Transcatheter Tricuspid Valve Replacement (TTVR)

Medicare Coverage for Transcatheter Tricuspid Valve Replacement (CAG-00467N)
National Center for Health Research Public Comment

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 transcatheter tricuspid valve replacement (TTVR). Based on the current evidence, including the TRISCEND II trial, we have concerns about the lack of clinically meaningful benefits and high rates of adverse events. Current data do not meet the required Medicare standard of “reasonable and necessary. However, if CED is finalized, the criteria should be strengthened, and the data should be analyzed after one year to determine if there is clear evidence that TTVR decreases mortality.

Key Concerns Regarding Outcome Data

The weaknesses of the study designs and analyses undermine the purported evidence that is currently available.

Mortality and Hospitalization: Despite the large sample, the TRISCEND II trial did not demonstrate a statistically significant reduction in mortality or hospitalization with TTVR compared to medical therapy (Hahn et al., 2024). Death is the most important outcome measure and mortality reduction should be a fundamental benchmark for evaluating the value of a high-risk, high-cost intervention. Hospitalization is also an important objective measure and the fact that TTVR patients are not showing a benefit is a major concern.

Quality-of-Life Outcomes: While TTVR showed improvements in quality-of-life measures, these outcomes were derived from unblinded assessments, leaving them vulnerable to placebo effects (Hahn et al., 2024; Spertus et al., 2020). For example, when patients are aware that they are being treated with a promising new surgery, they may have a more positive perspective when asked about their recovery and may also try harder on tests such as the 6-minute walk test. That is why subjective measures and those potentially influenced by lack of blinding must be interpreted cautiously and should not be combined with objective measures such as death and hospitalization in a composite outcome measure.

Composite measures can provide a broad assessment but, in this case, the most clinically meaningful outcomes are also less likely to be influenced by lack of blinding. Objective measures such as death and hospitalization should not be combined with subjective measures or with those that could be influenced by lack of blinding. We are pleased to see that CMS’ proposed CED would use a composite limited to death and hospitalization but urge that overall survival should be the primary outcome measure.

Adverse Events: Patients undergoing TTVR experienced significantly higher rates of severe complications:

• Severe Bleeding: 15.4% in the TTVR group vs. 5.3% in the control group.
• Arrhythmias/Conduction Disorders Requiring NEW Permanent Pacemakers: 17.8% in the TTVR group vs. 2.3% in the control group (Hahn et al., 2024).

These adverse event rates raise concerns about the safety profile of TTVR and its net benefit for patients, particularly since the Medicare population includes many frail individuals with multiple comorbidities. Medicare coverage seems impossible to justify given the results and the study’s shortcomings.

Underrepresentation of Key Medicare Populations

The data include appropriate age groups but lack the racial and ethnic diversity typical of Medicare beneficiaries.
Age: The TRISCEND II trial reported a mean patient age of 79.2 years, which is consistent with the older population likely to consider TTVR and with Medicare beneficiaries. However, outcomes for patients aged 80 and older, who are likely to be the most frail and with more comorbidities, should have been analyzed separately to determine what the benefits and risks are for those older patients that comprise a substantial segment of Medicare beneficiaries.
Demographic Representation: Most (75.5%) of the trial population were women, which is consistent with the higher prevalence of tricuspid regurgitation in women. The study included enough men to analyze the risks and benefits stratified by sex, but those analyses were not included in the published study. In contrast, there were too few patients representing racial and ethnic minorities to provide meaningful data on safety or effectiveness for those groups. Since Medicare patients are very diverse, this lack of diversity in the study raises concerns about the generalizability of the findings to all Medicare beneficiaries.

Recommendations for Strengthening CED Criteria

If CMS moves forward with CED for TTVR, we support the requirements that CMS has proposed and urge the inclusion of several more rigorous criteria to ensure that better evidence is collected to determine whether TTVR has benefits that outweigh the risks for Medicare beneficiaries, and that the procedure is thoroughly evaluated. Specifically:

1. Require Randomized, Double blind, Sham-controlled Studies to Demonstrate a Mortality Benefit
   • Require randomized, double blind, sham-controlled studies (Kodali et al, 2022) to show a statistically significant and clinically meaningful reduction in mortality as the primary endpoint.
   • Require studies to show a statistically significant and clinically meaningful reduction in hospitalization for any cause as a secondary endpoint with important quality of life implications. Other subjective quality of life measures can be used only if blinding is successful, but not as a composite outcome measure and only if blinding is successful (Green et al, 2000)
   • The CED should state that Medicare coverage of TTVR will be terminated if mortality benefits are not proven by the CED data within an appropriate time frame. These data should be analyzed and made public annually so that if TTVR patients do not show clear benefits within the first year, CMS, physicians, and patients have additional information to help them determine if TTVR has benefits that outweigh the risks.
2. Stratification by Age, Comorbidities, and Frailty
   • Require stratification by age and comorbidities to assess how these factors influence outcomes and adverse events in the Medicare population (Rockwood et al., 2005). Incorporating a valid frailty index such as the Clinical Frailty Scale could improve risk assessment, by taking into account physical, cognitive, and functional vulnerabilities, especially for a high-risk subgroup.
3. Long-Term Follow-Up
   • Mandate studies to include multi-year follow-up data on mortality, rehospitalizations, and sustained quality-of-life improvements, given the high-risk profile of the target population (Kodali et al., 2022).

Additional Recommendation

When CED is used, it is essential that CMS have access to all the data collected and has staff able to appropriately analyze the data as quickly as possible. Given the uncertainty of TTVR benefits for mortality or hospitalization, data should be analyzed annually until the data are sufficient to draw conclusions about safety and effectiveness.

Conclusions

TTVR is a high-risk intervention with no evidence of benefit in terms of mortality compared to medical treatment and significant potential for harm. We urge CMS to proceed more cautiously because of the lack of benefit for mortality or hospitalization, and because the study did not evaluate whether there were any differences in risks or benefits associated with race, gender, or co-morbidities. CED seems premature for TTVR at this time, but if CMS decides to finalize CED, we strongly urge that the CED data be analyzed annually to enable CMS to ensure that only those procedures with clear and substantial benefit to Medicare beneficiaries are covered. As a nation, we must prioritize treatments that demonstrate a meaningful balance of safety, efficacy, and cost-effectiveness.

References

1. Green, C. P., Porter, C. B., Bresnahan, D. R., & Spertus, J. A. (2000). Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. Journal of the American College of Cardiology, 35(5), 1245–1255. https://doi.org/10.1016/S0735-1097(00)00531-3
2. Hahn, R. T., Makkar, R., Thourani, V. H., et al. (2024). Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2401918 3. Kodali, S., Hahn, R. T., George, I., et al. (2022). Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC Cardiovascular Interventions, 15(5), 471–480. https://doi.org/10.1016/j.jcin.2022.01.016 4. Rockwood, K., Song, X., MacKnight, C., et al. (2005). A global clinical measure of fitness and frailty in elderly people. CMAJ, 173(5), 489–495. https://doi.org/10.1503/cmaj.050051
5. Spertus, J. A., Jones, P. G., Sandhu, A. T., & Arnold, S. V. (2020). Interpreting the Kansas City Cardiomyopathy Questionnaire in Clinical Trials and Clinical Care: JACC State-of-the-Art Review. Journal of the American College of Cardiology, 76(20), 2379–2390. https://doi.org/10.1016/j.jacc.2020.09.542

Less

Dear CMS,
I’m an Interventional Cardiologist with special focus on transcatheter treatment of valvular heart disease. At our institution, we have participated in variety of transcatheter tricuspid therapies including variety of TTVRs (Transcatheter Tricuspid Valve Replacement) and TEER (Transcatheter Edge to Edge Repair). Over the last few years, I have personally implanted numerous TTVRs including several Evoques as part of their TRISCEND I EFS, TRISCEND II pivotal RCT, Continued Access Study and now after their FDA approval in 2024. Overall, myself and our team have been extremely pleased with results and the patient outcomes.
TTVR brings lot of excitement to the patients and us treating physicians as there was relatively no effective treatment for tricuspid regurgitation outside of basic medical therapy. This excitement has impressed referring community as we are noticing increase in referrals to our clinic. Often time patients are travelling hours to get evaluated for this new therapy which at least at this time is very restricted and available at limited centers in the country. These are elderly patients who often are dependent on family, relatives and friends to bring them to clinic. Access to care is challenging and hence must be a critical consideration while deciding coverage, keeping in mind patient’s desire to get treated and importance of quality of life.
Access must be balanced with outcomes and therefore we must ensure not only patient safety but also highest quality of care. Fortunately, as a result of work from investigators, implanters, industry, this TTVR (Evoque) has become a very predictable procedure with easy to follow and teachable procedural technique. The company provides an in-depth procedural screening, watchouts and then assists in guiding echo imaging as well as device handling. Given the hemodynamic stability of this procedure, it can easily be performed by any single operator with the help of an imager (cardiologist or anesthesiologist). Post operative management is usually on a telemetry bed or cardiac intensive care unit mostly for hemodynamic management which most cardiologists manage, sometimes co-manage with intensivists. At least at our center, the safety outcomes are already better than what we saw in early days, thanks to the learnings from investigational studies.
In summary, this is a much-needed treatment and we healthcare professionals as well as patients welcome your coverage consideration and look forward to your final decision.
Thank you,
Sincerely,

Less

On behalf of the Medical Device Manufacturers Association (MDMA), I am pleased to submit comments to CMS on the proposed decision memo for Transcatheter Tricuspid Valve Replacement (TTVR).

MDMA is a national trade association that provides educational and advocacy assistance to hundreds of innovative companies in the field of medical technology. Our members, the majority of which are small to mid-sized medical device companies, have a strong record of delivering breakthrough therapies to treat chronic diseases and life-threatening conditions while lowering the cost of care. MDMA’s mission is to ensure that patients have timely access to the latest advancements of safe and e?ective medical technologies that improve health outcomes.

MDMA supports national Medicare coverage of TTVR under a National Coverage Determination (NCD) that includes Coverage with Evidence Development (CED). We also offer the following recommendations related to the draft proposed decision memo and Manual language, hereinafter referred to as “the Draft NCD”:

1. Expanding CED as approved labelling expands without requiring NCD reconsideration

The patient criteria set forth in the Draft NCD—"“Despite optimal therapy (OMT), patients must have symptomatic TR graded as at least severe with tricuspid valve replacement being considered as appropriate by a heart team”—match the labeled indications for use of the only TTVR device approved by the U.S. Food and Drug Administration (FDA) to date; however, other TTVR devices are currently undergoing premarket review by the FDA and are likely to receive marketing authorization while CED is in effect for TTVR.

MDMA urges CMS to include future FDA-approved indications for use for TTVR within the scope of coverage of the final NCD. Limiting the patient criteria as proposed in the Draft NCD would require CMS to undertake a full NCD reconsideration in the event that the manufacturer of the currently-marketed device or the manufacturer of a “follow-on” device receives approval from FDA for a broader indication. We believe that would be a waste of the limited resources and capacity of the CMS Coverage Analysis Group to conduct national coverage reviews. Allowing the scope of permissible CED studies to automatically expand along with the FDA-approved labelling will preserve precious resources and also increase the likelihood that the clinical evidence on outcomes in the Medicare population available when CMS ultimately reconsiders the NCD will match the full extent of FDA-approved labelling at that time.

2. Flexibility to adjust approved CED study protocols when warranted

It is not uncommon for clinical study protocols to be adjusted during the course of conducting the research. MDMA asks that CMS confirm in the final NCD that the agency will work with study sponsors to adjust and update CED study protocols through the course of the NCD.

3. CMS approval of CED studies

MDMA appreciates CMS’ ongoing effort to implement the Transitional Coverage for Emerging Technologies (TCET) initiative and to improve the CED pathway, which are intended to provide earlier access to new technologies for Medicare beneficiaries and support the collection of real world evidence in the Medicare population. We note that the finalization of any NCD requiring CED is only the first step toward achieving these objectives for some, which also may require the approval by CMS of protocols and initiation of studies. We urge CMS to work with manufacturers to expeditiously review and approve study protocols following the issuance of the final NCD for TTVR and similarly for future NCDs with CED that require CMS approval of studies.

In addition, whenever CMS utilizes its authority under section 1862(a)(1)(E) of the Social Security Act to provide national coverage under CED, we urge CMS to consider carefully whether certain study design requirements, as well as the requirement for CMS approval of individual clinical study designs, might unnecessarily limit beneficiary access. We agree with experts in clinical research from the University of Southern California Schaeffer Center for Health Policy & Economics, the Tufts Center for the Evaluation of Value and Risk in Health, and the Dartmouth Institute for Health Policy and Clinical Practice, who stated in comments filed during the initial public comment period, "We urge CMS to carefully consider how any coverage requirements . . . might impact equitable access to technologies under CED. Particular attention should be paid to avoiding undue barriers for underserved populations, rural areas, and other patient groups that may face challenges in accessing care. By thoughtfully designing CED requirements, CMS can help ensure that the benefits of new technologies are accessible to all Medicare beneficiaries, regardless of their geographic location or socioeconomic status."

Bringing innovative breakthrough devices such as TTVR to Medicare beneficiaries su?ering from debilitating disease is the intent and goal of the TCET program and the CED pathway. We appreciate the opportunity to comment on this important topic. If we can provide any additional information, please contact me at dwaldmann@medicaldevices.org or (202) 354-7171.

Sincerely,

Daniel Waldmann, JD
EVP , Health Policy & Reimbursement
Medical Device Manufacturers Association (MDMA)

Less

RE: Proposed Coverage Decision for Transcatheter Tricuspid Valve Replacement (TTVR) (CAG-00467N)

Dear Mr. Dolan,

The Robert J. Margolis, MD Institute for Health Policy at Duke University (“the Duke-Margolis Institute” or “the Institute”) appreciates the opportunity to comment on the Center for Medicare and Medicaid Services (CMS) proposed national coverage determination (NCD) for Transcatheter Tricuspid Valve Replacement (TTVR), published on December 19, 2024.

The Duke-Margolis Institute generates and analyzes evidence across the spectrum of health policy and supports the triple aim of better care, better health, and lower cost. A core mission of the Institute is to focus on increasing the value of biomedical innovation to patients. Institute experts are engaged in policy research and development efforts to improve the processes and infrastructure needed at CMS to ensure efficient access to new and innovative technologies.

The Institute’s comments are informed by an independent analysis of the proposed coverage determination and ongoing engagement with manufacturers, real-world evidence experts, providers, researchers, and payers, including CMS. As the TTVR national coverage assessment (NCA) is a pilot of the Transitional Coverage for Emerging Technologies (TCET) program, our comments describe how the proposed coverage determination aligns with overarching CMS coverage modernization goals. We also describe the steps CMS could take now to make this process more efficient, predictable, and timely. We recommend that CMS:

Direct early engagement with a wide variety of partners that could inform the outcomes of interest and key evidence questions that would best support coverage; and

Direct early engagement to help increase predictability, efficiency, and expediency of post-market evidence generation.

Our comments below detail these recommendations.

Goals of Modernized Medicare Coverage Processes
CMS has made several reforms to modernize Medicare coverage processes, with the goal of making Medicare coverage more transparent, predictable, and timely. In August 2024, CMS finalized the TCET pathway, a new expedited coverage pathway for devices with breakthrough designation.¹ The TTVR proposed coverage decision is a pilot for the TCET pathway.^2,3 Additionally, CMS has published:

guidance on the NCA Evidence Review process;

an example Clinical Endpoints Guidance document for Knee Osteoarthritis;

updated Coverage with Evidence Development (CED) guidance; and

proposed guidance on Study Protocols That Use Real-world Data.
CMS has also indicated forthcoming guidance documents on clinical endpoints in different therapeutic areas. These recent documents and steps are efforts to provide greater transparency into how CMS determines outcomes of interest for Medicare beneficiaries and evaluates evidence for Medicare coverage.

The Institute commends CMS for these important steps to reform and modernize Medicare coverage processes. Notably, these reforms were made within the context of limited resources for the Coverage and Analysis Group (CAG). CMS has described the NCD process as resource-intensive,⁴ and has highlighted resource constraints as the main reason for currently limiting the scope of the TCET pathway.¹ The Institute’s comments highlight additional steps CMS can take to support their goals, but acknowledge that these actions may require additional resources to be implemented. The Institute will therefore also highlight opportunities for CMS to build onto existing efforts to further their goals.

Value of Early Engagement
In the TTVR proposed decision memo, many of the endpoints and evidence questions that CMS identified for the TTVR proposed NCD were also discussed in a 2017 Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting on heart failure.⁵ Through MEDCAC meetings, CMS engages with experts in a public setting to align on evidence needs for novel technologies. CMS calls upon the MEDCAC panel of experts for advice on studies, endpoints, and horizon scanning for technologies that might be appropriate for Medicare coverage.⁶ The heart failure MEDCAC meeting served as a strong evidentiary base, raising points that CMS reiterated in the TTVR proposed decision. The Institute commends CMS for its commitment to early public engagement through MEDCAC meetings and the accompanying analysis with opportunity for public input.

There may be an opportunity to elevate the findings of the MEDCAC meetings to be more accessible. CMS posts publicly the minutes, voting record, and transcript from MEDCAC meetings. However, CMS could incorporate MEDCAC meeting findings into non-binding guidance for clinical disease areas. Publishing such a summary of key MEDCAC findings and how they might relate to Medicare coverage or post-market studies can proactively communicate CMS’ evidence expectations publicly, similar to the guidance documents. CMS may consider publishing summaries of the key findings and implications of MEDCAC meetings to make the outputs from these effective public meetings more accessible.

Additionally, there may be an opportunity for CMS to clarify how public input into MEDCAC meetings may be considered for TCET. CMS stated in the final TCET notice that the Agency is “particularly interested in engagement with patient advocacy organizations and medical specialty societies” through the NCD process that is utilized in the TCET pathway.¹ CMS also noted that the early “letter of intent” can help CMS plan for upcoming technologies in the TCET pathway, including potentially preemptively calling a MEDCAC meeting. It is not immediately clear how key party input—particularly physician and patient perspectives—may be incorporated into TCET decision-making.

We note that MEDCAC meetings are typically held in response to a CMS question regarding evidence or endpoints for an outstanding coverage question. There are opportunities for CMS to facilitate or direct multistakeholder early engagement to elucidate on evidence needs for novel therapeutic or product areas. This may be particularly effective when there is a lot of rapid development of novel products in a certain therapeutic area, and clinical guidelines may not yet reflect the novel treatment options. FDA takes a similar approach to gather key partner, expert, and public input on regulatory policy for growing areas of biomedical innovation through contracted public convenings and workshops.⁷ Such activities can support CMS’ ongoing efforts to produce guidance documents on clinical endpoints. Partners that could contribute to such early engagement include other federal agencies, manufacturers, data experts, specialty societies, researchers, clinicians, and patient advocacy groups. Incorporating clinician and patient perspectives into informing outcomes of interest may be particularly informative; as the end users of the products, they can provide perspective into what drives clinical decision-making.

To illustrate the value of early engagement with a wide variety of stakeholders, Duke-Margolis hosted a roundtable series, in collaboration with the Heart Valve Collaborative, that sought to inform a post-market evidence generation strategy for novel tricuspid valve interventions. The roundtable series came about because of broad stakeholder interest—particularly from clinicians involved in heart valve research and care—in discussing the growing evidence in a rapidly developing therapeutic area ahead of both FDA authorization and Medicare coverage consideration. The meeting series began two and a half years before the first breakthrough tricuspid valve intervention product was estimated to receive FDA authorization. The Institute convened clinicians, specialty societies, real-world data experts, manufacturers, payers, CMS, and FDA. Participants identified many of the same outcomes of interest identified in this proposed NCD decision memo. However, the shared perspectives of heart failure specialists, interventional cardiologists, and thoracic surgeons allowed for participants to have an in-depth discussion on the types of data and evidence that would support device adoption and clinical decision-making. For example, some providers emphasized the importance of understanding how different tricuspid valve devices impact patients based on tricuspid regurgitation etiology, others emphasized that they would want to know how these interventions interact with comorbidities before utilizing the devices. Identifying outcomes of interest and evidence needs for Medicare coverage was just one of the main topics of discussion; stakeholders clearly see a need to engage more broadly to proactively consider the endpoints and data collection needs that would impact access to and uptake of a novel medical product.

This type of engagement, in conjunction with ongoing reforms, would advance a more informed understanding of relevant evidence, and efficient ways to collect it, to support meeting CMS’ “reasonable and necessary” standard. Engaging with key partners could help increase coverage process predictability and improve the efficiency of not only the TCET Evidence Development Plan (EDP) finalization process, but also help manufacturers prepare pre-market trial endpoints in a way that aligns with CMS evidence priorities. CMS could direct early engagement with a wide variety of partners that could inform the outcomes of interest and key evidence questions that would best support coverage.

Additional Guidance on Study Designs and Data Collection
In this proposed NCD, CMS listed characteristics of the CED studies that would be considered successful for supporting national coverage for TTVR. First, a study would show clinically meaningful improvement when compared to optimal therapy. CMS noted that the pivotal trials were not powered to allow for evaluation of individual components, including all-cause mortality and heart failure hospitalization, which are proposed outcomes for TTVR CED studies. CMS also proposed requiring analyses on different etiologies and subgroups to identify differences in likelihood of benefit from TTVR, as well as the treatment conditions that lead to treatment success. Some of CMS’ concerns with the TTVR trials are inherent to many pre-market clinical trials. However, clarity on the endpoints or study designs that would be most important for determining clinical benefit may enable manufacturers to address CMS priorities earlier or take steps to work with clinicians and other partners to reduce the cost and improve the quality of post-market evidence. This could result in less burdensome and more effective post-market study requirements.

CMS provides this type of guidance within the TCET pathway before product approval to align with manufacturers on an EDP. However, CMS could potentially expand this effort to offer post-market evidence development guidance more broadly. CMS could consider providing guidance on study design through three potential avenues:
1. Written public guidance: This type of document could expand on existing efforts, such as the updated CED, clinical endpoints, and proposed real-world data (RWD) study guidance, which inform post-market study designs and outcomes of interest.
2. Individual guidance that builds on existing interactions: CMS could provide clear verbal or written guidance directly to individual manufacturers during the application for Medicare coverage for investigational device exemption studies.
3. Early engagement: CMS could offer public early engagement opportunities for patients, clinicians, data experts, and others to provide input into study designs and data sources that could support product uptake in different therapeutic areas.

Early public engagement may be a feasible strategy to incorporate expertise on data collection methods that might be most feasible in real-world settings. Involving clinicians and patients may help ensure that data collection is relevant, while considering the impact of such data collection on workforce burdens. For example, each type of stakeholder in the roundtable series described earlier discussed the types of data collection strategies and data sources that would address their evidence concerns. Participants discussed how traditional registry approaches, innovative methods of constructing registries, secondary uses of RWD, and point-of-care trials could all be appropriate data collection strategies given the identified outcomes of interest for tricuspid valve interventions. Participants suggested that a combination of different data collection methods might help reduce provider burdens while providing a more comprehensive picture of health benefits.

In therapeutic areas with multiple truly novel products in development that may face coverage questions, this platform of stakeholder engagement could help inform and build reliable and efficient data collection and evaluation methods. These early discussions may help partners build up necessary data infrastructures earlier and more efficiently, thus potentially reducing the costs of post-market evidence development in addition to improving the quality of the data collected. To this end, CMS can consider directing early engagement to help increase predictability, efficiency, and expediency of post-market evidence generation.

Importance of Additional Resourcing
There are several ways to advance the above recommendations for early engagement, such as through building on existing efforts, individual meetings with stakeholders, additional MEDCAC meetings with summaries, formalizing new guidance, or establishing formal processes for early, public engagement. The latter two options especially would place additional strain on CMS’ already limited resources. However, throughout the Medicare coverage reform process, there were many public comments showing that there is widespread interest from a variety of parties in having more opportunities to engage with CMS through meetings and guidance. Thus, any new expectations, engagement, or guidance should have a clear and valuable intent, with the goal of using any additional resources – such as CMS aims to devote to TCET – as efficiently as possible.

In recent years, Duke-Margolis has facilitated discussions with manufacturers, physicians, researchers, consultants, and payers around efficient and effective ways to use limited additional appropriations with accountability for greater clarity and speed to support CMS’ recent coverage process reforms, including TCET. Additional resources would allow the CAG team to reliably convene MEDCAC meetings and summarize them, direct early partner engagement, and create additional guidance as needed. These resources could also enable CMS to work through the current NCD waitlist more quickly, as well as support the TCET pathway and eventual product coverage reconsiderations.

In this tight fiscal environment, CMS should consider which of these reforms and additional activities may create the biggest impact within current resource constraints. CMS could also identify potential activities that could further coverage reform goals that could be supported through additional appropriations. Duke-Margolis will continue to work with CMS and other partners to help identify where additional resources could be most impactful, with a focus on the potential benefits and costs of additional reforms. CMS should continue to work with stakeholders to clarify the most effective ways to use additional resources to support coverage process modernization, as the diversity, complexity, and potential impact on beneficiaries of innovative medical products continues to expand.

Conclusion
The Duke-Margolis Institute supports the goals of CMS’ recent coverage process modernization efforts and commends CMS for its transparency regarding this TCET pilot. The Institute encourages CMS to consider expanding upon current efforts to proactively inform the public of CMS’ evidence expectations by directing or facilitating early engagement with a multitude of partners. The Institute also encourages CMS to consider offering additional clarity through engagement on the study designs, clinical endpoints, and data sources that would best support coverage. Judicious additional resourcing linked to progress on these goals will ensure CMS is equipped to support these changes and ensure the impact of additional reforms. Given the tight fiscal environment, the Institute will continue to work with CMS and other parties to identify the most efficient use for additional resources.

The Institute appreciates CMS’ consideration of our comments and the Administration’s support for advancing high-value, affordable health care.

Sincerely,

Hannah Graunke – Senior Policy Analyst
Beena Bhuiyan Khan – Research Director of Payment and Coverage Policy
Mark McClellan – Director

Disclosures
Beena Bhuiyan Khan is a former employee and shareholder of Abbott Laboratories and Boston Scientific Corporation.

Mark B. McClellan, MD, PhD, is an independent director on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ; co-chairs the Guiding Committee for the Health Care Payment Learning and Action Network; and receives fees for serving as an advisor for Arsenal Capital Partners, Blackstone Life Sciences, and MITRE.

References
1. Centers for Medicare & Medicaid Services, “Medicare Program; Transitional Coverage for Emerging Technologies (89 FR 65724),” Federal Register, August 12, 2024, https://www.federalregister.gov/documents/2024/08/12/2024-17603/medicare-program-transitional-coverage-for-emerging-technologies.
2. David Dolan and Laura Findeiss, “Proposed Decision Memo: Transcatheter Tricuspid Valve Replacement (TTVR) (CAG-00467N)” (CMS, December 19, 2024), https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&ncaid=314.
3. Steven A. Farmer, Lori M. Ashby, and Jonathan D. Blum, “Medicare’s New Pathway for Transitional Coverage for Emerging Technologies,” JAMA Health Forum 5, no. 11 (November 22, 2024): e243901, https://doi.org/10.1001/jamahealthforum.2024.3901.
4. Centers for Medicare & Medicaid Services, “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’ Final Rule,” Federal Register, January 14, 2021, https://www.federalregister.gov/documents/2021/01/14/2021-00707/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and.
5. Centers for Medicare & Medicaid Services, “Health Outcomes in Heart Failure Treatment Technology Studies” (CMS, March 22, 2017), https://www.cms.gov/medicare-coverage-database/view/medcac-meeting.aspx?MEDCACId=73.
6. Centers for Medicare & Medicaid Services, “Medicare Coverage Document - Factors CMS Considers in Referring Topics to the Medicare Evidence Development & Coverage Advisory Committee,” CMS, December 12, 2006, https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?MCDId=10.
7. “Federal Food, Drug, and Cosmetic Act,” 21 U.S.C § § 379h–2, accessed January 17, 2025, https://www.govinfo.gov/content/pkg/USCODE-2023-title21/pdf/USCODE-2023-title21-chap9-subchapVII-partC-subpart2-sec379h-2.pdf.

Less

January 18, 2025

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

Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR) Proposed Decision Memo

Dear Ms. Syrek Jensen,

Edwards Lifesciences (“Edwards”) is pleased that CMS is continuing its National Coverage Analysis (NCA) for Transcatheter Tricuspid Valve Replacement (TTVR) with the release of the Proposed Decision Memo on December 19, 2024. Edwards believes that the posting of the Proposed Decision Memo is an important step towards securing timely and equitable patient access to life-changing medical innovation. Patients with tricuspid regurgitation (TR) suffer from debilitating symptoms and currently have limited or no therapeutic treatment options. Patient and physician ability to access treatment with the EVOQUE transcatheter tricuspid valve replacement system (EVOQUE system), a U.S. Food and Drug Administration (FDA) Designated Breakthrough Device, will be facilitated via the finalization of a Medicare National Coverage Determination (NCD).

We appreciate the opportunity to submit comments on the TTVR Proposed Decision Memo. We support CMS’s proposed decision to issue coverage of TTVR 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

In the United States, more than 1.6 million people suffer from significant TR (moderate and above). (1,2) 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 EVOQUE system is the first FDA-approved TTVR technology indicated for the improvement of health status in patients with symptomatic severe TR despite being treated optimally with medical therapy, for whom tricuspid valve replacement is deemed appropriate by a Heart Team.

As summarized in the Proposed Decision Memo, two clinical trials informed the FDA approval of the EVOQUE system. The single-arm Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device (TRISCEND) Study evaluated the safety and effectiveness of the EVOQUE system, with 30-day and 1-year results published. (7,8) The second trial, the TRISCEND II pivotal trial, is an ongoing international, multicenter pivotal randomized clinical trial of 400 patients. One-year results were published in October 2024. The study authors concluded that “[f]or patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life.” (9) Improvement in patients' symptoms, function, and quality of life were evident 30 days after TTVR, continued to increase through 6 months and remained durable through 1 year. (10)

1. Support for Coverage of the Patient Population

Patient Criteria

Edwards supports coverage of TTVR when furnished according to each device’s FDA label. We are pleased to see that CMS proposes to issue coverage of TTVR consistent with the current approved indication for EVOQUE: “despite optimal therapy (OMT), patients must have symptomatic TR graded as at least severe with tricuspid valve replacement being considered as appropriate by a heart team.” As the only FDA-approved TTVR technology, this is critical to ensure patients receive timely access to this innovative therapy.

Other Uses of TTVR

In the section of the proposed policy on “Other Uses of TTVR,” CMS proposes that nothing in the proposed NCD would preclude coverage of TTVR through NCD 310.1 (Clinical Trial Policy) or through the Investigational Device Exemption (IDE) Policy. Edwards appreciates the clarification that the NCD, as proposed, would not preclude coverage of TTVR in these contexts.

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

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. (11) The Heart Team approach combines the knowledge of multiple disciplines, such as interventional cardiology, cardiac surgery, and interventional imaging. Edwards supports the preservation of this patient-centered team to promote the best possible outcomes.

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. (12) Edwards supports the proposed criteria requiring patients to be under the care of a Heart Team to ensure patients with TR receive the most clinically appropriate care.

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 TTVR 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 therapies, such as TTVR. 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 TTVR 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 outside the context of a trial. (12)

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 (e.g., TRISCEND II and an EVOQUE real-world study), the complete body of evidence generated under this NCD with CED will be used to support future reconsiderations and a durable coverage policy. Under this new CED process, Edwards has committed to generating substantial evidence to support coverage of TTVR and the patient and clinical communities will play an important role in further strengthening the TTVR body of evidence.

CED Subgroup Analyses

In the proposed CED study requirements, Edwards requests that CMS modify the language describing one of the subgroup analyses to evaluate treatment conditions under CED. Specifically, Edwards recommends CMS replace “Patient, practitioner, and facility level variables that predict the primary outcomes of the study,” to instead state, “Treatment conditions (e.g., practitioner and facility level variables).” As written, the proposed subgroup language may be complex and more inflexible than intended, as described in other sections of the decision memo. CMS states that CED will be complete when evidence is available to identify any “treatment conditions (operator, procedure, and facility characteristics) that contribute to expected outcomes.” To achieve this goal at the conclusion of CED, we believe the intent of the subgroup analysis is to understand the impact of different practitioner and facility level variables on TTVR outcomes.

***

As we have demonstrated in our long history of bringing innovative therapies to patients with Medicare coverage, Edwards is committed to the process CMS has defined for such technologies under the NCD with CED pathway. Edwards appreciates and takes seriously the responsibility of supporting this new TTVR therapy while generating additional evidence to ensure the best possible care for patients. We embrace our leadership role in partnering with patients and the clinical community to help this therapy move forward and collecting evidence to determine optimal access for patients.

We are acutely aware of the unmet need for patients with TR and encourage CMS to move swiftly and carefully to the next step of finalizing national coverage policy for TTVR, enabling patients’ timely and optimal access to this important innovation. 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

References
(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) Kodali, S., Hahn, R. T., George, I., et al. (2022). Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC. Cardiovascular Interventions, 15(5), 471–480. https://doi.org/10.1016/j.jcin.2022.01.016
(8) Kodali, S., Hahn, R. T., Makkar, R., et al. (2023). Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study. European Heart Journal, 44(46), 4862–4873. https://doi.org/10.1093/eurheartj/ehad667
(9) Hahn, R. T., Makkar, R., Thourani, V. H., et al. (2024). Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. NEJM,10.1056/NEJMoa2401918. https://doi.org/10.1056/NEJMoa2401918
(10) Arnold, S. V., Hahn, R. T., Thourani, V. H., et al. (2024). Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial. JACC, S0735-1097(24)09954-6. https://doi.org/10.1016/j.jacc.2024.10.067
(11) 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
(12) Khozin S, Blumenthal GM, Pazdur R. Real-world Data for Clinical Evidence Generation in Oncology. Journal of the National Cancer Institute. 2017;109(11). doi:10.1093/jnci/djx187

Less

The Evoque device for TTVR represents a significant advancement in the treatment of tricuspid valve disease, which is undertreated despite its considerable impact on morbidity and mortality. By offering a less invasive option for patients who are not surgical candidates, we have the potential to help address a critical unmet clinical need. Although there wasn’t mortality or heart failure hospitalization benefit in the study, we have seen some remarkable clinical success stories in patients who clearly wouldn’t have survived without treatment. Recently a patient came back for 3 month follow up. He had been in the hospital with end-stage right sided heart failure requiring multiple paracentesis to control his ascites. He was severely debilitated and deemed inoperable. He underwent TTVR and at 3 months he is back home and independent without any evidence of liver disease.

We support the need for Coverage with Evidence Development (CED) for the treatment of symptomatic tricuspid regurgitation (TR) graded as at least severe to determine the clinically benefits in patient populations that may have been underrepresented in the randomized controlled trials. While concerns about potential overuse and misuse are valid, these risks can be mitigated through a multidisciplinary approach to patient selection and management, as delineated in the proposed decision memo. The need to show clinically relevant and co-directional 2-year outcomes will also drive a responsible adoption of this novel transcatheter option. Additionally, continued collaboration with regulatory bodies and industry partners will be essential to promote evidence-based utilization, refine best practices, and monitor patient outcomes.

Susheel Kodali, MD; Rebecca Hahn, MD; Carolina P. Rezende, MHA, MS, PA-C

Less

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

RE: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen:

Abbott welcomes the opportunity to comment on the Proposed National Coverage Determination (NCD) for TTVR, CAG-00467N. Abbott is committed to transcatheter therapies for structural valve disease including FDA-Approved solutions in transcatheter aortic valve implantation (TAVI)[1], mitral valve transcatheter edge-to-edge repair (M-TEER)[2], and tricuspid valve 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 TTVR will ensure predictable and consistent coverage for all Medicare beneficiaries.

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. We appreciate that CMS has clarified in the NCA Issue statement that CAG-00467N is limited in scope to TTVR for TR.

Specifically, Abbott requests that CMS consider:

1) Establishing coverage for all FDA-approved indications,
2) Focusing on therapy-specific policies,
3) Allowing flexibility to account for continued clinical advancement while promoting equitable patient access, and
4) Adopting only evidence-driven operator and institutional requirements to provide TTVR, when sufficient evidence is available.

These recommendations are discussed below.

Establishing Coverage for All FDA-Approved Indications

Abbott encourages CMS to establish TTVR coverage for current and 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. As the NCD policy for TTVR is proposed under coverage with evidence development (CED), there is a framework to gather additional evidence for both current and future indications.

Focusing on Therapy-Specific Policies

Abbott supports the consistent focus on therapy-specific policies. In particular, Abbott supports the Proposed NCD policy requirement that the electrophysiologist be a mandatory member of the multi-disciplinary heart team (MDHT), as the evidence demonstrates a significant impact of existing pacemaker leads and need for new pacemaker implants after TTVR[4].

Allowing Flexibility to Account for Continued Clinical Advancement while Promoting Equitable Patient Access

NCDs with CED are often in effect without change for many years. Therefore, Abbott proposes that CMS consider potential developments in the field and avoid unintended access restrictions or negatively impact clinical practice evolution due to overly specific coverage criteria.

Restrictive requirements imposed on hospitals as a condition of coverage can reduce 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. Likewise, highly specific procedure requirements may not adequately support evolving clinical practice.

Abbott appreciates and agrees with CMS’s proposal to defer specific care management coverage requirements until sufficient evidence is available to appropriately balance equitable patient access with any site / operator restrictions. In particular, Abbott supports:

Focusing coverage requirements on those specifically related to TTVR patient safety and/or procedural success.

Embracing diverse and emerging modalities for intraprocedural imaging.

Allowing for patient management and care delivery guided by the site care team (e.g., patient consults) rather than prescriptive requirements .

Adopting Only Evidence-driven Operator and Institutional Requirements

TTVR is a promising new therapy for patients with TR. Due to the limited data currently available, it is difficult to establish appropriate operator and institutional requirements at this time. TTVR is proposed to be covered under CED. Consequently, Abbott supports the inclusion of operator and/or institutional requirements once CED data demonstrate their relationship to patient safety and procedural success. Any potential operator and/or institutional requirements must also be considered in the context of equitable beneficiary access, with a particular focus on underserved populations. Additionally, we advocate for making new evidence emerging from the CED publicly accessible.

Conclusion

Abbott thanks CMS for its dedication to developing a coverage policy for TTVR that will ensure 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] Hahn et al. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. NEJM. Oct 30, 2024. ePub ahead of print. DOI: 10.1056/NEJMoa2401918

Less

I support the proposed decisions as written. The role of the comprehensive heart team is imperative to optimize patient selection and outcomes. Preprocedural and intraprocedural imaging is under-appreciated when it comes to reimbursement. The lack of financial incentive despite spending the same amount of time as the operators in a procedure such as TTVR will limit access for patients not near major academic centers. Surgeons play an important role in the heart team but should not be required to be in the procedure itself. Interventionalists with training in structural heart procedures and a qualified echocardiologist can perform TTVR without a surgeon in the room the same way that they can perform valve-in-valve TMVR and TEER.

Less

We appreciate the opportunity to comment on this proposed Coverage with Evidence Development (CED) decision for tricuspid valve replacement (TTVR) for Medicare beneficiaries. Given that TTVR has not shown clinically meaningful benefit to beneficiaries and has been associated with a high rate of adverse events, we believe that TTVR does not meet the statutory “reasonable and necessary” criterion for Medicare beneficiaries. If CED is finalized, however, we recommend that the CED study criteria is strengthened by requiring a sham procedure control, double blinding, randomization, and adequate enrollment of underrepresented groups to best ensure that high-quality evidence is generated. Furthermore, the CED study should only be considered successful, and coverage should only be continued, if the study finds a statistically significant and clinically meaningful decrease in mortality.

Lack of Clinically Meaningful Benefit and Significant Concerns Given Adverse Events
TTVR does not address the severe and irreversible conditions that cause severe tricuspid regurgitation (TR), and therefore TTVR must be shown to improve mortality in order to have a clinically meaningful benefit for Medicare beneficiaries. The TRISCEND II trial, however, found no statistically significant difference in all-cause or cardiovascular mortality between TTVR and medical therapy. Instead, the primary outcome was driven by quality-of-life measures, but, as the trial was unblinded, these outcomes are unreliable due to placebo effect. Furthermore, the TRISCEND II study population is not racially or ethnically representative of the Medicare population. In particular, the trial had significantly low enrollment of Black participants – Black participants made up only 4.6% of the TTVR group and 3.8% of the control group, whereas 10.1% of Medicare beneficiaries are Black.[1] The numbers of non-white participants were also too small to determine whether outcomes differed by race and ethnicity. Consequently, the evidence does not show that TTVR leads to improvements in meaningful clinical outcomes for Medicare beneficiaries.

This lack of clinically meaningful benefit is especially concerning as there was a statistically significant increase in severe bleeding and the development of arrhythmias/conduction disorders requiring in permanent pacing in the TTVR group: 15.4% of those in the TTVR group experienced severe bleeding, and 17.8% developed arrhythmias/conduction disorders resulting in permanent pacing, compared to 5.3% and 2.3%, respectively, in the control group.

Consequently, we believe that nonconverage of TTVR is in the best interest of Medicare beneficiaries to avoid a harmful procedure with no clinical benefits.

Suggestions to Strengthen CED Study Criteria
If CMS does finalize CED for TTVR, we suggest that the CED study criteria be strengthened so that the study can better assess whether the procedure provides a clinically meaningful benefit to Medicare beneficiaries.
First, the CED study should be required to be a randomized trial with an objective primary endpoint, all-cause mortality, and not a composite endpoint. There should be a statistically significant and clinically meaningful decrease in mortality at one year in order for the study to be considered successful. Medicare coverage should be terminated if this benefit has not been shown after study conclusion.
Second, if the (non-composite) primary endpoint is not all-cause mortality, and includes a subjective evaluation (such as the Kansas City Cardiomyopathy Questionnaire), then a sham procedure control must be included. This structure will allow double blinding, which is critical for the validity of the trial. There should be evaluations to ensure that the blinding is adequate and maintained.

Conclusion
The improvements in quality-of-life measures in the TRISCEND II trial are insufficient to show benefit to Medicare beneficiaries due to the unblinded nature of the trial, and the objective endpoints measures in TRISCEND II show no statistically significant evidence of benefit. Given this lack of clinically meaningful benefit, combined with a statistically significant increase in adverse events, TTVR is neither necessary nor reasonable for Medicare beneficiaries, and should not receive Medicare coverage. If Medicare coverage is finalized through CED, CED study criteria must be strengthened and a statistically significant and clinically meaningful decrease in mortality must be required for continued coverage.

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

[1] https://www.kff.org/medicare/state-indicator/medicare-beneficiaries-by-raceethnicity/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D

Less

January 17, 2025

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

RE: Proposed Decision Memo for Transcatheter Tricuspid Valve Replacement (TTVR) (CAG-00467N)

Dear Ms. Syrek Jensen:

On behalf of Medtronic, we appreciate the opportunity to respond to CMS’ request for public comment on the proposed decision memo of the national coverage determination (NCD) for transcatheter tricuspid valve replacement (TTVR).

Medtronic is the world’s leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to the continual research and development necessary to produce high-quality products and to support innovative therapies that improve patients’ lives.

Medtronic is the manufacturer of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system. Medtronic received Breakthrough Device Designation and approval of an early feasibility study (EFS) by the FDA for the Intrepid TTVR System in September 2020. The Medtronic TTVR EFS (IDE G200199 / NCT 04433065) began enrolling patients with severe, symptomatic tricuspid regurgitation in October 2020 and received CMS IDE coverage in July 2021. We are committed to delivering meaningful, evidence-based solutions across the care continuum to provide the best possible outcomes for heart valve patients around the world.

Tricuspid regurgitation (TR) affects more than 2 million patients in the United States and is a highly undertreated disease due to the unsuitability of many patients for surgical intervention and the high morbidity and mortality associated with surgical intervention. TTVR is an innovative procedure that provides an important treatment option for patients with severe, symptomatic tricuspid regurgitation. Given the limited treatment options for these patients, it is important to ensure that patients who are clinically suitable for this critical procedure have access to the therapy while ensuring optimal patient outcomes.

Through the TTVR NCD process, CMS has an opportunity to issue a coverage policy for TTVR that is evidence-based and ensures equitable patient access to TTVR through a transparent and publicly accountable process. As CMS develops national policy on TTVR, we offer the following points for consideration:

Coverage Criteria: Medtronic supports CMS’ proposal to cover TTVR when furnished with an FDA-approved complete TTVR system for the treatment of symptomatic TR graded as at least severe.

Patient Criteria: Medtronic supports the language in the proposed decision memo covering patients with symptomatic TR graded as at least severe, despite optimal medical therapy, with tricuspid valve replacement being considered as appropriate by a heart team.

Physician Criteria: Medtronic supports the requirement that the patient is under the care (preoperatively and postoperatively) of a multi-disciplinary heart team.

CED Study Criteria: Overall, Medtronic is aligned with the CED principles and appreciates CMS’ focus on advancing transparency, predictability and flexibility within the CED program. The TTVR NCD with CED will remain in effect for several years and in that time new TTVR devices are expected to enter the market. Medtronic recommends CMS maintain flexibility during ongoing evidence generation and TTVR technology development as the evidence needs and clinical practice may change over time. We support a TTVR NCD with CED and understand the value of a study with an active comparator, but we also note that there may be instances where an active comparator does not align with the goals of evidence generation or adequately fill stated evidence gaps. CMS should consider a range of fit-for-purpose study designs, data sources, and methodological approaches to fulfill CED requirements, including flexibility with comparator requirements.

Other Uses of TTVR: Medtronic supports the continued coverage for FDA-approved clinical trials, which permits the ongoing evolution of and patient access to new TTVR systems.

Ensuring Optimal Outcomes: Medtronic supports a TTVR coverage policy that maintains a strong balance between patient access and high-quality patient outcomes. Medtronic encourages CMS to consider physician professional society and other clinical expert recommendations on infrastructure and operator requirements when finalizing the TTVR NCD to ensure that requirements align with patient clinical needs and the TTVR landscape.

Thank you for the opportunity to comment on the TTVR proposed decision memo. We appreciate CMS’ consideration of these comments and support TTVR coverage policy that provides timely beneficiary access and the best possible outcomes for patients.

Sincerely,

Jeff Farkas
Vice President, Health Economics, Policy & Reimbursement

Less

Adequate RVUs accounting for the imaging cardiologist for TTVR (and all structural heart cases) needs to be accounted for. Currently, the RVUs for a TEE are woefully inadequate for cases that can take hours at a time and we have to block our schedules for in order to do. Even the pre/post imaging for these cases takes longer than most other TEEs and therefore, TEEs for pre-procedure, post-procedure, and all intra-procedure cases for TTVR (and other structural cases) should be increased to reflect that actual time spent on these procedures they pre/post care that goes into the decision making for these patients. Thanks.

Less

I am writing in support of Medicare coverage for Transcatheter Tricuspid Valve Replacement (TTVR). As an active member of a heart care team at a busy community hospital, our experience suggests the lack of coverage for TTVR and Tricuspid TEER has negatively impacted numerous patients in whom this therapy - despite being clinically indicated and clinically validated - has sadly and frustratingly not been available for general use in the United States. It is obviously now available yet without national coverage patients will continue to lack access to this therapy. Our team would be more than willing to contribute our clinical data to a national data bank yet due to ever-dwindling resources this cannot be an excessively onerous process. There is no doubt in my mind that access to this therapy will positively impact patient's lives.

Thank you for this consideration

Less

The Honorable Chiquita Brooks-LaSure
Office of the Administrator
Centers for Medicare and Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

Dear Administrator Brooks-LaSure,

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 valve replacement (TTVR) under coverage with evidence development (CED). Transcatheter tricuspid edge to edge repair (T-TEER) and 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 T-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. 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 all major transcatheter valve trials, including TRISCEND II. 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 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 TTVR for heart failure patients with symptomatic TR, many of whom are Medicare beneficiaries.

Evidence Supporting TTVR 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. However, patients often have residual moderate TR, and T-TEER is not feasible in those with unsuitable tricuspid anatomy or TR due to implantable cardiac device leads 5. TTVR has emerged an alternative for symptomatic severe TR in these patients. The TRISCEND II trial demonstrated a significant improvement in quality of life with TTVR. Importantly, 76% of patients achieved no or trace residual TR at one year follow-up 6. The FDA approval of the first TTVR valve 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 TTVR, and we support a CED to both gather evidence and facilitate earlier access to TTVR. Despite improved quality of life scores and a reduction in TR, neither TRILUMINATE or TRISCEND II observed differences in rates of HF hospitalizations or mortality with T-TEER or TTVR at one year follow up 7. Since patients who undergo TTVR are elderly (mean age 79 in TRISCEND II), frail and have multiple co-morbidities that increase surgical risk and impact survival, quality of life improvement is often the primary clinical endpoint, rather than mortality outcomes. However, we also recognize HF hospitalizations as an important metric, and the study design of TRISCEND II led to several limitations which may have impacted outcomes.

First, TRISCEND II used the win-ratio method to assess a composite outcome that included mortality and HF hospitalizations, but was not sufficiently powered to determine effects of TTVR on the individual components of the composite endpoint 7. The control group was also small by study design and further diminished by withdrawals and cross-over to TTVR.

Second, TRISCEND II excluded patients with severe right ventricular (RV) dysfunction who may be least likely to improve following TTVR, but did not specify the method to evaluate RV function. 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 8. RV assessment by echocardiography is challenging and varies by technique 9. Multi-modality imaging with computed tomography (CT) or magnetic resonance imaging (MRI) in conjunction with hemodynamic measurements by catheterization is necessary for more accurate RV assessment 10.

Finally, outcomes following TTVR 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 TTVR 11. The impact of TR mechanism on outcomes was not addressed by TRISCEND II.

We propose these additional data for collection during the CED.

1. Subgroup analysis by RV function

2. Subgroup analysis by mechanism of TR

3. Subgroup analysis by frailty and co-morbidity index

4. 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 12. 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 TTVR and T-TEER cases.

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

1. Cardiac CT to assess tricuspid valvular anatomy prior to TTVR

2. Since TR is dynamic and affected by hemodynamic status, we suggest invasive hemodynamic assessment of volume status, TR, and RV function

3. Ideally TTVR 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 TTVR. We believe a NCD with CED is justified based on early clinical trial experience and needed to facilitate earlier access to TTVR 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.

12 Little et al, J Am Soc Echo 2023; 36(4): 350-365

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

Dear Administrator Brooks-LaSure,

On behalf of the Association of Black Cardiologists (ABC), we are grateful for the opportunity to comment on CMS’s ongoing analysis of coverage for Transcatheter Tricuspid Valve Replacement (TTVR). This technology represents a significant advancement in the treatment of tricuspid regurgitation (TR), a condition that causes debilitating symptoms and life-threatening complications for many Medicare beneficiaries, particularly those in underserved communities.

Access for Underserved Communities

We urge CMS to establish a comprehensive Medicare coverage policy that ensures equal access to TTVR for all patients, especially those in underserved communities. For many individuals, particularly in rural or economically disadvantaged areas, TTVR is not merely an option but their only viable treatment for TR. Without access to this technology, these patients face outcomes of higher mortality, as there are no alternative interventions available.

We strongly believe that the standard of care is getting the care you need in the community you live in. Ensuring patients can receive treatment close to home reduces barriers related to travel, costs, and follow-up care, thereby improving health equity and outcomes.

Avoiding Unintended Consequences

We also urge CMS to consider how overly restrictive coverage requirements may unintentionally exacerbate gaps in care. If policies impose excessive procedural volume requirements, demand multi-provider evaluations, or limit the availability of TTVR to select centers, they may inadvertently exclude patients who are most in need of the procedure. While these may be seen as unintended consequences of the process, it is imperative to recognize and address systemic barriers that these policies may create as they may result in preventable suffering and inequitable care.

Policy Recommendations for Equity and Access 1. Streamlined Evaluation Requirements: Allow evaluations to be conducted by a single Heart Team member, either in person or via telehealth, to reduce provider burden, especially for those in rural or underserved areas.

2. Remove Arbitrary Volume Thresholds: Evidence shows that outcomes for TTVR procedures remain excellent in both high- and low-volume centers. Volume requirements should not impede the opening of new sites or the continued operation of centers serving disadvantaged populations. Retaining these onerous requirements restricts access to care, risks more TTVR and TAVR Centers shutting their doors, prevents the opening of new ones, and drives differences in treatment outcomes, as “patient proximity to hospitals impacts facility choice even when reported health outcomes differ significantly.”

3. Ensure Coverage Without Delay: Swift adoption of an inclusive Medicare coverage determination for TTVR is essential. Lessons learned from prior policies for TAVR and other transcatheter interventions demonstrate that flexibility and patient-centered approaches promote equitable access while maintaining high standards of care.

Addressing Gaps in Health Care Services

Historical inequities in the diagnosis and treatment of valvular heart disease persist, particularly among racial and ethnic minorities. TTVR coverage must explicitly address these gaps by prioritizing resources for minority-serving hospitals, offering payment incentives for underserved patient populations, and increasing awareness about TR and treatment options within these communities.

Conclusion

CMS has a unique opportunity to ensure that all Medicare beneficiaries suffering from TR have timely access to the life-saving TTVR technology. By adopting policies that prioritize access, minimize barriers, and reflect the needs of underserved communities, CMS can affirm its commitment to patient-centered care.

Thank you for considering these recommendations. We look forward to working with CMS to advance policies that improve outcomes for all patients.

Less

January 17, 2025

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

RE: CAG-00467N, Proposed Decision Memo for Transcatheter Tricuspid Valve Replacement

The American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Heart Rhythm Society (HRS), Society for Cardiovascular Angiography and Interventions (SCAI) and 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 transcatheter tricuspid valve replacement (TTVR) and surgical tricuspid valve (TV) replacement procedures. The societies are supportive of a National Coverage Determination (NCD) for TTVR for patients with symptomatic tricuspid regurgitation graded as at least severe, under coverage with evidence development (CED). We appreciate the opportunity to comment on the proposed decision memo.

The societies are broadly supportive of the proposed decision memo for TTVR Medicare coverage with 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 the operator and institutional criteria previously recommended, as there is strong evidence supporting this approach based on successful experiences with transcatheter aortic valve replacement (TAVR) and mitral procedures. 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 TTVR is guided by robust evidence and best practices, ultimately benefiting patients by providing timely access to care while achieving optimal outcomes.

Operator and Facility Requirements

We support the general direction of the conditions of coverage outlined in the proposed decision memo. Care of TTVR patients should be guided by a multidisciplinary heart team (MDHT) with experience in the care and treatment of tricuspid regurgitation. However, the societies stand by our previous recommendations for operator and institutional volume requirements in order to optimize outcomes at new transcatheter TV interventional programs.

TTVR should be performed in hospitals equipped with the necessary infrastructure. The hospital must have an active cardiac surgery program with at least two cardiac surgeons experienced in treating valvular heart disease (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 TTVR must have access to a cardiac catheterization lab and an interventional/implantation suite. Operators need access to advanced imaging, including cine fluoroscopy and 2D/3D TEE during TTVR, and access to 2D/3D intracardiac echocardiography (ICE) is highly recommended. Rapid access to a cardiac electrophysiologist skilled in leadless pacemaker placement, and coronary sinus lead placement is also necessary. Availability of a cardiac electrophysiologist with guideline-recommended experience and skills for lead extraction is also required. In addition to the interventional echocardiographer, TTVR care facilities must have an echocardiographer trained in the quantitation of TR severity, identification of TR etiology and understanding of risk assessment using 2D/3D transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE). Furthermore, institutions participating in TTVR must have access to advanced cardiopulmonary support such as extracorporeal membrane oxygenation and/or ventricular support devices.

These complex procedures should only be performed at institutions that regularly conduct surgical TV operations and participate in the STS Adult Cardiac Surgical Database, where procedural outcomes can be monitored on a real-time dashboard offering comparisons to like facilities across the nation, thus ensuring targeted insights into the care provided are available to the clinical team. Similarly, only institutions with established interventional cardiology programs in PCI, balloon valvuloplasty, TAVR, mitral transcatheter edge-to-edge repair (M-TEER), catheter closure of periprosthetic leaks, and septal closure device deployment should offer transcatheter TV interventions.

The interventional echocardiographer, interventional cardiologist and surgeon will need to have appropriate training and experience in structural heart interventions in order to establish a TTVR program. Following the establishment of a program, all members of the multidisciplinary team will need to maintain minimal volume requirements for continued participation and will be monitored on an ongoing basis to ensure acceptable outcomes as defined by the Societies’ criteria.

Operator training is a crucial component for treating structural/valvular heart disease using a transcatheter approach. Construction of a training curriculum encompassing pre-procedural, clinical, imaging, procedural and post-procedural elements is essential. Criteria for fellowship and postgraduate training will be established by the participating Societies in an expert consensus statement currently under development.

The societies do maintain that due to the complexity of the TTVR procedure, that three physician operators should actively participate in the procedure until the institution can demonstrate consistent procedural safety as outlined below:

Current and future technologies for TTVR should require collaborative participation by the cardiologist, surgeon, and interventional echocardiographer. 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.

As mentioned in the decision memo, strong evidence for volume requirements in TTVR procedures is currently lacking and, to date, the societies have not published peer-reviewed guidance on facility and operator requirements for transcatheter TV interventions. However, 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). In addition, the 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). 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. 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).

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 TTVR procedures. 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 TTVR procedures are performed safely and effectively, providing the best possible care for patients with severe tricuspid regurgitation.

While the societies have suggested the following facility volume requirements to ensure quality standards and outcomes, we appreciate the inclusion of determining appropriate volume requirements based on findings in the Coverage with Evidence Development (CED) study. This approach allows for a data-driven determination of the optimal volume thresholds, ensuring that the standards set are both evidence-based and conducive to achieving the best possible patient outcomes.

Qualification to Initiate a TTVR Program
Open Heart Surgeries:	≥50 in the previous year prior to TTVR program initiation
Tricuspid Valve Surgeries:	≥20 in the 2 years prior to TTVR 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:	≥100 TAVR and ≥20 TEER per year or ≥200 TAVR and ≥40 TEER over the previous 2 years (STS/ACC TVT Registry Analysis)
Complete Transesophageal Echocardiograms (TEE):	≥200 per year or ≥400 over the previous 2 years (Wiegers et al., 2019; Little et al., 2023)

Qualifications to maintain a TTVR Program
Tricuspid Valve Interventions:	≥20 (transcatheter or surgical) of which ≥10 are transcatheter and ≥5 are TTVR in 1 year, or ≥40 (transcatheter or surgical) of which ≥20 are transcatheter and ≥10 are TTVR 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 (Bass et al., 2023), of which =25 are TEER procedures
	- Board eligibile, 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 ≥25 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 TTVR.

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, though the new CED structure does raise some questions.

1. How can we ensure that the correct patients are accurately identified for inclusion in the study with the resources available?
2. How can ensure that patients receiving TTVR truly have severe TR despite optimal medical therapy given the dynamic nature of the degree of regurgitation and the difficulty of achieving optimal imaging quality outside of experienced institutions?
3. How can we accurately compare the outcomes of patients with severe, massive, and torrential TR given the nuances of quantification?
4. Without proper training, is there a risk of treating moderate TR instead of severe TR, as specified in the proposed NCD? Verifying and documenting severe tricuspid regurgitation presents challenges in clinical practice. We are concerned that for facilities without adequate resources, and highly trained imagers, it may be challenging to ensure severe TR patients are identified to meet the study's requirements and generate meaningful data. Including only patients with symptomatic TR graded as at least severe ensures the integrity and validity of the study outcomes. It allows for a clear assessment of the TTVR's effectiveness and safety in the intended patient population.
5. The proposed NCD lists several areas of interest, including patient populations not included in the trial, such as those with pulmonary hypertension and left ventricle dysfunction. How can we ensure that study sponsors adequately capture this information accurately and comprehensively?
6. We also respectfully question the feasibility of including active comparators in the study design. The use of an active comparators is crucial for providing a more accurate assessment of the intervention's effectiveness by comparing untreated patients with the same condition. Without this context, it is not possible to determine effectiveness of the study treatment. How can we ensure that the cohort is matched appropriately to have a real comparator, given the heterogeneity of the severe TR population especially quantifying the severity of TR from claims data sources? Obtaining a precise comparator to evaluate study outcomes using real-world evidence is particularly challenging. We encourage CMS and the sponsor to be as stringent as possible in determining what constitutes an accurate active comparator.

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.

By addressing these queries, CMS and the study sponsors can ensure that the CED study produces robust and reliable evidence to inform future clinical practice and policy decisions. 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 societies thank CMS for the opportunity to provide comment on the proposed decision memo for the TTVR 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

Cathleen Biga, MSN, FACC
President, American College of Cardiology

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

Kenneth A. Ellenbogen, MD, FHRS
President, Heart Rhythm Society

James B. Hermiller, MD, MSCAI
President, Society for Cardiovascular Angiography and Interventions

Jennifer C. Romano, MD, MS
President, The Society of Thoracic Surgeons

References
1. 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.
2. 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.
3. 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. doi: 10.1056/NEJMsa1901109. Epub 2019 Apr 3. PMID: 30946551.
4. 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.
5. 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.
6. 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.
7. 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.
8. Wild MG, Stolz L, Rosch S, Rudolph F, Goebel B, Köll B, von Stein P, Rottbauer W, Rassaf T, Beucher H, Kraus M, Kassar M, Geisler T, Rück A, Ferreira-Martins J, Toggweiler S, Sagmeister P, Westermann D, Stocker TJ, Weckbach LT, Näbauer M, Settergren M, Dawkins S, Kister T, Praz F, Vorpahl M, Konstandin MH, Lüdike P, Keßler M, Iliadis C, Kalbacher D, Lauten P, Gerçek M, Besler C, Lurz P, Hausleiter J; PASTE Investigators. 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.
9. Awtry J, Newell P, Vinholo TF, Harloff M, Kerolos M, Manful A, Dey T, Kaneko T, Sabe A. 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.
10. 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.
11. 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.
12. 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).

Less

January 17, 2025
Administrator Chiquita Brooks-LaSure
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Brooks-LaSure,

As members of the Heart Valve Disease Policy Task Force, a national group of 30 leaders including clinician and patient advocates, we appreciate the opportunity to comment on the proposed decision memo for national coverage for Transcatheter Tricuspid Valve Replacement (TTVR). In particular, we wish to emphasize the critical importance of establishing a comprehensive Medicare coverage policy that includes all FDA-approved minimally invasive transcatheter devices to improve quality of life and functional status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy. Such a policy is not only pivotal in addressing the unmet needs of Medicare beneficiaries suffering from tricuspid regurgitation but also in facilitating timely access to innovative and life-saving technologies.

We applaud CMS’s decision to move forward using Coverage with Evidence Development (CED), which facilitates patient access and in practice means patients should not have to wait for extended periods to benefit from medical advancements, particularly for conditions like tricuspid regurgitation, with limited treatment options. Existing and infrequently utilized treatments, such as surgery, carry high risks for older or medically complex patients. The proposed CED policy allows emerging minimally invasive technologies, such as TTVR, to be made available while additional data is collected, addressing unmet needs and gaps in care for vulnerable populations. This greatly improves patients’ quality of life, by alleviating symptoms and increasing mobility and activity, allowing them to have much quicker recovery compared to open-heart surgery.

We also appreciate CMS recognizing that a critical component in the shared decision-making process of heart valve disease treatment is the clinician’s role in evaluating and guiding patient care. The HVD Policy Task Force supports CMS’s streamlined evaluation process that leverages the expertise of Heart Team members to ensure comprehensive and patient-centered assessments. This approach not only enhances care coordination but also promotes equitable access to TTVR across diverse geographic settings.

While it is important for patients to have the proper Heart Team, such teams should not be unduly burdened by size restrictions. This is especially crucial for those patients living in rural or economically disadvantaged areas in order to prevent access disparities to advanced treatments.

Furthermore, the Task Force greatly values CMS’s emphasis on shared decision-making. Empowering patients to work closely with Heart Teams experienced in the management of tricuspid regurgitation fosters informed and patient-centered care. This approach respects individual preferences and ensures that treatment decisions align with patients’ goals and priorities acknowledging that there is not a “one-size-fits-all" approach to care and treatment. By emphasizing trust in shared decision making, we can ensure equitable access, enabling all patients, regardless of socioeconomic status or geographic location, to receive the care they need.

However, the Task Force expresses concern that as proposed, the NCD does not establish coverage to all FDA labels and is instead tied an existing TTVR technology. By establishing coverage based on a singular FDA label, the NCD could inadvertently limit future access to FDA approved indications for patients who could benefit from these therapies. The HVD Policy Task Force recommends revising the NCD to incorporate broader indications, including coverage to all labels, to allow for the expansion of indications for TTVR and enable more patients to receive coverage.

We also ask that CMS ensure that Medicare Advantage remain compliant with this NCD. Compliance with the NCD by Medicare Advantage plans assures that all Medicare beneficiaries, regardless of whether they are enrolled in Medicare or a Medicare Advantage plan, have equitable access to the same innovative and life-saving treatments. Without such enforcement, there is a risk of variability in coverage, which could lead to disparities in patient care. Non-compliance by Medicare Advantage plans could result in denials, delays, or additional administrative hurdles for beneficiaries seeking treatments covered under the NCD. By mandating compliance, CMS can safeguard patients from unnecessary obstacles that could impact their timely access to care and overall health outcomes, helping protect more vulnerable populations.

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 transcatheter valve devices. 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
HealthyWomen
Heart Valve Voice
Hypertrophic Cardiomyopathy Association (HCMA)
Men's Health Network
National Hispanic Health Foundation
Partnership to Advance Cardiovascular Health
Preventive Cardiovascular Nurses Association
RetireSafe
WomenHeart: The National Coalition for Women with Heart Disease

Less

January 17, 2025

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

Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

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 Tricuspid Valve Replacement (TTVR) 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 proposed decision to issue coverage for TTVR. This decision will help enable access to an innovative therapy that meets a large unmet need for patients with severe tricuspid regurgitation and drive the ability to include diverse subgroups during the initial commercial rollout of this medical technology. 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 TTVR CED study that once approved, the study 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 thoughtful 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. Adoption of this approach is relevant not only for this NCD but should be adopted broadly under the TCET program and other NCDs with CEDs. We are also supportive of the appropriate flexibilities inherent within the Heart Team requirements which account for the fact that Heart Teams have matured and have deep experience in the pre- and post-procedure management of patients.

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.

Less

Tricuspid regurgitation (TR) is a significant and often under-recognized condition, affecting approximately 1.6 million individuals in the United States, with moderate or severe cases. Despite its prevalence, only about 8,000 patients undergo surgical intervention annually, typically in conjunction with left heart surgeries. This stark disparity underscores the urgent need for effective, accessible, and less invasive therapies for this vulnerable patient population.

Functional TR, the most common form of the disease, is often secondary to cardiomyopathies, left ventricular valve disease, or pulmonary conditions. Severe TR is associated with a dismal five-year survival rate of just 34% in patients with concomitant heart failure with reduced ejection fraction (HFrEF). While medical therapies such as diuretics and ACE inhibitors provide symptomatic relief, they fail to address the underlying mechanical pathology of the valve, leaving patients at risk for progressive right ventricular (RV) dysfunction, repeated hospitalizations, and diminished quality of life.

The advent of transcatheter tricuspid valve repair and replacement (TTVR) is a critical advancement in the management of TR. TTVR provides a minimally invasive alternative to surgery, with early evidence demonstrating significant improvements in symptom relief, functional status, and overall hemodynamics. For high-risk patients who are ineligible for surgery, TTVR represents not just a new option, but often the only viable pathway to improved survival and quality of life.

Access to TTVR is essential to closing the care gap for TR patients, many of whom suffer silently due to a lack of effective treatment options. By supporting TTVR, CMS has the opportunity to enable transformative care for a largely underserved population, reducing hospitalizations, improving clinical outcomes, and restoring quality of life to patients who have long been left without hope. Moreover, expanding coverage for TTVR will foster innovation and continued research into the management of TR, ensuring that all patients, regardless of surgical risk, have access to life-changing care.

The inclusion of TTVR as a covered therapy aligns with CMS’s goals of improving patient outcomes, reducing healthcare costs, and advancing equitable access to innovative treatments. We strongly urge CMS to prioritize coverage for TTVR to address the unmet need for safe and effective therapies for patients with severe TR. By doing so, CMS will play a pivotal role in improving the lives of millions of Americans affected by this debilitating condition.

Less

Dear Ms. Syrek Jensen,

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients worldwide. We develop and supply medical devices in numerous clinical areas, including cardiology, which serve the needs of many patients, including Medicare beneficiaries. We appreciate the opportunity to provide comments regarding the Centers for Medicare & Medicaid Services’ (CMS) National Coverage Analysis (NCA) for Transcatheter Tricuspid Valve Replacement (TTVR) (CAG-00467N).

Tricuspid regurgitation (TR) is a serious condition often linked with congestive right heart failure, leading to debilitating symptoms. Approximately 2.5 million people in the U.S. have at least moderate TR, with prevalence increasing with age.[1] Although previously considered benign, new evidence shows TR is associated with higher mortality and poor long-term survival.[2] Symptoms of TR include fatigue, heart rhythm abnormalities, shortness of breath, and edema, which can significantly affect quality of life.[1] Compelling findings from the TRISCEND II pivotal trial highlight the importance of treating tricuspid regurgitation (TR) in a timely manner. From a patient perspective, relieving symptoms may be just as critical as addressing death or stroke endpoints in terms of maintaining or improving quality of life. The results from the trial have shown compared to optimal medical therapy (OMT) alone, treating patients with symptomatic and severe or greater TR using transcatheter tricuspid valve replacement (TTVR) combined with OMT led to substantial improvements in patients' symptoms, function, and overall quality of life. These benefits were noticeable 30 days after TTVR procedure, continued to increase through six months and remained durable throughout one year. This pivotal trial underscores the importance of timely intervention in improving the lives of patients suffering from TR. [4] Surgery is often reserved for severe cases and combined with other left-sided procedures due to significant operative risks, leaving many patients untreated. Untreated TR can weaken the right ventricle and cause right-sided heart failure. [1] Currently there are few treatment options available for patients with severe TR resulting in symptoms that persist despite medical therapy.

The introduction of TTVR offers a promising percutaneous treatment option for severe TR, which addresses a significant unmet clinical need. Boston Scientific supports the use of TTVR in improving patient outcomes and quality of life.

Boston Scientific’s comments are based on the expertise of our clinical leadership and experience serving patients around the world. To inform our recommendations, we thoroughly reviewed CMS’ Transcatheter Tricuspid Valve Replacement (TTVR) Proposed Decision Memo, the recommendations submitted to CMS by the coalition of specialty societies on July 19, 2024 (American Association for Thoracic Surgery (AATS), Association of Black Cardiologists (ABC), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Heart Rhythm Society (HRS), Society for Cardiovascular Angiography and Interventions (SCAI) and Society of Thoracic Surgeons (STS)), and the public comments of other stakeholders.

Our key recommendations are as follows, with further detail provided below:

• Expand Coverage Beyond CMS-Approved Trials
• Provide Flexibility within Heart Team Approach
• Support for TTVR Facility Requirements
• Support for TTVR Operator Requirements

Expand Coverage Beyond CMS-Approved Trials
We strongly encourage CMS to allow coverage for TTVR under an NCD with evidence development through mandatory participation in a CMS-approved registry. Limiting coverage to CMS-approved clinical trials is unnecessarily restrictive given the compelling clinical evidence for TTVR. The cumulative mortality of untreated severe TR of any etiologies is ~30%, ~50%, and ~70% at 1-, 2-, and 4-year follow-up, respectively, and the prevalence increases with age (up to 4% beyond the age of 75 years).[3] Recent data, including the TRISCEND II pivotal trial, demonstrate efficacy of transcatheter tricuspid valve replacement (TTVR) and significant improvement in patient quality of life, as published in the New England Journal of Medicine and the Journal of the American College of Cardiology.[4,5] To reach a large existing burden of patients suffering from TR, TTVR should be allowed to be done outside a clinical trial setting. The population of patients affected by this condition continues to grow, and it is crucial that more accessible treatment options are available to physicians. Allowing TTVR to only be performed within a clinical trial setting limits the availability and accessibility of this potentially life-changing procedure to a broader patient population. To better serve patients and address the increasing demand, we propose TTVR be performed outside of clinical trials. Additionally, we are also concerned the added complexity and costs associated with administration and site participation in a CMS-approved clinical trial could result in slower therapy adoption that limits patient access.

Provide Flexibility Within Heart Team Approach
The composition and role of the Multidisciplinary Heart Team (MDHT) is critical in ensuring patient safety and optimal outcomes for valve procedures. As described in the CMS proposed NCD, the MDHT should include an interventional cardiologist, echocardiographer, and cardiac surgeon. Each member plays a vital role in procedural planning and therapeutic strategy selection, and each must have experience in the care and treatment of tricuspid regurgitation.

We urge CMS to allow TTVR Programs flexibility in crafting their intra-procedural team, allowing for various co-operator scenarios, as well as an assistant-at-surgery option. While all operators should be a part of the MDHT, there may be variability in what is required intra-operatively. BSC recommends the following:

• An Interventional Cardiologist from the MDHT should be the primary or first operator performing the TTVR.
• A second physician, Interventional Cardiologist or Surgeon, from the MDHT may jointly participate in the intra-operative technical aspects of TTVR, as appropriate.
• An Echocardiographer must be a part of the MDHT and provide intra-operative imaging guidance.
• All physicians involved in the intraoperative portion of the TTVR must be certified or equivalent in their specialty.

While we support CMS’s proposed MDHT composition, we recommend further clarifications or edits to specific requirements as described below:

• Heart Failure Cardiologist: We recommend removing the added requirement of subspecialty certification for the participating Cardiologist. Expertise in managing heart failure patients is sufficient and removing additional requirements is essential to support patient access, considering the extremely limited number of certified Advanced Heart Failure and Transplant specialists.
• Multi-modality Imaging Specialists: Because cardiology imaging subspecialists typically specialize in a single imaging modality, we recommend clarifying the imaging team must have expertise in multiple imaging modalities, but not that every individual specialist have expertise in multiple imaging modalities.
• Echocardiographer: We do not support the imager should be considered a co-surgeon for claims processing. While the role of the echocardiographer is critical to the TTVR procedure, the echocardiographer provides visualization guidance and not operative assistance. This suggestion also conflicts with existing regulations, as a unique CPT(R) code exists to describe the unique work of the echographer for these procedures.

Support for TTVR Facility Requirements
Boston Scientific (BSC) agrees with the Professional Societies and many stakeholders that hospitals must demonstrate sufficient resources to perform a minimum number of mitral or tricuspid valve replacements. We recommend some adjustments to the Professional Society recommendations for procedural volume requirements as noted below, to ensure safety while preventing the exclusion of capable centers to facilitate broader patient access.

Professional Society Recommendations and BSC Comments
a. =50 open heart surgeries in the previous year prior to the TTVR program initiation BSC supports
b. =20 tricuspid valve surgeries in the 2 years prior to TTVR program initiation BSC proposes: = 10 open tricuspid valve replacement surgeries in the 2 years prior to TTVR program initiation. We recommend that facilities have specific experience with tricuspid valve replacement surgery (vs. unspecified tricuspid surgeries) and we have lowered the number with consideration for the limited volumes for these procedures
c. =2 physicians with cardiac surgery privileges BSC supports
d. =1 physician with interventional cardiology privileges BSC supports
e. =1 board certified/board-eligible cardiac electrophysiologist available for pacemaker implantation or lead extraction when required BSC supports
f. =100 TAVR and =20 Transcatheter Edge to Edge Repair (TEER) procedures per year or =200 TAVR and =40 TEER over the previous 2 years BSC supports
g. =200 complete TEE performed per year or =400 complete TEE performed over the previous 2 years BSC supports

Support for TTVR Operator Requirements
Boston Scientific (BSC) agrees with the Professional Societies it is essential to establish procedure volume and operator competency requirements for members of the MDHT responsible for patient care.

Professional Society Recommendations and BSC Comments
To optimize outcomes at a new TTVR intervention program, the primary catheter operator (interventional cardiologist or surgeon) should document:

• =50 career structural valve procedures (Bass et al., 2023), of which =25 are TEER procedures BSC supports
• Board eligibility or certification in either interventional cardiology or cardiothoracic surgery BSC supports
• Certification of device-specific training BSC supports To optimize outcomes at a new TTVR intervention program, the interventional echocardiographer should document:
• =50 career structural valve disease procedures of which =25 are TEER procedures BSC supports
• Level 3 or equivalent board eligibility or certification in echocardiography BSC supports
• Certification of device-specific training BSC supports

In summary, BSC recommends the following:

Expand Coverage Beyond CMS-Approved Trials
Boston Scientific’s review of the existing clinical data concludes there is sufficient evidence to support patient access to TTVR outside the context of a CMS-approved clinical trial. We recommend evidence development through a CMS-approved registry, such as the existing STS/ACC TVT Registry.

Provide Flexibility within Heart Team Approach
Boston Scientific supports a multidisciplinary heart team (MDHT) approach, recognizing each MDHT member plays an important role in procedural planning, therapeutic strategy, and care delivery. While specific experience requirements are advised for members of the intra-operative heart team, we believe team composition decisions and intra-operative member roles are best made by the site. Therefore, we urge CMS to grant sites flexibility in the composition of their intraoperative MDHT to allow for both ‘co-surgeon’ and ‘assistant-at-surgery’ scenarios. Additionally, we recommend CMS modify or clarify requirements for the Heart Failure Specialist, Multi-Modality Imaging Specialists, and Echocardiographers as described above.

Support for TTVR Facility Requirements
Boston Scientific is largely aligned with the Professional Society recommendations regarding Facility Requirements, with one exception. We recommend the facility have a track record specific to tricuspid valve replacement surgery (distinct from tricuspid TEER).

Support for TTVR Operator Requirements
Boston Scientific is aligned with the Professional Society recommendations regarding Operator Requirements, with no suggested changes or edits to what they have proposed.

*********************************************************************************************

Thank you for considering our comments. We look forward to working with CMS to expand access to safe, innovative TTVR therapies for Medicare beneficiaries. Please contact me at liesl.hargens@bsci.com if you have any questions.

Sincerely,

Liesl Hargens
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. Enriquez-Sarano M, Messika-Zeitoun D, Topilsky Y, et al. Tricuspid regurgitation is a public health crisis. Prog Cardiovasc Dis. 2019;62(6):447-451. doi:10.1016/j.pcad.2019.10.009.
3. Hausleiter J, Stolz L, Lurz P, et al. Transcatheter Tricuspid Valve Replacement. J Am Coll Cardiol. 2024: S0735-1097(24)09961-3. doi:10.1016/j.jacc.2024.10.071.
4. Arnold SV, Hahn RT, Thourani VH, et al. Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results from TRISCEND II Pivotal Trial. J Am Coll Cardiol. 2024: S0735-1097(24)09954-6. doi:10.1016/j.jacc.2024.10.067.
5. Hahn RT, Makkar R, Thourani VH, et al. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. 2025:392(2):115-26. doi:10.1056/NEJMoa2401918.

Less

I have reviewed the Proposed Decision Memo regarding Transcatheter Tricuspid Valve Replacement and am writing to express my support. This therapy has the potential to improve the quality of life of many patients. As with other transcatheter valve therapies, I think the heart team approach is valuable and that patients benefit from an evaluation that includes physicians of different specialties. I think the specific operator requirement should be at the discretion of each institution. At a minimum this would include an interventional cardiologist and an imager. Hospitals that currently offer transcatheter mitral valve therapies should be able to offer TTVR.

Less

I am writing in support of the Evoque tricuspid valve replacement therapy
Currently, the only available approved therapy for those patients with severe symptomatic tricuspid insufficiency is T – TEER. And although patients improve following successful implementation of a tri clip, there are still way too many patients that do not qualify because of anatomical issues. I feel an adjunct therapy like the evoke tricuspid replacement is necessary in this arena. I do agree that these procedures need to be performed in centers that currently provide mitral valve therapy such as M-TEER and T-TEER. Weather a surgeon needs to be intimately involved in the procedure remains debatable, however, their contribution in part of the heart team, remains essential.

Less

To whom it may concern

I am an interventional cardiologist and a physician who uses this technology. I am an interventional cardiologist and a physician who uses this technology. Our experience has been excellent.

Technology like evoke is necessary for patients.

But we must also remember that in order to have this technology we have to appropriately assign reimbursement to the effort. This not only includes an adequate RVU criteria for the implant but we must also have the same for the imaging physician.

These cases are time intensive and complicated. They demand a high physician reimbursement to allow this technology to continue.

Less

To Whom It May Concern,

I am writing in support of the proposed coverage criteria for Percutaneous Tricuspid Valve Replacement. I think the technology will address an unmet need, perhaps more so than in the case of mitral therapies (in view of the low volumes of tricuspid surgeries currently being performed in the United States). I believe the technology should be available to centers currently performing Mitral TEER. While the multidisciplinary team as outlined is essential for decision making and pre and post op care, I believe the operator selection is best left to individual center discretion.

Less

Out of the first 4 patients that we treated, they have all reported marked improvement at 1 month post procedure. They all are on lower diuretic doses. They have more energy less edema. One patient told us after TAVR he felt a little better but after TTVR he felt like a new man. All patients did much better on their 6 minute walks. One patient had to stop 12x pre-procedure and post procedure made the entire 6 mins without stopping. Another patient couldn't go 5 ft pre-procedure and post procedure went a full 2 mins before she had to stop the first time. We are all still learning how much this will have an impact on our patients. Maybe we been downplaying the burden these symptoms have had on our patients because with didn't have a treatment. The hope is that we see continued quality of life improvement as we have seen with my patients at my institution.

Less

I am writing in support of the NCD for TTVR. At our institution we are continuing to see an increase need to treat high risk patients with tricuspid valve disease as we have seen the progression of the disease lead to worsened heart failure over time. Specifically at our institution we have identified approximately 100 patients through our AI echo surveillance program that would benefit from TTVR. Access to TTVR should not be limited to geography or hospital affiliation. In addition, there are two considerations I would like to mention with regards to the NCD. I am advocating for the continued involvement of Cardiothoracic surgeons on the heart valve team in the decision making process to treat patients with TTVR. I believe a lot of the success of TAVR was due to the involvement of both the surgeon and interventional cardiologist discussing the patient collectively on a team. Second consideration is for expansion of reimbursement of TEE cardiologist/sonographer for TTVR. The skill set and time requirement to perform a TEE for TTVR is extensive compared to a standard TEE and is absolutely critical to a successful deployment. I would like to thank the CMS for developing this policy around TTVR in support of advancing patient care.

Less

On behalf of The Mended Hearts, Inc., a patient advocacy group dedicated to promoting heart health and preventing cardiovascular diseases, I am writing to express our strong support for the Centers for Medicare & Medicaid Services (CMS) decision to cover transcatheter tricuspid valve replacement (TTVR) under Coverage with Evidence Development (CED) for the treatment of symptomatic tricuspid regurgitation (TR) graded as at least severe.

This decision is a significant milestone for heart health and patient care for several reasons:

1. Addressing an Unmet Medical Need: Severe tricuspid regurgitation is a debilitating condition that can lead to heart failure and significantly impair the quality of life. Many patients with severe TR are not suitable candidates for traditional surgical interventions due to high surgical risks. The availability of TTVR offers a less invasive alternative, providing hope and a potential lifeline for these patients.

2. Improving Patient Outcomes: By covering TTVR under CED, CMS is ensuring that patients have access to this innovative treatment while simultaneously gathering crucial data on its effectiveness and safety. This approach not only facilitates immediate patient care but also contributes to the broader medical understanding and future advancements in treating TR.

3. Enhancing Quality of Life: Patients suffering from severe TR often experience symptoms such as fatigue, swelling, and shortness of breath, which can severely limit their daily activities and overall well-being. Access to TTVR can alleviate these symptoms, allowing patients to lead more active and fulfilling lives. With an estimated 8,000 TTVRs performed annually, CMS’s decision will help improve the life of thousands of TR patients.

4. Supporting Evidence-Based Medicine: The CED framework promotes the collection of real-world evidence, which is essential for validating the long-term benefits and risks of new medical technologies. This evidence-based approach ensures that patient care decisions are grounded in robust clinical data, ultimately leading to better health outcomes.

The Mended Hearts, Inc. commends CMS for its commitment to advancing patient care through innovative treatments and evidence-based decision-making. We believe that the coverage of TTVR under CED will have a profound positive impact on the lives of many heart disease patients and their families.

Thank you for your leadership and dedication to improving heart health. We look forward to continuing to support CMS in its efforts to enhance patient care and outcomes.

Less

Dear CMS,

I am writing to oppose medicare payment for a percutaneious tricuspid valve (Evoque). This is not because it does not work but instead because it may not have efficacy is will certainly be overused within the United States healthcare system.
Tricuspid regurgitation is an extremely prevalent finding and is often asympotmatic and importantly often leads to no significant clinical issues. In fact, non-sham studies show that using the Evoque valve only affects a patient's subjective feeling of well being. This is most likely secondary to placebo effects, as there were no sham arms. No objective benefits were seen.
If this valve is approved we can presume that it will be vastly overused, thus resulting in major expenses ($47,000 per valve) and minimal patient benefit, plus by definition some harm.
I would strongly recommend not approving this valve until adequate studies have shown measurable (not subjective) benefits.

I have been practicing cardiology for over 30 years and have never referred a patient for a stand alone tricuspid valve repair/replacement
Sincerly,

Scott Valent MD
Interventional Cardiology

Less

The pivotal trial mostly was positive for subjective endpoints. Note that mortality was increased in the device arm, as was cardiovascular mortality. Thus, there is a decent chance that this device makes people feel better right until it kills them. Part of the problem is likely that the TR is secondary, and the valve replacement doesn't affect the underlying process.
There is a long history of people living entirely without tricuspid valves. Thus, the burden of proof is on the valve makers to prove that their device is superior to no valve at all. The available evidence doesn't do that.

Less

The CMS requirement that primary outcomes for death and heart failure hospitalization be reported at 2-years would seem reasonable as results from TRISCEND may have been positive had the trial been powered for this. However, this requirement moving forward would to me seem to impose a disproportionate financial burden of additional technologies, when a meaningful KCCQ improvement at 1-year has been enough for 2 of the original therapies (Triclip and Evoque) to be FDA approved. I think it's important to report the 2-year outcomes, but not vital to the field.

Less