JACC Cardiovasc Interv. 2024 Feb 26;17(4):505-515. doi: 10.1016/j.jcin.2023.11.012. Epub 2024 Feb 7. PMID: 38340102.
[14] Hahn, Rebecca T., et al. Transcatheter valve replacement in severe tricuspid regurgitation. New England Journal of Medicine 392.2 (2025): 115-126.
[15] Zack, Chad J., et al. National trends and outcomes in isolated tricuspid valve surgery. Journal of the American College of Cardiology 70.24 (2017): 2953-2960.
[16] Chen, Qiudong, et al. Isolated tricuspid operations: the society of thoracic surgeons adult cardiac surgery database analysis. The Annals of thoracic surgery 115.5 (2023): 1162-1170.
[17] Sorajja, Paul, et al. "Transcatheter repair for patients with tricuspid regurgitation." New England Journal of Medicine 388.20 (2023): 1833-1842.
[18] Hahn et al. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. NEJM. Oct 30, 2024. ePub ahead of print. DOI: 10.1056/NEJMoa2401918.
[19] Tomlinson S, Rivas CG, Agarwal V, Lebehn M, Hahn RT. Multimodality imaging for transcatheter tricuspid valve repair and replacement. Front Cardiovasc Med. 2023 Jul 12;10:1171968. doi: 10.3389/fcvm.2023.1171968. PMID: 37502182; PMCID: PMC10368950.
[20] Edwards EVOQUE Tricuspid Valve Replacement System Instructions for Use. Accessed from: https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230013C.pdf
[21] TriClip G5 System Instructions for Use. EL2142807 (2025-03-25). Accessed from: https://manuals.eifu.abbott/en/detail-screen.html

Less

Public Comment on Proposed Coverage with Evidence Development for Tricuspid Valve Transcatheter Edge-to-Edge Repair (CAG-00468N)

UCSF Team for High-Value Care

We appreciate the opportunity to comment on the proposed Coverage with Evidence Development (CED) decision for tricuspid valve transcatheter edge-to-edge repair (T-TEER) for tricuspid regurgitation (TR). Since T-TEER has not been shown to provide meaningful benefit to Medicare beneficiaries, we believe that it should not receive Medicare coverage. However, if CMS finalizes CED, in order to strengthen the evidence generated in the CED trial, CMS should require 1) a non-composite primary endpoint of all-cause mortality, 2) follow-up through 5 years, 3) that any hospitalization outcome includes all hospitalizations, and 4) no (or very limited) crossover, and 5) blinding with a placebo (sham) procedure control, if there are any subjective outcomes.

Lack of Evidence of Clinical Benefit and Concerning Adverse Event Trends
As noted in the proposed decision, the evidence supporting T-TEER is limited and mainly relies on the results of the TRILUMINATE Pivotal trial, which also supported FDA approval of the only currently-FDA-approved T-TEER device. T-TEER has not been shown to provide a meaningful clinical benefit as it has not been shown to reduce all-cause mortality, tricuspid valve surgeries, or all hospitalizations at 1 or 2 years. While the 2-year outcomes of the TRILUMINATE Pivotal trial showed a statistically significant decrease in annualized rate of recurrent heart failure hospitalizations from an intent-to-treat analysis, these results are limited due to a high crossover rate (59%) from the control group to the device group after 1 year. Furthermore, these results were not accompanied by a decrease in all hospitalizations. We agree with CMS that, based on the current evidence, T-TEER is not reasonable nor necessary for Medicare beneficiaries.

The improvements in TR grade, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, and 6-minute walk distance (6MWD) seen in the TRILUMINATE Pivotal trial do not suggest sufficient benefit as to justify any coverage, including CED. As patients and echocardiogram assessors were not blinded to treatment status, it is uncertain how much of the improvement in these outcomes was due to the placebo effect. Furthermore, the reduction of TR grade is not meaningful to Medicare beneficiaries as it did not translate into a reduction in mortality or hospitalizations. Although there were no statistically significant differences, the T-TEER group had numerically higher rates of critical adverse events than the control group at 1 and 2 years (T-TEER v. control): allcause mortality (8.6% v. 8.0% at 1 year and 17.9% v. 17.1% at 2 years), cardiovascular death (5.8% v. 4.0% and 12.4% v. 9.6%), heart failure-related death (4.4% v. 2.9% and 8.8% v. 7.3%), and hospitalizations (35.3% v. 34.2% and 58.8% v. 54.0%). These adverse events trends are concerning in light of an absence of any clinically meaningful benefit.

Suggestions to Strengthen CED Trial
If CMS decides to finalize CED for T-TEER, we believe that the CED patient and study criteria can be improved in order to increase the rigor of the trial and the quality of the evidence that it generates. For the patient criteria, optimal medical therapy should be defined as at least 90 days at maximally tolerated doses of guideline-directed medical therapy. For the study criteria, CMS should require a primary outcome of all-cause mortality as opposed to a composite primary outcome, as all-cause mortality is the most meaningful outcome to patients and should be evaluated on its own. Additionally, any hospitalization outcome (individual or in a composite) should include all hospitalizations, not a selected subgroup (such as heart failure hospitalizations). If CMS finalizes the current CED study criteria to allow a composite primary outcome, CMS should not allow outcomes other than all-cause mortality and all hospitalizations to be included in the composite primary outcome. Due to the limitations caused by the high rate of crossover in the TRILUMINATE Pivotal trial, there should be no (or very limited) crossover allowed between the control and T-TEER groups in the CED study. Finally, primary outcomes should be measured over a minimum of 5 years, with analyses conducted for each year of follow-up, to better understand the long-term benefits and risks of T-TEER.

Conclusion
We believe that, given the current evidence, T-TEER is neither reasonable nor necessary for Medicare beneficiaries, and therefore T-TEER should not receive Medicare coverage, even under CED. If CMS determines that there is sufficient justification to provide CED, we believe the above modifications to the proposed CED study criteria will generate the best evidence to better determine whether T-TEER is reasonable and necessary for Medicare beneficiaries.

UCSF Team for High-Value Care
Rita Redberg, MD MSc
Sarah Bitter, MA

Less

The Honorable Mehmet Oz, MD
Office of the Administrator
Centers for Medicare and Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

Dear Dr. Oz,

On behalf of Mayo Clinic, we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposed national coverage decision (NCD) for transcatheter tricuspid transcatheter valve edge to edge repair (T-TEER) under coverage with evidence development (CED). T-TEER and transcatheter tricuspid valve replacement (TTVR) represent a significant advance in therapeutic options for symptomatic TR despite optimal medical therapy. Although tricuspid regurgitation (TR) is recognized as a major contributor to poor outcomes in heart failure 1, prior to tricuspid TEER and TTVR, there were few options to mitigate its effects. Optimal medical therapy is limited to diuretics for decongestion but does not halt or correct TR most of the time. Isolated tricuspid valve surgery to replace or repair the valve may be associated with increased risk and higher operative mortality compared to other valve surgeries 2. Tricuspid valve surgery has a class 1 recommendation only if performed at the time of left heart surgery 3, which may not be feasible in high-risk patients, or those with isolated TR.

Mayo Clinic is a leader in valvular heart disease (VHD) and heart failure (HF), and has participated in major transcatheter valve trials, including tricuspid intervention trials. Mayo Clinic investigators have published extensively on mechanisms and outcomes in VHD and specifically on primary and secondary TR. We have a large VHD and HF referral practice across our three sites in the Midwest, Arizona and Florida. We perform both T-TEER and TTVR and are increasingly referred high risk patients with advanced HF who are not candidates for surgical repair or replacement. We support the proposed NCD with CED, which would enable access to T-TEER for heart failure patients with symptomatic TR, many of whom are Medicare beneficiaries.

Evidence Supporting T-TEER in Heart Failure

The TRILUMINATE trial, published in 2023, established the benefit of T-TEER to reduce symptomatic severe TR with associated improved quality of life 4. T-TEER is not feasible in patients with unsuitable tricuspid anatomy or TR due to implantable cardiac device leads 5, and TTVR, recently addressed by a CMS NCD 6, may be a more appropriate alternative in these cases. However, TTVR has not been shown to significantly impact the rate of heart failure hospitalizations (HFH) at 1 year follow-up 7. While earlier data from TRILUMINATE were limited by low event rates in both the treatment and control groups, two-year follow-up has now demonstrated reductions in HFH, a clinically important metric in this older, frail cohort with multi-morbidity 8. The FDA approval of the first T-TEER system in 2024 makes this therapeutic option potentially available to patients with symptomatic severe TR without alternative treatments. However, without an NCD, access will remain limited.

Comments and Suggestions for CED Subgroup Analysis

We agree that additional data is needed to identify patients most likely to benefit from T-TEER, and we support a CED to both gather evidence and facilitate earlier access to T-TEER. However, since patients who undergo T-TEER are elderly (mean age 78 at randomization in TRILUMINATE), frail and have multiple co-morbidities that increase surgical risk and impact survival, quality of life improvement and reduction in HFH are often the more clinically relevant endpoints, rather than mortality outcomes. The trial extended follow up led to important observations: 1. the impact of T-TEER on HFH may not occur until after 1 year of improved hemodynamic effect from decreased TR, 2. over half of patients managed medically continue to progress and may still benefit from subsequent T-TEER 9. However, the sudy design resulted in several limitations which may have affected outcomes.

First, TRILUMINATE allowed for crossover to T-TEER after one year, resulting in a very small control group. Event rates among the small remaining control group was low, likely reflecting the relative stability of the remaining control patients, which may have been a lower risk “less sick” group than the cross-over patients. Thus, the crossover group may have mitigated differences in survival between T-TEER and medical therapy.

Second, TRILUMINATE did not require assessment of right ventricular (RV) function or risk stratification by RV function prior to T-TEER. Accurate RV function assessment prior to TTVR is critical because chronic, severe symptomatic TR leads to progressive RV dysfunction which negatively impacts survival after tricuspid intervention 10. RV assessment by echocardiography is comprehensive but can be challenging and is complemented by other imaging technqiues 11. Multi-modality imaging with computed tomography (CT) or magnetic resonance imaging (MRI) in conjunction with hemodynamic measurements by catheterization is complementary for more accurate RV assessment 12.

Finally, outcomes following T-TEER may vary based on etiology of TR (primary vs secondary, atrial vs ventricular) and should be considered together with a comprehensive risk assessment prior to T-TEER, and reduction in mortality risk may be evident in patients with low or intermediate TR clinical risk scores13. The impact of TR mechanism on outcomes was not addressed in TRILUMINATE.

We propose these additional data for collection during the CED.

Subgroup analysis by RV function
Subgroup analysis by mechanism of TR
Subgroup analysis by frailty and co-morbidity index including clinical risk scores that predict outcomes in patients with TR
Inclusion of multi-modality imaging and invasive hemodynamic measurements in pre-procedure RV quantification and TR assessment

Comments on the Heart Team and Suggested Pre-Procedural Evaluation and Planning

At our centers, a multi-disciplinary heart team (structural surgeon, structural interventionalist, HF cardiologists, multi-modality cardiac imagers, interventional echocardiographer) consensus is routine and required prior to any transcatheter structural interventions. Electrophysiologists are on site and available for immediate consultation in the event of post-procedure heart block but are not always involved in pre-procedural planning unless the patient has an implantable cardiac device lead.

Interventional echocardiography has emerged as a new imaging specialty focused on defining valvular anatomy and guiding structural interventions 14. The American Society of Echocardiography has outlined training guidelines and minimum procedural volumes necessary for competency in Interventional Echocardiography, which are above and beyond the level III training requirements for specialists in echocardiography. As the tricuspid valve can be difficult to visualize, we feel strongly this expertise is critical during both T-TEER and TTVR cases.

Based on our institutional experience, we propose these additional measures for pre-procedural planning.

Cardiac CT to assess tricuspid valvular anatomy prior to T-TEER

Since TR is dynamic and affected by hemodynamic status, we suggest invasive hemodynamic assessment of volume status, TR, and RV function with right heart catheterization

Ideally T-TEER should be performed when a patient is optimally diuresed, which may require pre-procedural hospitalization.

Thank you for the opportunity to comment on this proposed NCD for T-TEER. We believe a NCD with CED is justified based on early clinical trial experience and needed to facilitate earlier access to T-TEER for patients without other viable options to manage heart failure. We support the CED to acquire further evidence to identify patients most likely to benefit, and hope this will enable expanded access to all who need it. We appreciate your consideration of these comments and are available to answer any additional questions.

Sincerely,

Grace Lin MD MBA
Professor of Medicine, Mayo Clinic College of Medicine
Chair, Cardiovascular Medicine, Mayo Clinic Florida
On Behalf of Mayo Clinic Departments of Cardiovascular Medicine

Less

NCHR Comment on Medicare Coverage for Tricuspid Valve Transcatheter Edge-to-Edge Repair

The National Center for Health Research appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposal for Coverage with Evidence Development (CED) for Tricuspid Valve Transcatheter Edge-to-Edge Repair (T-TEER). Based on current data, including the TRILUMINATE Pivotal trial, we believe that T-TEER should not be considered eligible for Medicare coverage due to clear evidence of harms and a lack of evidence of a clinically meaningful benefit for Medicare beneficiaries.

Lack of clinically meaningful benefit:

T-TEER has not demonstrated that it improves survival, reduces the need for tricuspid-valve surgeries, or decreases the overall hospitalization rate. Although the TRILUMINATE Pivotal trial showed a statistically significant decrease in recurrent heart failure hospitalizations in the intention-to-treat (ITT) analysis after two years, the implications are not clear for patients in the real world who make the decision about whether to use this treatment or not. ITT analysis is especially misleading because 59% of the placebo group crossed over to the device group after one year but were counted as the control group in the ITT analysis because that was how they were assigned.

Furthermore, because the trial was unblinded, the reported improvement in the KCCQ score is likely to be biased by the placebo effect.

Evidence of harm:

The one-year and two-year outcomes of the TRILUMINATE Pivotal trial each indicate higher rates of adverse events in the T-TEER group when compared to the control group. Although not statistically significant, these findings at least indicate a lack of benefit. For example:

• Cardiovascular death: 5.8% (T-TEER) vs. 4.0% (Control) at one year, and 12.4% (T-TEER) vs. 9.6% (Control) at two years
• All-cause mortality: 8.6% (T-TEER) vs. 8.0% (Control) at one year, and 17.9% (T-TEER) vs. 17.1% (Control) at two years
• Hospitalizations: 35.3% (T-TEER) vs. 34.2% (Control) at one year, and 58.8% (T-TEER) vs. 54.0% (Control) at two years

Recommendations for strengthening CED:

We encourage CMS to reconsider whether there is currently sufficient evidence to provide coverage for T-TEER, given the known risks and uncertain benefits. If CMS decides to finalize CED despite the shortcomings of available evidence, we strongly urge strengthening the CED study by requiring:

• A primary outcome of all-cause mortality, instead of a composite primary outcome, given the bias of subjective outcome measures in an unblinded study
• Include all hospitalizations in an outcome measure
• Five years of follow-up, analyzed at the end of each year

There are clear problems with composite outcome measures that include subjective and objective measures. CMS should not consider such composite measures appropriate, especially in unblinded trials.

Conclusions:

Based on available evidence, we conclude that T-TEER is neither necessary nor reasonable for Medicare beneficiaries and should therefore not receive Medicare coverage until there is clear and credible evidence of benefit. Should CMS decide to finalize CED, CMS should strengthen the CED criteria as suggested above to ensure that data will eventually be available to determine if the benefits of T-TEER outweigh the risks.

Less

May 2, 2025

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

Re: CAG-00468N Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

Dear Ms. Syrek Jensen,

On behalf of the Advanced Medical Technology Association (AdvaMed), we are pleased to submit comments to the Centers for Medicare & Medicaid Services (CMS) on the Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) proposed decision memo. AdvaMed appreciates CMS’s opening of a National Coverage Analysis (NCA) for a new Breakthrough-device designated technology.

AdvaMed member companies produce the 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. We are committed to ensuring patient access to lifesaving and life-enhancing devices and other advanced medical technologies in the most appropriate settings.

AdvaMed and CMS share a common goal – the establishment of a clear and expeditious coverage process, based on scientifically sound clinical evidence with appropriate safeguards, for emerging technologies that will benefit Medicare-eligible patients, including the 54 percent of Medicare-eligible patients enrolled in Medicare Advantage organizations in 2023(1). These goals are evident in the intent of the Transitional Coverage for Emerging Technology (TCET) pathway. We thank CMS for finalizing the TCET guidance to help ensure Medicare beneficiaries have timely access to innovative technologies.

AdvaMed supports the timely release of this proposed decision to issue coverage for T-TEER. This decision will help enable access to an innovative therapy that meets a large unmet need for patients with severe tricuspid regurgitation. Additionally, AdvaMed supports coverage with evidence development (CED) as a mechanism to allow patient access while generating evidence for an innovative promising technology. However, we ask CMS to confirm our interpretation of the T-TEER CED studies that once approved, the studies may be updated and adjusted throughout the duration of the NCD. The ability to update CED studies is important given that under the new CED and TCET process, much of the study is designed prior to coverage. Learnings from commercial experience may help guide the design of the study. Furthermore, data assets may evolve and grow, and the CED study should be updated to utilize the best available data, especially given CMS’s stated goal of utilizing fit-for-purpose data.

We are appreciative of the approach CMS has taken in their design of CED criteria including both the patient and provider requirements. With regards to the patient criteria, we support accommodation of all FDA-approved indications, not just the FDA-approved indication for a single device. Such an approach will eliminate the need to reopen the NCD prematurely and allow for any additional indications to be studied in the context of a CED study.

With regards to the design of the Heart Team in the proposed decision memo, we question the need for an electrophysiologist (EP) on the Heart Team for T-TEER. An EP was not part of the Heart Team in the TRILUMINATE Pivotal Trial (2). Further, there is recent published evidence that shows there is no evidence warranting an EP on the Heart Team for T-TEER (3). Therefore, we recommend that EPs be removed as a requirement for the T-TEER Heart Team. Additionally, we seek clarity on the proposed Heart Team requirement for a “multi-modality imager” and whether this is an additional requirement to the interventional echocardiographer. The primary imaging modality for T-TEER is currently echocardiogram for both diagnosis and treatment. However, we believe that it may be most beneficial to refrain from specifying the imaging modality and recommend instead that the NCD requires a generic imaging specialist, which would allow appropriate flexibility in practice to be covered without the need to update the NCD in the future. Streamlining such requirements also aligns with the President’s goals for reducing unnecessary burden.

We encourage CMS to work quickly in finalizing this National Coverage Determination, following the close of this comment period. We look forward to continuing our work with the Agency. If you have questions regarding these comments or if you require additional information, please contact me at tburke@advamed.org.

Sincerely,

Tara Burke, PhD
Vice President, Payment & Healthcare Delivery Policy
AdvaMed

References:
1) “July 2024: A Data Book: Healthcare Spending and the Medicare Program.” Medicare Payment Advisory Committee (MedPAC), Chapter 9, 16 July 2024, www.medpac.gov/document-type/data-book/. Accessed 13 January 2025.

2) Naik H, Price MJ, Kapadia S, Whisenant BK, Tadros P, Makkar R, Asgar AW, Fam N, Tang GHL, Mehta SR, Byrne T, Singh G, Panaich SS, Peterman K, Trusty PM, Hamid N, Hahn RT, Adams DH, Sorajja P. Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial. JACC Clin Electrophysiol. 2025 Jan 20:S2405-500X(25)00010-6. doi: 10.1016/j.jacep.2025.01.001. Epub ahead of print. PMID: 39903153.

3) Goebel B, Lurz P, Schmitz T, Bekeredjian R, Nickenig G, Mollmann H, von Bardeleben RS, Schmeisser A, Heitkemper M, Atmowihardjo I, Estévez-Loureiro R, Donal E. Outcomes of tricuspid transcatheter edge-to-edge repair in subjects with endocardial leads. EuroIntervention. 2025 Mar 3;21(5):e253-e261. doi: 10.4244/EIJ-D-23-01033. PMID: 40028727; PMCID: PMC11849534.

Less

Dear CMS,

Edwards Lifesciences (“Edwards”) is pleased that CMS has proposed a National Coverage Determination (NCD) for Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) and appreciates the opportunity to submit comments on the Proposed Decision Memo released on April 3, 2025.

Patients with tricuspid regurgitation (TR) suffer from debilitating symptoms and previously had limited or no therapeutic treatment options. In early 2024, both transcatheter tricuspid valve replacement (TTVR) and tricuspid transcatheter edge-to-edge repair technologies were approved by the Food and Drug Administration, offering patients and physicians new treatment options for the treatment of TR. Edwards believes that the posting of the Proposed Decision Memo is another important step towards securing timely and equitable patient access to these life-changing medical innovations.

We support CMS’s proposed decision to issue coverage of T-TEER under Coverage with Evidence Development (CED) to provide Medicare beneficiaries with timely access to this innovative new therapy.

Our comments focus on:

1. Support for coverage of the patient population;
2. Support for the role of Heart Teams in the care of this patient population; and
3. Support for ongoing evidence generation under Coverage with Evidence Development (CED).

Background

The addition of T-TEER alongside TTVR marks the beginning of a paradigm shift in the treatment of tricuspid regurgitation. In the United States, more than 1.5 million people suffer from significant TR (moderate and above).(1,2) Patients with severe TR suffer from significant and frequent symptoms affecting their everyday lives, including edema, ascites, shortness of breath, and chest pain which significantly impact their ability to care for themselves and to participate in everyday activities.

The prevalence of moderate or greater TR is more frequent in women than men, with approximately four times as many women with the disease.(3) The prevalence of TR increases with age and the incidence of TR is expected to increase with an aging population.(4) Most patients with TR are medically managed for their symptoms and are not treated for the underlying disease.(5,6)

The Edwards PASCAL transcatheter tricuspid valve repair system is a T-TEER technology currently being studied in the US for the treatment of severe tricuspid regurgitation.

1. Support for coverage of the patient population

Patient Criteria

Edwards supports coverage of T-TEER when furnished according to each device’s FDA label. We are pleased to see that CMS proposes to issue coverage of T-TEER consistent with a device’s FDA market authorized indication. This will enable future T-TEER devices and future indications as approved by the FDA to be covered under this coverage decision, without requiring a reopening and reconsideration of the coverage decision. The language, as proposed, results in a flexible coverage policy that will accommodate new FDA-approved T-TEER technologies.

2. Support for the role of Heart Teams, in the care of this patient population

Edwards supports the proposed criteria that a patient is under the care of a Heart Team. Heart Teams play an important role in the selection and provision of the most clinically appropriate care for patients with TR.

As per the “2019 AATS/ACC/ASE/SCAI/STS Expert Consensus Systems of Care Document: A Proposal to Optimize Care for Patients With Valvular Heart Disease,” Heart Teams have emerged as the standard of care in managing patients with valvular heart disease and ensure a multi-disciplinary approach to managing structural heart patients pre- and post-operatively.(7) The Heart Team approach combines the knowledge of multiple disciplines, such as interventional cardiology, cardiac surgery, and interventional imaging. In current clinical practice and as recommended in the multi-society consensus for treatment of patients with valvular heart disease, Heart Teams regularly consult with other specialists as needed.(7)

Edwards supports the preservation of this patient-centered team to promote the best possible outcomes.

3. Support for ongoing evidence generation under Coverage with Evidence Development (CED).

CED Requirement

Edwards supports CED and the principles of fit-for-purpose studies that strengthen the T-TEER body of evidence to ultimately inform a future durable coverage policy. Edwards invests significantly in the evidence generation process for our technologies. Edwards supports the use of the NCD process, which utilizes CED in circumstances where additional clinical evidence is needed to enable timely access to innovative new therapies, such as T-TEER. An NCD with CED, when streamlined, efficient and time-limited, can be a powerful tool for CMS to ensure patients have timely and equitable access, while ensuring additional evidence is developed for promising technologies.

Because it is essential to better understand the outcomes of T-TEER outside the context of a randomized controlled trial (RCT), real world evidence (RWE) will play a critical role in continuously monitoring and analyzing the outcomes of interest during the maturation of the procedure and technology among the treatment of Medicare beneficiaries. Sources of RWE include electronic health records, registry data, claims data, and other documentation of patient health status in a standard care setting.

Real-world data (RWD) is typically collected in a standard care setting and RWE study results can be more generalizable to a broader population of beneficiaries. Furthermore, RWE can provide more information about subpopulations because of large sample sizes. However, it is important to note that while RWE is a tool to supplement RCT data, RWE does not supplant the importance of robust clinical trial evidence.

Leveraging the strengths of both clinical trials and RWE study designs, the complete body of evidence generated under this NCD with CED will be used to support future reconsiderations and a durable coverage policy.

The T-TEER NCD is specific to a class of devices, not a single device. Given there may be unique attributes of each device, we encourage CMS to consider the full range of fit-for-purpose study designs and consider a range of data sources and methodological approaches. Edwards recommends that fit-for-purpose evidence generation in the context of Medicare coverage determinations should:

• Be designed with patients and their needs in mind;
• Be limited to the essential data needed to address unanswered questions and demonstrate to CMS that the innovation is reasonable and necessary;
• Utilize, where appropriate, RWD, including payer claims, electronic clinical and patient data, and registry data collected prospectively;
• Reflect the best available data at the time; and
• Allow for the collection of data in the most efficient and least burdensome way for providers and the study sponsor.

CED Subgroup Analyses

Edwards agrees with CMS that subgroup analysis is critical for understanding optimization of patient selection for T-TEER.

The proposed decision memo includes a CED study subgroup of “patients with advanced hepatic dysfunction.” We request that CMS remove “advanced” from this subgroup. There is no standard clinical definition of “advanced” hepatic dysfunction. Documentation of hepatic dysfunction in the medical record often indicates that the condition is significant.

Furthermore, we ask CMS to enable appropriate flexibility to address the potential challenges in subgroup analyses in CED studies, including challenges related to the ability to:

• Manage variability in data capture and reporting. This is a challenge especially in real world data, where registries, electronic health records, and claims data may not be fully reported or populated.
• Identify subgroups in data. Data to identify subgroups in physician notes and medical documentation are not always consistently reported. For example, right ventricular (RV) dysfunction is a clinical judgment and how RV dysfunction appears in medical records and physician notes varies; there is no singular definition and reporting mechanism.
• Capture adequate sample size. Treatment of certain subgroups may not reach sufficient volumes to achieve adequate sample size for statistical analysis.

Considering these potential challenges, we encourage CMS to give flexibility to study sponsors to develop methodologies, and algorithms as appropriate, to define subgroups evaluated in the context of a CED study and its selected data source. Furthermore, we ask CMS to consider that data methodologies and data source availability will evolve with time, so each study protocol should be evaluated based on the best available data at the time the study is designed and to allow for study protocols to be refined, especially given the duration of an NCD with CED and the potential technologies coming to market in this timeframe.

***

Thank you for your consideration of our comments.

Sincerely,

/s/

Daveen Chopra
Corporate Vice President and General Manager, Transcatheter Mitral and Tricuspid Therapies (TMTT)
Edwards Lifesciences

(1) Stuge O, Liddicoat J. Emerging opportunities for cardiac surgeons within structural heart disease. J Thorac Cardiovasc Surg. Dec 2006;132(6):1258-61. doi:10.1016/j.jtcvs.2006.08.049
(2) Singh JP, Evans JC, Levy D, et al. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). The American journal of cardiology. 1999;83(6):897-902.
(3) Hahn R. Tricuspid Regurgitation. N Engl J Med 2023;388:1876-91. doi:10.1056/NEJMra2216709
(4) Utsunomiya H, Itabashi Y, Mihara H, et al. Functional Tricuspid
Regurgitation Caused by Chronic Atrial Fibrillation. Circulation: Cardiovascular Imaging. 2017;10(1):e004897. doi:10.1161/CIRCIMAGING.116.004897 (5) Otto C, Nichimura R, Bonow R, et al. 2020 ACC/AHA Guideline for the Management of Patients with Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021;143:e72-e227. doi:10.1161/CIR.0000000000000923
(6) Chorin E, Rozenbaum Z, Topilsky Y, et al. Tricuspid regurgitation and long-term clinical outcomes. Eur Heart J Cardiovasc Imaging. 2020;21(2):157-165. doi:10.1093/ehjci/jez216
(7) Nishimura RA, O’Gara PT, Bavaria JE, Brindis RG, Carroll JD, Kavinsky CJ, Lindman BR, Linderbaum JA, Little SH, Mack MJ, Mauri L, Miranda WR, Shahian DM, Sundt TM III. 2019 AATS/ACC/ASE/SCAI/STS expert consensus systems of care document: a proposal to optimize care for patients with valvular heart disease: a joint report of the American Association for Thoracic Surgery, American College of Cardiology, American Society of Echocardiography, Society for Cardiovascular Angiography and Interventions, and The Society of Thoracic Surgeons. Ann Thorac Surg 2019 April 19

Less

May 2, 2025
Administrator Mehmet Oz
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Oz,

As members of the Heart Valve Disease Policy Task Force, a national group of 30 leaders including clinician and patient advocacy organizations, we appreciate the opportunity to comment on CMS’s proposed NCD regarding Tricuspid Valve Transcatheter Edge-to-Edge Repair (T-TEER), also known as the TriClip G4 System. We wish to emphasize the critical importance of establishing a comprehensive Medicare coverage policy that includes all FDA-approved minimally invasive transcatheter therapies for patients with symptomatic severe tricuspid regurgitation (TR).

A broad and inclusive coverage framework is essential to ensure timely access to innovative treatments – such as T-TEER – that have demonstrated meaningful improvements in quality of life, functional capacity, and reduced hospitalizations. This is especially vital for patients living with heart valve disease, where early intervention can help preserve independence, prevent disease progression, and ultimately reduce the burden on the healthcare system.

Patients treated with T-TEER have consistently shown improvements in quality of life and reduced hospitalizations. These outcomes are clinically meaningful and directly impact patients' ability to remain active and independent, while avoiding repeated hospital stays and disease progression. Patients with symptomatic TR often face debilitating fatigue, shortness of breath, and repeated hospitalizations that severely limit their independence and quality of life. T-TEER offers hope for these patients – it allows them to regain control of their lives and live to their fullest potential.

We applaud the growing recognition of T-TEER as an important advancement in the treatment of symptomatic tricuspid regurgitation. T-TEER has shown clinically meaningful and sustained improvements in patients' daily function, quality of life, and ability to remain active in their communities. According to two-year follow-up data from the TRILUMINATE trial, patients treated with T-TEER reported sustained improvements in New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, and significant reductions in heart failure hospitalizations. [1] These outcomes are much more than numbers; they represent hundreds of patients who have been able to spend more time with their loved ones, stay out of the hospital, and have the freedom to live their lives. This trial data further demonstrates the need for timely access to T-TEER.

We agree that involving a multidisciplinary heart team is vital for patient-centered evaluation. However, we encourage CMS to reconsider the inclusion of an electrophysiologist (EP) as a required heart team member. While EPs are essential in other structural heart contexts, they are not central to the T-TEER procedure or the assessment and management of TR. Requiring an EP may place unnecessary burdens on programs, particularly in rural and underserved areas, potentially limiting access to care.

Individualized decision-making by an experienced Heart Team is key to ensuring patients receive care aligned with their medical needs, preferences, and life goals. We strongly support CMS’s emphasis on shared decision-making and encourage continued focus on equitable and patient-centered approaches.

T-TEER is a minimally invasive, catheter-based procedure that does not require open-heart surgery, making it a safer and more accessible option for medically complex patients. Patients should not be denied access to this evidence-based therapy based on precautionary measures that do not reflect the nature of the procedure. The coverage policy should reflect the real-world delivery of care and prioritize equitable access.

In conclusion, we appreciate and strongly advocate for an inclusive and forward-thinking coverage policy that prioritizes patient access and upholds the principles of patient-centered care to minimally invasive tricuspid valve regurgitation treatment. We appreciate the opportunity to provide input and look forward to working collaboratively with CMS to advance patient-centered policies.

Thank you for your attention to this important issue.

Sincerely,
The Heart Valve Disease Policy Task Force

Alliance for Patient Access
Caregiver Action Network
Conquering CHD
HealthyWomen
Heart Valve Voice U.S.
Hypertrophic Cardiomyopathy Association
Men’s Health Network
The Mended Hearts, Inc.
Partnership to Advance Cardiovascular Health
Preventive Cardiovascular Nurses Association
RetireSafe

[1] Kar, Saibal, et al. “Two-Year Outcomes of Transcatheter Edge-To-Edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Trial.” Circulation, 30 Mar. 2025, https://doi.org/10.1161/circulationaha.125.074536.

Less

On behalf of the Association of Black Cardiologists (ABC), we appreciate the opportunity to submit comments on the CMS National Coverage Determination (NCD) for Transcatheter Tricuspid Valve Edge-to-Edge Repair (T-TEER). Founded in 1974, ABC is a nonprofit organization with a global membership, including health professionals, community health advocates, and institutional members. Our mission is to promote the prevention and treatment of cardiovascular disease (CVD), including stroke, in Black populations and other groups facing barriers to optimal health. Through education, research, partnerships, and advocacy, the Association works to advance cardiovascular health and improve outcomes in communities nationwide.

Background
Tricuspid regurgitation (TR) affects more than 1.6 million U.S. adults and is increasingly recognized as a serious contributor to heart failure, morbidity, and mortality (Ilonze et al., Heart Fail Clin. 2023 Jul;19(3):379–390. doi:10.1016/j.hfc.2023.02.009). Despite this, TR has long received less clinical research attention than other valvular diseases (Id). We appreciate that the proposed NCD noted that the agency is “interested in health disparities and equity aspects that should be considered in the review.” As such, below we provide details regarding concerning disparities with respect to TR.
Women are more frequently affected by TR, and Black patients are disproportionately impacted by structural heart disease, with a higher prevalence of non-ischemic cardiomyopathy contributing to functional TR (Id.). However, these populations are also among the least likely to receive advanced valvular interventions due to referral bias, socioeconomic/geographic barriers, and underrepresentation in clinical trials (Id.).

The urgency of equitable access to transcatheter therapies like T-TEER is underscored by the persistent and disproportionate burden of cardiovascular disease in Black men. Between 2000 and 2022, Black men experienced approximately 416,500 excess cardiovascular deaths and 12.5 million excess years of potential life lost (YPLL) compared to White men (Arun AS, Sawano M, Lu Y, et al. Excess Cardiovascular Mortality Among Black Americans 2000–2022. J Am Coll Cardiol. 2024;84(6):581–588.
doi:10.1016/j.jacc.2024.06.004). Specifically for heart failure, a condition linked to TR, Black men saw 25,604 excess deaths and more than 740,000 excess YPLL (Id.). These sobering figures reflect the human toll of persistent disparities in cardiovascular care, including limited access to innovative therapies like T-TEER. CMS must prioritize policies that enable timely, local access to structural heart interventions for these at-risk populations. While T-TEER represents a promising minimally invasive therapy for patients who are not surgical candidates, access to this procedure remains uneven. Ensuring broad and accessible Medicare coverage of T-TEER is critical to reversing systemic disparities and improving outcomes for historically underserved populations. T-TEER represents a critical advancement in the treatment of TR, particularly for patients who are not candidates for surgery and face serious consequences without intervention. ABC urges CMS to consider the following areas in developing the final NCD:

Importance of Broad Access
T-TEER is a catheter-based procedure with the potential to significantly improve symptoms, reduce hospitalizations, and extend survival for patients with severe TR. As CMS considers coverage, it is essential to ensure that patients across a wide range of clinical and geographic settings can benefit from this technology. For patients in rural or underserved areas who cannot travel long distances to specialty centers, timely, local access may be the only realistic option.

As ABC noted in its February 2023 Roundtable on valvular heart disease (VHD), the most vulnerable patients, often Black men, are often those with the least access to early diagnosis and advanced therapies. Barriers to treatment, such as limited transportation, gaps in primary care, and mistrust of the health system, can all contribute to delayed diagnosis and treatment. These disparities directly affect outcomes and underline the urgency of ensuring local availability of T-TEER. In this context, access to T-TEER is not only therapeutic but also preventive, offering an opportunity to reduce avoidable hospitalizations, disease progression, and associated complications (ABC Valvular Heart Disease 2023 Roundtable White Paper, pp. 13-20).

Avoiding Barriers Tied to Procedural Volume
ABC is concerned that facility volume requirements may create unnecessary barriers to care. Research shows that hospitals located in high area deprivation index (ADI) regions are less likely to meet high or medium procedural volume thresholds (Barker CM, Kemp LS, Mancilla M, Mollenkopf S, Gunnarsson C, Ryan M, David G. Inequities in Access to Tricuspid Valve Treatments: The Impact of Procedure and Volume Requirements. JACC: Advances. 2024 Oct 18;3(11):101342. doi: 10.1016/j.jacadv.2024.101342). One study found that patients from such areas often travel longer distances to reach hospitals that satisfy volume criteria, potentially delaying care and impacting outcomes (Barker CM, et al. Area Deprivation Index and Access to Structural Heart Interventions. 2023).
Further, as previously discussed, non-Hispanic Black patients with TR experience more severe disease at diagnosis and worse long-term survival than White patients. In an analysis of over 9,800 patients with moderate or greater TR, non-Hispanic Black adults had significantly higher 10-year all-cause mortality, even after adjustment for comorbidities (Olgun Kucuk H, Lara-Breitinger K, Scott C, et al. Racial Disparities in Long-Term Survival Among Patients With Moderate and More Severe Tricuspid Regurgitation, 2023).

CMS must also consider that procedural volume requirements may inadvertently deepen structural inequities in access to care. As highlighted in the ABC VHD Roundtable White Paper, hospitals serving predominantly minority and socioeconomically disadvantaged populations are often excluded from providing structural heart procedures like TAVR or T-TEER due to these arbitrary thresholds—even when the quality of care delivered matches or exceeds that of higher-volume centers. ABC's position, informed by peer-reviewed data, is clear: volume is not a proxy for quality. In fact, several analyses have found no significant difference in outcomes between high- and low-volume TAVR centers (ABC Valvular Heart Disease 2023 Roundtable White Paper, pp. 18-19).

Moreover, minority patients are more likely to seek care at lower-volume hospitals due to geography, insurance status, and longstanding exclusion from specialty referral networks. Requiring high procedural volume to participate in offering T-TEER risks perpetuating a two-tiered system in which minority patients are consistently referred away from their trusted local providers to distant institutions, resulting in delayed or forgone care. As the ABC report notes, “access to care—not just insurance, but proximity and availability—must be the focus if we are to close persistent racial disparities in cardiovascular health outcomes” (ABC Valvular Heart Disease 2023 Roundtable White Paper, p. 4).

Overly rigid volume standards could prevent capable hospitals from offering T-TEER, limiting timely treatment and potentially worsening outcomes by restricting this important therapy to a small number of large centers who are able to meet the volume requirements.

Recommendations The following recommendations are reinforced by the findings of the ABC 2023 Roundtable on Valvular Heart Disease, which underscore that advancing equitable access to structural heart procedures like T-TEER must be a CMS priority.

Support for Broad Geographic Availability: CMS should design coverage in a way that allows for the adoption of T-TEER at hospitals serving geographically dispersed populations, including rural communities. This will help minimize delays and ensure that patients are not forced to travel unreasonable distances for care.

CMS should also recognize the important distinction between being affiliated with a large cardiovascular center and actually delivering high-quality, patient-centered care. As ABC emphasized during its 2023 convening on valvular heart disease, quality care is not confined to the walls of elite institutions. When community hospitals and minority-serving health centers are adequately resourced, they can offer the same level of excellence, and are often better positioned to address patient needs in more responsive ways because they are anchored in the community. Policymaking that equates quality with geography or institutional prestige risks reinforcing systemic inequities in care delivery.

Avoid Restrictive Volume Thresholds: CMS should not tie coverage to arbitrary institutional procedure volumes, particularly when outcomes are not clearly linked to center volume. Smaller Community and minority-serving health centers across the country provide quality, state-of-the-art care and are trusted by the individuals and families in the communities they serve. Allowing appropriately credentialed hospitals to offer T-TEER will broaden access and improve the consistency of care delivery (ABC Valvular Heart Disease 2023 Roundtable White Paper, pp. 15-17, 22.).

Conclusion
We urge CMS to consider policies that enable broad and timely access to T-TEER for all Medicare beneficiaries who may benefit, thus promoting patient-centered care and ensuring that promising new therapies are not limited by geography, or burdensome procedural criteria. Thank you for the opportunity to submit these comments and for your consideration of our concerns and recommendations. We look forward to continuing to work with you and your CMS colleagues on policies that promote innovation and access for all patients to reduce, prevent, and treat cardiovascular disease.

Less

May 2, 2025

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

RE: CAG-00468 Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

Dear Ms. Syrek-Jensen:

The American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Heart Rhythm Society (HRS) and The Society of Thoracic Surgeons (STS) are the professional medical societies representing the physician and health care professionals who care for tricuspid regurgitation (TR) patients having tricuspid transcatheter edge-to-edge repair (T-TEER) and surgical tricuspid valve (TV) repair procedures. Collectively, we represent over 60,000 cardiovascular professionals. The societies are supportive of the development of a National Coverage Determination (NCD) for T-TEER and we appreciate the opportunity to comment on the proposed decision memo.

The societies are broadly supportive of the proposed decision memo for T-TEER Medicare coverage under Coverage with Evidence Development (CED). We recognize the importance of this initiative and appreciate the efforts CMS has made to ensure that patients have access to innovative treatments. We acknowledge that CMS is proposing a novel course for this NCD, which places greater responsibility on the trial sponsor for the rational dispersion of a new, breakthrough device. However, the societies remain committed to operator and institutional volume criteria, as there is strong evidence supporting this approach based on data related to mitral and tricuspid procedures (Badhwar et al., 2020; Hameed et al., 2025; Awtry et al., 2023; Sorajja et al., 2017).

While understanding that CMS may be charting a different path, we are committed to assisting CMS and the sponsor in navigating delivery of this new therapy. Our goal is to ensure that the implementation of T-TEER is guided by robust evidence and best practices, ultimately benefiting patients by providing timely access to care while achieving optimal outcomes.

Multidisciplinary Heart Team
Care for T-TEER patients should be overseen by a multidisciplinary heart team (MDHT) experienced in managing tricuspid regurgitation as outlined in the proposed decision memo. It has come to our attention that some hospitals are misinterpreting the MDHT requirements in the proposed decision memo as well as the final decision memo for TTVR, believing that every patient must consult with every member of the MDHT. We encourage CMS to clarify that this is not the case. It is recommended that, at a minimum, patients should be seen in consultation by an interventional cardiologist and a cardiac surgeon, with imaging reviewed by an interventional echocardiographer. Additional specialists should be included based on the patients' individual comorbidities and pathoanatomy.

Operator and Facility Requirements
The societies stand by our recommendations for operator and institutional volume requirements in order to optimize outcomes at new transcatheter TV interventional programs. As transcatheter tricuspid valve interventions (TTVI) continue to evolve, establishing facility volume requirements has become a crucial consideration in maintaining outcomes. Current registries and randomized trials show that optimal T-TEER results by TVARC criteria are achieved in only ~50% of patients and all studies consistently show residual tricuspid regurgitation is associated with higher mortality and heart failure hospitalizations. Thus the argument that even sites involved in the trial could be excluded if volume requirements were required (Vemulapalli et al., 2025) may be justified to improve efficacy of the device and outcomes. While ensuring broad access to this life-changing therapy is essential, maintaining high-quality patient outcomes is paramount and requires that centers performing these procedures accumulate sufficient experience and expertise to optimize efficacy. Striking the right balance between accessibility and procedural proficiency is fundamental to optimizing patient care, particularly for a relatively new procedure in a highly variable anatomy with known procedural complexity. From the report of the randomized controlled trial of T-TEER, the average number of devices required to achieve the limited efficacy reported, is ~2/patient with procedure time of 151.0 ± 71.7 min (Sorajja et al., 2023). Studies across various transcatheter procedures have demonstrated that hospitals with higher procedural volumes tend to have better patient outcomes. Increased experience leads to enhanced procedural efficiency, fewer complications, and improved long-term success. In TTVI—a complex and emerging field—having standardized volume thresholds can serve as a safeguard for both patients and providers.

There is strong evidence supporting the correlation between higher procedural volumes and better outcomes in TAVR (Vemulapalli et al., 2019; Mauler-Wittwer et al., 2022; Bansal et al., 2021) and mitral TEER (Chhatriwalla et al., 2019; Grayburn et al., 2024; Sorajja et al., 2017). In addition, TAVR volume also impacts outcomes for M-TEER (Awtry et al., 2023). There is growing evidence that a volume-outcome relationship also exists for T-TEER. One study notes that setting TAVR volume criteria for defining TEER centers could help ensure the best outcomes without restricting access to care (Awtry et al., 2023). A recent report of a large tricuspid TEER registry showed that higher center experience (≥21 patients/year) resulted in higher intraprocedural and clinical success (Wild et al., 2024). The volume-outcome association has also been evaluated in a recent study comparing T-TEER with isolated tricuspid valve surgery using the Medicare fee-for-service Inpatient Claims and Master Beneficiary Summary Files (Shimoda et al, 2025). This study showed T-TEER, outcomes appear to rapidly improve up to a volume of ~20 cases but may further improve with >60 cases. This continuum of improvement mirrors the findings with M-TEER from the STS-TVT registry which showed improved outcomes (composite of MR ≤1+, no mortality and no cardiac surgery) beginning at 50 cases with continued improvement to 200 cases (Chhatriwalla et al, 2019). There may also be a relationship between surgical volume and transcatheter outcomes for specific valve interventions. Mortality and heart failure hospitalizations following mitral TEER are lower at centers with higher surgical mitral valve repair volume (Grayburn et al., 2024). Thus, the volume-outcome relationship appears to be consistent for a broad spectrum of transcatheter device therapies. In addition the total volume of transcatheter device therapies may also influence outcomes.

The societies' commitment to maintaining operator and institutional volume criteria is further supported by recent studies demonstrating the impact of procedural volume on outcomes. The bRIGHT study found no significant difference in TR outcomes between low and high-volume sites, though patients at low-volume sites had less severe disease but higher rates of new onset renal failure (Lurz et al, 2024). The PASTE registry indicated that center experience is crucial for procedural and clinical success with the PASCAL system (Wild et al, 2023). A study comparing T-TEER and isolated tricuspid valve surgery highlighted the importance of performing procedures at experienced centers for optimal outcomes, showing that higher procedural volumes are associated with decreased two-year mortality for both strategies (Shimoda et al, 2025).

Higher surgical and transcatheter volume centers are more likely to have established protocols and experienced teams, which contribute to consistent and high-quality care. These centers often have better infrastructure and support systems in place to handle the complexities of T-TEER procedures. Greater M-TEER heart team experience should translate to the T-TEER procedure with established interventionalist-imager communication and intra-procedural protocols. Surgeons and interventional cardiologists who regularly perform these procedures are more adept at managing potential complications and achieving optimal results. Regular practice and experience are crucial for maintaining and improving procedural skills. By adhering to our recommended criteria, we can ensure that T-TEER procedures are performed safely and effectively, providing the best possible care for patients with severe tricuspid regurgitation.

While ensuring access to transcatheter tricuspid valve interventions in underserved areas is critical, facilitating underperforming programs in these regions—rather than connecting patients to high-performing centers—can inadvertently become a form of healthcare inequity. High-quality, resource-intensive programs demand sophisticated infrastructure, specialized expertise, and robust institutional support to deliver safe and effective outcomes. Lowering standards or tolerating suboptimal care in underserved areas risks reinforcing disparities rather than resolving them. Instead, the focus should remain on ensuring that every patient, regardless of geography, receives care that meets stringent safety and quality benchmarks. Strategic investments should prioritize strengthening programs that can meet these requirements rather than simply proliferating lower-performing centers under the guise of accessibility.

T-TEER should only be performed in hospitals with the appropriate infrastructure. The institution must have an active cardiac surgical program supported by at least 2 institutionally based cardiac surgeons experienced in the treatment of patients with VHD and at least one physician with interventional cardiology privileges. This aligns with the 2018 AATS/ACC/SCAI/STS Expert Consensus on Transcatheter Aortic Valve Replacement (TAVR) recommendations (Bavaria et al., 2019). Similarly, for transcatheter mitral valve interventions (Bonow et al., 2020), institutions must have at least one interventional echocardiographer; a cardiologist with level 3 training and National Board of Echocardiography certification or testamur status, or a cardiac anesthesiologist with level 2 training and advanced perioperative transesophageal echocardiography (PTeXAM) certification or testamur status.

High-quality pre- and post-procedural care facilities with staff experienced in managing open-heart surgery patients and MHDT consultations are essential. Physicians performing T-TEER must have access to a cardiac catheterization lab and an interventional/implantation suite. Operators must have access to advanced imaging, including cine fluoroscopy and 2D/3D transesophageal echocardiography (TEE) throughout the T-TEER procedure, and access to 2D/3D intracardiac echocardiography (ICE) is highly recommended. Facilities should have rapid access to a cardiac electrophysiologist with expertise in lead extraction, leadless pacemaker placement, and coronary sinus lead placement.

By their very nature, these complex procedures should only be undertaken in institutions that routinely perform surgical TV operations and participate in the STS Adult Cardiac Surgical Database with outcomes that equal or exceed those expected for their case mix relative to national benchmarks. Similarly, only institutions with interventional cardiology programs that have established programs in PCI, balloon valvuloplasty, TAVR, M-TEER, catheter closure of periprosthetic leaks, deployment of septal closure devices, and advanced mechanical circulatory support to address right ventricle dysfunction, with outcomes that equal or exceed those established nationally for similar procedures, should offer transcatheter TV intervention.

T-TEER should be performed by at least two physicians working as co-operators. An interventional echocardiographer must serve as a co-operator and provide imaging expertise during all aspects of the procedure; An interventional cardiologist or cardiac surgeon, as the other co-operator, must provide expertise in wire, catheter, and device manipulation and deployment. The interventional echocardiographer may not also provide anesthesiology care during the same procedure. At the MDHT’s discretion, if appropriate, an additional physician, either an interventional cardiologist or a cardiac surgeon, can be involved as a third operator in the procedure. We support coverage and payment that appropriately reflect the contributions of all physicians involved, especially in cases where a patient's clinical condition necessitates multiple intraoperative participants. All physicians who participate in the procedure must be board certified or equivalent in their specialty and have received device-specific training as required by the device manufacturer. All T-TEER institutions must submit complete data to the STS/ACC TVT Registry.

As the field advances, setting data-driven volume benchmarks for TTVI can help ensure that both patient safety and equitable access remain at the forefront. Standardized volume requirements can serve as a framework to uphold procedural excellence while ensuring patients everywhere have access to safe, effective transcatheter tricuspid valve interventions. Finding the right balance will require collaboration between medical professionals, health systems, and policymakers, but the ultimate goal remains clear – delivering the highest quality care to those who need it most.

Qualification to Initiate a T-TEER Program
Open Heart Surgeries	≥50 in the previous year prior to T-TEER program initiation
Tricuspid Valve Surgeries	≥20 in the 2 years prior to T-TEER program initiation
Physicians with Cardiac Surgery Privileges	≥2
Physician with Interventional Cardiology Privileges	≥1
Cardiac Electrophysiologist	1 board certified, eligible, or equivalent available for pacemaker implantation or lead extraction when required
TAVR and TEER Procedures	≥50 TAVR and ≥20 TEER per year or ≥100 TAVR and ≥40 TEER over the previous 2 years (Bass et al., 2023 ACC/AHA/SCAI advanced training statement on interventional cardiology (coronary, peripheral vascular, and structural heart interventions): A report of the ACC Competency Management Committee.)
Complete Transesophageal Echocardiograms (TEE)	≥200 per year or ≥400 over the previous 2 years (Wiegers et al., ACC/AHA/ASE Advanced Training Statement on Echocardiography. 2019; Little et al., Recommendations for Special Competency in Echocardiographic Guidance of Structural Heart Disease Interventions: From the American Society of Echocardiography. 2023)

Qualifications to maintain a T-TEER Program
Tricuspid Valve Interventions	≥20 tricuspid valve interventions (transcatheter or surgical) of which =10 are transcatheter over 1 year, or ≥40 tricuspid valve intervention (transcatheter or surgical) of which =20 are transcatheter over 2 years
Specialty Expertise	The initial complement of specialty expertise must be maintained
Transcatheter Structural Cases	≥50 per year or ≥100 over the previous 2 years

Operator Requirements
Primary Catheter Operator	- ≥50 career structural valve procedures), of which =20 are TEER procedures (Bass et al., 2023)
	- Board eligible, equivalent, or certified in either interventional cardiology or cardiothoracic surgery
	- Certification of device-specific training
Interventional Echocardiographer	- ≥50 career structural valve disease procedures, of which =20 are TEER procedures
	- Level 3 or equivalent board eligibility or certification in echocardiography
	- Certification of device-specific training

Registry Requirement
The societies recommend that the heart team and hospital participate in a prospective, national, audited registry. The success of the STS/ACC TVT registry is well-established. Mandatory reporting to the STS/ACC TVT registry under CED through a supplementary module will facilitate post-market surveillance, long-term outcome measurement, and comparative effectiveness research for this still nascent breakthrough emerging technology. This supplementary module, developed by the STS and ACC with input from specialty societies and other stakeholders, will enhance the existing TVT registry for TAVR and mitral valve TEER systems. Emphasizing the importance of obtaining complete one-year outcomes data, including patient-reported outcomes, is crucial.

Participation in society-run registries is essential for several reasons:

1. Real-World Insights: These registries capture data from routine clinical practice, providing insights into how treatments and interventions perform outside the controlled environment of clinical trials. This real-world relevance is vital for understanding the practical effectiveness of medical procedures and treatments.
2. Longitudinal Data: Society-run registries often track patients over long periods, allowing for the collection of longitudinal data. This data reveals trends and long-term outcomes, which are valuable for assessing the effectiveness and safety of treatments over time, as well as determining if a treatment is reasonable and necessary.
3. Diverse Data: By including data from a wide range of institutions and patient populations, the TVT registry provides a comprehensive picture of how treatments work across different demographics and clinical settings. This diversity ensures that the findings are applicable to a broad spectrum of patients.

Over the past decade, the STS/ACC TVT Registry and Coordinated Registry Network have supported 23 regulatory decisions and ensured the evidence-based evaluation of transcatheter valve therapy (TVT) technology. When TAVR was first approved under the NCD with CED in 2012, it was limited to high-risk patients who were too compromised to undergo open heart surgery for surgical aortic valve replacement (SAVR). Over time, data collected through the registry provided evidence demonstrating the safety and efficacy of the procedure, thereby enabling intermediate and low-risk populations to benefit from this once novel therapy. This method of evidence generation creates significant value for manufacturers and the broader device ecosystem, with substantial benefits to public health. Additionally, this model of data collection through the STS/ACC TVT Registry sets the standard for newer technologies, such as T-TEER.

Overall, participation in these registries is vital for advancing medical knowledge and improving healthcare delivery, especially as new technologies emerge. The robust governance structures and auditing strategy of these registries ensure transparency and accountability, enhancing the credibility of the evidence generated and making it a reliable source for informing medical practice and policy.

CED Study Requirements
The societies are supportive of a CED study. We believe that in addition to standard measures of disease severity, it would be important to provide provisions for the TVT registry to broaden their data elements and require appropriate clinical, imaging (echocardiographic and computed tomography) and hemodynamic parameters. Without a comprehensive and accurate data registry, the goal of learning about relevant subgroups and their outcomes in the CED, will not be possible.
Considering the numerous challenges associated with requesting an extremely comprehensive and robust data set—including capturing, storing, and analyzing such data –we are committed to assisting CMS and the trial sponsors by offering our expertise in all aspects of CED studies.

The STS/ACC TVT Registry was aware of the intent by one device manufacturer to leverage the registry data but was not involved in the development of the evidence development plan, which is concerning. Historically, a letter of support from the societies would have been required as part of the application process associated with other types of initiatives to list the trial on clinicaltrials.gov if the societies were not themselves the sponsor. This new CED process appears to bypass that requirement during protocol review and approval, which could present issues. If society-run registries are being utilized for the CED study and in the evidence development plan, it is crucial to engage us in the earlier phases of the CED development process to ensure comprehensive and effective protocol development as well as providing enough time for necessary registry updates to best support and achieve device manufacturers’ CED study needs.

Another concern of the societies is the requirement of an active contemporaneous comparator cohort. Use of large, aggregated health systems databases and/or claims data linked to electronic health records may provide this comparator with important known limitations: lack of standardized data collection, lack of data quality control, lack of consistent active follow-up, potential for bias in the setting of missing data. In addition, the medical management of tricuspid regurgitation continues to evolve, introducing temporal bias which should be mitigated in the data collection. These limitations may result in significant bias in the results of between group outcomes.

The societies thank CMS for the opportunity to provide comment on the proposed decision memo for the T-TEER NCD. The societies are largely supportive of the proposal for Medicare coverage and would be pleased to engage with CMS further on this issue. Please direct any questions or concerns to Amanda Stirling, Regulatory Affairs Associate, at 202-375-6553 or astirling@acc.org.

Sincerely,

David R. Jones, MD
President, American Association for Thoracic Surgery

Christopher M. Kramer, MD, FACC
President, American College of Cardiology

Theodore Abraham, MD, FASE
President, American Society of Echocardiography

Mina K. Chung, MD, FHRS, MD, FHRS
President, Heart Rhythm Society

Joseph F. Sabik III, MD
President, The Society of Thoracic Surgeons

References
1. Badhwar V, Vemulapalli S, Mack MA, Gillinov AM, et al. Volume-Outcome Association of Mitral Valve Surgery in the United States. JAMA Cardiol. 2020 Oct 1;5(10):1092-1101.
2. Hameed I, Ahmed A, Waldron C, et al. Mitral Valve Repair: Optimal Annual Case Volume for Surgery. JACC Adv. 2025 Mar;4(3):101589.
3. Awtry J, Newell P, Vinholo TF, et al. The Relation Between Hospital Transcatheter Aortic Valve Replacement Volume and Transcatheter Edge-to-Edge Repair Outcomes: A Study Using the National Readmissions Database. Am J Cardiol. 2023 Oct 28:S0002-9149(23)01132-3.
4. Sorajja P, Vemulapalli S, Feldman T, et al. Outcomes With Transcatheter Mitral Valve Repair in the United States: An STS/ACC TVT Registry Report. J Am Coll Cardiol. 2017 Nov 7;70(19):2315-2327.
5. Vemulapalli, S, Wang T, Smith J, et al. How Procedural Volume Prerequisites Could Impact Access to Tricuspid Transcatheter Edge-to-Edge Repair. Journal of the American College of Cardiology, 2025; 75(12), 1456-1468.
6. Sorajja P, Whisenant B, Hamid N, et al. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023 May 18;388(20):1833-1842.
7. Vemulapalli S, Carroll JD, Mack MJ, Li Z, Dai D, Kosinski AS, Kumbhani DJ, Ruiz CE, Thourani VH, Hanzel G, Gleason TG, Herrmann HC, Brindis RG, Bavaria JE. Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. N Engl J Med. 2019 Jun 27;380(26):2541-2550.
8. Mauler-Wittwer S, Noble S. Volume-Outcome Relationship in Surgical and Cardiac Transcatheter Interventions with a Focus on Transcatheter Aortic Valve Implantation. J Clin Med. 2022 Jun 30;11(13):3806.
9. Bansal A, Kumar A, Jain V, Reed G, Puri R, Kalra A, Krishnaswamy A, Harb SC, Kapadia SR. Impact of Hospital Procedural Volume on Use and Outcomes of Urgent/Emergent Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2021 May 4;10(9):e019670.
10. Chhatriwalla AK, Vemulapalli S, Holmes DR Jr, Dai D, Li Z, Ailawadi G, Glower D, Kar S, Mack MJ, Rymer J, Kosinski AS, Sorajja P. Institutional Experience With Transcatheter Mitral Valve Repair and Clinical Outcomes: Insights From the TVT Registry. JACC Cardiovasc Interv. 2019 Jul 22;12(14):1342-1352.
11. Grayburn PA, Mack MJ, Manandhar P, Kosinski AS, Sannino A, Smith RL 2nd, Szerlip M, Vemulapalli S. Comparison of Transcatheter Edge-to-Edge Mitral Valve Repair for Primary Mitral Regurgitation Outcomes to Hospital Volumes of Surgical Mitral Valve Repair. Circ Cardiovasc Interv. 2024 Apr;17(4):e013581.
12. Shimoda TM, Ueyama HA, Miyamoto Y, et al. Comparison of Transcatheter Versus Surgical Tricuspid Repair Among Patients With Tricuspid Regurgitation: Two-Year Results. Circulation: Cardiovascular Interventions. 2025;18(1)
13. Lurz P, Rommel KP, Schmitz T, et al. Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study. J Am Coll Cardiol. 2024;84(7):607-16.
14. Wild MG, Stolz L, Rosch S, et al. Transcatheter Valve Repair for Tricuspid Regurgitation: 1-Year Results from a Large European Real-World Registry. J Am Coll Cardiol. 2024 Oct 24:S0735-1097(24)09955-8.
15. Bavaria, J, Tommaso, C, Brindis, R. et al. 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement: A Joint Report of the American Association for Thoracic Surgery, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2019 Jan, 73 (3) 340–374.
16. Bonow, R, O’Gara, P, Adams, D. et al. 2019 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Mitral Valve Intervention: A Joint Report of the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and The Society of Thoracic Surgeons. J Am Coll Cardiol. 2020 Jul, 76 (1) 96–117.
17. Bass TA, Abbott JD, Mahmud E, et al. 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions): A Report of the ACC Competency Management Committee. Circ Cardiovasc Interv. 2023 Apr;16(4).
18. Wiegers SE, Ryan T, Arrighi JA, et al. 2019 ACC/AHA/ASE Advanced Training Statement on Echocardiography (Revision of the 2003 ACC/AHA Clinical Competence Statement on Echocardiography): A Report of the ACC Competency Management Committee. J Am Coll Cardiol. 2019 Jul 23;74(3):377-402.
19. Little SH, Rigolin VH, Garcia-Sayan E, et al. Recommendations for Special Competency in Echocardiographic Guidance of Structural Heart Disease Interventions: From the American Society of Echocardiography. J Am Soc Echocardiogr. 2023 Apr;36(4):350-365.

Less

April 30, 2025

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

RE: CAG-00468N, Proposed Decision Memo for Transcatheter Edge-to-Edge Repair (T-TEER) for Tricuspid Valve Regurgitation

Boston Scientific (BSC), a leader in the medical device industry, is committed to transforming lives through innovative medical solutions that improve the health of patients globally. We develop and supply medical devices in numerous clinical areas, including cardiology, which serve the needs of many patients, including Medicare beneficiaries.

Support for T-TEER NCD
BSC supports the Center for Medicare and Medicaid Services (CMS) initiative to establish a National Coverage Determination (NCD) for Transcatheter Edge-to-Edge Repair for the treatment of patients with tricuspid valve regurgitation (T-TEER). We support the coverage of T-TEER under Coverage with Evidence Development (CED) for procedures performed within the context of a CMS approved clinical trial, as proposed by CMS. BSC further urges CMS to finalize coverage for procedures involving PMA -approved T-TEER devices, utilizing a CMS-approved registry as the mechanism for continued evidence generation.

Tricuspid Regurgitation Symptoms and Treatment Options
The most common manifestation of Tricuspid Valve Disease (TVD) is Tricuspid Regurgitation (TR). TR is a serious condition often associated with congestive right heart failure, with symptoms that may include fatigue, palpitations, shortness of breath with exertion, peripheral edema, ascites, painful hepatomegaly, jugular vein distention, and hypotension.¹ These symptoms often severely impair daily functioning and lead to frequent interactions with the healthcare system. Many patients with severe TR also suffer from multiple comorbidities.²

Treatment for TR is dependent on the underlying cause and severity. Medications, such as diuretics and ACE inhibitors, can be used to manage symptoms and treat underlying conditions. TR often progresses to an advanced stage before diagnosis. These patients are at elevated surgical risk and may therefore have limited treatment options. Interventional and surgical options may include valve repair or replacement.¹

Tricuspid Transcatheter Edge-to-Edge Repair
T-TEER is a minimally invasive treatment to improve quality of life and functional status in patients with symptomatic severe TR, despite optimal medical therapy, who are at intermediate or greater risk for surgery. The TriClip™ T-TEER System received PMA approval from the FDA in April 2024.

The TriClip™ TRILUMINATE pivotal trial (NCT03904147) demonstrated safety and efficacy of T-TEER in patients with symptomatic severe TR, as well as improvements to the patient’s functional capacity, reduction in hospitalizations, and increase in overall quality of life (QoL).³

Comparing the Evidence for Mitral Transcatheter Edge-to-Edge Repair and T-TEER
In August 2014, CMS issued a NCD for Transcatheter Mitral Valve Repair (TMVR) (20.33). CMS issued an updated NCD for TMVR in January 2021, at which time the policy was renamed Transcatheter Edge-to-Edge Repair for Mitral Valve Regurgitation (M-TEER).

Consistent with the pivotal trial for M-TEER, the pivotal trial for T-TEER was a prospective, randomized, controlled trial design that compared device treatment plus optimal medical management to medical management alone.

In both cases, two-year outcomes were published in the New England Journal of Medicine and demonstrated meaningful clinical benefits, including a significant reduction in hospitalization rates, reduced all-cause mortality, and substantial improvements in QoL for patients.⁴

The current body of clinical evidence supporting T-TEER is comparable in rigor and scope to the evidence that was available at the time of the initial NCD for mitral valve repair in 2014. The NCDs for TMVR and M-TEER have successfully advanced appropriate patient access while continuing evidence development through registry participation, with clearly defined operator and facility training and experience requirements.

BSC encourages CMS to maintain consistency in terms of evidentiary requirements for coverage by establishing an NCD for T-TEER that fulfills the CED requirement through prospective collection of data in a CMS approved registry.

BSC Recommendation
We strongly urge CMS to finalize a NCD with CED using national registry participation as a mechanism for continued evidence generation for PMA-approved T-TEER devices used in the treatment of TR. This approach would align with CMS’s existing policy framework under NCD 20.33 for M-TEER, which couples CED with defined operator and institutional training and experience criteria. Applying a consistent coverage model for T-TEER would promote equitable access to this critical therapy for Medicare beneficiaries.

Thank you for considering our comments. We look forward to working with CMS to ensure the best clinical outcomes for Medicare beneficiaries, as well as help to drive healthcare innovation through the expansion of access to proven therapies.

Please contact me at liesl.hargens@bsci.com if you have any questions.

Sincerely,

Liesl Hargens
Global Vice President, Health Economics and Market Access
Boston Scientific Corporation

REFERENCES

1. Khan BB, Graunke H, McClellan M. Coverage and Evidence Roundtables: Tricuspid Valve Interventions. February 7, 2024. Accessed January 8, 2025. https://healthpolicy.duke.edu/sites/default/files/2024-02/Coverage%20and%20Evidence%20Roundtables%20Tricuspid%20Valve%20Interventions.pdf
2. Tricuspid valve regurgitation: What you need to know. Cleveland Clinic. March 19, 2025. Accessed April 16, 2025. https://my.clevelandclinic.org/health/diseases/21627-tricuspid-valve-regurgitation
3. Saibal Kal, et al. Two-year Outcomes of Transcatheter Edge-to-edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Trial. AHA I ASA Journals. March 30, 2025. Accessed April 1, 2025.
4. Sorajja P, Whisenant B, Hamid N, et al. Transcatheter Repair for Patients with Tricuspid Regurgitation. New England Journal of Medicine. 2023;388(20):1833-1842. doi:10.1056/nejmoa2300525

Less

RE: Coverage of Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) (CAG-00468N)

On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and 35 million volunteers and supporters, we appreciate the opportunity to comment on the proposed national coverage determination (NCD) for tricuspid transcatheter edge-to-edge repair (T-TEER) for the treatment of symptomatic tricuspid regurgitation (TR) under Coverage with Evidence Development (CED) in the Medicare population.

Optimal Medical Therapy (OMT)
The Centers for Medicare & Medicaid Services (CMS) proposes to cover T-TEER for the treatment of symptomatic TR, despite optimal medical therapy (OMT). Patients must have symptomatic TR with tricuspid valve repair determined, by a heart team, to be appropriate.

As proposed, coverage of T-TEER would be conditioned upon a patient receiving OMT. We believe thirty days on stable OMT is appropriate to proceed with T-TEER if the patient remains symptomatic. This was the requirement for the TRILUMINATE Pivotal trial (which studied the safety and effectiveness of the Abbott TriClip system).

Symptomatic Tricuspid Regurgitation (TR)
CMS proposes coverage of T-TEER for the treatment of “symptomatic tricuspid regurgitation.” We encourage CMS to align its coverage policy with the Food and Drug Administration’s approved premarket approval application for TriClip and the TRILUMINATE pivotal trial which indicates the use of T-TEER for patients with symptomatic severe TR. We would include in this condition severity, patients with signs such as liver congestion and peripheral edema refractory to medical therapy.

Heart Team Composition
The proposed NCD states that a patient (preoperatively and postoperatively) must be under the care of a “heart team,” which includes, at minimum, the following:

1. Cardiac surgeon;
2. Interventional cardiologist;
3. Cardiologist with training and experience in heart failure management;
4. Electrophysiologist;
5. Multi-modality imaging specialists; and
6. Interventional echocardiographer.

CMS proposes to require that all the specialists listed above have experience in the care and treatment of tricuspid regurgitation.

We support the benefits that a patient receives from having a multidisciplinary team of providers. However, we do not believe it is necessary for an electrophysiologist to be a mandatory part of the heart team in evaluating and managing T-TEER. We recognize the important role electrophysiologists play and, as such, they could be consulted in specific cases but given the low risk of pacemaker with T-TEER, we do not believe their inclusion in the heart team is necessary for coverage. In addition, the role of the imaging specialist and/or the interventional echocardiographer should not be considered as mandatory for the heart team care minimum. While imaging is a critical component of the evaluation of the patient both preoperatively and postoperatively, it may be done expertly by the heart failure cardiologist, the interventional cardiologist or the cardiac surgeon.

Additionally, while it is important that the heart team consists of expert specialists and providers, its composition (number and type of providers) should not hinder patient access to T-TEER. We encourage CMS to re-evaluate each required member of the heart team—as part of the evidence development portion of this NCD—and omit other providers in its coverage policy, beyond electrophysiologists, if appropriate.

Coverage with Evidence Development (CED)
When there is limited evidence, as we believe is the case with T-TEER, CED has been a pathway to Medicare coverage for services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data. We support coverage under CED to expedite earlier beneficiary access to T-TEER while ensuring that systematic patient safeguards are in place.

We agree with CMS that evidentiary gaps remain, and longer-term data of larger, diverse cohorts is needed to assess outcomes such as mortality, heart failure hospitalization, Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement, procedural success, TR reduction, rates of single leaflet device attachment (SLDA) and tricuspid valve reintervention rates, at discharge, 30 days post-discharge, one-year post-discharge, and beyond. We encourage support of a national TVT registry with benchmarks and outcomes, and the use of patient reported outcomes measures in assessing outcomes of T-TEER.

Conclusion
In summary, we support coverage of T-TEER for patients with symptomatic severe TR. We agree that evidentiary gaps remain and support coverage under CED. We do not believe it is necessary to require an electrophysiologist, or imaging specialist on the heart team, and we encourage further evaluation (through the CED process) to determine if the number of providers required on the heart team could be further reduced.

Thank you for the opportunity to submit comments on this NCD. If you have any questions or require any additional information, please contact Maryellen Guinan at (202) 785-7948 or Maryellen.Guinan@heart.org.

Sincerely,
Keith Churchwell, MD, FAHA
President, American Heart Association

Less

Public Comment in Support of CMS Proposed Decision for T-TEER Coverage

As a Professor of Cardiovascular Medicine and Director of Interventional Cardiology and Structural Heart Fellowships at UC Davis Medical Center, I have devoted my academic and clinical career to the advancement of structural heart therapies. My specific expertise in tricuspid valve disease is reflected in my extensive research contributions, including numerous peer-reviewed publications, clinical trial participation, and textbook chapters focused on transcatheter therapies for tricuspid regurgitation, including the T-TEER approach. I have actively participated in clinical studies evaluating Triclip therapy and related innovations, and have firsthand experience with patients who have had profound and transformative clinical improvements following T-TEER procedures.

One particularly memorable patient was a woman with advanced chronic heart failure caused by severe tricuspid regurgitation, who had become unable to perform even basic activities of daily living due to progressive right-sided heart failure. Despite maximal medical therapy, including escalating doses of diuretics, she suffered recurrent hospitalizations for volume overload and was trapped in a cycle of worsening frailty and poor quality of life. Following successful T-TEER therapy, she experienced a marked reduction in heart failure hospitalizations and a dramatic improvement in her daily functioning and independence — an outcome previously unattainable with any available therapies.

Tragically, there remains a large population of patients like her in our communities who, until now, have had no viable treatment options. T-TEER represents a unique advance, offering a safety and efficacy profile unmatched by any other therapy for these patients. I strongly support CMS’s proposed decision to cover T-TEER under Coverage with Evidence Development.

However, it is very important that CMS reconsider the requirement for an electrophysiologist to be a mandatory member of the heart team. Other structural heart procedures, such as transcatheter aortic valve replacement (TAVR), are known to cause conduction disturbances and frequently require pacemaker implantation, yet do not require formal electrophysiologist involvement in the decision-making process. Adding a mandatory electrophysiologist requirement for T-TEER would impose an unnecessary burden, introduce delays in the evaluation and treatment of very sick and symptomatic patients, and could inadvertently limit access to this transformative therapy. It is sufficient that the heart team will involve an electrophysiologist as needed but this requirement should not be mandatory. Streamlining heart team requirements is essential to ensuring timely and equitable care for the many patients urgently awaiting this option.

Jason H. Rogers, MD, FACC, FSCAI
Professor, Cardiovascular Medicine
University of California, Davis Medical Center
4860 Y Street, Suite 2820
Sacramento, CA 95817
jhrogers@ucdavis.edu

Less

As a practicing clinician, I strongly support CMS’s proposed national coverage decision (NCD) for transcatheter tricuspid edge-to-edge repair (T-TEER). Severe, symptomatic tricuspid regurgitation (TR) is a devastating condition, and in my clinical experience, T-TEER has been truly life-changing for patients.

I have personally treated patients with T-TEER who have experienced remarkable recoveries:

One patient, previously unable to bend down to tie their shoelaces due to severe dyspnea, can now walk miles without shortness of breath.

Another patient, reliant on a motorized scooter due to severe ascites and lower extremity edema, regained full mobility following T-TEER.

A third patient, who previously required paracentesis every other week due to recurrent heart failure-related ascites from TR, no longer requires any fluid removal procedures after undergoing T-TEER.

These examples highlight how T-TEER can restore independence, prevent hospitalizations, and dramatically improve quality of life for patients with limited treatment options.

I fully support CMS’s approach to coverage with evidence development (CED) to further advance the clinical evidence base. However, I respectfully urge CMS to adopt a flexible Heart Team structure that balances expertise with patient access. The Heart Team should include key specialists: an interventional cardiologist, a cardiac surgeon, an imaging specialist, and a clinician experienced in heart failure management. Importantly, the heart failure specialist role should be inclusive of any cardiologist with substantial experience managing congestive heart failure and valvular heart disease, not limited only to formally designated heart failure subspecialists. This flexibility will allow more centers to offer T-TEER safely and expediently, without unnecessary procedural delays.

Additionally, while electrophysiology consultation is valuable when specific arrhythmic concerns arise, requiring an electrophysiologist for every case would unnecessarily burden the Heart Team structure and could delay access to treatment without demonstrable added benefit for most patients.

Recent data, including the TRILUMINATE trial, reinforce the safety and efficacy of T-TEER in significantly improving outcomes for this vulnerable population. Expanding access to this therapy is critical to improving patient-centered outcomes and reducing heart failure hospitalizations.

I commend CMS for its leadership on this issue and strongly encourage finalizing this NCD to maximize patient access to T-TEER.

Sincerely,
Gagan Singh MD
Director, Structural Heart Program
University of California Davis Health System
Sacramento CA

Less

Novitas and First Coast appreciate the opportunity to provide comments and support the proposed guidance. This proposed policy is grounded in various guidelines, which corresponds with CMS' recent focus highlighted during the LCD Writer's meeting, indicating that the National Coverage Analysis (NCA) is informed by the medical community. In the explanation of the team members, the NCA does not state that it is necessary for an electrophysiologist to be on the team but may be beneficial in some cases. ‘Consensus documents supporting the concept of a heart team include European Society of Cardiology (ESC) / European Association for Cardio-Thoracic Surgery (EACTS) Guidelines 2021, which state, “Decisions concerning treatment and intervention should be made by an active and collaborative Heart Team with expertise in valvular heart disease (VHD), comprising clinical and interventional cardiologists, cardiac surgeons, imaging specialists with expertise in interventional imaging, cardiovascular anesthesiologists, and other specialists if necessary (e.g. heart failure specialists or electrophysiologists).’ Therefore, we recommend that the inclusion of an electrophysiologist on the T-TEER team be optional consistent with the text of the NCA.

Less

This is a great technology for an otherwise disabling valvular disease for which therapies were limited and associated with significant patient risk. To determine whether indicated in symptomatic patients despite optimal medical therapy, a heart team that includes at a minimum cardiac surgeon, interventional cardiologist, heart failure cardiologist, electrophysiologist, and interventional echocardiographer is warranted. Coverage CMS with evidence development (CED) for on-label TriClip™ patients under the care of such a team is also a great idea

Less

As an investigator in the TRILUMINATE early feasibility and pivotal trials, I fully support the current decision memo published by CMS on T-TEER. We have seen now at 2 years, that T-TEER with TriClip system reduces heart failure hospitalization (HFH) vs guideline directed medical therapy (GDMT) alone, and that more TR reduction is associated with better improvement in KCCQ quality of life score (Kar et al Circulation 2025, Tang et al JACC 2024). We also see that delaying T-TEER, while can still achieve satisfactory outcomes, in certain patients they developed more HFH, worse TR, more diuretic use and lower KCCQ score with poorer quality of life. I believe that timely diagnosis and intervention for symptomatic severe TR would be beneficial, as we have seen in surgery. I also support the multi-scociety's professional document on heart team and operator experience requirements for T-TEER, as it is more complex than M-TEER, specifically on the juxtaposition of echo imaging and device manipulation to achieve moderate or less TR and the safety outcomes seen in the TRILUMINATE trial. However, I do not believe an EP specialist needs to be a required member of the heart team to evaluate patients for T-TEER, as the risk of pacemaker in T-TEER is extremely low, compared >20% with TTVR, which I agree an EP specialist should be required as part of the TTVR heart team.

Less

I have been involved and performing tricuspid clip procedures for approximately 6 years. I am the Director of Cardiology and the Cardiac Catheterization Laboratory at a large Community Hospital in an underserved community. We have 6 adjacent hospitals that do not have a valve program or provide TEER. We have large numbers of patients with advanced heart failure and severe tricuspid regurgitation (TR) that are failing medical therapy. The ability to treat these patients with TriClip has significantly improved the patient's quality of life and recurrent admissions for heart failure. This statement is not true for all patients but is true for the majority (80%) of patients we have treated. For patients not responding to diuretic therapy, whom are not surgical candidates (which is the majority), Triclip offers a valuable treatment option. Team members should be similar to TEER of the mitral valve and include a heart failure specialist, a surgeon with expertise in valve surgery and an imaging specialist. We have also used intra cardiac echocardiography (ICE) for most of our cases. Additional awareness of severe TR to our HF and Electrophysiology Partners is required. We receive a significant number of referrals from both.

Less

Honorable members,
As an interventional cardiologist who helped develop the structural heart program at Banner Heart hospital in Mesa with the introduction of TAVR in 2011, I support national coverage for the treatment of tricuspid insufficiency with devices used for edge to edge repair of the tricuspid valve. There are many patients in our practice who are limited by their valvular insufficiency and require repeat admissions to the hospital and multiple visits to our heart failure clinic who can have their lives dramatically improved with this therapy. Surgical tricuspid valve procedures have failed to be durable and have posed significant risk to patients for decades and are rarely used, leaving patients with no option other than medical therapy and deteriorating quality of life. Please consider coverage for this therapy which will significantly impact our patients.

Sincerely,
Alphonse M. Ambrosia, DO, FACC
Interventional Cardiologist
Chairman of Structural Heart Committee
Banner Heart Hospital
Mesa, Arizona

Less