Transcatheter Aortic Valve Replacement (TAVR)

Thank you for the opportunity to place public comment in regard to the proposed NCD changes for TAVR.

I have been fortunate enough in my years as a cath lab nurse, nurse practitioner, and structural heart coordinator to see the TAVR process through many lenses. I have had the opportunity to care for patients through the entirety of their TAVR workups, procedures, and follow up. Practicing in Kansas and New Mexico, I have also had the opportunity to care for patients not only in urban settings, but also in rural areas. These are the patients I expect are mostly likely to have anticipated benefit from the proposed NCD changes.

However, I do not believe these perceived benefits to be accurate.

I applaud the committee for trying to ease the burden these workups can have on patients, and as a provider in a system where approximately 25% of our patients are below the poverty level, it is a worthy challenge. But I would argue we can ease the burden without removing several of the safeguards that have made TAVR so successful in the last 2 decades, and I would urge the committee to reconsider the following:

1-The heart team composition
TAVR was built on the concept of patient shared decision making through meaningful discussion of risks, benefits, and alternatives to therapies. Removing the face-to-face requirement for the multidisciplinary teams makes this impossible. As both my IC and CS physicians would acknowledge, there's nothing more powerful than "the eyeball test". Seeing a "low risk" surgical patient based on STS who can barely walk, has limited social and financial resources, etc is more powerful than a STS calculation. In fact, while the TVT registry no longer requires the 5 meter walk pre-TAVR, our practice continues to have our patients complete this, and intentionally does so right in front of our multidisciplinary office space. On the other side of that coin, the concepts of lifetime management have become increasingly important as we have introduced lower and lower risk populations to TAVR therapy, and there are several subpopulations that are sincerely better served with a SAVR. An interventional cardiologist is not a cardiothoracic surgeon, and a cardiothoracic surgeon is not an interventional cardiologist. In order to have a true shared decision conversation with a patient about these therapies, you need both. COVID tested the systems of structural heart programs. Many became more resilient, and more creative. It is certainly possible to consolidate testing and evaluation for the patients without removing the face-to-face assessment requirement, and I would urge the committee to consider retaining this requirement.
Additionally, I would encourage CMS to consider adding a structural heart coordinator/valve clinic coordinator to the list of essential personnel in the Heart Team. Not only do coordinators deal with the patients the most, but improve efficiency in collaboration, workup, and outcome tracking. While individual physicians may have a strong grasp on their personal procedural outcomes, coordinators deal with program-wide outcomes. LVADS and Renal Denervation decisions mandate coordinators/navigators as an essential part of the team, and the recently presented EVOLVE study again confirmed the importance of the coordinator role in the structural heart space.

2-lessening the volume requirements for TAVR operators/centers
While a straightforward TAVR is a beautiful thing, any person who has experienced a TAVR complication knows that when a complication happens (rare as they may be), experience matters. In fact, studies have shown that higher volume physicians are less likely to have patients suffer significant complications such as death, stroke, and MI compared to low-volume physicians. Additionally, by removing the hospital volume criteria, one could anticipate a surge of new low-volume centers, where not only may the physician experience be limited, but the full team experience can be non-existent. Major TAVR complications require immediate intervention, which is not possible without experience. We have learned a lot from our decades of TAVRs, and minimizing volume requirements puts patients back into higher risk situations unnecessarily.

3-removing mandated registry participation
This is possibly the most concerning of the proposed changes. Not only do the proposed changes weaken some of the current safeguards, but removing the nationwide standard for tracking outcomes and being able to compare programs in an "apples to apples" fashion is not only detrimental to programs, but to providers, and most importantly to patients. The TVT registry currently allows programs to compare their outcomes to that of similarly sized programs to identify areas for improvement, celebrate successes, and ensure consistent follow up and valve performance. To remove the mandated registry while also making such significant changes to the NCD will make it more difficult to track how these changes actually impact patient outcomes. "Apples to apples" becomes "apples to oranges". Removing the registry requirement allows programs to only look at limited outcome metrics, and does not improve the drive for consistent quality improvement.

Again, I thank you for taking the time to consider my comments on the matter.

Sincerely,
Lauren Heckethorn, CNP
Structural Heart Coordinator
Presbyterian Cardiology

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TAVR Commentary Part II

Dear CMS officials,

I applaud the proposed revision for CMS coverage related to TAVR.

The heart team has been an important development in cardiac care centers across the country. Your proposal preserves the heart team while expediting patient care through the use of a team review.

Your proposal for single or a two operator procedure is appreciated. I personally believe that with current TAVR technology two experienced operators are best for each case. This may or may not include a cardiac surgeon, or may or may not include an interventional cardiologist, provided experienced operators are skilled at performing all aspects of the procedure. This may change over times as different platforms may be developed for single operator use.

In my experience, the level of interest and involvement of surgeons in Transcatheter Aortic Valve Replacement (TAVR) procedures varies. While some programs have surgeons performing the majority of the procedure with the interventional cardiologist playing a more minor role. Local heart teams need the flexibility to determine the most effective approach to patient care. While bailout emergency cardiac surgery during TAVR is possible, it is also true for coronary angiography and PCI. In our patient population in a rural and underserved community, access to care is limited. I applaud the ability to make individual heart team decisions for which operators will be required to be in the procedure.

During the COVID-19 pandemic, our hospital faced a critical shortage of cardiac surgeons and interventional cardiologists. This severely limited our ability to provide life-saving care to the region’s urgent need for TAVR procedures. Fortunately, as part of increased flexibility during the public health emergency (PHE), CMS granted temporary permission to perform the procedure without the traditional requirement of one cardiac surgeon and one interventional cardiologist. This flexibility allowed my program to continue treating patients suffering from severe aortic stenosis. For two years, our outcomes remained excellent, surpassing the national average. Despite this, we continued to improve with two interventional cardiologists performing the procedure. Additionally, we published a study suggesting no significant differences in outcomes during the PHE period.

Thank you for your updated proposal for coverage.

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1. Support asymptomatic severe AS coverage: Expanding TAVR to carefully selected asymptomatic patients (LV dysfunction, rapid progression, biomarker elevation) is clinically justified by natural history and emerging evidence; recommend Coverage with Evidence Development.
2. Maintain mandatory registry participation:Removing registry requirements undermines CED integrity precisely when expanding to unproven populations; real-world outcome tracking is essential for safety surveillance, device performance monitoring, and equity in case selection.
3. Maintain mandatory dual IC/CTS operative involvement:Surgeon presence provides irreplaceable bailout capacity for procedural complications, intra-operative decision partnership, and trainee education; removing this requirement systematically erodes cardiothoracic surgery workforce engagement at teaching hospitals.
4. Maintain minimum procedural volume thresholds: Asymptomatic AS populations demand *higher* operator competency (lower margin for error), not lower; fragmented low-volume centers produce incomparable outcomes, impede fellow training adequacy, and undermine CED comparability to trial data.

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To the Centers for Medicare & Medicaid Services:

Thank you for the opportunity to comment on the proposed revisions to the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).

I strongly support the proposed revisions and commend CMS for conducting a comprehensive and evidence-based review. The proposal appropriately aligns Medicare coverage with FDA-approved indications and reflects the remarkable maturation of transcatheter valve therapies over the past two decades. It balances patient access, innovation, and evidence-based care while maintaining an important emphasis on quality.

Removal of Coverage with Evidence Development

The proposal to remove Coverage with Evidence Development (CED) for patients with symptomatic severe aortic stenosis is appropriate. Multiple randomized clinical trials, long-term follow-up studies, and extensive real-world experience have demonstrated that TAVR is a safe, effective, and durable therapy across the spectrum of surgical risk. Continued CED as a condition of reimbursement for this mature indication is no longer necessary.

Conversely, I support maintaining CED for asymptomatic severe aortic stenosis. Although emerging evidence is encouraging, important questions remain regarding patient selection, timing of intervention, lifetime valve management, durability, coronary access, repeat intervention, and outcomes in broader Medicare populations. Continued evidence generation for these patients is appropriate.

Quality Must Remain the Foundation of TAVR Expansion

The extraordinary success of TAVR has been driven not only by technological innovation but also by an unwavering commitment to quality. As CMS appropriately expands access, preserving the national quality infrastructure that has supported the safe adoption of TAVR is essential.

Although TAVR is now routinely performed, it remains a technically complex structural heart intervention. Outcomes continue to depend on appropriate patient selection, multidisciplinary decision-making, multimodality imaging, operator expertise, procedural planning, device selection, and comprehensive follow-up. Important complications—including mortality, stroke, vascular injury, bleeding, permanent pacemaker implantation, paravalvular regurgitation, valve dysfunction, and repeat intervention—remain critical measures of procedural quality.

As TAVR expands into younger patients, lower-risk populations, increasingly complex anatomy, and new programs, systematic quality assessment becomes more—not less—important.

The STS/ACC TVT Registry has become one of the greatest quality improvement initiatives in cardiovascular medicine. It has established national benchmarks, enabled risk-adjusted performance assessment, identified emerging safety signals, informed regulatory and coverage decisions, strengthened clinical practice guidelines, and driven continuous quality improvement across TAVR programs.

Accordingly, participation in a national quality registry should remain an expectation for all TAVR programs. Registry participation should no longer be viewed as evidence generation for an established therapy but rather as an essential component of quality assurance, transparency, accountability, and continuous quality improvement. Continued reporting of meaningful clinical and patient-centered outcomes should remain an integral part of maintaining high-quality TAVR programs while minimizing unnecessary administrative burden whenever possible.

The Heart Team and Operator Expertise

The continued emphasis on the multidisciplinary Heart Team is one of the greatest strengths of the proposed policy. Collaborative evaluation has been fundamental to the success of TAVR and should remain a cornerstone of structural heart care.

The purpose of the Heart Team is not to satisfy a prescribed process but to ensure that the patient remains at the center of every decision. By integrating expertise from interventional cardiology, cardiac surgery, cardiovascular imaging, anesthesia when appropriate, and other specialists, the Heart Team provides individualized recommendations that consider anatomy, procedural risk, lifetime management, and, most importantly, the patient's goals and preferences.

Equally important, flexibility in implementation is paramount. Structural heart programs differ in size, referral patterns, available expertise, and institutional resources. CMS should define the principles of multidisciplinary collaboration while allowing institutions the flexibility to operationalize those principles in ways that best serve their patients. The Heart Team should be defined by its function rather than its form.

Operator expertise is likewise fundamental to procedural quality. Successful TAVR requires technical proficiency, sound clinical judgment, advanced imaging expertise, careful patient selection, and effective management of procedural complications. Although procedural volume alone should not define quality, it remains an important surrogate for maintaining proficiency. CMS should therefore exercise caution when reducing minimum operator experience thresholds. Over time, validated risk-adjusted outcome measures should become the primary assessment of operator and program quality; however, until these metrics are fully developed, maintaining appropriate minimum experience requirements remains an important safeguard for Medicare beneficiaries.

Looking Forward

Finally, as structural heart disease continues to evolve, continued investment in physician training will be important. Contemporary structural interventions require expertise that extends beyond catheter skills to include multimodality imaging, multidisciplinary decision-making, and longitudinal patient management. Formal structural heart training pathways will help ensure that future generations of physicians continue to deliver safe, high-quality care.

In summary, I strongly support the proposed revisions to the National Coverage Determination. CMS has appropriately recognized that symptomatic TAVR has matured beyond the need for Coverage with Evidence Development while maintaining evidence generation for emerging indications.

As access continues to expand, quality must remain the foundation of TAVR. Broad patient access and rigorous quality assessment are complementary—not competing—priorities. Preserving the national quality infrastructure, supporting collaborative Heart Team care, recognizing the importance of operator expertise, and continuing to invest in physician training will help ensure that the continued expansion of TAVR is accompanied by accountability, transparency, innovation, and the highest standards of care for Medicare beneficiaries.

Thank you for your thoughtful consideration of these comments.

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As the Executive Medical Director of a system’s cardiovascular service line who cares for patients with severe aortic stenosis, I support CMS's proposed updates to the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) and encourage further modernization of requirements that may unintentionally delay treatment for appropriate patients.

Current requirements for separate evaluations by both a cardiac surgeon and an interventional cardiologist, along with rigid procedural staffing requirements, do not always reflect contemporary clinical practice or the needs of today's patients. While the multidisciplinary Heart Team remains essential, there are many straightforward patients whose clinical presentation, imaging, and treatment pathway are clear. In these cases, permitting greater flexibility in evaluation requirements could reduce unnecessary appointments, minimize travel and scheduling burdens, and help patients receive treatment more efficiently while preserving appropriate Heart Team oversight.

Timely access to TAVR is especially important because delays in treatment have been associated with worse outcomes, including increased heart failure hospitalizations, urgent or emergent procedures, and mortality while awaiting intervention. Studies have demonstrated that prolonged wait times for TAVR can lead to clinical deterioration and increased healthcare utilization, resulting in higher costs for the healthcare system and greater burden for patients and caregivers.^1,2

I also support expanding coverage for patients with severe asymptomatic aortic stenosis. Recent evidence has demonstrated the benefits of earlier intervention, including reductions in death, stroke, and unplanned cardiovascular hospitalizations compared with clinical surveillance alone.³ Earlier treatment may help prevent disease progression and avoid the urgent admissions and complications that frequently occur when intervention is deferred until symptoms develop.⁴

Additionally, I support CMS's proposal to provide greater operator flexibility while maintaining the Heart Team model. Experienced Heart Teams should have the ability to determine the most appropriate procedural approach based on patient needs, operator expertise, and program capabilities. Allowing qualified interventional cardiologists or cardiac surgeons to serve as the primary operator can improve scheduling flexibility and facilitate more timely treatment, particularly for urgent or non-elective patients, while preserving quality and patient safety. Contemporary TAVR outcomes remain excellent, and conversion to open surgery has become exceedingly uncommon in experienced programs.^5,6

In summary, updating the NCD to support asymptomatic severe aortic stenosis coverage, streamline evaluation requirements for appropriate patients, and allow greater operator flexibility would better align Medicare policy with current evidence and clinical practice. These changes would reduce unnecessary barriers to care, improve access to timely treatment, and maintain the high standards of quality and safety that patients deserve.

References

1. Elbaz-Greener G, et al. Circulation. 2018. Association of wait times with outcomes among patients referred for TAVR.
2. Barbash IM, et al. JACC Cardiovascular Interventions. 2020. Impact of treatment delays on TAVR outcomes and healthcare utilization.
3. EARLY TAVR Trial Investigators. New England Journal of Medicine. 2024. Early TAVR versus clinical surveillance in asymptomatic severe aortic stenosis.
4. Lindman BR, et al. Journal of the American College of Cardiology. 2019. Clinical progression and outcomes in asymptomatic severe aortic stenosis.
5. Grover FL, et al. Annals of Thoracic Surgery. 2017. Contemporary outcomes and need for surgical conversion during TAVR.
6. Carroll JD, et al. JAMA. 2020. STS/ACC TVT Registry outcomes demonstrating continued improvements in TAVR safety and effectiveness.

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Having launched TAVR in 2012 and watched the evolution of this intervention at a 3 star site now approaching 3000 cases it is clear that mandating 2 operators is an unnecessary burden at times challenging access to care and a procedure that has (with a few exceptions such as alternative access cases) evolved into a single operator intervention. Removing this mandate in no way would stand in the way of the heart team collaborating with two operators when appropriate and/or necessary

SCAI position statement as delineated below has my very strongest support

Heart Team
Collaboration is essential
Initial evaluations must include both IC and surgeon members of team
Visit flexibility, such as telehealth, is critical

Operator Requirements
Support CMS’s recommendation to remove the mandatory two-operator requirement
Recommend clarification in the language to specify TAVR be conducted by a single or two qualified operators, who may include an interventional cardiologist and/or cardiac surgeon
Composition of the operative team should be determined by the local heart team
Justification should not be required for teams of two operators to be covered

Coverage for Other Indications
CED is an appropriate avenue for other indications that have less evidence than severe AS
Other indications that should be covered include:
Aortic regurgitation
Severe bicuspid stenosis
Symptomatic moderate AS

Continuous Quality Improvement
Should include registry reporting

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To: Coverage and Analysis Group, Centers for Medicare & Medicaid Services
RE: Public Comment on Proposed Decision Memo for TAVR – Optimizing Operator Flexibility to Include Vascular Surgeons

Dear Members of the Coverage and Analysis Group,

We appreciate the opportunity to comment on the Proposed Decision Memo for the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination (NCD). We strongly support CMS’s forward-thinking proposal to modernize the structural heart framework by moving away from rigid, legacy volume requirements and increasing operator flexibility for the multi-disciplinary Heart Team.

To fully realize the clinical benefits of this updated policy and maximize patient safety, we urge CMS to refine the final NCD to explicitly recognize board-certified vascular surgeons as qualified co-implanters within the flexible operator framework (alongside an interventional cardiologist or cardiac surgeon). While modern delivery systems have minimized profile sizes, vascular access paths and their associated complications remain the primary drivers of procedural morbidity and mortality. Vascular surgeons are increasingly integrated into structural heart programs, providing expertise that directly improves patient outcomes.

Supporting Clinical Evidence

1. Mitigating and Preventing Access Complications

Vascular access complications in transfemoral TAVR remain strongly associated with prolonged hospitalization, increased costs, and elevated 30-day and 1-year mortality [1,2]. Real-world clinical data shows that vascular surgeons are actively required to intervene in up to 7% of transfemoral procedures—with over 90% of those interventions driven by highly calcified, hostile iliofemoral anatomy or the emergent management of catastrophic vascular disruptions [3,4].

Furthermore, integrating vascular surgery into the pre-procedural phase significantly safeguards patient outcomes among patients with significant peripheral artery disease [5].

2. The Rapid Growth and Proven Safety of Transcarotid Access (TCA)

As structural heart programs actively transition away from invasive, higher-morbidity transthoracic approaches (such as transapical and direct aortic), alternative peripheral access routes have grown rapidly. Among these, Transcarotid Access (TCA) has emerged as a safe and effective non-femoral strategy.

Large-scale data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) TVT Registry robustly establishes the safety profile of TCA[6,7,8]. Lower Stroke Rates: Propensity-matched registry data demonstrates that TCA achieves a significantly lower 30-day stroke rate compared to transaxillary/subclavian access (3.1% vs 5.9% for self-expanding valves; 4.2% vs 7.4% for balloon-expandable devices). Reduced Mortality: TCA is associated with a dramatic reduction in 30-day mortality when compared directly to traditional transthoracic access (4.2% vs 7.7%), alongside significantly shorter intensive care unit (ICU) stays and faster times to discharge.

3. Vascular Surgeons as Uniquely Qualified Carotid Experts

The clinical success, low stroke rates, and reproducibility of the transcarotid approach depend entirely on flawless surgical exposure of the common carotid artery, maintaining precise proximal and distal vascular control, and executing meticulous arterial repair [9].

These maneuvers represent the definitive core competencies of board-certified vascular surgeons, routinely honed through high-volume experience with Carotid Endarterectomy (CEA) and Transcarotid Artery Revascularization (TCAR) [10]. Because the technical execution of this access site directly dictates local vascular integrity and stroke mitigation, vascular surgeons are uniquely qualified to serve as a co-implanter alongside a TAVR operator (interventional cardiologist or cardiac surgeon) when alternative access is required.

Requested Revision to the Final NCD

To ensure Medicare beneficiaries have seamless access to this specialized expertise, we request that CMS amend the operator infrastructure language to explicitly state: "The multi-disciplinary Heart Team retains the local autonomy to utilize a board-certified vascular surgeon as an official qualified co-implanter alongside an interventional cardiologist or cardiothoracic surgeon, particularly when advanced alternative vascular access, complex calcified peripheral anatomy, or specialized endovascular closure techniques are required."

Conclusion

Formally incorporating the specialized endovascular and surgical access capabilities of vascular surgeons into the new, flexible operator model perfectly aligns with CMS’s goal of modernizing TAVR care. This change ensures that the local Heart Team can be precisely tailored to the anatomical realities of the patient. Thank you for your consideration of this enhancement.

Sincerely,

Kalkidan Bishu, MD, Interventional Cardiology
Ryan Clark, MD, Cardiac Surgery
Megan Coylewright, MD, Interventional Cardiology
Benjamin Jorgensen, MD, Vascular Surgery
James Miller, MD, Cardiac Surgery
Jason Schultz, MD, Interventional Cardiology
Benjamin Selle, DO, Vascular Surgery

Essentia Health-Saint Mary’s Heart and Vascular Center
Duluth, Minnesota

Bibliography
1. Généreux P, Webb JG, Svensson LG, Kodali SK, Satler LF, Fearon WF, Davidson CJ, Eisenhauer AC, Makkar RR, Bergman GW, Babaliaros V, Bavaria JE, Velazquez OC, Williams MR, Hueter I, Xu K, Leon MB; PARTNER Trial Investigators. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial. J Am Coll Cardiol. 2012 Sep 18;60(12):1043-52. doi: 10.1016/j.jacc.2012.07.003. Epub 2012 Aug 8. PMID: 22883632.
2. Laakso T, Moriyama N, Raivio P, Dahlbacka S, Kinnunen EM, Juvonen T, Valtola A, Husso A, Jalava MP, Ahvenvaara T, Tauriainen T, Piuhola J, Lahtinen A, Niemelä M, Mäkikallio T, Virtanen M, Maaranen P, Eskola M, Savontaus M, Airaksinen J, Biancari F, Laine M. Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement - Results From the FinnValve Registry. Circ Rep. 2020 Feb 28;2(3):182-191. doi: 10.1253/circrep.CR-20-0007. PMID: 33693226; PMCID: PMC7921363.
3. Gallitto E, Faggioli G, Saia F, Palmerini T, Pini R, Bruno AG, Feroldi FM, Alaidroos M, Ghetti G, Taglieri N, Caputo S, Donati F, Marrozzini C, Gargiulo M. The role of the vascular surgeon in transcatheter aortic valve implantation. Vascular. 2025 Aug;33(4):861-869. doi: 10.1177/17085381241237844. Epub 2024 Mar 19. PMID: 38504140.
4. Fanaroff AC, Manandhar P, Holmes DR, Cohen DJ, Harrison JK, Hughes GC, Thourani VH, Mack MJ, Sherwood MW, Jones WS, Vemulapalli S. Peripheral Artery Disease and Transcatheter Aortic Valve Replacement Outcomes: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Therapy Registry. Circ Cardiovasc Interv. 2017 Oct;10(10):e005456. doi: 10.1161/CIRCINTERVENTIONS.117.005456. PMID: 29042398; PMCID: PMC5683430.
5. ? George JM, Hatzis CM, Ritzer L, Khera S, Tang G, Kini A, Faries P, Tadros RO. Surgical External Iliac Artery Access for Transcatheter Aortic Valve Replacement Is a Safe, Suitable Alternative to Common Femoral Artery Access. Cureus. 2023 Jun 6;15(6):e40028. doi: 10.7759/cureus.40028. PMID: 37425500; PMCID: PMC10323864.
6. Allen KB, Watson D, Vora AN, Mahoney P, Chhatriwalla AK, Schwartz JG, Keller A, Sodhi N, Haugan D, Caskey M. Transcarotid versus transaxillary access for transcatheter aortic valve replacement with a self-expanding valve: A propensity-matched analysis. JTCVS Tech. 2023 Aug 3;21:45-55. doi: 10.1016/j.xjtc.2023.07.019. PMID: 37854813; PMCID: PMC10580150.
7. Kirker E, Korngold E, Hodson RW, Jones BM, McKay R, Cheema M, Heimansohn D, Moainie S, Hermiller J, Chatriwalla A, Saxon J, Allen KB. Transcarotid Versus Subclavian/Axillary Access for Transcatheter Aortic Valve Replacement With SAPIEN 3. Ann Thorac Surg. 2020 Dec;110(6):1892-1897. doi: 10.1016/j.athoracsur.2020.05.141. Epub 2020 Jul 24. PMID: 32712098
8. Allen KB, Chhatriwalla AK, Saxon J, Hermiller J, Heimansohn D, Moainie S, McKay RG, Cheema M, Jones B, Hodson RW, Korngold E, Kirker E. Transcarotid versus transthoracic access for transcatheter aortic valve replacement: A propensity-matched analysis. J Thorac Cardiovasc Surg. 2022 Aug;164(2):506-515. doi: 10.1016/j.jtcvs.2020.09.133. Epub 2020 Oct 21. PMID: 33229170.
9. Sherwood M, Allen KB, Dahle TG, Devireddy CM, Gaca J, Garcia S, Grubb KJ, Kaneko T, Kliger CA, Lederman RJ, Messenger JC, Parikh PB, Poulin MF, Sanchez C, Ukaigwe A, Yun JJ, Mahoney PD. SCAI Expert Consensus Statement on Alternative Access for Transcatheter Aortic Valve Replacement. J Soc Cardiovasc Angiogr Interv. 2025 Feb 25;4(3Part A):102514. doi: 10.1016/j.jscai.2024.102514. Erratum in: J Soc Cardiovasc Angiogr Interv. 2025 Jun 06;4(7):103798. PMID: 40231056; PMCID: PMC11993896.
10. AbuRahma AF, Avgerinos ED, Chang RW, Darling RC 3rd, Duncan AA, Forbes TL, Malas MB, Murad MH, Perler BA, Powell RJ, Rockman CB, Zhou W. Society for Vascular Surgery clinical practice guidelines for management of extracranial cerebrovascular disease. J Vasc Surg. 2022 Jan;75(1S):4S-22S. doi: 10.1016/j.jvs.2021.04.073. Epub 2021 Jun 19. PMID: 34153348.

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July 15, 2026

Joseph Hutter, MD
Lead Medical Advisor

Sarah Fulton, MHS
Lead Analyst
Center Medicare & Medicaid Services

Re: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2, NCA-CAL-321)

Dear Dr. Hutter and Ms. Fulton:

The 20 undersigned patient advocacy, health professional, and family caregiver organizations applaud and thank the Centers for Medicare & Medicaid Services (CMS) for its proposed National Coverage Determination (NCD) update for Transcatheter Aortic Valve Replacement (TAVR)[1] and this opportunity to provide comment. The proposed updates to Medicare’s national TAVR coverage policy represent a transformative milestone for heart-valve disease patients and their families. The TAVR procedure is often preferred by patients with severe aortic stenosis (AS) because it avoids open-heart surgery and allows quicker treatment and recovery. It also reduces first-year health care costs by about $10,000 per patient for Medicare and taxpayers.[2]

By lifting the 14-year Coverage with Evidence Development (CED) requirement,[3] CMS is formally recognizing that TAVR is reasonable and necessary for the treatment of severe, symptomatic AS. In addition, updates to the TAVR coverage criteria related to pre-procedural patient assessment, intraoperative requirements, and operator and hospital procedural volume requirements shift the focus to where it matters most: TAVR proficiency, data-driven quality, patient experience, and relevant operator expertise.

We urge CMS to finalize these pivotal changes to expand TAVR access, and build on this progress by extending the same national coverage approach—without CED—to Medicare patients with asymptomatic severe AS. Such a decision would not only align with the CMS Administrator’s goals to modernize and streamline Medicare utilization management, but it would also remove barriers to less invasive AS care for all beneficiaries, in all areas of the U.S.

Additionally, once the TAVR NCD is finalized, we encourage CMS to reconsider use of CED in Medicare, because it interferes in the practice of medicine and impacts access to care for millions of beneficiaries annually.

Ending CED for Symptomatic Severe Aortic Stenosis (AS) Is Overdue

An estimated 2.5 million people over the age of 75 have AS, one of the most common types of heart valve disease. Left untreated, it can progress rapidly to severe AS, and once symptoms appear, 1 in 10 may die within five weeks.[4]

When the FDA first approved TAVR in 2011, it was an important advancement for older adults[5] with severe, symptomatic aortic stenosis who needed their valves replaced but were too ill or frail to withstand open-chest surgery. The American College of Cardiology and Society for Thoracic Surgeons sent a formal request to Medicare to initiate a TAVR NCD requiring CED,[6] and co-led the introduction of the CMS-approved, TVT registry clinical study in 2012.

By 2017, TAVR became the clinical standard of care for most patients with symptomatic, severe AS, supported by robust randomized trial data and reflected in professional society guidelines[7] soon thereafter. Despite this clear clinical consensus nearly 10 years ago, Medicare coverage for TAVR remained subject to CED, creating a growing disconnect between specialty clinical guidelines and CMS policy. CMS reconsidered the NCD in 2019,[8] which expanded TAVR coverage to lower-risk patients but kept the CED and other outdated coverage requirements.

This incongruence is starkly reflected in patient access. In 2019, the CED registry reported that only 72,991 patients received TAVR. That may sound like a high level of access, but a 2017 article in the American Heart Association Journal, Circulation: Cardiovascular Quality and Outcomes,[9] found that only 31% of U.S. patients potentially eligible for TAVR had been treated with the procedure.

Not surprisingly, TAVR access issues hit patients who live in underserved communities the hardest. Research on TAVR access inequalities[10] from February 2026 found that areas with lower-than-expected TAVR utilization due to CED coverage restrictions are not just experiencing access gaps, but also significantly higher rates of death.

In another example, USC Schaeffer Center research finds that patients in rural areas are underrepresented at TAVR hospitals and can’t access the procedure closer to home.[11] Delayed care can cost patients both their money and their lives. Those treated more than ninety days after diagnosis face a 50 percent higher risk of death over three years and nearly $37,000 in additional health care costs compared to those treated promptly.[12] And even at a TAVR hospital, CED’s onerous requirements add an average of 59 days to the timeline between diagnosis and treatment.[13]

There have now been more than 25 TAVR clinical trials and more than 1 million TAVR patients captured in the required registry, with results published in nearly 20,000 articles. CMS can confidently declare success in lifting the CED and other requirements, and we join the American public in supporting them. In May, the Alliance for Aging Research commissioned a poll of 1,000 U.S. adults on the potential impact of these changes.[14] Overall, 77% of participants said they agree Medicare should cover TAVR “the same way that it covers open-heart surgery” and 67% said they would be more likely to support a political candidate who “supports requiring Medicare to broaden patient access to TAVR.”

Emphasizing Proficiency, Data-Driven Quality, Patient Experience, and Relevant Operator Expertise

We also support the other updates in the proposed decision memo. These include:

• Reducing patient burden: shifting the heart team evaluation to using medical records plus one required in-person visit with a member of the heart team, which will provide immense relief to patients and their families;
• Modernizing quality metrics: judging hospitals on quality improvement instead of rigid yearly procedure counts, helping ensure that patient outcomes dictate success;
• Putting patients at the center: promoting shared decision-making and patient-centered treatment selection;
• Expanding health access: allowing single-operators where appropriate and prioritizing procedural proficiency over rigid structural volume requirements—including eliminating annual quotas for unrelated cardiac procedures—safeguarding quality while broadening hospital participation in historically underserved communities;
• Requiring data sharing: making CED clinical study data accessible to both CMS and the public to better inform research and future coverage policy; and
• Future-proofing pathways: utilizing Medicare Administrative Contractor (MAC) coverage discretion to accommodate future clinical indications creates a vital coverage framework without undergoing the lengthy NCD reopening process.

CMS Should Apply the Same Standards to Asymptomatic Severe AS

CMS should not impose CED for newer indications of TAVR, including use in asymptomatic patients, where the clinical evidence base is already clear and continuing to evolve through routine clinical practice. Research in the October 2024 New England Journal of Medicine study found that treating severe AS patients with TAVR prior to experiencing any symptoms lowered risk of death, stroke or unplanned hospitalization for cardiovascular outcomes compared with those who had routine clinical surveillance (also known as “watchful waiting”).[15]

The FDA approved TAVR to treat asymptomatic AS in May 2025, and patients have been facing inconsistent Medicare coverage as they wait for CMS to make its decision. While we are supportive of inclusion of TAVR coverage for asymptomatic AS in the NCD, we oppose the application of CED and other conditional coverage requirements on this indication. Thousands of published studies for prior TAVR indications demonstrate that layering restrictive coverage requirements on to the asymptomatic AS indication is more likely to delay access and create unnecessary barriers to care. CMS should provide clear and consistent national coverage rather than rely on CED mechanisms that are no longer justified.

We Encourage CMS to Reconsider Use of CED in Medicare

Once the TAVR NCD is finalized, we encourage CMS to reconsider use of CED in Medicare, because it interferes in the practice of medicine and impacts access to care for millions of beneficiaries annually. Since 2005, when Medicare created CED, CMS has applied it to more than 30 treatments and tests for certain cancers, sickle cell disease, and severe hearing loss (cochlear implants), among other conditions.[16] And in April 2022, Medicare applied CED to an entire class of FDA-approved treatments for early Alzheimer's disease. This marked the first time Medicare extended CED beyond medical devices and diagnostics to restrict the on-label use of FDA-approved prescription drugs.

The CED restriction on Alzheimer’s therapies has been more significant than the agency predicted. A May 11 article in STAT News found that “People on Medicare are not getting the recently approved Alzheimer’s medications nearly as much as federal officials anticipated.”[17]

Older adults meet with their health care providers, often alongside family caregivers, to discuss the benefits and risks of treatment, according to their diagnosis and needs. Section 1801 of the Social Security Act bars federal officials from interfering in the practice of medicine, which raises questions about CMS's authority to condition Medicare coverage on participation in a study. In a January 2021 advisory opinion,[18] then-HHS General Counsel Robert Charrow found that CMS's use of CED was fundamentally inconsistent with the law and concluded that such restrictions were unlawful. Though that opinion has since been rescinded, its legal reasoning has not been refuted.

Conclusion

We thank CMS for this patient-centered proposal and urge the agency to finalize it, together with the changes requested above, without unnecessary delay. Please contact Candace DeMatteis, Policy Director at the Partnership to Fight Chronic Disease at candace.dematteis@fightchronicdisease.org; or Sue Peschin, President & CEO, Alliance for Aging Research at speschin@agingresearch.org, with any questions. We welcome the opportunity to serve as a resource to CMS as this policy is finalized.

Respectfully submitted,

Alliance for Aging Research
Alliance for Patient Access
ASCP - Age Friendly Pharmacists and Pharmacies
Association of Black Cardiologists
Caregiver Action Network
CaringKind, The Heart of Alzheimer's Caregiving
Global Alzheimer's Platform Foundation
Global Coalition on Aging
HealthHIV
Lupus and Allied Diseases Association, Inc.
Lupus Foundation of America
National Alliance for Caregiving
National Association of Nutrition and Aging Services Programs (NANASP)
National Consumers League
National Minority Quality Forum
National Grange
Nevada Chronic Care Collaborative
Partnership to Fight Chronic Disease
RetireSafe
Voices of Alzheimers

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Thank you for the opportunity to comment on the proposed National Coverage Determination for transcatheter aortic valve replacement, CAG-00430R2. I am an interventional and structural cardiologist, and I strongly support CMS’s effort to update a coverage policy that was created when TAVR was still an emerging technology. The proposed framework appropriately recognises that the field has changed substantially, while continuing to emphasise careful patient selection, multidisciplinary decision-making, appropriate institutional capability, and ongoing assessment of quality.

I support ending coverage with evidence development for patients with symptomatic severe aortic stenosis. TAVR has now been studied across the spectrum of surgical risk in numerous randomised trials, with longer-term follow-up available from several pivotal studies, and its performance has also been evaluated in very large national registries. The accumulated evidence establishes TAVR as a standard treatment option for appropriately selected patients rather than an investigational therapy that should remain dependent on evidence development as a condition of coverage. Continuing to treat routine TAVR for symptomatic severe aortic stenosis as though the central questions of safety and effectiveness remain unresolved would no longer reflect contemporary clinical practice.

The Heart Team should remain an important part of valve care, but its value lies in the quality of the clinical judgment it provides, not in requiring the same sequence of encounters for every patient. Multidisciplinary discussion is essential when anatomy is complex, when both surgery and TAVR are reasonable options, or when decisions are influenced by frailty, bicuspid valve disease, concomitant coronary or valvular pathology, vascular access, procedural risk, or anticipated valve durability. By contrast, requiring a patient with an obvious indication and a straightforward treatment pathway to attend additional consultations solely to fulfil a coverage rule may increase burden and delay without changing the decision. Allowing parts of the Heart Team assessment to occur through structured record review is therefore a sensible evolution of the policy.

I also believe that the regulatory approach to TAVR should be proportionate to the way other complex cardiovascular procedures are governed. PCI and surgical valve replacement depend on professional standards, hospital credentialing, institutional quality systems, registry reporting, and peer oversight rather than a national coverage policy specifying every operational feature of care. TAVR should not be subject to a uniquely prescriptive framework unless there is clear evidence that additional requirements improve outcomes. The institutional standards proposed by CMS—including established structural heart and cardiac surgical capability, suitable post-procedural care, and a continuous quality-improvement process—provide meaningful safeguards without unnecessarily dictating how each program must organise individual patient evaluations.

National registry surveillance remains highly valuable and should continue to play a central role in benchmarking outcomes, detecting safety signals, and supporting quality improvement. The STS/ACC TVT Registry has made an enormous contribution to the responsible development of TAVR in the United States, and maintaining broad participation should remain a priority for the structural heart community. However, the importance of the registry does not necessarily mean that participation must remain permanently embedded in the NCD as a condition of payment. High levels of participation in surgical and PCI registries have been achieved through professional expectations, institutional quality programs, and accreditation, and a similar model should be achievable for TAVR.

I therefore support the overall direction of the proposed NCD: ending coverage with evidence development for symptomatic severe aortic stenosis, preserving meaningful Heart Team involvement while permitting more efficient implementation, and retaining appropriate standards for institutional capability and quality oversight. I also agree that asymptomatic severe aortic stenosis should be treated differently, as important questions remain regarding the timing of intervention, long-term durability, reintervention, and the relative merits of TAVR, surgery, and surveillance in patients with longer life expectancy. The final policy should reflect the maturity of TAVR for symptomatic disease while maintaining a more cautious evidence-generating framework where clinically important uncertainty remains.

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Dear Members of the Coverage and Analysis Group,

I appreciate the opportunity to comment on the Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR).

At Stanford Biodesign, we believe that a disciplined approach to innovation across the continuum of care is the key to solving healthcare challenges in the U.S. and across the globe. For more than two decades, we’ve demonstrated that innovation can be taught, learned, practiced, and perfected. From our position at the metaphorical and physical start line for healthcare innovation, we at the Stanford Biodesign Policy Program have focused our research on the often decade-long journey for a novel health technology to become the standard-of-care treatment for a disease state.

With this decision memo, the Coverage and Analysis Group (CAG) at Centers for Medicare & Medicaid Services (CMS) proposes to modernize the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR) by retiring the Coverage with Evidence Development (CED) requirements for symptomatic beneficiaries. With this change, the agency recognizes the maturity of a technology supported by an evidence base including 17 randomized controlled trials involving 10,686 patients and real-world data from over 450,000 beneficiaries across more than 800 sites. TAVR has transitioned from investigational technology to a standard-of-care procedure.

Furthermore, the agency is charting a course that uses CED to eliminate hospital-level procedural volume requirements. Such programmatic requirements ensure high-quality patient outcomes yet also contribute to barriers to access, producing geographic care disparities and imposing substantial travel burdens on rural and low-income populations. By proposing a transition toward individual operator competency and direct outcome measurement, CMS is moving coverage policy from institutional alignment to operator-level alignment, which should increase the number of hospitals capable of offering TAVR. This shift is essential to maintaining high standards of care while enabling beneficiaries to receive life-saving treatment closer to home.

However, the 14-year journey TAVR has taken to reach this milestone should not serve as the default coverage blueprint for every emerging technology. Mandatory CED registries impose administrative and financial burdens on hospitals that wish to offer the procedure, requiring additional, unreimbursed investment beyond direct patient care. CMS should test each NCA under CED to make sure the open clinical questions for manufacturers and hospitals remain practical and achievable in a timely manner. Evidence questions required under CED should be sufficient to demonstrate that a therapy has met the threshold for "reasonable and necessary," rather than be predicated on what may be feasible with registry data or on what is desired by academic, clinical, or payer stakeholders. Establishing a clear evidentiary threshold for what is "reasonable and necessary" is critical for the sustainability of the innovation ecosystem. While a high-cost procedure like TAVR may generate sufficient revenue for hospitals to justify data collection investments, lower-cost innovations may not achieve widespread adoption if they face the same lengthy evidentiary path from market entry to standard of care. Continuing efforts to reform CED into a time-limited tool with defined sunset triggers will ensure it remains a bridge to access rather than a permanent barrier to innovation.

Thank you for your consideration.
Note: The opinions expressed here are my own and do not represent those of Stanford University.

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I appreciate the opportunity to comment on the proposed National Coverage Determination for TAVR. I am a cardiac surgeon and active TAVR operator. My program has performed over 1000 TAVR procedures, and I have seen the benefits that this operation can afford patients. I respectfully urge CMS to consider the following modifications to ensure continued patient safety, optimal outcomes, and appropriate evidence generation.

First, while the proposed framework removes the joint operator requirement, CMS should explicitly recognize that a dual-specialty operator model consisting of both a cardiac surgeon and an interventional cardiologist remains the optimal approach for TAVR patients. The complementary expertise of both specialists enhances patient safety and ensures immediate access to the skills needed to manage complex anatomy and procedural complications. Every program of size will have seen the direct benefits of this approach.

Second, CMS should require all new TAVR programs to utilize a dual-specialty operator model during their first year of operation. This is particularly important in lower-volume settings where institutional experience, infrastructure, and heart team collaboration are still developing. This will also foster an environment of cooperation between surgeons and interventional cardiologists that has been the cornerstone of program success.

Finally, CMS should maintain Coverage with Evidence Development (CED) for clinical indications where important evidence gaps remain, including asymptomatic severe aortic stenosis, bicuspid valve anatomy, moderate aortic stenosis, valve-in-valve TAVR, aortic insufficiency, and low-risk patients. CED should also apply to all procedures performed by new TAVR programs without prior experience and to newly FDA-approved TAVR valves until sufficient real-world evidence is available.

Maintaining these safeguards will support patient safety, preserve the multidisciplinary Heart Team model, and promote continued evidence-based expansion of TAVR therapy. Thank you for your consideration.

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We support maintaining operator flexibility so qualified Heart Teams can determine the most appropriate procedural approach based on patient complexity, procedural considerations, institutional expertise, and available resources. The final policy should preserve flexibility for programs to use either a single-operator or two-operator model when clinically and operationally appropriate.

We support extending coverage to patients with severe asymptomatic aortic stenosis. Emerging evidence, including findings from the EARLY TAVR trial, suggests that earlier intervention in appropriately selected patients can reduce death, stroke, and unplanned cardiovascular hospitalizations compared with clinical surveillance. Expanding coverage will enable clinicians and patients to make individualized treatment decisions while potentially avoiding disease progression and urgent hospitalizations.

We also support CMS's proposal to discontinue Coverage with Evidence Development (CED) requirements for symptomatic severe aortic stenosis. TAVR is a well-established therapy supported by extensive clinical trial, registry, and real-world evidence. The TVT Registry has played an essential role in advancing quality and evidence generation, and continued participation in established quality registries can support ongoing oversight while reducing unnecessary administrative burden.

The proposed evaluation flexibilities are particularly important. Many Medicare beneficiaries travel significant distances to receive structural heart care, and multiple in-person evaluations can create unnecessary burdens and delays. Allowing Heart Teams to tailor the evaluation process to individual patient needs can improve efficiency and access while preserving multidisciplinary decision-making. Many programs will likely continue to obtain evaluations from both physicians whenever feasible because those complementary perspectives strengthen shared decision-making and Heart Team review.

We also encourage CMS to recognize the full multidisciplinary nature of the Heart Team. Beyond physicians, successful TAVR programs depend on nurses, valve coordinators, advanced practice providers, registry personnel, quality staff, and administrative professionals to coordinate care, support patients, and sustain program quality. As implementation moves forward, clear expectations regarding team roles, documentation, communication, and asynchronous Heart Team review will help promote consistency while preserving flexibility.

We support maintaining operator flexibility so qualified Heart Teams can determine the most appropriate procedural approach based on patient needs, institutional expertise, and local resources. At the same time, the final policy should preserve flexibility for programs that continue to use a two-operator model when clinically or operationally appropriate. Different care models can achieve excellent outcomes when supported by appropriate expertise and oversight.

Finally, workforce sustainability should remain an important consideration. Shortages of cardiothoracic surgeons and other specialized clinicians continue to affect programs nationwide, particularly in rural and underserved communities. Policies that preserve the Heart Team model while allowing operational flexibility will help ensure that limited specialty resources can be deployed effectively without compromising quality.

In summary, we believe these proposed updates appropriately modernize the TAVR coverage policy by expanding access to evidence-based care, reducing unnecessary administrative burden, and providing programs with greater flexibility while preserving multidisciplinary Heart Team care, quality oversight, and local clinical judgment. We encourage CMS to finalize these provisions with clear implementation guidance to support consistent, high-quality care across diverse practice settings.

Thank you for your consideration.

References

EARLY TAVR Trial Investigators. New England Journal of Medicine. 2024.
Elbaz-Greener G, et al. Circulation. 2018.
Barbash IM, et al. JACC: Cardiovascular Interventions. 2020.
Carroll JD, et al. JAMA. 2020.
Otto CM, et al. 2021 ACC/AHA Guideline for the Management of Valvular Heart Disease.
Shah PB, et al. Structural Heart Disease Care During the COVID-19 Public Health Emergency. JACC and associated multisociety guidance documents.

Renee Bernard MSN, APRN
Brown University Health - Rhode Island Hospital
401-413-0579
Renee.Bernard@brownhealth.org
VP, of Cardiovascular Institute

Ginger Biesbrock Dsc, PA-C, MPH, FACC
Advocate Health
904-580-0190
ginger.biesbrock@advocatehealth.org
Senior VP, National Heart & Vascular Service Line

Michael Busky
Ascension Alexian Brothers
815-988-6505
michael.busky@Ascension.org
VP, Operations & COO

Deval Daily MS
UChicago Medicine
847-334-2395
Deval.daily@uchicagomedicine.org
VP, Chief Operational Transformation Officer

Jasmina Katinic DNP, NP-C, APRN, CCRN-K, AACC
HCA Healthcare, West Florida Division
727-318-7583
jasmina.katinic@hcahealthcare.com
Division Assistant Vice President Structural Heart and Vascular Program

Sara May MAOM, BSN, RN
Emory Healthcare
678-843-7447
sara.may@emoryhealthcare.org
Senior Vice President, Heart and Vascular Service

Gordon Wesley DBA, FACHE
UChicago AdventHealth
205-777-7394
gordon.wesley@adventhealth.com
Senior Vice President, Chief Strategy Clinical Integration Officer

Kelly Beltz BS, RHIA
St. Alphonsus
208-350-1374
kelly.beltz@saintalphonsus.org
CV Health Informatics Data Registrar

Sara Dezell MSN, APRN, AGCNS-BC
St. Cloud
218-371-9208
DezellS@centracare.com
VCC

Katie Kennedy MSN, APRIN, NP-C
Community Heart & Vascular
317-409-6471
kkennedy2@ecommunity.com
Structural Heart Pogram Manager

Misty Theriot BSN, RN, CPHQ
Lake Charles Memorial Hospital
337-494-4759
mtheriot@lcmh.com
Valve Clinic Coordinator, STS/ACC TVT Registry Site Manager

Tom Wills MPPM,BSN,RN
Baptist Health
205-317-4588
tom.wills@bmhcc.org
Chief Administrative Officer

Lannae Ewing MBA, MSN, APN-C
Virtua Our Lady of Lourdes Hospital
609-605-6123
lewing@virtua.org
VP Cardiac Operations

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Centers for Medicare & Medicaid Services (CMS)
Coverage and Analysis Group (CAG)
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (CAG-00430R2), Addendum to Co-Signed Executive Summary Supporting Elizabeth Perpetua's Public Comment on July 13, 2026

Complete List of Organization (1) and Individual Co-Signatories (65) 66 total co-signatories through July 15, 2026 To be emailed directly to CAGInquiries@cms.hhs.gov with co-signatories' contact information

ADDENDUM TO CO-SIGNED EXECUTIVE SUMMARY (COMPLETE LIST OF CO-SIGNATORIES THROUGH JULY 15, 2026)

This executive summary accompanies and is co-signed in support of a public comment submitted by Dr. Elizabeth M. Perpetua, DNP, ACNP-BC, ARNP, FACC on the proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) CAG-00430R2. Implementation guidance and evidence, which are not yet part of the evidentiary record for this reconsideration of the TAVR NCD, are provided in support of Dr. Perpetua’s four requests for the final NCD.

Since 2020, TAVR programs have had multi-professional society guidance, the current TAVR NCD 20.32, and empirical evidence for the roles needed for hospitals to justify essential, interprofessional Heart Team infrastructure to furnish TAVR: coordinators, advanced practice clinicians, and nurses. (Otto 2017, Bavaria 2018, Nishimura 2019, Perpetua 2019, Otto 2021)

The proposed NCD creates a mandatory and discretionary tier of Heart Team membership criteria, using the language “must include” for the interventional cardiologist and cardiac surgeon and “may include” for advanced practice clinicians and nurses, among others. To date, there is no evidence or guideline available, or provided in the CMS evidence review, to support changing the interprofessional Heart Team infrastructure of advanced practice clinicians and nurses from mandatory to discretionary.

REQUESTS FOR THE FINAL NCD

1. Add a valve coordinator as a required criterion of the Heart Team / program facilities requirement, consistent with the ventricular assist device NCD (20.9.1) and renal denervation NCD (CAG-00470N), multi-professional society guidance, and evidence presented in the full public comment. (Otto 2017; Bavaria 2018; Nishimura 2019; Otto 2021)
2. Restore the advanced practice clinician (nurse practitioner, clinical nurse specialist, or physician associate) as a required criterion of the Heart Team / program facilities requirement, consistent with the current TAVR NCD (20.32), multi-professional society guidance, and evidence presented in the full public comment. (Bavaria 2018; Nishimura 2019)
3. Restore nurses as a required criterion of the Heart Team / program facilities requirement, consistent with the current TAVR NCD (20.32) and evidence presented in the full public comment.
4. Convene a CMS meeting that includes valve coordinators and advanced practice clinicians. This workforce possesses deep knowledge and experience most proximal to patients and NCD implementation and should be heard directly before the Final NCD is issued.

Crosswalk:

Current NCD (20.32), Nationally Covered Indications A2: MUST INCLUDE (a) …cardiac surgeon, interventional cardiologist…, (b)…other physicians, advanced patient practitioners, nurses...

Proposed NCD (CAG-00430R2), Provision B2, Physician and Heart Team Criteria: (a) MUST INCLUDE cardiac surgeon, interventional cardiologist; (b) MAY INCLUDE other physicians, advanced practice clinicians, nurses...

Requested language for the Final NCD: MUST INCLUDE cardiac surgeon, interventional cardiologist, coordinator, advanced practice clinicians, and nurses…

RATIONALE

Harm in patients with severe aortic stenosis accrues in delay before treatment, not during it. Mortality while awaiting valve replacement reaches 11.6% at six months, and contemporary U.S. data show that evaluative encounters, cardiac specialist visits and imaging, explain approximately 83% of the excess time to treatment for TAVR compared to SAVR. (Malaisrie 2014; Stinis 2026) A national registry study corroborates that this is not hypothetical: investigators reported that “whether and when a multidisciplinary heart team evaluation occurred was sometimes difficult to ascertain due to the lack of an explicit process at many centers or confusion regarding which clinicians comprised the heart team.” (Lindman 2023)

Professional society guidance has named valve coordinators and advanced practice clinicians as Heart Team members and institutional facilities requirements since 2017. (Otto 2017, Bavaria 2018, Nishimura 2019, Otto 2021) A national survey confirms who is responsible for the implementation that the NCD mandates: 82% of structural heart coordinators hold a nursing degree, and coordinators screen referrals, ensure completion of Heart Team evaluation, and coordinate care across the continuum. (Perpetua 2019) In the EVOLVE study, the first multicenter, mixed methods study of U.S. TAVR Heart Teams, physicians named coordinators and advanced practice clinicians as essential, central team members without prompting. Exemplar quotes included: from an interventional cardiologist, “The core members of the team are obviously my valve coordinator... that's pretty much the only way that we're able to do anything and get it done in a timely fashion” and, from a cardiac surgeon, "The nurse practitioners are actually absolute key, I think, more than really any of us, because all of us are interchangeable, but the advanced practice clinician and the people she works with are really central. It really is driven by them." (Coylewright 2026; Kolte 2026) When these roles are defined and deployed, outcomes improve: the BENCHMARK registry, isolating the coordinator role through propensity matching across 2,323 patients in 7 countries, found significantly shorter length of stay and fewer complications, without a safety penalty. (Lauck 2026)

Naming these roles as essential Heart Team membership and facilities requirements would align the Final NCD with CMS’ own precedent. CMS already identifies “advanced practice clinicians, nurses” as mandatory Heart Team members in the current TAVR NCD (20.32). CMS already names a program coordinator in the ventricular assist device NCD (20.9.1) and a hypertension navigator in the renal denervation NCD (CAG-00470N).

WHO WE ARE

The undersigned are patient advocates and clinical valve coordinators, advanced practice clinicians, nurses, and physicians who operationalize TAVR programs and Heart Teams across the United States. We support Dr. Perpetua's public comment and its four requests, and we ask that CMS name this Heart Team implementation infrastructure – valve coordinators, advanced practice clinicians, and nurses – as mandatory in the Final NCD.

CO-SIGNATORIES

The following organizations join in these requests.

1. Heart Valve Voice US. Washington, DC.

The following Heart Team colleagues join in these requests.

1. Jenna Abington, BSN, RN. Structural Heart Program Manager. Huntsville Hospital, Huntsville, AL.

2. Yousif Ahmad, MBBS, PhD, FACC, FSCAI. Structural Interventional Cardiologist and Director of Complex Coronary Intervention, Division of Cardiology, University of California San Francisco, UCSF Health, San Francisco, CA.

3. Wayne Batchelor, MD, MHS, FACC, FSCAI. Director of the Interventional Heart Program, Inova Health System Director of Interventional Heart Disease Research, Education, and Innovation; Associate Director, Inova Heart and Vascular Institute. Inova Heart and Vascular Institute, Falls Church, VA.

4. Russell Brandwein, MS, PA-C, AACC. Physician Associate and Executive Leadership. Executive Director, Columbia Interventional Cardiovascular Care and Columbia Structural Heart and Valve Center. Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, NY.

5. Marcus R. Burns, DNP, RCIS, AACC. Lead Advanced Practice Provider, Structural Heart. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN.

6. Christina Cantey, DNP, FNP-C, CCK, FACC. Structural Heart Program Nurse Practitioner. Huntsville Hospital, Huntsville, AL.

7. Ken Chan, ACNPC-AG, CCK, CCRN, RCIS, AACC. Structural and Interventional Cardiology Acute Care Nurse Practitioner. University of Texas Health, Houston, TX.

8. Richard Cheng, MD, FACC, FSCAI. Structural Interventional Cardiologist and Heart Failure Specialist. Associate Director of Interventional Cardiology, Director of Structural Interventional Cardiology Research, Interventional and Advanced Heart Failure Transplant Cardiology, Division of Cardiology, Department of Medicine, University of California Los Angeles, UCLA Health, Los Angeles, CA.

9. David J. Cohen, MD, MSc. Structural Interventional Cardiologist. St. Francis Hospital and Heart Center, Roslyn, NY.

10. Megan Coylewright, MD, MPH, FACC, FSCAI. Structural Interventionalist/Interventional Cardiologist. Essentia Health, Duluth, MN.

11. Ashley Dacey, DNP, AGACNP-BC, CCK. Structural Heart Nurse Practitioner. Banner University Cardiovascular Institute, Phoenix, AZ.

12. Jennifer Daniel, RN. Structural Heart and Valve Clinic Coordinator. University of Colorado Medical Center of the Rockies.

13. Sara Dezell, APRN, CNS. Clinical Nurse Specialist, CentraCare Heart and Vascular Center, St. Cloud, MN.

14. Abdallah El Sabbagh, MD. Interventional and Structural Cardiologist. Mayo Clinic, Jacksonville, FL.

15. Sammy Elmariah, MD, MPH, FACC, FSCAI. Chief, Interventional Cardiology and Director, Cardiac Catheterization Laboratory. Cardiology Division, Department of Medicine, University of California San Francisco, UCSF Health, San Francisco, CA.

16. Nathan Ferreira, MPAS, PA-C. Physician Associate. Interventional and Structural Program Manager, Interventional Program/Structural Heart Disease Program/Adult Congenital Heart Disease Program. Intermountain Health, Murray, UT.

17. John Frederick, MD. Cardiothoracic Surgeon. Division Chief, Cardiothoracic Surgery, Sanger Heart and Vascular Institute, Charlotte, NC.

18. Philippe Généreux, MD. Interventional Cardiologist. Co-Director, Structural Heart Disease Program, Morristown Medical Center, Morristown, NJ.

19. Kimberly A. Guibone, DNP, ACNP-BC, FACC. Cardiology Nurse Practitioner. Beth Israel Deaconess Medical Center, Boston, MA.

20. Tanush Gupta, MD. Structural and Interventional Cardiologist. Assistant Professor, Larner College of Medicine, University of Vermont Medical Center, Burlington, VT.

21. T. Sloane Guy, MD, MBA. Director of Robotic and Minimally Invasive Cardiac Surgery, The Georgia Heart Institute at Northeast Georgia Medical Center, Gainesville, GA.

22. Abdul Moiz Hafiz, MD. Interventional Cardiologist. Director, Structural Heart Program; Division of Cardiology; Southern Illinois University School of Medicine. Springfield, IL.

23. Marian Hawkey, RN. Nurse Project Lead, Structural Heart. Hackensack University Medical Center, Hackensack, NJ. Officer, Transcatheter Valve Research, Division of Cardiology. Columbia University Irving Medical Center. New York, NY.

24. Lynn Hickman, MSN, AGACNP-BC. Valve Clinic Coordinator, Ascension Alexian Brothers, Elk Grove Village, IL

25. Jeanne Huchting, ACNP. Structural Heart Program Nurse Practitioner. UCLA Medical Center. Los Angeles, CA.

26. Ignacio Inglessis-Azuaje, MD. Interventional Cardiologist. Program Director, Structural Heart Disease Program, Massachusetts General Hospital, Boston, MA.

27. Douglas R. Johnston, MD, FACS. Chief of Cardiac Surgery, Surgical Director, Bluhm Cardiovascular Institute, Northwestern Medicine; Patrick McCarthy Professor of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL.

28. Clayton A. Kaiser, MD. Cardiac Surgeon. Aortic Director, Ascension Saint Thomas Heart, Nashville, TN.

29. Tsuyoshi Kaneko, MD. John M. Shoenberg Chair of Cardiovascular Medicine; Division Director of Cardiothoracic Surgery, Washington University School of Medicine; Co-Director, Heart and Vascular Center, Barnes Jewish Hospital. St. Louis, MO.

30. Hyo Jin Kang, MSN, APRN, AGNP-C. Nurse Practitioner and Clinical Director, Structural Heart Program. The Mt. Sinai Hospital, New York, NY.

31. V. Antoine Keller, MD, FACC, FACS. Professor and Chief, Division of Cardiac Surgery. University of Mississippi Medical Center, Jackson, MS.

32. Dhaval Kolte, MD, PhD, MPH, FACC, FSCAI. Structural Interventional Cardiologist, Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School, Boston, MA.

33. Dharam J. Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCAI. Interventional Cardiologist. Jim and Norma Smith Distinguished Chair for Interventional Cardiology, Professor of Medicine UT Southwestern Medical Center; Section Chief, Interventional Cardiology; Cardiac Catheterization Lab Director, William Clements University Hospital. Dallas, TX.

34. Tana La Placa, DNP, MSN, APN-BC, RNFA. Nurse Practitioner. Outpatient Clinical Coordinator, Division of Cardiothoracic Surgery, Department of Cardiac Surgery, Rutgers Robert Wood Johnson Medical School. New Brunswick, NJ.

35. Martin B. Leon, MD. Interventional Cardiologist. Professor Emeritus, Cardiology Division, Columbia University Medical Center; Executive Chairman for Research, Education, and The Leon Center for Transformative Innovation, Cardiovascular Research Foundation. New York, NY.

36. Brian R. Lindman, MD, MSc, FACC. Clinical/Imaging Valve Specialist, Administrative Leadership, and Researcher. Medical Director, Structural Heart and Valve Center. Vanderbilt University Medical Center, Nashville, TN.

37. J. Gregory Lugo, MD. Cardiovascular and Thoracic Surgeon. Heart & Vascular Center, Lake Charles Memorial Hospital, Lake Charles, LA.

38. Michael J. Mack, MD. Chair, Cardiovascular Governance Council and Medical Director, Cardiovascular Surgery, Baylor Scott and White Health, Dallas, TX.

39. Rebecca Marcantuono, MSN, CRNP, ACNP-BC. Acute Care Nurse Practitioner and Structural Heart Valve Coordinator. Jefferson Health, Philadelphia, PA.

40. Joan Michaels, MSN, RN, FACC. Washington, DC.

41. Rose Nguyen, MBA. Administrative Director. Empath Health Services, Seattle, WA.

42. Tom C. Nguyen, MD, FACS, FACC. Professor and Chair, Department of Cardiovascular Sciences at Florida International University; System Chief Executive of Baptist Heart and Vascular Care; Director of Minimally Invasive Valve Surgery; Barry T. Katzen Endowed Chair.

43. Kristin Pasquarello, MPAS, PA-C. Administrative Director – Heart Valve Center. The Heart Valve Center, Physician Partners Medical Group, Roslyn, NY.

44. Mary Petersen, RN. Structural Heart Manager. St. Luke's Hospital, St. Louis, MO.

45. Andrei Pop, MD. Interventional Cardiologist. Ascension Medical Group Illinois – Heart and Vascular Care, Elk Grove, IL.

46. Dianna Ramsey, BSN, RN. Clinical Director. Empath Health Services, Seattle, WA.

47. Michael J. Reardon, MD. Professor and Chief of Cardiac Surgery. Allison Family Distinguished Chair of Cardiovascular Research. Houston Methodist Hospital, Houston, TX.

48. Caitlin O’Callaghan Reen, CNP, FACC. Lead Advanced Practice Provider, Structural Heart Program. Massachusetts General Hospital, Boston, MA.

49. Cara C. Richardson. MSN, ACNP-BC, AACC. TAVR Program Coordinator. Tennessee Valley Healthcare System, US Dept of Veterans Affairs, Nashville, TN.

50. Michael Rinaldi, MD, FSCAI. Structural Interventional Cardiologist. Structural Heart Medical Director, Sanger Heart and Vascular Institute, Charlotte, NC.

51. Isabelle Rittenhouse, MHA, BSN, RN. Clinical Outcomes Specialist, STS/ACC TVT and LAAO Registries, Inova Shar Heart and Vascular, Falls Church, VA.

52. Mark Russo, MD. Chief of Cardiac Surgery, Professor of Surgery, and Director of Structural Heart Disease at Rutgers Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital. New Brunswick, NJ.

53. Nancy Satou, RN. Clinical Informatics Specialist, David Geffen UCLA School of Medicine, Department of Surgery, Division of Cardiac Surgery, Division of Thoracic Surgery, Los Angeles, CA.

54. Falin Schaefer, DNP, FNP-C. Nurse Practitioner, Transcatheter Heart Valve Program, Stanford Healthcare, Palo Alto, CA.

55. Susan J. Schnell, MSN, ACNP-BC. Administrative Leadership. Chief Operating Officer, Columbia Heart Source. New York, NY.

56. Jonathan Schwartz, MD. Structural Cardiologist. Advocate Health Enterprise Medical Director of Innovation, Advocate Health, Charlotte, NC.

57. Catherine Shah, DNP, FNP-C, AACC. Nurse Practitioner/Structural Heart Clinical Program Lead Advanced Practice Provider, Sanger Heart and Vascular Institute, Atrium Health, Charlotte, NC.

58. Richard J. Shemin, MD. Robert & Kelly Day Chair in Cardiothoracic Surgery, Chief of Cardiothoracic Surgery, David Geffen UCLA School of Medicine, University of California Los Angeles; Co-Director of the Cardiovascular Center, UCLA Ronald Reagan Medical Center. Los Angeles, CA.

59. Eric Skipper, MD. Cardiothoracic Surgeon, Structural Heart Surgical Director, Sanger Heart and Vascular Institute, Charlotte, NC.

60. Martina Kelly Speight, MSN, FNP-BC. Transcatheter Valve Nurse Practitioner. Stanford Health Care, Stanford, CA.

61. Misty Theriot, BSN, RN, CPHQ, FACC. Valve Clinic Coordinator, STS/ACC TVT Registry Site Manager. Heart and Vascular Center, Cardiovascular-Thoracic Surgery. Lake Charles Memorial Hospital, Lake Charles, LA.

62. Melissa Todice, MSN, ARNP, FNP-BC, CCK. Lead Structural Heart Nurse Practitioner. Yale New Haven Hospital, New Haven, CT.

63. Lindsey von Kiel, DNP, AGNP-BC. Nurse Practitioner Coordinator. The Heart Valve Center, Physician Partners Medical Group, Roslyn, NY.

64. Evelyn H. Wilder, MSN, FNP-BC, CPHQ, AACC. Clinical Effectiveness Consultant IV, Clinician. Structural Heart, Sutter Health, Sacramento, CA.

65. Janet Fredal Wyman, DNP, ACNS-BC, FACC. Clinical Nurse Specialist, Structural Heart and Valve Disease. Henry Ford Health. Detroit, M.

REFERENCES

1. Malaisrie SC, McDonald E, Kruse J, et al. Mortality while waiting for aortic valve replacement. Ann Thorac Surg. Nov 2014;98(5):1564-70; discussion 1570-1. doi:10.1016/j.athoracsur.2014.06.040

2. Stinis C, Tunis S, Lauck S, et al. Impact of pre-procedural requirements on time to aortic valve replacement: Transcatheter AVR vs surgical AVR. Am Heart J Plus. Jan 2026;61:100698. doi:10.1016/j.ahjo.2025.100698

3. Lindman BR, Fonarow GC, Myers G, et al. Target Aortic Stenosis: A National Initiative to Improve Quality of Care and Outcomes for Patients With Aortic Stenosis. Circ Cardiovasc Qual Outcomes. Jun 2023;16(6):e009712. doi:10.1161/circoutcomes.122.009712

4. Otto CM, Kumbhani DJ, Alexander KP, et al. 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults with Aortic Stenosis. A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. 2017;doi:10.1016/j.jacc.2016.12.006

5. Bavaria JE, Tommaso CL, Brindis RG, 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, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. 2018;doi:10.1016/j.jacc.2018.07.002

6. Nishimura RA, O’Gara PT, Bavaria JE, et al. 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 Society of Thoracic Surgeons. 2019;73(20):2609-2635. doi:10.1016/j.jacc.2018.10.007

7. Otto CM, Nishimura RA, Bonow RO, 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. Feb 2 2021;77(4):e25-e197. doi:10.1016/j.jacc.2020.11.018

8. Perpetua EM, Clarke SE, Guibone KA, Keegan PA, Speight MK. Surveying the Landscape of Structural Heart Disease Coordination: An Exploratory Study of the Coordinator Role. Structural Heart. 2019/05/04 2019;3(3):201-210. doi:10.1080/24748706.2019.1581962

9. Coylewright M, Kolte D, Kruse G, Strong S, Elmariah S, Suri R, Perpetua EM. A Multicenter, Mixed Methods Study of United States Heart Teams and Health Policy: The EVOLVE Study Design and Protocol. Journal of the Society of Coronary Angiography and Interventions. 2026; in press.

10. Kolte D, Perpetua E, Kruse G, et al. EVolution Of heart vaLVe teams and the patient Experience (EVOLVE): A Multicenter, Mixed Methods Study of TAVR Programs Across the U.S. June 25, 2026. Invited late breaking science abstract for New York Valves. New York, NY.

11. Lauck SB, Saia F, Durand E, et al. Impact of a Clinical Valve Coordinator on Hospital Length of Stay and Patient Outcomes: Results From the BENCHMARK Registry. Struct Heart. Jan 2026;10(1):100740. doi:10.1016/j.shj.2025.100740

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As a cardiac surgeon at a high-volume TAVR center, I work alongside our structural cardiologists as part of the Heart Team caring for patients with aortic stenosis. The outstanding outcomes achieved with TAVR in the United States are not the result of a single technology or specialty, but of an evidence-based, multidisciplinary approach. A formal evaluation by both a structural cardiologist and a cardiac surgeon remains important, particularly as TAVR is increasingly offered to younger and lower-risk patients where anatomy, lifetime valve management, future coronary access, and the role of surgery deserve careful consideration as part of shared decision-making.

The collaborative dual-operator model has been a defining strength of TAVR programs and should be preserved. Although complications are uncommon, they can be sudden and life-threatening, and having both procedural specialists actively involved provides the expertise needed to optimize outcomes when unexpected events occur. As indications continue to expand, it is equally important that national policy continue to support ongoing evidence development through the TVT Registry and clinical research, particularly for low-risk patients, bicuspid aortic valve disease, and valve-in-valve procedures where important questions remain. These principles have served our patients well and should continue to guide the evolution of TAVR care.

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Thank you for the opportunity to provide my thoughts and comments on the proposed Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination.

I currently serve as the Senior Director for the Cardiovascular, Neuroscience and Spine Service Lines for the University of Colorado Health's Southern Colorado Region where I oversee multiple TAVR programs. The region consists of and serves a geographically dispersed population across urban, mountain, frontier, and rural communities throughout southern Colorado, northern New Mexico, northwestern Texas, and western Kanas. Collectively, these programs care for patients who often travel substantial distances to access advanced structural heart services. As a result, I am particularly appreciative of the thoughtful flexibility reflected in this proposal and its recognition of the unique access challenges faced by patients outside major metropolitan areas.
For many of our patients, access to care is not simply a matter of scheduling an appointment. Patients frequently travel several hours, through mountain passes, along the plains, with the need to arrange overnight stays to reach a structural heart program. Many are older adults living on fixed incomes who face significant costs associated with transportation, lodging, parking, meals, caregiver support, copayments, and coinsurance. As a result, policies that require additional visits or create unnecessary delays can have a meaningful impact on both access and affordability.
These barriers disproportionately affect patients living in rural and frontier communities, creating healthcare access disparities that can be difficult to overcome without thoughtful policy flexibility. Reducing unnecessary burdens while preserving quality standards is an important step toward improving equitable access to life-saving cardiovascular care.

For this reason, I support the proposed evaluation flexibilities. Maintaining the Heart Team is essential and should remain a cornerstone of high-quality valve care. However, preserving the Heart Team does not require every patient to follow the same resource-intensive pathway. The ability to leverage multidisciplinary review while streamlining evaluations for straightforward patients will reduce travel demands, shorten wait times, and help patients navigate the treatment process more efficiently. In a region where a single clinic appointment can require a full day of travel, these changes will have a tangible impact on patients and families.

I also support the proposed expansion of coverage for severe asymptomatic aortic stenosis. In geographically dispersed populations, delays in treatment can be particularly problematic because patients may not have easy access to ongoing surveillance or rapid evaluation when symptoms develop. Earlier intervention may provide an opportunity to address disease progression before patients experience clinical deterioration and may reduce the challenges associated with delayed recognition of symptoms among geographically isolated populations. Aligning coverage with contemporary evidence allows patients to receive treatment at a more appropriate point in their disease course rather than waiting for significant clinical decline.

Another important aspect of the proposal is operator flexibility. From a regional health system perspective, the ability to determine the most appropriate operator model based on local resources and patient needs is critical. Coordinating multiple specialists across large service areas can create scheduling constraints that delay treatment, particularly for urgent cases. TAVR programs today operate in an environment very different from when the original NCD was established. Clinical experience has grown substantially, technology has advanced, and outcomes continue to improve. The most important safeguards for patients are an experienced Heart Team that includes both surgical and procedural physicians working jointly, demonstrated programmatic outcomes, robust quality oversight, and immediate access to advanced cardiovascular services—not a one-size-fits-all procedural model, but allows each program to be established without relaxing on quality outcomes and processes.

The proposal also appropriately recognizes the workforce realities facing healthcare organizations. Recruiting and retaining specialized cardiovascular clinicians is increasingly challenging, particularly in rural communities. These pressures are expected to continue as workforce shortages deepen over the coming decade. Policies that provide flexibility while preserving accountability will allow health systems to deploy highly specialized expertise where it is needed most and help ensure continued access to high-quality cardiovascular care for patients living far from major metropolitan centers.

Ultimately, what I find most compelling about the NCD draft is that it strengthens patient access without sacrificing quality. It preserves the principles that have made TAVR programs successful while removing barriers that can create unnecessary burdens for patients, families, and healthcare teams. For health systems serving large geographic regions, these changes will help deliver timely care when it is needed, reduce avoidable travel and expense, and better meet the needs of the communities we serve.

Thank you for allowing and considering my comments and for your continued commitment to ensuring that Medicare beneficiaries have equitable access to safe, high-quality, and evidence-based cardiovascular care.

Sincerely,

Bradden Cannon
Senior Director, Cardiovascular, Neuroscience and Spine Service Lines
UCHealth Southern Colorado Region

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July 15, 2026

Submitted electronically via the CMS Medicare Coverage Database

Sarah Fulton, MHS, Lead Analyst
Joseph Hutter, MD, MA, Lead Medical Officer
Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2)

Dear Ms. Fulton and Dr. Hutter:

JenaValve Technology, Inc. (JenaValve) appreciates the opportunity to comment on the proposed decision memorandum for the national coverage determination (NCD) on transcatheter aortic valve replacement (TAVR), national coverage analysis (NCA) CAG-00430R2, issued June 15, 2026. JenaValve is the manufacturer of the Trilogy aortic valve, the first and only transcatheter therapy approved by the U.S. Food and Drug Administration (FDA) for aortic regurgitation (AR), under premarket approval (PMA) P250024, granted March 17, 2026, for symptomatic, severe native-valve AR at high or greater surgical risk. We are grateful for the care with which the Centers for Medicare & Medicaid Services (CMS) has stewarded the TAVR evidence base since 2019, and for the agency’s consideration of JenaValve’s comment during the first comment period.

I. Introduction and Interest of JenaValve
AR at high or greater surgical risk is principally a disease of older adults, and JenaValve’s interest in this reconsideration is an interest in the Medicare beneficiaries that will live with the determinations of the final TAVR NCD language.
The guiding principle of these comments is the intent to calibrate the requirements to the presence or absence of sufficient evidence to guide clinical practice. As such, it is prudent to reduce the burden for the settled, guideline-supported, on-label population and to preserve the requirement for high quality data collection and heart-team safeguards where clinical paradigms are uncertain and patient safety concerns remain high. Framed this way, some but not all of the relief the NCD requestor seeks track with protection of patient centered outcomes.
We present our support for the proposed burden relief and four numbered requests, and we respectfully ask for a specific response to each in the final decision memorandum. Requests 1 through 3 operate entirely within provisions that the current NCD and the draft already contain and require no determination beyond aortic stenosis (AS); Request 4 is structured so that this most novel element can be declined without disturbing the rest.

II. JenaValve’s Positions in Brief
As written, the draft does not confine coverage to AS: in operation it covers the full spectrum of aortic valve disease, delivered only through off-label use of systems designed for stenosis, freely and with no registry requirement. That is the patient-safety issue that weighs most heavily on JenaValve.
In plain terms, JenaValve asks CMS to do four things, without disruption to on-label AS care:

• Support the reporting burden relief for on-label symptomatic, severe AS TAVR: the Coverage with Evidence Development (CED) sunset, the surgical volume requirement modernization, and the streamlined evaluation.
• Retain a registry-reporting requirement for patients undergoing TAVR with indications that are outside the severe, symptomatic, tricuspid aortic stenosis FDA indication and for newly FDA-approved TAVR indications, with each of these eventually graduating out of CED as its evidence base matures.
• Maintain the requirement for documented cardiac surgical and interventional cardiology evaluation prior to every TAVR, in whatever format each specialty performs the evaluation.
• Cover TAVR for symptomatic, severe native-valve aortic regurgitation (AR), the newly FDA-approved indication, under the same CED pathway the draft proposes for asymptomatic AS. If CMS is not prepared to do so in this decision, the final NCD should state expressly that it neither covers nor precludes coverage of TAVR for AR, leaving determinations to the Medicare Administrative Contractors (MACs) pending a separate national coverage analysis. Silence will be read as non-coverage.

III. JenaValve’s Positions in Direct Reference to the Proposed Language
A. Support for the Proposed Burden Relief for On-Label AS TAVR
JenaValve supports the burden relief that the draft extends to on-label TAVR for symptomatic, severe AS: the sunset of Coverage with Evidence Development (CED), the modernization of the volume requirements, and the streamlined patient evaluation. These provisions recognize a mature evidence base, and subsequent requests do not alter this population. The requests are each calibrated so that on-label AS populations maintain every element of the proposed relief. JenaValve respectfully requests that CMS finalize these provisions as proposed.
B. Request 1: Do Not Narrow the Scope of NCD 20.32; Clarify the Scope of the Final Decision in Its Operative Text, and Retain the Existing Title
The current NCD does not have an AS-only scope. Since 2019 it has covered TAVR beyond each system’s FDA-approved indication through CED, and CMS has approved studies under the NCD on exactly that basis, including JenaValve’s AR studies. The question this reconsideration presents is not whether to extend the NCD beyond AS but rather whether to narrow it. It should not be narrowed.
CED already supplies the mechanism by which AR uses, including the FDA-approved AR indication, may be covered while their evidence matures, as Request 4 develops in full. Preserving that continuity requires no determination beyond AS: only a manual section, set out in the enclosure, confirming that TAVR for uses this NCD does not address, whether for AR or otherwise off-label, may be covered pursuant to a CMS-approved study or registry under CED.
Section II.C of the proposed decision memorandum offer the most salient points for consideration: this NCD addresses TAVR for AS and does not address TAVR for other conditions, naming AR specifically. The operative coverage text, however, is silent regarding AR. The savings clauses (Section I.C of the decision summary and Section D of the Appendix A manual language) preserve contractor discretion only for beneficiaries seeking TAVR for AS; and the draft would retitle NCD 20.32 as TAVR for Aortic Stenosis. Taken together, that combination invites the conclusion that the final NCD excludes AR altogether. The concern has a mechanism: under the 2019 NCD, AR treated off-label with an AS-approved system sits inside the framework through the off-label CED condition, so it is the proposed deletion of that condition, compounded by the retitle, that would place those cases outside it.
The clarification also carries operational weight, because the operative text is the only place an AS-only boundary can actually live. The aortic valve disease patient travels one diagnostic pathway whether the echocardiogram ultimately shows AS, AR, or mixed disease, and the draft’s payment condition is label-blind: an AS-approved system holds PMA for its own indication whatever anatomy it is placed in, coverage is not determined by the valve pathology, and with the off-label CED condition deleted, no registry any longer captures the valve pathology that separates on-label from off-label use. The AS-only scope exists on paper only. In practice, the draft covers the full spectrum of aortic valve disease, only through off-label use of AS-approved systems, freely and with no registry requirement, despite known dangers of this approach. The proposed NCD scope is enforceable only against the one system actually labeled for AR, unenforceable against every system that is not indicated for native AR. That is why the boundary the agency intends must be stated in the operative text rather than left to inference.
JenaValve therefore requests that CMS not narrow the scope of NCD 20.32 and that, to the extent the final decision nonetheless states an AS-only scope, CMS (a) carry the Section II.C scope sentence, the agency’s own, into Section A of the Appendix A manual language, where contractors and the field will actually encounter it; (b) delete the two for-AS limiters in the savings clauses, or add one sentence to the same effect, so those clauses cannot be misread as excluding by negative implication uses the NCD does not address; (c) retain the existing title of NCD 20.32; and (d) add the manual section set out in the enclosure, confirming that TAVR uses this NCD does not address, whether for AR or otherwise off-label, may be covered under CED pursuant to a CMS-approved study or registry. JenaValve respectfully requests that CMS specifically address this request in the final decision memorandum and, should the agency decline, identify the evidence and reasoning on which it relies.
C. Request 2: Finalize Hospital Criterion B3(c) So That Registry Participation Satisfies It, and Require Registry Capture for Every Use Outside a System’s FDA-Approved Indication and for Every CED Indication
Approximately one in ten AS TAVR procedures has been performed off-label: 9.5% of 23,847 procedures in the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry from 2011 to 2014, with per-center rates as high as 34.7% (Hira et al., JAMA Cardiology 2017). Bicuspid anatomy alone, excluded from every pivotal trial, now accounts for roughly 10% of contemporary TAVR (American College of Cardiology, April 2024). As distinct measurements from different periods, the two mark the 2017 figure as a floor, as TAVR has approximately doubled since 2017, rising from roughly 50,000 procedures annually (Vemulapalli et al., 2019) to 72,991 procedures in 2019, the first year that TAVR volume exceeded all forms of surgical aortic valve replacement (Carroll et al., 2020), and surpassing 100,000 annual procedures by 2023, with 100,501 procedures performed across 838 US sites (Cleveland Clinic, 2025). For these patients and other clinical situations such as with leaflet modification, shock states and complex anatomy, best practices and outcomes remain unknown or described only in selected populations. Furthermore, patient risk stems from case selection and long-term adverse outcomes, not implant technique alone. In NOTION-2, low-risk bicuspid patients had a higher one-year stroke rate with TAVR than with surgery (5.4% versus 1.6%) and more paravalvular regurgitation, and in PARTNER 2, transthoracic access showed a five-year rate of death or disabling stroke of 59.3% versus 48.3% for surgery, findings reflected in the memorandum’s own evidence review.
Those figures are knowable only because the current NCD conditions coverage of off-label use on CED with consecutive TVT capture, which is also what enables identification of underserved populations. The draft removes that safety net while relying on it: the Vekstein 2025 analysis supporting termination of CED is itself TVT Registry data; National Quality Forum (NQF) #3610 is computed from the registry; Section B4 states that any future reconsideration would consider answers to the CED questions; and the coverage analysis recognizes the broader quality-measurement role of registries. The draft also removes facility volume floors and invites new programs while carrying forward only a general, nonspecifc “continuous quality improvement process” (proposed NCD § B.3). Absent a national registry-reporting requirement, by what mechanism will CMS identify whether newly established TAVR programs are performing to accepted standards?
The requirement is also proportionate to its object: every alternative source of these critical data cost more and create more missingness within the dataset. Participation in the TVT registry costs a fraction of what commercial data sources such as Optum, IQVIA, Truveta, or Definitive Healthcare charge, and far less than what any single innovator would spend standing up its own national post-approval registry, the very burden Section II describes. Claims data cannot close the gap due to the Medicare Provider Analysis and Review (MedPAR) file lacking the clinical elements, the etiology, morphology, hemodynamic severity, and functional status, on which meaningful TAVR outcomes analysis depends. Nor is a manufacturer’s registry the answer as an industry-run registry invites designs aligned to commercial goals; a shared registry stewarded by the professional societies does not.
The UK TAVI registry of the National Institute for Cardiovascular Outcomes Research (NICOR) and the FRANCE TAVI registry are built on the TVT registry’s consecutive, national, society-stewarded capture of transcatheter valve therapy. The partnership among FDA, CMS, and the professional societies that this registry represents is internationally recognized and respected for the value it brings to patients and health systems. The TVT registry is the rare thing in healthcare that is simultaneously the cheapest option, the best option, and the least conflicted option.
JenaValve therefore requests that hospital criterion B3(c) be finalized so that participation in the TVT registry is deemed to satisfy the continuous-quality-improvement requirement, and so that such participation is required, at a minimum, for every TAVR furnished outside the FDA-approved indication of the system used and for every indication furnished under CED, with data elements on demographics, etiology, and morphology aligned across FDA, CMS, and the registry’s professional-society stewards. The mechanism is operationally simple: an on-label opt-out at case submission for on-label symptomatic AS, while a hospital that simply continues consecutive all-comer enrollment, which is the registry’s methodological standard and the simplest single workflow, satisfies B3(c) automatically. The settled population graduates from CED and mandatory reporting exactly as the draft provides. JenaValve respectfully requests that CMS specifically address this request in the final decision memorandum and, should the agency decline, identify the evidence and reasoning on which it relies.
D. Request 3: Maintain the Documented Cardiac Surgical and Interventional Cardiology Evaluation Prior to Every TAVR
The requirement for documented evaluation by cardiac surgery and interventional cardiology before every TAVR is a patient-safety safeguard that has served Medicare beneficiaries well. The proposed Patient Evaluation criteria would replace it with an initial heart-team review, which may be conducted asynchronously by record review, and a single independent evaluation by one TAVR operator (proposed NCD § B.2). As Request 2 describes, the risk in the populations of concern stems from case selection and long-term outcome, and there is no workable definition of a complex TAVR by which to legislate which cases warrant both perspectives and which do not; the requirement should therefore apply to every TAVR. Because the request is format-flexible, leaving to each specialty the manner in which it performs and documents its evaluation, it is fully compatible with the streamlined evaluation the draft proposes and that JenaValve supports in Section II.
JenaValve therefore requests that the final NCD maintain the requirement for documented cardiac surgical and interventional cardiology evaluation prior to every TAVR, in whatever format each specialty performs the evaluation. JenaValve respectfully requests that CMS specifically address this request in the final decision memorandum and, should the agency decline, identify the evidence and reasoning on which it relies.
E. Request 4: Finalize the Decision at the Level of Aortic Valve Disease, with One Coverage Rule
TAVR now spans the whole spectrum of aortic valve disease: on-label for AS; on-label for AR where Trilogy is available; and off-label, with systems designed for stenosis, everywhere else. A patient who arrives in heart failure travels the same diagnostic pathway whichever lesion the echocardiogram reveals, and the joint comment of the American Association for Thoracic Surgery, the American College of Cardiology, the Heart Failure Society of America, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons in this reconsideration’s first comment period recommends that the indication be written at the level of aortic valve disease. JenaValve asks that the final decision adopt that scope and apply one coherent rule: indications enter coverage under CED with mandatory TVT participation and graduate out as their evidence matures, exactly as symptomatic severe AS now has.
The request has three parts, ordered from least to most novel.
First, retain for off-label uses of AS-approved systems the architecture the current NCD already contains and the draft would delete: coverage conditioned on CED with mandatory TVT participation, and non-coverage of such uses furnished outside CED. This is the 2019 NCD’s rule, coverage of off-label use only in CED studies as the memorandum itself describes it, applied to the same population; non-coverage absent CED is the enforcement edge that makes the data flow, and drawing the covered and non-covered line within AS is a determination about the disease this NCD governs, requiring no reach beyond it.
Second, cover under CED, with mandatory TVT participation, TAVR for symptomatic, severe native-valve AR at high or greater surgical risk. This is the newly FDA-approved indication, phrased by indication rather than by product, though we make no secret that Trilogy presents it. Three considerations support exercising that authority now. The evidentiary reference is already in the record: the 2025 European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines on which the memorandum relies for its AS determinations, including asymptomatic AS, carry a Class IIb, Level B recommendation for TAVR in selected native AR (Section 7 of the guidelines). This request is calibrated to that strength: CED, the same pathway the draft affords asymptomatic AS. The real-world alternative to coverage is not the absence of a procedure but the continued off-label implantation of stenosis valves in non-calcified, dilated AR anatomy, with the malposition, embolization, residual regurgitation, and second valves that mismatch produces. That default remains payable and, under the draft, unmeasured. The result is the asymmetry Request 1 identified: an AS-only scope enforceable against the one system labeled for AR and unenforceable against every system that is not, an outcome we respectfully invite the agency to reconcile with the reasonable-and-necessary standard of section 1862(a)(1)(A) of the Social Security Act.
And the evidence is of a kind CMS’s CED standards accommodate. The ALIGN-AR pivotal (Vahl et al., The Lancet 2024; two-year outcomes, Makkar et al., The Lancet 2025) could not ethically randomize: no device was approved for AR, and conservatively managed symptomatic severe AR carries one-year mortality exceeding 20%. FDA therefore prospectively set objective performance goals within the investigational device exemption protocol, and both co-primary endpoints cleared them by wide margins: observed one-year all-cause mortality of 7.8% (upper confidence bound 12.3%) against a 25% goal anchored to natural history, and a 30-day safety composite of 26.7% (upper bound 34.0%) against a 40.5% goal (p<0.0001). CED scientific standard 5 expressly permits a justified single-arm design, and the randomized surgical comparison is now enrolling in the ARTIST trial (NCT06608823), which we offer as the contemporaneous comparator. Operationalization is equally ready: Trilogy’s New Technology Add-on Payment (NTAP)-linked International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS) code, effective October 1, 2026, makes every AR case identifiable in claims, and this is precisely the gap the FDA-CMS RAPID pathway announced in April 2026 exists to close; Trilogy fits its logic and missed only its timing. If CMS regards the 2025 ESC/EACTS guidelines as an appropriate evidentiary reference for extending coverage to asymptomatic AS, what is the principled basis for affording no weight to the same document’s recommendation for TAVR in selected native AR?
That evidence base has grown since approval. The pivotal experience now spans 700 patients at 30 US sites, and the results held as the cohort grew fourfold: a 30-day safety composite of 24.0%; one-year mortality of 7.7%, superior to the 25% goal rather than merely non-inferior (p<0.0001), and 13.3% at two years; heart-failure hospitalization of 5.1% at one year; reintervention of 1%; and 30-day mortality of 1.6% in a cohort whose mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score predicted 3.8% for surgery (Makkar et al., The Lancet 2025). These are Medicare-aged patients at US sites.
Third, a fallback, so that the novel element cannot jeopardize the rest. If the agency concludes it cannot reach AR within this reconsideration, JenaValve requests that the final decision
(i) say so in terms that neither cover nor foreclose AR, confirming that contractor discretion under section 1862(a)(1)(A), the Clinical Trial Policy (NCD 310.1), and the investigational device exemption pathway remain available in the interim;
(ii) commit to considering TAVR for AR through a prompt separate review, on a complete formal request or on the agency’s own initiative; and
(iii) in any event finalize the off-label architecture in the first part of this request, which stands entirely within AS.
A consolidated set of proposed revisions to the Appendix A manual language, implementing Requests 1 through 4, is below. JenaValve respectfully requests that CMS specifically address each of the three parts of this request in the final decision memorandum and, should the agency decline any of them, identify the evidence and reasoning on which it relies.

IV. Request for Responses in the Final Decision Memorandum
The proposed decision memorandum itself acknowledges that CMS will respond to public comments in the final decision memorandum, as required by section 1862(l)(3) of the Social Security Act. In that spirit, and to aid the agency’s review, JenaValve has presented its views as a statement of support and four discrete, numbered requests, and respectfully asks that the final decision memorandum specifically address each of Requests 1 through 4.

V. Conclusion
The agency’s own precedent supplies a further disposition to consider. In the national coverage analysis of cardiac computed tomographic angiography (CAG-00385N), CMS proposed a national coverage-with-evidence-development policy and, after weighing the public comments, finalized the analysis on March 12, 2008 by making no change to the existing Manual language; and in CAG-00446N, concluded August 30, 2016, CMS completed a full national review on a formal request and determined that no national policy was appropriate at that time, leaving determinations to the contractors case by case. The agency may likewise conclude this reconsideration without adopting the proposed revisions, leaving the 2019 NCD and its CED, registry, and evaluation safeguards in effect. JenaValve does not urge that outcome, and its support for the burden relief in Section III.A is unqualified, but retaining the 2019 NCD in full would be preferable to finalizing a text that removes those safeguards while leaving unstated the scope they policed.
JenaValve is grateful for the seriousness and fairness the agency has brought to this process and for its consideration of these comments.

Respectfully submitted,

John Kilcoyne
Chief Executive Officer
JenaValve Technology, Inc.
4 Cromwell
Irvine, California 92618

Enclosure: Consolidated proposed revisions to the Appendix A Medicare NCD Manual language, implementing Requests 1 through 4. Full proposed redline of revisions sent via USPS overnight to the addressees.

Enclosure: Consolidated Proposed Revisions to the Appendix A Medicare NCD Manual Language, Implementing Requests 1 Through 4
JenaValve proposes the following revisions to the Medicare NCD Manual language set out in Appendix A of the proposed decision memorandum. Except as revised below, JenaValve supports finalizing the Appendix A language as proposed, including the burden relief for on-label AS TAVR described in Section III.A of this letter.

Revision 1 (Request 1(a)): scope statement in Section A. Add to Section A (General) of the manual language the following sentence, carrying the principle of Section II.C of the proposed decision memorandum into operative text: “This NCD addresses TAVR for the treatment of aortic stenosis; it does not address, and takes no position on, TAVR for other conditions, including aortic regurgitation.”

Revision 2 (Request 1(b)): savings clauses. In Section I.C of the decision summary and Section D of the Appendix A manual language, delete the two for-AS limiters so that contractor discretion is preserved for all uses this NCD does not address, or add to each clause the following sentence: “Nothing in this section limits contractor discretion with respect to uses this NCD does not address.”

Revision 3 (Request 1(c)): title. Retain the existing title of NCD 20.32, Transcatheter Aortic Valve Replacement (TAVR), rather than retitling the NCD as TAVR for Aortic Stenosis.

Revision 4 (Requests 1(d) and 4): new section on coverage of other TAVR uses under CED. Add the following new section to the Appendix A manual language: “E. Coverage of Other TAVR Uses Under Coverage with Evidence Development. TAVR for uses this NCD does not otherwise address, whether for aortic regurgitation or otherwise outside the FDA-approved indication of the transcatheter heart valve system used, may be covered pursuant to a CMS-approved study or registry under Coverage with Evidence Development, with mandatory participation in a prospective, national, audited registry such as the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry. TAVR for symptomatic, severe native-valve aortic regurgitation in patients at high or greater surgical risk, furnished in such a study or registry, is covered under this section. TAVR for uses described in this section furnished outside a CMS-approved study or registry is not covered.”

Revision 5 (Request 2): hospital criterion B.3(c). Finalize criterion B.3(c) so that participation in a prospective, national, audited registry is deemed to satisfy the continuous quality improvement requirement, and so that such participation is required, at a minimum, for every TAVR furnished outside the FDA-approved indication of the system used and for every indication furnished under CED, with data elements on demographics, etiology, and morphology aligned across FDA, CMS, and the registry’s professional-society stewards.

Revision 6 (Request 3): patient evaluation. Provide in Section B.2 that, prior to every TAVR, the patient has a documented evaluation by a cardiac surgeon and by an interventional cardiologist, in whatever format each specialty performs and documents its evaluation.

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Thank you for the opportunity to provide comments on the proposed TAVR NCD. As a cardiovascular service line executive responsible for three TAVR programs serving very different patient populations across our health system, I have a unique view into how national policy translates into real-world patient access.

From an operational standpoint, I believe CMS has struck the right balance in this proposal. The expansion of coverage to asymptomatic severe aortic stenosis is appropriate and reflects the growing body of evidence supporting earlier intervention. We routinely see patients whose disease progresses while under surveillance, resulting in avoidable admissions, clinical deterioration, and more complex episodes of care. Earlier treatment offers an opportunity to improve outcomes while reducing the downstream burden associated with delayed intervention.

The proposed evaluation flexibilities are equally important. Many of our patients travel significant distances to receive specialty valve care. Requiring multiple in-person consultations can add weeks to the treatment pathway while creating additional costs and logistical challenges for Medicare beneficiaries and their families. Maintaining the Heart Team while allowing programs flexibility in how evaluations are completed recognizes that not every patient requires the same pathway. This approach supports timely access without compromising care quality.
I also support the removal of the mandatory joint intraoperative participation requirement. In our experience, coordinating the schedules of both a cardiac surgeon and an interventional cardiologist can be one of the greatest barriers to timely treatment, particularly for urgent or non-elective cases.

When patients are symptomatic and deteriorating, treatment should not be delayed because two specialists must simultaneously be available for a procedure that can be safely performed by a qualified operator within an established Heart Team program. This flexibility is also increasingly important from a workforce perspective. Like many health systems, we face ongoing challenges recruiting and retaining highly specialized cardiovascular clinicians. Current workforce pressures are expected to continue over the coming decade, particularly in cardiac surgery. Policies that allow programs to deploy limited resources more effectively will improve access, enhance efficiency, and help ensure sustainability while maintaining high-quality outcomes.
Overall, I believe the proposed changes are practical, evidence-based, and aligned with how high-performing TAVR programs operate today. They will reduce barriers to care, improve treatment timeliness, and allow health systems to better meet the needs of patients across diverse communities while preserving the quality standards that have made TAVR one of the most successful structural heart interventions in modern medicine.
Thank you for your consideration.

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July 15, 2026

Centers for Medicare and Medicaid Services
Attn: Dr. Mehmet Oz, Administrator of the Centers for Medicare and Medicaid Services
Submitted on cms.gov

Re: Comments on Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2)

On behalf of National Taxpayers Union (NTU), the nation’s oldest taxpayer advocacy organization, we write with brief comments on the Centers for Medicare and Medicaid Services’ (CMS) proposed Decision Memo regarding the National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR). NTU was founded in 1969 to achieve favorable policy outcomes for taxpayers with Congress and the executive branch. Our experts and advocates engage policymakers on important matters affecting taxpayers in a variety of settings, including administrative actions that impact health care spending.

Taxpayers have a compelling interest in ensuring that Medicare’s coverage policies encourage the adoption of medical innovations that can meaningfully bend the long-term cost curve of federal health care programs. While new or recently introduced therapies often require high upfront costs, they can yield significant savings down the line by reducing the utilization of health care resources and shortening expensive hospital stays. This has proven especially true in the cardiac space. A growing body of evidence¹ suggests the TAVR procedure, now in its 15th year of use as an alternative for patients who would otherwise be at risk with traditional open-heart surgery, can also provide significant value to Medicare by serving as a less invasive and cost effective alternative to surgical aortic valve replacement (SAVR) for patients suffering from aortic stenosis (AS).

As such, NTU commends CMS for proposing to expand access to TAVR for Medicare beneficiaries. Broadening eligibility to include asymptomatic patients with severe AS under Coverage with Evidence Development (CED), ending certain CED requirements for symptomatic patients, and streamlining burdensome operational requirements for providers, will allow more beneficiaries to receive timely treatment before disease progression requires more risky and resource-intensive care.

Any serious effort to shore up our nation’s finances must address the unsustainable growth of federal entitlement programs. Mandatory spending now accounts for roughly 60% of the federal budget², and Medicare’s burden on taxpayers will only worsen as the U.S. population continues to age. Between 2024 and 2054, the share of federal noninterest outlays consumed by major health care programs is projected to rise from 28% to 39%.³ Against this bleak backdrop, CMS needs to be proactive about supporting technological innovations that lower costs, particularly in areas that account for a disproportionate share of overall health spending, such as inpatient hospital care.

Hospital systems are the single largest drivers of health care spending in recent years.⁴ Between 2022 and 2024, spending on hospital care represented 40% of the overall growth in national health expenditures.⁵ This surge outpaced every other source of medical spending, including physician services and prescription drugs. According to CMS, in 2024, hospital prices rose at their sharpest rate since 2007.⁶

It is not difficult to see why taxpayers have a stake in reducing extended hospital stays among Medicare beneficiaries, especially in matters related to cardiovascular health. Heart disease already imposes a significant burden on the U.S. health care system, with one in three adults receiving treatment for a cardiovascular condition or risk factor in 2020. Between 2020 and 2050, annual health care costs for cardiovascular conditions are projected to nearly quadruple, rising from $393 billion to $1.49 trillion.⁷ And yet, the fiscal burden of heart disease on Medicare is far from a long-term problem: the fund that pays for beneficiaries’ hospital stays is currently projected to run out of money by 2033⁸ if no reforms are enacted.

Encouraging fiscal signs have appeared with previous medical breakthroughs in the cardiac space. For example, in our extensive 2023 paper, “How Much is Medicine Worth to the American Taxpayer?” we recounted research showing that a cluster of pharmaceutical interventions for hypertension, cholesterol, and diabetes slowed per-capita Medicare spending by $824 in the 2000s.⁹ More recently, a comprehensive Aon study of 139,000 employees taking GLP-1 medications between 2022 and 2024 found significant, rapid cost-growth reductions in treating health problems, led by reductions in heart attacks and strokes.¹⁰

While addressing the fiscal imbalances at the heart of Medicare requires a multitude of solutions, covering TAVR for asymptomatic patients under CED is a step in the right direction. Heart valve disease is currently undertreated in the U.S.¹¹, and AS is one of the most common and dangerous forms of the disease. Data from the PARTNER 3 trial indicates that, in low-risk patients, TAVR fares better than SAVR at reducing death, stroke, or rehospitalization one year after the procedure.¹² Yet, more importantly for taxpayers, the average length of hospitalization for a TAVR patient was three days, compared to one week for SAVR. This seemingly minor difference actually represents considerable budgetary savings.

In addition to extending coverage to asymptomatic patients, NTU also supports the proposal to phase out CED requirements for symptomatic AS patients being treated with TAVR. While a CED mandate is important for collecting safety data on novel medical treatments, it could, at the same time, be delaying the wider introduction of TAVR into the Medicare population if left in place too long. CMS first implemented a CED requirement for symptomatic patients in 2012, and since then, evidence supporting the procedure’s safety and cost effectiveness has continued to grow. At this point, keeping the CED stipulation for this particular population just creates more paperwork for providers and acts as a barrier to treatment for patients.

NTU has previously noted the need to carefully deploy CED in situations that demand a thoughtful balance between access and affordability for taxpayers. In June of 2025, our comments to CMS in Executive Order 14192 observed, “In theory, CED could help to expedite the introduction of lifesaving diagnostics and treatments, but in practice, it has sometimes functioned in a contrary manner by effectively stranding therapies in regulatory limbo.” We raised then, and reiterate now, the need for a methodical evaluation of CED’s mission and execution to improve transparency, impact, predictability for stakeholders, and cost-effectiveness for taxpayers.¹³

We are also encouraged by plans to simplify operational requirements for providers that perform TAVR procedures. In a similar vein to CED mandates, many of these rules were first implemented when the safety and efficacy profile of TAVR was still being evaluated. Failing to update these rules can limit the reach of this procedure. In particular, we applaud CMS for seeking to eliminate minimum procedural volume requirements for hospitals. While these requirements made sense when TAVR was still in its infancy, rigid volume thresholds unnecessarily restrict otherwise qualified providers from offering what is now known to be a safe and effective procedure.

To sum up, NTU supports efforts by CMS to expand the reach of TAVR to more Medicare beneficiaries. Deploying innovative treatments that reduce the long-term burden of cardiovascular disease on hospitals directly addresses one of the fastest growing sources of health care spending. At the same time, we urge CMS to exercise strong caution to ensure that loosened operational requirements for providers don’t result in the performance of unnecessary procedures. Other sensible guardrails will need to remain in place to protect patients and taxpayers from the overuse of TAVR.

Thank you for your consideration of these comments, and should you have any questions on this or any other fiscal or regulatory matter before CMS, we are at your service.

Sincerely and respectfully,

Alexander Ciccone
Policy and Government Affairs Manager
National Taxpayers Union

1 See, for example, https://pmc.ncbi.nlm.nih.gov/articles/PMC10625447/. The authors conclude that:

Another excellent summary of research on the economic benefits of TAVR for patients in the category of severe symptomatic aortic stenosis (SSAS) appears in the comments of Professors David E. Bloom and Joseph S. Knee, of the Harvard T.H. Chan School of Public Health, filed 7/14/26 on CMS.gov. The comment authors note:

In NTU’s opinion, the findings of this research are relevant to the fiscal condition of Medicare and other taxpayer-funded programs.

2 https://www.pgpf.org/federal-budget-guide/

3 https://www.ntu.org/publications/detail/ntu-comments-on-medicare-and-medicaid-coverage-of-anti-obesity-medications

4 https://www.realclearhealth.com/articles/2026/04/01/hospitals_perverse_incentives_are_inflating_healthcare_costs_1174043.html

5 https://www.kff.org/health-costs/hospital-spending-accounted-for-40-of-the-growth-in-national-health-spending-between-2022-and-2024/

6 https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2025.01683

7 Forecasting the Economic Burden of Cardiovascular Disease and Stroke in the United States Through 2050: A Presidential Advisory From the American Heart Association | Circulation

8 What’s in the 2026 Medicare Trustees Report? • Bipartisan Policy Center

9 How Much is Medicine Worth to the American Taxpayer? A Cost-Benefit Analysis - Publications - National Taxpayers Union

10 Referenced in Proposed Changes to Kentucky's Medicaid Outpatient Pharmacy Program can Help Taxpayers - Publications - National Taxpayers Union

11 About Heart Valve Disease | Heart Disease | CDC

12 Placement of Aortic Transcatheter Valves 3 - American College of Cardiology

13 NTU Comments to Centers for Medicare and Medicaid Services, “Unleashing Prosperity Through Deregulation of the Medicare Program (Executive Order 14192) - Request for Information,” June 10, 2025; summaries available at Medicare Regulatory Relief Request for Information | CMS

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For important information regarding the potential impact of operator and hospital volume requirements for TAVR on 1-year cardiovascular outcomes of patients undergoing TAVR, please see a submitted academic manuscript at the following link: https://hdl.handle.net/10161/35389

This manuscript is currently under review, and was performed by the steering committee of the Society of Thoracic Surgeons / American College of Cardiology TVT Registry and others to help inform decision-making regarding the potential impact of hospital and operator volume requirements on 1-year cardiovascular outcomes of patients undergoing TAVR. The analysis leverages the TVT Registry, the largest source of data on patients undergoing transcatheter aortic valve replacement in the United States. We hope this will help inform decision-making regarding balancing access to TAVR and TAVR outcomes.

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July 15, 2026

ELECTRONIC SUBMISSION

JoAnna Baldwin
Acting Director, Coverage and Analysis Group

Center for Clinical Standards and Quality Centers for Medicare & Medicaid Services (CMS)
Department of Health and Human Services
Attention: CAG-00430R2

RE: Proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2)

Dear Ms. Baldwin:

On behalf of Medtronic, I am pleased to provide public comment on CMS’s proposal regarding TAVR in the treatment of aortic stenosis (AS).

Medtronic is the world’s leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. As a global leader in both surgical and transcatheter heart valve therapies, including the CoreValve™ and Evolut™ transcatheter aortic valves, Medtronic maintains a robust technology and clinical development program on TAVR and 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.

Medtronic is firmly committed to improved access of therapies to patient populations, particularly those in underserved communities; to high quality care; and to the continued development of a real-world evidence base for treating AS. Medicare’s national coverage policy on TAVR has provided medically appropriate access to TAVR therapy while promoting high quality care and continuous knowledge development to improve outcomes for Medicare beneficiaries. Changes to the TAVR NCD must therefore be approached carefully to maintain a strong balance between quality and access to TAVR therapy.

The proposed TAVR NCD makes a variety of changes to the coverage policy for TAVR, including refinements to the heart team approach, modifications to covered indications, changes to facility and operator requirements, and revisions to ongoing evidence development requirements. Medtronic appreciates the thoughtful consideration given by CMS to the proposed revisions to the TAVR NCD. Some of these proposals support the provision of high-quality care, some raise significant concerns, and some require further clarification to understand their potential impact.

In brief, Medtronic has the following recommendations on the proposed NCD:

• Quality of Care. The high quality of care expected of TAVR programs for AS patients and driven by comprehensive and standardized data must not be jeopardized as CMS seeks to expand coverage access. CMS must not compromise on high quality patient outcomes and should continue to require the use of established mechanisms such as registry reporting for a minimal period (such as 30 days) for quality improvement as new data and analytic tools evolve. Standardized and comprehensive registry data that include patient reported outcomes have been the backbone of quality benchmarking and evidence development.
• Multidisciplinary Heart Team. CMS' support of the heart team is laudable and can be strengthened further by making clear that team consensus is required on a patient's course of therapy and that all preprocedural visits deemed necessary by the team to determine suitability for TAVR are covered.
• New and Nationally Covered Indications – Moderate AS. CMS should not revoke CED for patients with symptomatic AS that is not severe. The agency actively committed to CED for the non-severe AS population in 2012, reaffirmed that in 2019, and should continue to honor that commitment in 2026.

We include specific text to incorporate these recommendations into the final NCD in Exhibit 1. More detail regarding Medtronic’s positions follows.

Quality of Care: Hospital Requirements, Quality Reporting and Registry Data

The proposed NCD removes hospital volume requirements and significantly reduces operator volume requirements to perform TAVR procedures. CMS also removes the CED requirement for all hospitals to participate in a national registry (i.e., TVT-R).

We are concerned that the significant reduction in procedural volume requirements to perform TAVR procedures will jeopardize quality of care for Medicare beneficiaries precisely when CMS is also removing the most effective mechanism now in place – mandatory registry reporting – to monitor and improve care for Medicare beneficiaries.

While the proposed NCD includes hospital criteria requiring hospitals to have a continuous quality improvement process in place, we believe CMS underestimates the role of registries in comparison to the relative immaturity of the “increasing ability to share and aggregate standardized data” and “powerful analytical tools” it suggests as alternatives for data to monitor and track quality.

In order to ensure quality of care in an environment of much looser standards for hospitals to perform TAVR procedures, and to provide greater transparency to patients on specific hospital performance in the context of much looser standards for hospital TAVR programs, Medtronic believes the quality provisions in the NCD must be strengthened significantly.

First, we believe CMS should consider minimum TAVR procedural volume requirements for hospitals to perform TAVR procedures (in addition to the proposed operator volume requirements). This is particularly important for new TAVR programs. In its proposal, CMS t acknowledges the proven positive connection between quality and volume and how the Agency believes that the “maturity” of the “existing, broad and competitive market” for practitioners experienced with TAVR should create no difficulty with establishing and maintaining programs. It is counterintuitive then that CMS would not include a requirement that ensures TAVR sites can continue to provide high quality care for AS patients and that openly recognizes the shared accountability that hospitals have with operators and heart teams.

Most importantly, the high quality of care expected of TAVR programs for AS patients, which is currently driven by comprehensive and standardized data, must not be jeopardized as CMS seeks to expand coverage access. We firmly believe CMS should continue to require the use of established mechanisms, such as registry reporting for a minimal period (such as 30 days), for quality improvement as new data and analytic tools evolve. CMS has clear statutory authority to require registry reporting for this purpose, and we enclose legal analysis which documents this authority as Exhibit 2. Standardized and comprehensive registry data that include patient reported outcomes have been the backbone of quality benchmarking and evidence development. New TAVR programs in particular must establish that they can assure and sustain good patient outcomes.

The clinical community has collaborated to reduce the burden of data collection, streamlining and reducing data elements and collection methods. We believe that those efforts should continue and that requiring the use of more streamlined reporting for a smaller data set and shorter time frame for a limited period, especially for new programs, represents the most appropriate next step toward broadening the use of real world data – one that does not compromise on high quality patient outcomes.

The ability to benchmark in a complete and comprehensive fashion, risk adjust for the TAVR population at an institutional level, and harmonize data standards should be central as CMS considers increasing its reliance on real world data. We recognize CMS’ desire to broaden access and use of newly available analytic tools, but caution that these tools cannot provide the level of national benchmarking and comparison as well as appropriate risk-adjustment that TVT-R is currently capable of providing. While business intelligence tools exist that can draw on structured electronic health records and obviate the need for data entry, these tools are not currently enabled with risk-adjustment specific to TAVR nor standardized across hospitals. AI-enabled automated extraction of TAVR related information from unstructured EHR data and notes are even less mature than these business intelligence tools. Accordingly, CMS should encourage the exploration of these types of tools while requiring quality improvement to be performed through established mechanisms so as not to sacrifice the high quality of TAVR care that has been achieved for Medicare beneficiaries.

We also note the importance that patient reported outcomes have played in understanding and evaluating TAVR as an effective therapy modality. As CMS increases its focus on real-world evidence, it should foster an environment where robust data collection is encouraged. Patient reported outcomes are not available comprehensively at this time through any other instrument than TVT-R. CMS should continue to set the standard high for data and push new entrants to meet the high standards that existing TAVR programs have had to meet and maintain, and that patients currently expect and deserve.

Utilizing a consistent, national registry-based approach to quality reporting for TAVR will provide the most effective and uniform way to measure, compare, and improve quality for TAVR services; provide transparency to patients as they consider their options on where to receive TAVR services; and maintain availability and access to the rich set of data provided through registry sources that has enabled improvements in patient care, advancements in operator technique, and continued development of TAVR technology and devices that spur further improvements in patient care for patients with heart valve disease.

CMS should use its statutory authority to require that facilities must ensure continuous quality improvement by assessing procedural outcomes through the established mechanisms of national registry reporting or other means described by national certification organizations or bodies with oversight of transcatheter heart valve therapies and making necessary programmatic adjustments to assure patient safety. (See Exhibit 1 for Medtronic suggested text.)

Multi-Disciplinary Heart Team: Team Requirements and Access to Care

CMS proposes to continue heart teams that require the active engagement of interventional cardiologists and cardiac surgeons in the care of patients with AS. In particular:

• The heart team must include interventional cardiologists and cardiac surgeons with clinical privileges at the hospital where TAVR will be furnished.
• Suitability for SAVR or TAVR must be evaluated based on individual patient characteristics, and patient evaluation must include at least one in-person evaluation by a heart team TAVR operator.
• TAVR procedures must be performed in hospitals that have on-site structural heart interventional cardiology and cardiac surgery programs and post-procedural ICUs with experience managing patients who have had open-heart valve procedures.
• Dual operators to perform TAVR procedures are no longer required but may occur if determined appropriate by the heart team.

Medtronic supports these provisions, which ensure ongoing roles for interventional cardiologists and cardiac surgeons in the provision of TAVR therapy and place TAVR programs in hospitals equipped to provide a wide range of interventional and surgical approaches that AS patients may require. These provisions support not only high-quality TAVR care, but high-quality care across the growing range of structural heart interventional therapies performed in hospitals that furnish TAVR therapy.

Each TAVR program will have their own protocols for assessing patient suitability for TAVR and assigning appropriate and unique roles for operators during the procedure. We believe CMS’ proposal recognizes that and request that it be articulated more clearly that the heart team must reach consensus about the patient’s course of therapy before the patient’s procedure. We also request that CMS clearly articulate that, should a TAVR program and its heart team have a successful protocol that involves two physicians assessing each patient in addition to chart review, such a protocol would be considered covered by CMS. Finally, we appreciate that CMS outlines the various permutations of operators that a heart team might see as appropriate. We request that CMS add language in its decision discussion and text to clearly recognize that the heart team’s decision means that each operator’s role would be covered and would be specialized and distinct, should the heart team choose one of these permutations.

We also wish to note that we believe CMS’ proposals around the heart team, including the volume requirements, will further patient access to appropriate TAVR therapy. As we described at length in our comment letter in January, we believe that appropriate access to TAVR is the result of a multitude of factors, driven by providing AS patients with the education and referral networks they need to access a qualified heart team and heart program for appropriate diagnosis, treatment, and follow-up – not simply a matter of increasing the number of sites that can provide TAVR. Our internal analysis of Medicare claims through 2023 demonstrates that CMS’ proposed requirements for operator volume in prior years would have a minimal impact on the number of TAVR procedures Medicare beneficiaries receive. As proposed, the requirements would result in the need for some physician operators to increase their volumes to continue furnishing TAVR procedures. However, we note that those operators in aggregate provided fewer than 0.2% of TAVR procedures in 2023 and were often located in areas proximate to other TAVR programs. Accordingly, we believe that CMS can expand beyond these requirements in recognition that higher volumes are correlated with higher outcomes, and to help new TAVR programs achieve those higher outcomes. We applaud CMS for recognizing the centrality of a heart team in appropriate access to TAVR therapy.

In the final NCD, we recommend that CMS consider requiring the consensus of the heart team on an individual patient’s course of therapy prior to their procedure. Additionally, we request that CMS clarify that any additional preprocedural visits deemed necessary by the heart team – beyond those listed in the proposed NCD to determine the suitability of the patient for TAVR relative to other courses of treatment – are covered by Medicare. Finally, we request CMS acknowledge the separate and distinct roles of all the operators the heart team deems appropriate for a TAVR procedure. (See Exhibit 1 for Medtronic suggested text.)

New and Nationally Covered Indications: Moderate AS

The proposed NCD maintains TAVR as an inpatient benefit and changes the covered population – and the language describing the covered population – from “symptomatic aortic valve stenosis” to “symptomatic severe AS” (covered without CED) and “asymptomatic severe AS” (covered with CED).

We firmly believe TAVR should remain an inpatient benefit only, particularly as new sites that have less experience start programs. Further, we are deeply concerned that restricting the national coverage policy to “severe AS” may limit future coverage of new indications for patients with symptomatic AS – in particular moderate AS– that are now in clinical trials and covered by CMS either under the TAVR CED policy or CMS’s IDE coverage policy. These trials were conceived and executed under the language of the existing NCD, which appropriately sets forth a clear pathway to coverage of future treatments for patients with moderate AS.

This clear pathway is critical given the growing number of Medicare beneficiaries who elect to receive their benefits under Medicare Advantage. National coverage is meant to provide clear guidance on new therapies that improve patient health outcomes and ensure uniform applicability across Medicare beneficiaries regardless of where they live or how they elect to receive benefits. CMS’s proposal creates a situation where beneficiaries who have AS will face a patchwork of access to TAVR of care depending on the degree of their disease, whereas under the existing NCD, they could have confidence in access once FDA approval is granted.

CMS made a strong commitment dating back to 2012 to foster the development of the evidence base for all patients with symptomatic AS, specifically disagreeing with a comment suggesting that Medicare’s coverage policy should be limited to patients with symptomatic severe AS. That year, CMS finalized coverage for TAVR for all symptomatic aortic stenosis patients under CED, noting a belief “that there is promising but inadequate evidence to conclude at this time that TAVR generally improves health outcomes for Medicare beneficiaries with symptomatic aortic stenosis (italics added).” CMS should continue to honor that commitment.

We also note that under Azar v. Allina Health Services, 139 S. Ct. 180 (2019) (https://www.supremecourt.gov/opinions/18pdf/17-1484_4f57.pdf), the agency was reminded of the requirement for it to provide the public with advance notice and a chance to comment on rules, requirements, or policies that establish or change Medicare benefits or payments. While Azar may not specifically apply to NCDs, we note that CMS typically views it as good practice to seek comment thoroughly with regard to coverage (a view with which we strongly agree given the importance of coverage decisions to Medicare beneficiary access to care).

CMS’s proposed NCD does not address or acknowledge its current coverage policy that extends CED for TAVR to the symptomatic non-severe AS population. Nor does CMS’ proposed NCD explicitly propose to terminate CED for TAVR for the symptomatic non-severe AS population, though it does explicitly propose to terminate CED for TAVR for the symptomatic severe AS population. We are concerned that the absence of consideration given to the symptomatic non-severe AS population sets a dangerous precedent for CMS to reduce coverage without appropriate notice and comment.

CMS should not remove coverage of TAVR for beneficiaries with moderate AS, but instead should revise the proposed NCD to include CED for any patient with symptomatic AS outside of severe AS (which is proposed for coverage without CED). This would appropriately capture the coverage of symptomatic moderate AS under CED in the proposed new policy, carrying forward CMS’ commitment to these patients and maintaining the longstanding coverage that exists today. (See Exhibit 1 for Medtronic suggested text.)

In conclusion, Medicare’s national coverage policy on TAVR has provided access to TAVR therapy while promoting high quality care and continuous knowledge development to improve outcomes for Medicare beneficiaries. Changes to the TAVR NCD must therefore be approached carefully to maintain a strong balance between quality and access to TAVR therapy. We appreciate CMS’ consideration of these comments.

Sincerely,

Ing-Jye Cheng
Senior Director, Health Economics, Policy, and Reimbursement
Interventional Cardiology Therapies and Structural Heart

Suggested additions are in ALL CAPS

20.32 - Transcatheter Aortic Valve Replacement (TAVR) for Aortic Stenosis

A. General
Transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter aortic valve implantation) is used in the treatment of aortic stenosis. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the aortic valve.

B. Nationally Covered Indications
The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) for severe aortic valve stenosis (or aortic stenosis (AS)) when furnished with a complete aortic valve and implantation system that has received Food and Drug Administration (FDA) premarket approval (PMA) for that system’s FDA-approved indication, and the following conditions are met.

1. Patient Criteria
TAVR is covered for the treatment of Medicare beneficiaries with:

2. Physician and Heart Team Criteria
Heart Team: The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary team of medical professionals with a specialized focus in cardiac care. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. THE HEART TEAM’S CONSENSUS ON THE PATIENT’S COURSE OF THERAPY IS REQUIRED PRIOR TO THE PROCEDURE. The heart team:

3. Hospital Criteria
TAVR procedures must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:

4. CED Study Criteria
TAVR items and services are furnished for the treatment of asymptomatic severe AS with a complete aortic valve and implantation system that has received FDA PMA for that system’s FDA-approved indication in the context of a CMS-approved CED study.

CED studies for asymptomatic severe aortic stenosis patients must meet requirements of sections B2 (Physician and Heart Team Criteria) and B3 (Hospital Criteria), have an active, contemporaneous comparator and address at least one of the following questions:

• Does TAVR, SAVR, or close surveillance until symptom onset better improve health outcomes? This is particularly relevant for patients with lower surgical risk, longer life expectancy, preserved left ventricular ejection fraction, and bicuspid aortic valves.
• What are the long-term valve re-intervention rates of TAVR vs SAVR and does having re-interventions impact health outcomes?
• Can longer term, risk-standardized, patient-centered health outcomes replace volume criteria for TAVR operators?

CED STUDIES FOR ALL OTHER SYMPTOMATIC AORTIC STENOSIS PATIENTS MUST MEET REQUIREMENTS OF SECTIONS B2 (PHYSICIAN AND HEART TEAM CRITERIA) AND B3 (HOSPITAL CRITERIA) AND ADDRESS AT LEAST ONE OF THE FOLLOWING QUESTIONS:

1. WHEN PERFORMED OUTSIDE A CONTROLLED CLINICAL STUDY, HOW DO OUTCOMES AND ADVERSE EVENTS COMPARE TO THE PIVOTAL CLINICAL STUDIES?
   
2. WHAT IS THE LONG TERM DURABILITY OF THE DEVICE?
   
3. WHAT ARE THE LONG TERM OUTCOMES AND ADVERSE EVENTS?
   
4. WHAT MORBIDITY AND PROCEDURE-RELATED FACTORS CONTRIBUTE TO TAVR PATIENTS’ OUTCOMES?

CMS-approved CED studies must adhere to the following scientific standards …

Exhibit 2: Legal Analysis On Authority to Require Registry Reporting Outside of CED

TO Ing-Jye Cheng ORGANIZATION Medtronic

FROM Beth Halpern
Beth Roberts
James Huang
TELEPHONE 202-637-8609
202-637-8636
202-637-3696
Washington, DC

DATE May 13, 2026

SUBJECT Facility Requirements in Medicare National Coverage Determinations

This memorandum addresses your questions about whether the Centers for Medicare & Medicaid Services (CMS) can include requirements for facilities to participate in a quality reporting registry or obtain certification from a national organization for coverage under a national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR).¹ CMS currently is reconsidering the NCD for TAVR,² and we understand that you believe the revised NCD should include requirements to ensure that facilities providing TAVR procedures meet appropriate standards for quality of care and continuous quality improvement through established mechanisms including registry reporting. We have identified several NCDs that illustrate CMS’ authority to implement these requirements.³ Using its broad discretion in how it implements its NCDs under the Medicare Act and the Administrative Procedure Act, CMS could require facilities to participate in a registry or be certified by a third party in order to furnish Medicare-covered TAVR procedures under an updated NCD that does not require data collection for coverage under CED.

An NCD is “a determination by the Secretary with respect to whether or not a particular item or service is covered nationally” under the Medicare program. In order for most items or service to be covered by Medicare Parts A and B, the item or service must be “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

Although CMS has not defined “reasonable and necessary” in regulation, it has established guidance for the Medicare Administrative Contractors (MACs) to use when making their determinations of whether an item or service is reasonable and necessary that include consideration of the facility in which the item or service is provided:

CMS has a long history of applying these criteria when developing NCDs and establishing requirements in NCDs for the setting in which a covered item or service can be furnished. CMS has required facilities to be approved by CMS, be certified by a third party, or to comply with standards including data collection and analysis, established by CMS.

In a coverage policy that predates the current NCD process, CMS (then called the Health Care Financing Administration, (HCFA)) determined that “liver transplants in adults with certain specified conditions are medically reasonable and necessary if performed in facilities that meet certain criteria and are approved by HCFA for liver transplants.”⁷ The current adult liver transplant NCD continues to require covered transplants to be furnished in a facility that is approved by CMS as meeting institutional coverage criteria for liver transplants,”⁸ and the pediatric liver transplant NCD requires pediatric liver transplant programs to be operated jointly by a facility that meets those institutional coverage criteria.⁹ Similarly, the NCDs for heart transplants,¹⁰ intestinal and multi-visceral transplantation,¹¹ and pancreas transplants¹² require facilities to be approved by Medicare to perform those procedures.

CMS also has implemented NCDs that require facilities to meet criteria established by third parties. For example, instead of requiring CMS to approve facilities, as it does in the transplant NCDs discussed above, the NCD for Ventricular Assist Devices requires facilities to be “credentialed by an organization approved by CMS.”¹³ Facilities that provide lung volume reduction surgery (LVRS) must either by certified by the Joint Commission on Accreditation of Healthcare Organizations under the LVRS Disease Specific Care Certification Program or be approved as Medicare lung or heart-lung transplantation hospitals.¹⁴ The NCD for Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity required facilities to be certified by the American College of Surgeons or by the American Society for Bariatric Surgery for procedures performed between February 21, 2006, and September 24, 2013.¹⁵ CMS’s decision to establish the certification requirement in 2006 was “supported by the evidence at that time of rapid growth of bariatric surgery programs, improved outcomes in the older Medicare population at higher volume facilities and with higher volume surgeons (Flum 2005) and by consensus opinion for the need for facility standards from the professional societies and other physicians in comments submitted in response to the proposed decision memorandum for bariatric surgery (CMS Bariatric Surgery 2006).”¹⁶ CMS removed the certification requirement when the agency had sufficient evidence to conclude that “continuing the requirement for certification for bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries.”¹⁷

The 2005 version of NCD on Percutaneous Transluminal Angioplasty (PTA) for procedures performed concurrent with carotid stent placement in patients at high risk for carotid endarterectomy established “a list of minimum standards modeled in part on professional society statements on competency” for facilities.¹⁸ Among other requirements, each facility was required to collect data on all carotid artery stenting procedures performed at its site and to analyze that data to ensure patient safety not less frequently than every six months.¹⁹ CMS adopted this approach because it was not able to identify an organization to lead efforts to create the “national mechanism to monitor facilities and physicians for competency and expertise in performing carotid stenting procedures” that many commenters supported.²⁰

In its 2023 reconsideration of this NCD, CMS recognized that “a standardized, nationwide registry – for all carotid artery procedures – would be helpful to monitor procedural safety, further evolve patient risk stratification, and to facilitate auditing and quality improvement, including comparison of local outcomes to national and other benchmarks,” but the agency concluded that mandated registry participation was no longer necessary “for a technology that has been investigated and used widely in various forms.”²¹

The current TAVR NCD uses coverage with evidence development (CED) and has several requirements for facilities that provide covered TAVR procedures, including participation in a prospective, national, audited registry that tracks specific outcomes and analyzes the data on outcomes and adverse events.²² Following the precedents set by the NCDs discussed above, CMS could require facilities to participate in a registry that allows facilities to monitor, evaluate, and improve the quality of care they provide or be certified by a third party in order to furnish Medicare-covered TAVR procedures under an updated NCD that does not require data collection for coverage under CED.

Under the Medicare Act and the Administrative Procedure Act (APA), CMS has broad discretion in how it implements its NCDs, so long as the NCD requirements are “based on consideration of the relevant factors” bearing on if the item or service is reasonable and necessary” and do not reflect a clear error of judgment, such as not being based in the evidence before the agency.²³ CMS itself has shown that it has the authority to be flexible about adopting facility requirements in NCDs to protect and improve the quality of care provided to Medicare beneficiaries, including use of registries and third-party certifications.

The choice of mechanisms to ensure facility quality is driven by the current evidence and policy considerations. If currently available evidence shows that facility standards would help improve the quality of care (e.g., that facilities meeting certain standards are associated with better outcomes), then CMS can implement coverage policies requiring facilities to satisfy those requirements. At its discretion,²⁴ CMS can give facilities a choice of methods of meeting the facility requirements, as it has done in other NCDs, to reduce burdens on hospitals and on CMS and empower facilities to manage their own quality measurement and improvement. Making a registry one of those options would allow facilities to monitor their own quality while encouraging physicians, hospitals, manufacturers, and other stakeholders to continue to expand the evidence base for these procedures. The data collected by a registry also could be used by patients to choose their health care procedures and providers.

We would be happy to discuss any questions you have about this memorandum.

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As director of cardiovascular leadership at Longview Regional Medical Center, I support the proposed NCD updates, which align with current clinical standards and evidence-based practice. We as a collaborative team believe these changes will improve patient access while maintaining high-quality outcomes.

Our support is focused on the following key provisions:

Symptomatic Severe Aortic Stenosis: We support the removal of Coverage with Evidence Development (CED) for symptomatic patients. TAVR is a mature, evidence-based therapy for this population, and the CED requirement is no longer necessary to ensure appropriate access or quality.

Asymptomatic Severe Aortic Stenosis: We support the continuation of CED for appropriately selected asymptomatic patients. This pathway allows for earlier clinical intervention before the onset of irreversible cardiac damage while maintaining a structured mechanism for data collection.

Operator Flexibility: We endorse the proposed operator flexibility allowing either an interventional cardiologist or a cardiac surgeon to serve as the TAVR operator. This model preserves the essential Heart Team approach while allowing for procedural flexibility based on patient anatomy and provider expertise.
Site-Level Volume Standards: We support volume requirements that are strictly grounded in contemporary published evidence. Thresholds should serve to ensure institutional readiness and quality without acting as an artificial barrier to access where adequate infrastructure and clinical expertise exist.
We urge CMS to finalize these updates to better support patient care and program sustainability.

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TAVR is a mature, extensively studied therapy. More than a decade of randomized trials across the full surgical risk spectrum has answered the questions that originally justified Coverage with Evidence Development for symptomatic severe aortic stenosis.
We value and practice the heart team concept, which in our experience reaches consensus on management in the large majority of cases. The bottleneck is not the clinical decision. It is the logistics of documenting it. Requiring independent in-person evaluations by both a cardiac surgeon and an interventional cardiologist, layered onto separate clinic schedules, routinely adds weeks to the pathway in many practices. These are elderly patients, often traveling long distances, who carry real mortality risk while they wait. Delay in this population is not neutral. Permitting asynchronous heart team review of the record, with one required in-person evaluation by a TAVR operator, preserves multidisciplinary input while removing the constraint that drives wait times. Younger patients, particularly those with complex anatomy, may still warrant in-person cardiac surgical evaluation and a deliberate discussion of lifetime management strategy. That judgment can be managed by the heart team rather than a mandate applied to every patient. I strongly support this change.
I likewise support making joint intraoperative participation a heart team judgment. Requiring both specialties to be physically present for every case has not altered management in straightforward transfemoral procedures. It consumes scarce operator time better directed to cases where that expertise matters, including complex anatomy, alternative access, and high-risk patients. Single operator TAVR, at the discretion of an experienced heart team, is appropriate and overdue.
These changes allow experienced teams to treat patients efficiently and in their best interest, without diluting the multidisciplinary standard of care. I urge CMS to finalize them.
Respectfully submitted,

Jeremy Rier DO, FACC, FSCAI
Chris Bruce, MBChB, MRCP
Jae Yoon Park, MD, FACC, FSCAI
Paul H. Tolerico, MD, FACC
WellSpan Structural Heart Team

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July 15, 2026

Joseph Hutter, MD
Lead Medical Advisor

Sarah Fulton, MHS
Lead Analyst
Centers for Medicare & Medicaid Services

Re: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2, NCA-CAL-321)

Dear Dr. Hutter and Ms. Fulton:

The Partnership to Fight Chronic Disease (PFCD) applauds CMS for taking the important step of removing the Coverage with Evidence Development (CED) requirement for transcatheter aortic valve replacement (TAVR) for patients with symptomatic severe aortic stenosis. This proposal reflects what should be a basic principle of Medicare coverage: when the evidence is strong and ample, coverage policy should match it. We urge CMS to treat it not as an isolated action, but as the beginning of a broader, principled commitment to align Medicare coverage with the weight of available clinical evidence — including TAVR for asymptomatic, severe aortic stenosis (AS) and, urgently, for FDA-approved therapies that slow the progression of Alzheimer's disease.

CMS Has Made the Right Call on TAVR — and Set an Important Precedent

PFCD commends CMS for taking this step and encourages extension of the NCD without CED for people with asymptomatic, severe AS seeking TAVR. TAVR has accumulated more than a decade of robust real-world and clinical trial evidence — including 17 randomized controlled trials and observational data from nearly 460,000 patients — confirming it is a safe, durable, and effective treatment for severe AS. After fourteen years under CED, one of the longest running such requirements in Medicare's history, we agree with CMS that removing this coverage barrier is the right outcome.

We are encouraged that this action signals a broader willingness by CMS to revisit other long-standing CED coverage limitations, including the restrictions placed on FDA-approved disease-modifying Alzheimer’s therapies. The decision is significant precisely because of what it demonstrates: when clinical evidence matures, Medicare will act to remove coverage barriers. We encourage CMS to apply this approach consistently and across conditions.

Alzheimer's Disease Cannot Wait

Every day matters for patients and families living with Alzheimer’s. Medicare’s coverage policies should not stand between patients and the treatments they and their physicians have determined are appropriate. Two available FDA-approved anti-amyloid monoclonal antibody therapies — lecanemab and donanemab — slow the progression of Alzheimer's disease. Both gained FDA approval for use in patients with early-stage Alzheimer's disease with confirmed amyloid pathology. Both are currently covered by Medicare only under CED — a requirement that, in practice, creates additional barriers to treatment which translates into treatment delays and disease progression.

The Evidence Record Is Robust and Directly Responsive to CMS's CED Questions

The evidence base for anti-amyloid therapies has expanded substantially since CMS first imposed its CED requirement more than four years ago. Since CMS issued its 2022 CED determination — anchored to clinical data for a therapy that is no longer on the market — nearly a dozen peer-reviewed studies have documented the safety and efficacy of lecanemab and donanemab, amply answering every question CMS asked when it initially imposed CED limitations on Medicare coverage. In the coming weeks, PFCD will publish a white paper making the affirmative case for prompt reconsideration of the NCD for amyloid-targeting therapies. We invite CMS to consider that analysis as a resource in its ongoing work.

Delay Carries Health Consequences

For people living with Alzheimer's disease, the consequences of delayed treatment are irreversible. It has been estimated that as many as 2,000 people a day with Alzheimer’s progress from early to moderate stage of disease, where they no longer qualify for the therapies. For these individuals and their loved ones, every day counts.

PFCD calls on CMS to:

Finalize the proposed removal of the CED requirement for TAVR in symptomatic, severe AS and include asymptomatic, severe AS without CED as well.

Apply the same evidence-based standard to anti-amyloid Alzheimer's disease therapies by promptly reconsidering and removing the CED limitation on Medicare coverage.

Establish a clear, predictable process for reviewing long-standing CED requirements on a proactive basis, so that coverage policy keeps pace with the accumulation of new evidence.

PFCD stands ready to work with CMS, Congress, patients, caregivers, and the medical community to ensure that people living with Alzheimer’s disease can benefit from timely access to innovations that improve and extend lives.

Respectfully submitted,

Candace DeMatteis
Vice President, Policy
Partnership to Fight Chronic Disease
www.fightchronicdisease.org
www.PFCDAlz.org

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July 15, 2026
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality
Coverage and Analysis Group
7500 Security Boulevard
Baltimore, MD 21244
RE: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2)

We appreciate CMS’ thoughtful consideration of of the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR).
As a practicing general cardiologist, I have taken care of many patients with aortic stenosis for over 40 years. I recognize the appeal of a non-surgical alternative to surgical AVR, but it is important to intervene when it is best for patients. High quality clinical data support AVR ONLY for symptomatic patients. We note that using statewide hospital discharge, emergency department, and ambulatory data from the California Department of Health Care Access and Information (HCAI) and the U.S. Census since the introduction of TAVR, AVR (TAVR plus SAVR) rates nearly quadrupled in California. (data presented at public HCAI meeting 11/10/25). This exponential explosion of people getting AVR deserves close examination for concern of a rush to replace aortic valves in people who would be better off waiting, for example, for symptoms and for severe aortic stenosis. The current Edwards proposed changes to the NCD , such as extending to patients with moderate AS and to asymptomatic patients. would mean more people getting TAVRs who will not benefit. With revenue of $4.5 billion from TAVR in 2025, Edwards is not the right source for changes in CMS policy. The changes suggested by Edwards will result in many patients needlessly suffering both the immediate harms of TAVR, with known common risks such as atrial fibrillation, aortic regurgitation and pacemaker placement, and earlier failure of the biological TAVR valve without any benefits for having had earlier aortic valve intervention.

Need to convene a MEDCAC meeting
The questions posed by CMS for the NCD with CED for TAVR in symptomatic patients have not been answered satisfactorily. The NCD requires that all questions are answered before a CED requirement can be sunsetted, There are many emerging questions on the long term durability of these TAVR valves, thus it would be the wrong time to sunset the CED for the TVT registry. In fact, long term data is needed more than ever as the average age for TAVR is dropping significantly with the move into lower risk populations, and information on long term durability of the TAVR valves is critical. Average age in the original PARTNER trials was around 83 years, but that average for TAVR has dropped significantly in the last decade. Now, many of the younger Medicare population, ages 65 – 75 getting TAVR, will need to undergo very risky TAVR replacement procedures in the next 5 – 10 years. We note that a surgically placed mechanical valve lasts about 30 – 40 years.

Problems with EARLY TAVR trial

The Edwards sponsored EARLY TAVR trial had numerous methodological weaknesses and does not show clinical benefit for patients. For asymptomatic patients, there is no evidence of mortality benefit or any other clinically meaningful outcomes. Thus, TAVR is neither reasonable nor necessary and should not receive Medicare coverage. TAVR is premature in these asymptomatic patients and will subject them to procedural risk, which includes death and stroke, risk of atrial fibrillation, and need for permanent pacemaker, without any benefits. Furthermore, as these tend to be younger patients, their remaining lifespan generally exceeds the known lifespan for the TAVR valves, which means a second and risky procedure. For symptomatic patients, we believe that Coverage with Evidence Development (CED) should remain in place to ensure continued data collection for this population.
Lack of Clinically Meaningful Benefit for Asymptomatic Patients
Patients with severe aortic stenosis are asymptomatic for many years and are at low risk for death during that time. [1] Since these patients feel well and are at low risk of death, improvements in clinical outcomes - mortality or stroke incidence - are needed to show benefit from intervention with TAVR. The recent randomized unblinded clinical trial of TAVR in asymptomatic patients, EARLY TAVR,[2] did not find any mortality or stroke benefit with intervention compared to clinical surveillance. Similarly, the EVOLVED trial,[3] a smaller study focused on a subset of asymptomatic patients with myocardial fibrosis, compared conservative management to intervention with either transcatheter or surgical aortic valve replacement and found no benefit on mortality for intervention.
EARLY TAVR did appear to show a reduction in heart failure hospitalizations and an improvement in quality-of-life measures, but these subjective findings are severely limited by the trial’s unblinded study design. In EARLY TAVR, patients, investigators, and the independent clinical events committee were aware of treatment assignments. Consequently, improvements in heart failure hospitalizations—which requires a subjective decision about the cause of hospitalization—and quality-of-life measures may reflect the placebo effect instead of actual improvement due to the intervention.
The apparent reduction in unplanned cardiovascular hospitalizations in EARLY TAVR is also driven by poor study design. It is not an actual benefit to patients. About 25% of the control arm converted to TAVR before 6 months. These conversions were counted as “unplanned” hospitalizations because symptoms developed soon after randomization, which led to conversion to TAVR, before planned monitoring at 6 months. An EARLY TAVR investigators, expressed concerns that the difference in unplanned hospitalizations is due to “subtraction anxiety” of control patients: patients became more aware of (or even developed) symptoms in response to feeling they “missed out” on TAVR by being randomized to the control group.[4] This is a major methodological flaw in this study. The EARLY TAVR authors do not explain why this group of patients, who all went an average of > 6 METS on an exercise treadmill test prior to randomization, so quickly developed symptoms after randomization to the control group. “Subtraction anxiety” likely explains this peculiar phenomenon in the non-intervention arm of the EARLY TAVR trial. As part of recruitment for such interventional trials, there is a lot of hype and build up for getting the device, and patients can feel they drew the short straw when they are not randomized to intervention. Dr. Gada explained that many patients joined the EARLY TAVR trial because they wanted to get a TAVR. The control group were told they could cross over or “convert” to TAVR if they developed any symptoms. It was in their interest, therefore, to develop symptoms—which were subjectively self-reported—and did in suspiciously high numbers.
CED for Symptomatic Patients
We believe that the CED requirement should be continued for symptomatic patients. Continued data collection for symptomatic patients—and public availability of this data—is essential. Currently, data collected within the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry is not publicly available. Deidentified data from the TVT Registry must be made publicly available.
Conclusion
As there is no evidence of clinically meaningful benefit for Medicare beneficiaries, TAVR for asymptomatic patients is not reasonable or necessary and should not receive Medicare coverage. To better understand long-term device performance, data collection for TAVR conducted in symptomatic patients should continue, and this data should be publicly available.

Submitted on behalf of the UCSF Team for High-Value Care

Rita Redberg, MD MSc

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July 15, 2026

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-0430R2)

Dear Ms. Baldwin,

On behalf of the MedTech Association (AdvaMed), we appreciate the opportunity to submit comments on the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-0430R2). AdvaMed and the Centers for Medicare & Medicaid Services (CMS) share a common goal – ensuring timely access for Medicare beneficiaries to clinically appropriate, innovative technologies based on scientifically sound clinical evidence.

AdvaMed member companies develop and produce a wide range of medical devices, diagnostic tests, and digital health solutions that transform care through earlier detection, less invasive approaches, and more effective disease management. Our members, large and small, are united in their commitment to improving patient outcomes and ensuring Medicare beneficiaries have access to lifesaving and life-enhancing technologies.

Symptomatic and Asymptomatic Patients
As we stated in our comments on the first reconsideration of the TAVR National Coverage Determination (NCD) in January, we support the agency's stated focus on coverage of TAVR in both symptomatic and asymptomatic patients.
To that end, the proposed NCD changes the covered population – and the language describing the covered population – from “symptomatic aortic valve stenosis” to “symptomatic severe AS” (covered without CED) and “asymptomatic severe AS” (covered with CED). We are concerned that the proposed restrictions to the covered population may limit current and future coverage for patients. Trials are typically conceived and executed under the language of an existing NCD with the expectation of a clear pathway to future covered treatment.

The agency is required to provide the public with advance notice and a chance to comment on any rule, requirements, or policies that establish or change Medicare benefits or payments. CMS’s proposed NCD does not explicitly address or acknowledge all changes within the proposed NCD that would alter its current coverage policy, which extends CED for TAVR to the symptomatic non-severe aortic stenosis population and to other uses of approved TAVR systems outside of their FDA-approved indications. This sets a concerning precedent for CMS to limit coverage without appropriate notice and comment.
AdvaMed remains supportive of coverage of TAVR in both symptomatic and asymptomatic patients. We urge the agency to provide necessary notice and comment and to explicitly state any proposed changes in the NCD that may limit coverage to populations that are covered under the current coverage policy. Any limitation on the scope of the final decision should likewise be stated in the operative coverage text rather than left to inference from the savings clauses or from a revised title.

Heart Team
AdvaMed supports CMS’s proposed continuation of the heart team. A multidisciplinary team promotes collaboration and can leverage the experience of multiple disciplines to optimize patient care. The heart team should remain the foundation of high-quality care. We believe CMS’s support of the heart team can be strengthened further by encouraging pre-procedural team consensus on a patient’s course of therapy. Additionally, we request that CMS clarify that, should the heart team deem necessary additional pre-procedural visits beyond those listed in order to determine the suitability of the patient for TAVR relative to other courses of treatment, all visits deemed necessary by the heart team would be considered covered by Medicare.

We look forward to continuing to work with CMS throughout this process. If you have any questions regarding these comments or require additional information, please contact me at astock@advamed.org.

Sincerely,

Amber Stock
Vice President, Payment & Healthcare Delivery Policy
AdvaMed

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July 15, 2026
Submitted electronically to: CAGInquiries@cms.hhs.gov
Centers for Medicare & Medicaid Services (CMS)
Coverage and Analysis Group (CAG)
7500 Security Boulevard
Baltimore, MD 21244

Ms. Joanna Baldwin & Ms. Meredith Loveless,

Edwards Lifesciences commends CMS for its proposed modernization of the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). The draft policy reflects careful consideration of contemporary evidence, the evolving needs of Medicare beneficiaries with aortic stenosis (AS), and stakeholder feedback. Edwards supports CMS’ efforts to modernize this policy that advances timely access for Medicare beneficiaries to appropriate treatment while preserving the quality safeguards for patients that have enabled TAVR to become one of the most rigorously studied and successful innovations in cardiovascular care.

Edwards urges CMS to finalize many of the proposed policy updates and also respectfully offers several recommendations, as summarized below. Detailed rationale, supporting evidence, and specific policy recommendations are provided in our full comments.

• Finalize coverage of TAVR for symptomatic severe AS without CED
• Finalize coverage of TAVR for asymptomatic severe AS under § 1862(a)(1)(A)
• Finalize the Heart Team as the foundation of high-quality aortic stenosis care, while allowing flexible patient evaluation and the ability to determine the TAVR operator approach based on patient needs, preserving joint participation when appropriate
• Finalize removal of hospital volume thresholds while maintaining facility infrastructure, physician proficiency, and continuous quality improvement requirements
• Clarify that emergency TAVR is exempt from pre-procedure evaluation requirements that may be intended for elective procedures
• Cover moderate AS under § 1862(a)(1)(E)

The success of TAVR in the United States has been a shared achievement of many acting in the best interest of patients – reflecting contributions of CMS, FDA, specialty societies, the multidisciplinary Heart Team, hospitals, industry partners, and patients themselves. The Heart Team, inclusive of both cardiac surgery and interventional cardiology, has been foundational to this progress. The proposed modernization is an opportunity to build on this shared foundation by preserving the Heart Team’s central role in multidisciplinary shared decision-making while allowing programs the operational flexibility to determine the most appropriate evaluation pathway, procedural staffing model, and care-delivery workflow based on patient needs. In doing so, CMS can preserve the quality infrastructure these stakeholders jointly established while helping more Medicare beneficiaries receive timely, appropriate care.

Edwards appreciates CMS' leadership and its continued commitment to evidence-based, patient-centered coverage policy. If the experience of the past 15 years is a guide, a thoughtfully modernized NCD can preserve accountability and quality while reducing unnecessary barriers to care – allowing more patients with AS to benefit from timely treatment in the care of a Heart Team. Edwards looks forward to continuing this shared progress and thanks you for your consideration of our comments.

Daniel J. Lippis
Corporate Vice President, Transcatheter Aortic Valve Replacement
Edwards Lifesciences

Download entire comment.

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These proposed changes are well overdue and will substantially benefit patients with AS by expanding timely access to TAVR.. Similar to PCI, complication rates requiring surgical intervention are very rare and don't justify mandated involvement of both a cardiac surgeon and interventional cardiologist in every TAVR procedure. The current requirements create substantial barriers to timely care of these patients causing delays that can have significant negative consequences.

However, there does not seem to be any good rationale to remove the requirement for participation in the TVT Registry. Having a mechanism to monitor quality of care at all programs is a good thing and should continue. Any program that has the resources to have a structural program should be able to support data submission to the TVT Registry and should continue to be required to do so. And this data should be publicly available and reported.

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July 15, 2026

RE: Transcatheter Aortic Valve Replacement (TAVR) and National Coverage Analysis
Dear Coverage and Analysis Group:

I write as the Chair of Critical Care Cardiology and am a practicing Structural Interventional Cardiologist (IC) at Mayo Clinic where my practice engages me daily in the care of patients with aortic stenosis. I appreciate CMS's willingness to reconsider a policy first written in 2012, when TAVR was investigational. I hope the committee is willing to take an evidence-based approach and to limit barriers to a lifesaving therapy – a goal we are currently falling short of achieving in today’s practice.

TAVR is now one of the most rigorously studied and reproducible therapies in cardiovascular medicine, and the Proposed Decision Memorandum takes meaningful steps toward matching coverage to that reality. It is important to first recognize that TAVR is highly reproducible and can be safely performed by an IC with additional training after core coronary fellowship.

The goals of the current policy decision should ensure the broadest access possible to this technology while avoiding policy errors and pitfalls that have plagued prior CMS/coverage decisions that net resulted in harm to populations at large.

1. The standard should be the needs of the patient, not the interests of providers

Several stakeholder comments frame the volume, staffing, and Heart Team requirements as safeguards of quality. In practice, many of these requirements are strawman arguments to protect the case volume, referral patterns, and employment of existing programs and their staff. While those are legitimate institutional/societal interests, they cannot be the interests or focus that CMS is charged with protecting. The Medicare program exists to serve beneficiaries, and coverage policy should be judged by whether it improves access to and outcomes of care for patients.

In my home institution (which will not be affected by current changes) we focus on decisions keeping a core mission of the needs of the patient must come first. Where a requirement demonstrably protects patients, it should stay. Where a requirement principally constrains competition, needlessly restricts access or entrenches existing providers without a corresponding patient benefit, it should be removed. I ask CMS to apply that test explicitly to every element of the final NCD, and to resolve doubt in favor of the beneficiary.

2. The mandated Heart Team is not evidence-based, is inconsistent with how comparable procedures are governed and needlessly creates a barrier to access

The Heart Team concept originated as an expert-consensus construct during the introduction of TAVR; it was never validated against an alternative in a controlled study, and no trial has demonstrated that a CMS-mandated two-specialty evaluation improves patient outcomes versus evaluation by a qualified operator. It currently exists to create barriers to widespread adoption from a time when the benefit remained uncertain. Retaining it as a condition of coverage therefore rests on tradition rather than evidence.

This is thrown into sharp relief by how Medicare treats comparable cardiovascular procedures. Neither percutaneous coronary intervention (PCI) nor coronary artery bypass grafting (CABG) is subject to a national coverage requirement for a mandated multidisciplinary evaluation of every case. Most tellingly, surgical aortic valve replacement (SAVR) — an open operation carrying greater peri-procedural risk than contemporary transfemoral TAVR — carries no Medicare requirement that patients first be evaluated by an interventional cardiologist. It is internally inconsistent to demand a mandated surgical evaluation before a percutaneous valve, while imposing no reciprocal requirement before the more invasive surgical valve.

I support preserving access to multidisciplinary input where the treating physician judges is valuable, and I support the added flexibility in the Proposed Decision Memorandum. But CMS should frame shared decision-making as the expected standard of good practice rather than as a rigid, case-by-case coverage condition unsupported by outcome data.

My patients in Minnesota have to travel great distances and/or coordinate with care-givers times/methods for these evaluations. There is additional cost for unneeded evaluations and implantations can be delayed if they cannot be obtained in a timely manner.

As examples, I have had to transfer 90+ year old patients from referring centers to my CICU who’s TAVR interventions have been delayed by “co-evaluation by a surgeon”. A well-intentioned recommendation introduced a barrier to care that harmed patient with no conceivable benefit.

Accordingly, in the absence of evidence of benefit and with a very real cost in terms of access AND application – CMS must suggest heart team evaluation as a good practice but allow providers to determine the value in a patient’s case. This policy would be consistent with all other cardiovascular procedures and minimize cost delivering the procedure.

3. Coverage should be tied to program outcomes, not procedural volume

Volume is a surrogate; outcomes are the target. It is true that early registry analyses identified an inverse association between procedural volume and 30-day mortality — in the pivotal analysis of more than 113,000 procedures, risk-adjusted mortality was 3.19% at the lowest-volume quartile versus 2.66% at the highest (Vemulapalli N Engl J Med. 2019). But that association is very modest in absolute terms, and it fails to account for the harm to the patient that doesn’t get TAVR – the patient that cannot travel to or overcome the regulatory hurdles imposed by CMS bureaucracy.

Contemporary TAVR is a safe, standardized procedure, and medicine already has mature models for matching complexity to capability without denying access. In coronary care and in cardiogenic shock, lower-acuity cases are managed locally while higher-complexity patients are transferred up a defined hierarchy of care. For PCI simple/emergency cases are performed in referral centers and complex cases transferred. CV medicine is acquainted with a tiered or hub-and-spoke framework —straightforward transfemoral cases can be performed at qualified local programs and complex anatomy, valve-in-valve, or high-risk cases are referred to advanced centers. This would balance quality with access far more precisely than a blunt volume floor that simply prevents new programs from opening and would provide internal validity with other CV procedures.

Finally, the volume mandate cannot be reconciled with CMS's own treatment of SAVR. Medicare imposes no minimum-volume condition of coverage on SAVR – in which the median annual surgeon volume in the US is 16 cases and falling (Salemi et al. JACC, 2019). It makes no sense to impose a coverage volume requirement on TAVR that supersedes SAVR volumes while imposing none on the more invasive and riskier surgical alternative. CMS should replace the volume conditions with skill requirements – number of large bore access, ability to perform coronary protection and/or ability to perform pacing services.

Unfortunately, the most egregious evidence of the political impact on CMS recommendations is that there remains no requirement for onsite Electrophysiology – however pacemaker implantation remains the most commonly needed service after TAVR. Secondarily, there is no requirement for vascular surgery – although rare – is vastly more common than CV surgery.

Accordingly, I implore CMS to take an evidence-based approach and focus on beneficiary access – and rather than a blunt volume requirement list skills that providers/centers must have immediately available in order to offer TAVR.

4. A mandated on-site surgical program is not required for safety, as the PCI experience definitively showed

We have run this experiment before. For years, coverage and guideline policy required on-site cardiac surgical backup for PCI, on the theory that patients would be endangered without an operating room and surgical team immediately available. Two large, randomized trials disproved it. In CPORT-E, more than 18,000 patients undergoing non-primary PCI at hospitals without on-site surgery had outcomes non-inferior to those treated where surgery was available, with 6-week mortality of 0.9% versus 1.0%.nThe MASS COMM trial reached the same conclusion, with no meaningful difference in death, myocardial infarction, repeat revascularization, or stroke, and emergency surgery required in only 0.1%–0.3% of cases. On the strength of that evidence, PCI without on-site surgery is now standard, and the earlier restriction is understood to have withheld timely care from patients. Let’s not have CMS make the same error again.

The parallel to TAVR is direct. The rate of TAVR complications requiring emergency surgical conversion is formidably low and continues to fall as devices, imaging, and technique mature. Conditioning coverage on an on-site surgical program repeats a mistake that has already been corrected in the far larger PCI population. CMS should not require an on-site surgical program as a condition of TAVR coverage; it should instead require a documented, pre-arranged transfer and rescue protocol, which is how the PCI field resolved precisely this question.

As discussed above, a focus on what skills/procedures are needed to safely perform the procedure should be emphasized rather than volume or on-site CV surgery.

5. Retaining these restrictions will continue to deny care to at risk patients

Restrictive facility requirements do not fall evenly across the population. When new programs cannot open, TAVR concentrates in large, wealthy, urban centers, and the patients left behind are disproportionately rural, low-income, female, and from racial and ethnic minority groups. The data on this are consistent and substantial.

Hospitals that established TAVR programs between 2012 and 2018 were concentrated in wealthier, more urban markets, leaving rural and disadvantaged communities without local access. Even within major metropolitan areas that already have TAVR programs, areas with higher proportions of Black and Hispanic residents and greater socioeconomic disadvantage have significantly lower rates of TAVR after adjustment for age and comorbidity. Black and Hispanic patients remain markedly underrepresented among TAVR recipients relative to their share of the older population, and both aortic stenosis diagnosis and treatment are lower among these groups. These access gaps compound an already severe problem of undertreatment: in a contemporary real-world analysis, aortic valve replacement was performed in only 60.7% of patients with severe aortic stenosis within four years of diagnosis, meaning roughly four in ten patients with a Class I indication went untreated, a pattern of undertreatment confirmed in national utilization data (Genereux et al JACC 2023). Current CMS guidelines have clearly done a poor job of providing access to patients across the US.

Every facility requirement that prevents a qualified local program from opening therefore has a predictable human cost, borne most heavily by the patients Medicare should be most concerned about. Preserving access must be treated as a safety issue in its own right, because for a patient with symptomatic severe aortic stenosis, no accessible therapy is the most dangerous option of all.

Accordingly, while societies and providers with clear conflict want to impose restrictions that entrench the role of their constituents, CMS’s role is to make sure that we provide access to the people it serves.

6. Conclusion: align coverage with the evidence and democratize access

TAVR is the single greatest advance in cardiovascular medicine of the twenty-first century. It is safe, reproducible, and supported by one of the deepest evidence bases of any device therapy — now extended by the EARLY TAVR trial to patients with severe asymptomatic disease. A therapy, this mature and this well-studied should carry the minimum restrictions necessary to protect patients, and no more.

History should inform this decision. Prior CMS coverage requirements have demonstrated harm despite best intentions.
Examples abound - the on-site surgical mandate for PCI, volume thresholds applied unevenly across valve therapies, heart failure readmission policies that increased mortality. Restricted access without evidence hurt patients for years before the evidence forced their revision. CMS has the opportunity to avoid repeating that pattern.

I respectfully urge the agency to finalize an NCD that removes coverage-conditioning volume floors in favor of skill and procedure-based requirements (i.e. Electrophysiology availability); (b) treats the Heart Team as a best practice rather than a rigid coverage condition, consistent with how SAVR, PCI, and CABG are governed; (c) does not require an on-site surgical program, requiring instead a defined rescue-and-transfer protocol; and (d) is evaluated at every step against a single question — does this provision serve the Medicare beneficiary?

CMS success' should be measured by how many eligible patients get appropriate safe treatment - in 2030 I worry only 2/3rd of eligible patients will be treated if we stay the course.

While I recognize that these recommendations come with the best of intentions, unintended consequences of health policies are usually the norm not the exception. Let’s ensure the needs of the patient come first.

Thank you for the opportunity to comment and for the agency's commitment to timely, equitable access to this lifesaving therapy.

Respectfully submitted,

Benjamin Hibbert MD PhD FRCPC FACC
Chair Critical Care Cardiology
Structural and Interventional Cardiology
Mayo Clinic

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As the national representative of more than 1,000 leading tax-paying hospitals and health systems throughout the United States, the Federation of American Hospitals (FAH) appreciates the opportunity to comment on the proposed decision memorandum reconsidering the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (NCD 20.32; CAG-00430R2). Many FAH members operate TAVR programs and care for the Medicare beneficiaries with aortic stenosis who depend on access to this therapy, which is why we offer the following two comments directed at ensuring the coverage criteria remain administrable and keep pace with evolving treatment options.

The current NCD permits coverage for symptomatic patients with “aortic valve stenosis,” while the proposed update would permit coverage only for patients with “severe” aortic valve stenosis. However, to date the FDA has approved TAVR valves for severe aortic stenosis and severe aortic valve regurgitation. In addition, there are currently several clinical trials in process to determine the efficacy of TAVR for moderate-to-severe aortic stenosis. This creates conflict not only today, but also for any future additional FDA approved indications. If the FDA approves any of these valves for moderate or moderate-to-severe disease, the proposed language would preclude coverage even for an FDA-approved indication, creating a coverage gap that could persist until CMS reopened and revised the NCD.

We note that the proposed coverage criteria already tie coverage to a system “that has received Food and Drug Administration (FDA) premarket approval (PMA) for that system’s FDA-approved indication.” Because coverage is already limited to the FDA-approved indication, removing “severe” does not extend coverage to any indication the FDA has not approved. It simply allows coverage to follow future FDA approvals without requiring a new coverage reconsideration. To align coverage with current and future FDA approvals, we recommend that CMS revise the coverage criteria as follows:

The current NCD requires that the heart team’s physicians have “independently examined the patient face-to-face, evaluated the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy.” The proposed update expands the required elements of the patient evaluation to include several components that are, in most cases, already part of the evaluation and documentation process. We recommend that CMS clarify this requirement by replacing “estimated patient life expectancy” with an objective, established standard.

As proposed, “estimated patient life expectancy” is subjective and undefined. The proposal specifies no threshold, method, or documentation standard, which invites inconsistent application across heart teams and creates unnecessary uncertainty and audit exposure for providers acting in good faith. We recommend that CMS adopt the objective, established standard already used in the Implantable Cardioverter Defibrillators NCD (NCD 20.4), which the agency and providers have applied successfully. Under that approach, the patient evaluation provision would read as follows:

This substitution preserves the “lifetime management considerations” the proposed decision relies upon while replacing an open-ended clinical estimate with a bright-line standard that is administrable and consistent with existing CMS policy.

FAH appreciates CMS’s consideration of these comments and its work to modernize the TAVR NCD. We would welcome the opportunity to provide any additional information that would be helpful.

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Thank you for the opportunity to comment on the proposed National Coverage Determination for TAVR.
As a healthcare administrator involved in oversight of a structural heart program, I support CMS’s effort to modernize the TAVR coverage framework so that it better reflects contemporary evidence, current care delivery, and the capabilities of experienced multidisciplinary valve programs.
From a healthcare operations perspective, these changes will reduce unnecessary delays for patients who need treatment and allow for improved access to care. TAVR programs today are supported by mature clinical pathways, imaging protocols, scheduling processes, quality infrastructure, and post-procedure follow-up systems. Streamlining evaluation pathways and reducing duplicative requirements is less burdensome on patients and allows care teams to focus on moving appropriate patients efficiently from diagnosis to treatment while preserving the collaborative decision-making that remains central to successful Heart Team programs.
I strongly support maintaining the multidisciplinary Heart Team model. However, flexibility in how evaluations and care coordination are performed better reflects contemporary practice and allows organizations to use clinical resources where they create the greatest value for patients.

Specifically, I support:

• Removing unnecessary Coverage with Evidence Development requirements for symptomatic patients to reduce avoidable delays, decrease administrative burden, and allow clinical teams to focus more directly on getting appropriate patients to treatment in a timely manner.
• Expanding coverage to include patients with asymptomatic severe aortic stenosis through Coverage with Evidence Development.
• Removing the mandatory requirement that both an interventional cardiologist and cardiac surgeon perform every procedure, while preserving the multidisciplinary heart team model.
• Allowing greater flexibility in patient evaluation processes, including use of asynchronous reviews when appropriate.
• Updating operator requirements to focus on ongoing procedural competency rather than historical career volume thresholds.

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July 15, 2026

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2)

The American Board of Thoracic Surgery (ABTS) respectfully submits comments on the proposed National Coverage Determination (NCD) regarding transcatheter aortic valve replacement (TAVR). As the certifying body for cardiothoracic surgeons in the United States, ABTS is committed to ensuring the highest standards of training, competence, and patient safety in the care of patients with thoracic and cardiovascular disease. Our comments are offered in that context.

Although we agree with many aspects of the proposed NCD, we have strong concerns. Many issues, as proposed, have the distinct possibility of disrupting the collaborative heart team approach to care and jeopardizing the successful and safe introduction of TAVR into clinical practice. These include:

1. Support for Innovation with Appropriate Clinical Guardrails

ABTS recognizes the transformative impact of TAVR in appropriately selected patients and supports continued innovation in transcatheter therapies. Expansion of therapeutic options has improved outcomes and broadened access to care. At the same time, ABTS emphasizes that expansion of indications must remain aligned with robust clinical evidence. Use of TAVR outside well-supported indications or without adequate supporting data may be detrimental and unsafe, with the risk of exposing patients to uncertain durability.

Thus, we support coverage of asymptomatic AS with Coverage with Evidence Development (CED) but strongly suggest that all consecutive patients are enrolled prospectively in a national database that includes 30-day outcomes at a minimum and can be linked to claims data. As proposed, performing CED with a “contemporaneous comparator” can only be performed retrospectively using claims data and is unlikely to give an accurate assessment of clinical outcomes.

Furthermore, we propose that CED be required for other indications for which there is a paucity of evidence of patient benefit. Specific situations include use for bicuspid valves, valve-in-valve implantation, young patients (< age 70), moderate AS (if/when FDA approved) and isolated aortic regurgitation.

2. Importance of Procedural Appropriateness and Heart Team Decision-Making

We strongly support the continued requirement for a multidisciplinary heart team approach in patient evaluation and treatment selection. Optimal outcomes in structural heart disease are achieved when: (1) Patient selection is evidence-based (2) Risks and alternatives, including surgical options, are carefully explored and considered through an informed and educated conversation (3) Decisions are made collaboratively by physicians with complementary expertise (4) Those same physicians jointly participate in the performance of TAVR.

As currently proposed, the NCD states “An initial evaluation by the heart team, which could be asynchronous using medical records to identify patient suitability for TAVR or other treatments…” implies and allows for no meaningful collaboration. Furthermore, nowhere does it specifically state that a patient has to be seen by a cardiac surgeon. We propose CMS change evaluation process to “Both the Heart Team's interventional cardiologist and cardiac surgeon must evaluate the patient to determine whether the patient is a suitable candidate for TAVR”

3. Operator Competency and Certification Standards

As indications for TAVR evolve, it is critical that operator competency standards progress in parallel. ABTS strongly recommends that: (1) Proceduralists performing structural heart interventions should demonstrate rigorous, validated training pathways (2) Ongoing participation in maintenance of certification and quality assessment programs is essential and (3) Institutions must ensure appropriate case volumes and continuing education to maintain proficiency across proceduralists, including both interventionalists and surgeons.

4. Institutional Requirements and Programmatic Oversight

High-quality outcomes are closely linked to programmatic structure, experience, and accountability. ABTS supports maintaining standards that ensure institutional readiness to safely perform TAVR, including (1) Availability of appropriate infrastructure and personnel (2) Access to surgical expertise for complex cases and complications. (3) Participation in national registries and transparent outcomes reporting. The current proposal for institutions to perform “continuous quality improvement” is vague and insufficient to assure optimal patient outcomes. We feel that participation in a national registry to allow individual institutional performance comparison to national benchmarks is the optimal process to assure continuous quality improvement.

Although proposed NCD cites requirements for operator experience, evidence shows that TAVR outcomes are more closely correlated with institutional procedural volumes (Kumbhani et al., J Am Coll Cardiol., in press, 2026). We, thus propose that CMS reinstitute minimal institutional volume requirements.

5. Patient Safety and Responsible Expansion of Indications

In summary, expansion of TAVR coverage should proceed in a manner that prioritizes: (1) patient safety (2) durability of outcomes, particularly in younger and lower-risk populations (3) appropriate evidence development for new indications.

The successful introduction of TAVR into clinical practice occurred due to an effective and collaborative heart team approach to proper patient selection and careful assessment of patient outcomes by a national registry that included almost all patients receiving TAVR. Although we appreciate the well-meaning efforts to reduce provider burden and improve access to care, the proposed changes will not meaningfully address either issue and in fact jeopardizes this successful program of care delivery.

The ABTS maintains that modifying the proposed NCD to address these issues is critical to optimizing outcomes for all patients.

Sincerely,
Michael Mack, MD
Chair, on behalf of the American Board of Thoracic Surgery

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Medicare has used the existing TAVR NCD CED to determine coverage for several IDE trials of TAVR for aortic valve regurgitation (AR). See G150035, G190117, and G240185, which are listed under the approved CED studies. The proposed decision language explicitly notes in Section II.C that AR is not within the scope of the NCD. It seems that future IDE approvals would then fall directly under the review process of the IDE coverage regulations. Is that correct?

Outside of trials approved under the IDE regulations or the Medicare Clinical Trial Policy NCD, how will Medicare coverage of TAVR for pure aortic valve regurgitation performed be determined if the proposed decision is finalized as drafted? The MAC delegation in Section I.C appears limited to aortic stenosis.

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Thank you for the opportunity to comment on the proposed National Coverage Decision (“NCD”) for TAVR. We appreciate CMS’s thoughtful review of this important issue, its engagement with public comments, and its efforts to balance patient access with evidence-based care.

We respectfully urge CMS to reconsider several aspects of the proposed rule. In particular, we urge CMS to (i) retain Coverage with Evidence Development (“CED”) for the indications identified above, (ii) preserve, rather than relax, the documented independent heart-team evaluation, and (iii) preserve the dual-operator requirements in the final NCD. These provisions have underpinned the safety record TAVR has built to date and weakening them now, as the therapy extends to younger and lower-risk patients, would remove safeguards at precisely the moment they matter most. We appreciate CMS's continued diligence on this important issue and welcome the opportunity to provide any additional data or perspective that would be useful to this reconsideration.

(I) Coverage with Evidence Development: Should Remain for Several Key Indications

CED should remain in place for TAVR in areas where important clinical questions remain and the science remains incomplete, including severe aortic stenosis, moderate aortic stenosis, bicuspid aortic valve disease, pure aortic regurgitation, valve-in-valve procedures, and low-surgical-risk patients. Continued CED provides an important mechanism to ensure expansion of indications is accompanied by robust collection of outcome data for patients of all ages.

TAVR has been a valuable therapy for many patients, but its use has already expanded rapidly into younger patients despite limited long-term durability and lifetime-management data. For example, trends from the Northern New England Cardiovascular Disease Study Group Consortium show that by 2022, TAVR comprised more than half of all isolated AVRs in patients aged <65 years(1) and similarly, an analysis published in the Annals of Thoracic Surgery reported that among 2,360 patients <60 years undergoing AVR in California, New York, and New Jersey, approximately half of the patients receiving a bioprosthetic valve underwent TAVR rather than surgery.(2) More recent data confirm that this trend persists: as of 2026, TAVR accounted for 36% of AVRs in patients under 65,(3) even though current ACC/AHA guidelines recommend SAVR over TAVR in this age group.(4) Alarmingly, this data also suggest a 9.9% one-year mortality rate for TAVR patients under 65.(5)

Removing CED at this stage risks accelerating adoption beyond the evidence base and may expose patients to avoidable long-term harm.

(II) Patient Evaluation: Maintain documented, face-to-face, collaborative input

CMS should require documented, independent surgical, and interventional cardiologist input of the rationale as part of the heart-team evaluation and in person assessment of the patient. Requiring the presence and participation of both a cardiac surgeon and interventional cardiologist ensures that patients have access to the full spectrum of expertise and treatment options, prevent specialty bias, and allows the patient to remain truly informed of their options. This established collaborative model has been shown to improve patient selection, procedural planning, complication management, and overall outcomes.

The goal is not to impede but to support a collaborative check-and balance system that ultimately prioritizes patient care.

(III) TAVR Operator: Maintain Dual-Operator Requirement

CMS should preserve the dual-operator requirement, with one operator being a cardiac surgeon. The success of TAVR in the United States was built on a multidisciplinary model involving both interventional cardiology and cardiac surgery that prioritizes patient safety and supports successful outcomes. Removing this requirement risks eroding the collaborative framework that prioritizes comprehensive patient care. Further, while catastrophic complications are uncommon, when they occur, they may require immediate surgical judgment or intervention. There is not sufficient evidence, particularly in new indications such as asymptomatic aortic stenosis, that a single-operator or single-specialty model provides equivalent safety across the full range of TAVR patients.

These safeguards protect Medicare beneficiaries while allowing innovation to continue in an evidence-based and patient-centered manner.

For these reasons, as set forth above, we respectfully urge CMS to retain CED for the indications identified above, and to preserve, rather than relax, the important evidence-based independent heart-team evaluation and dual-operator safe-guards in the final NCD.

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July 15, 2026

Joanna Baldwin
Interim Director, Coverage and Analysis Group (CAG)
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

RE: Transcatheter Aortic Valve Replacement National Coverage Determination - CAG-00430R2

Dear Ms. Baldwin,

On behalf of The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS), we write to provide comments on the second reconsideration of the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination (NCD). Together, our organizations represent more than 8,000 surgeons, researchers, and allied healthcare professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lungs, and esophagus, as well as other surgical procedures within the chest.

STS and AATS support CMS's proposal to retire Coverage with Evidence Development (CED) for patients with symptomatic severe aortic stenosis (AS). More than a decade of evidence generated through the STS/ACC TVT Registry and numerous clinical studies has established TAVR as a safe and effective treatment for appropriately selected patients with symptomatic severe AS. We also support CMS's proposal to apply CED to patients with asymptomatic severe AS, where important questions regarding optimal timing of intervention and long-term outcomes remain.

However, we believe that CED should continue to apply to additional patient populations for whom the evidence base remains limited or is rapidly evolving. As TAVR expands beyond the populations evaluated in the pivotal clinical trials, continued prospective data collection through a robust national registry is essential to ensure patient safety, monitor long-term outcomes, and inform future coverage decisions.

Specifically, our organizations strongly recommend that CMS maintain CED for the following patient populations:

Patients with Symptomatic Severe Bicuspid Aortic Stenosis

AATS and STS recommend continued CED for patients with symptomatic severe bicuspid AS. Although TAVR use in bicuspid valve patients has expanded rapidly, prospective evidence remains very limited, and these patients were largely excluded from the landmark randomized trials supporting TAVR approval. Bicuspid valve anatomy presents unique challenges, including asymmetric calcification, subvalvular outflow tract calcification, variable annular morphology, and associated aortopathy, all of which may influence procedural success, valve performance, annular rupture risk, pacemaker risk, durability, and long-term outcomes.¹ Continued evidence generation through CED will provide critical information regarding patient selection, procedural outcomes, valve durability, and lifetime management strategies in this growing patient population.

Patients Requiring Prosthetic Aortic Valve Reintervention

We recommend continuing CED for patients undergoing transcatheter treatment for failed surgical or transcatheter bioprosthetic valves. As increasing numbers of patients undergo bioprosthetic valve replacement at younger ages, repeat intervention is becoming more common. Additional real-world evidence is needed to evaluate coronary obstruction risk, valve in valve TAVR durability and thrombosis, patterns of structural valve deterioration, repeat intervention, and long-term patient outcomes.² Registry-based evidence will be essential to guide patient selection and inform future clinical practice.

Patients with Aortic Regurgitation Requiring Treatment by the Heart Team

Our organizations recommend explicitly including patients with native aortic regurgitation (AR) under CED. Historically, TAVR evidence has focused almost exclusively on calcific aortic stenosis, and prospective data supporting use in AR remains very limited. The recent FDA approval of dedicated transcatheter technologies for AR represents an important advancement, but real-world evidence will be critical to evaluate safety, effectiveness, durability, and appropriate patient selection as adoption expands.^3,4 Continued CED will facilitate systematic data collection while ensuring appropriate oversight during early implementation.

Patients Identified by the Heart Team as Younger, Low Surgical Risk, or with Life Expectancy Greater than 10 Years

We recommend continuing CED for younger patients, those at low surgical risk, and patients with an anticipated life expectancy exceeding 10 years. In these populations, the primary unanswered question is long-term valve durability and lifetime management. Emerging evidence in this specific subgroup suggests significant differences in long-term survival, repeat intervention, and valve performance between transcatheter and surgical valve replacement, underscoring the need for continued evidence generation before routine expansion of TAVR in these patients.^5,6 CED provides the appropriate framework to evaluate long-term outcomes and health system burden that cannot be captured within existing clinical trials.

Patients with Symptomatic Moderate Aortic Stenosis

Our organizations recommend explicitly including patients with symptomatic moderate AS under CED. Although randomized clinical trials evaluating TAVR in moderate AS are ongoing, current evidence remains insufficient to support broad expansion of coverage. Trial participants are highly selected and may not reflect the broader Medicare population. A CED framework will allow CMS to collect real-world evidence regarding patient selection, procedural outcomes, functional status, and long-term clinical benefits/risk while this indication continues to evolve.⁷

We believe that maintaining CED for these expanding indications appropriately balances patient access with responsible evidence generation. The STS/ACC TVT Registry has demonstrated the value of CED in generating high-quality national evidence that has informed clinical practice, FDA regulatory decisions, professional society guidelines, and prior CMS coverage determinations. Continuing this approach for emerging TAVR indications will help ensure that future coverage expansions are supported by robust clinical evidence while maintaining the highest standards of patient safety and quality of care. Furthermore, discontinuing registry requirements simultaneously to liberalizing operator and institutional requirements will prevent CMS from determining the safety of these proposed changes.

Additionally, we believe that the draft NCD fails to clearly specify how the required evidence will be collected. Without an explicit requirement to participate in a national clinical registry capable of capturing standardized patient, procedural, and longitudinal outcomes, data collection is likely to become fragmented and inconsistent across institutions. This could limit CMS's ability to evaluate the safety, effectiveness, durability, and appropriate use of TAVR in these evolving patient populations. Our organizations therefore strongly encourage CMS to clearly identify an established national registry, such as the STS/ACC TVT Registry, or establish equivalent clinical registry participation requirements as the mechanism for satisfying CED. A standardized registry infrastructure is critical to ensuring complete, high-quality real-world evidence that can meaningfully inform future coverage decisions and clinical practice.

Patient Evaluation: We appreciate CMS's recognition that the Multi-Disciplinary Heart Team model has been fundamental to the safe and successful adoption of TAVR since the original NCD in 2012. The Heart Team has served as the cornerstone of patient-centered decision-making by ensuring that each patient receives a comprehensive evaluation from physicians with complementary expertise in surgical and transcatheter therapies. This collaborative approach has contributed to excellent patient outcomes, supported appropriate patient selection, and facilitated the responsible expansion of TAVR to broader patient populations. Our organization strongly supports CMS's continued endorsement of the Heart Team model as TAVR indications continue to evolve.

However, in this current draft NCD, CMS fails to define the role of the cardiac surgeon within the evaluation and treatment process, exposing the potential exclusion of surgical evaluation. As TAVR expands to increasingly complex patient populations, or lower risk patients with evolving valve indications, the need for comprehensive surgical assessment has become critically important. Cardiac surgeons bring essential expertise in lifetime management of valvular heart disease, operative risk assessment, alternative treatment strategies, and the management of procedural complications. We therefore strongly recommend that CMS explicitly requires patient evaluation by both a cardiac surgeon and an interventional cardiologist as part of the Heart Team assessment before a patient proceeds with TAVR. This expectation should be clearly articulated within the final NCD to preserve the multidisciplinary framework that has been central to the program's success.

Operator Requirement: Our organizations also recommend that CMS retain an explicit requirement for two qualified operators during TAVR procedures. The two-operator model has been a defining feature of the Heart Team approach and has contributed significantly to procedural safety, particularly in the management of unexpected complications requiring immediate multidisciplinary expertise. Although operator experience and procedural efficiency have improved substantially over the past decade, TAVR remains a complex structural heart intervention with the potential for catastrophic complications requiring rapid decision-making and surgical intervention. The presence of both an interventional cardiologist and a cardiac surgeon provide complementary technical expertise that enhances patient safety throughout the procedure. This will be even more important as evolving indications present increasing complexity.

Maintaining the two-operator requirement also reinforces shared accountability for patient outcomes and preserves the collaborative model that has driven the success of the national TAVR program. Our organizations are very concerned that removing this expectation will gradually erode the multidisciplinary nature of TAVR care, resulting in greater variability in patient evaluation and procedural practice across institutions. Given the continued expansion of TAVR into increasingly variable clinical scenarios, we believe the evidence strongly supports preserving both a clearly defined multidisciplinary evaluation process and a two-operator procedural requirement as foundational elements of the Medicare TAVR program.

Facility and Operator Volume Requirements

In the CMS TAVR NCD proposal, CMS proposes to eliminate facility-level procedural volume requirements and instead mandate operator volume requirements, on-site cardiac surgery and structural heart programs, and critical care resources. We appreciate the importance of maintaining high standards for TAVR programs and agree that appropriate infrastructure, multidisciplinary expertise, and experienced operators are essential to ensuring safe, high-quality patient care.

However, we are concerned that eliminating facility-level volume standards while placing greater emphasis on individual operator procedural thresholds is not fully supported by the available evidence and will have unintended consequences. Current data demonstrate that TAVR outcomes are influenced by operator experience and institutional experience, underscoring the importance of evaluating performance at the program level rather than relying predominantly on individual procedural volumes.

Recent analyses from the STS/ACC TVT Registry demonstrate that outcomes are influenced not only by individual operator experience but also by institutional experience and broader programmatic characteristics.⁸ These findings reinforce that successful TAVR programs depend on coordinated multidisciplinary teams, established institutional infrastructure, standardized processes, and robust quality improvement systems. Procedural outcomes reflect the performance of the entire program, not solely the procedural volume of an individual operator.

We believe that the proposed operator volume thresholds place undue emphasis on individual procedural counts without adequately accounting for program-level performance. As written, the proposal could exclude a substantial proportion of currently practicing operators, despite their participation in experienced, high-performing TAVR programs with high quality outcomes.

Our organizations support maintaining minimum hospital volume requirements, including at least 20 TAVR procedures annually (or 40 procedures over two years), as an appropriate foundation for ensuring programmatic quality. However, operator expectations should recognize the continuous nature of the available evidence and be evaluated within the context of an established multidisciplinary Heart Team and high-performing TAVR program, rather than relying on inflexible procedural thresholds alone.

Thank you for considering these comments. We appreciate CMS’s consideration and remain committed to collaborating on policies that guarantee safe, effective, and accessible aortic valve therapies for all patients.

For additional information or clarification, please contact Molly Peltzman, Director of Health Policy and Regulatory Affairs, at mpeltzman@sts.org.

Sincerely,

Joseph Woo, MD
AATS President

Vinay Badhwar, MD
STS President

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July 15, 2026

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00430R2 Transcatheter Aortic Valve Replacement

The American College of Cardiology (ACC), the Society for Cardiovascular Angiography & Interventions (SCAI), and The Society of Thoracic Surgeons (STS) appreciate the opportunity to comment on the proposed decision memo for the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). The current NCD has been instrumental in establishing a robust, evidence-based framework for TAVR through national registries and multidisciplinary care, and data-driven quality oversight. As the Centers for Medicare and Medicaid Services (CMS) considers updates to this policy, we believe it is important to build upon this successful foundation while maintaining the safeguards that have supported high-quality patient care and evidence generation. We strongly support modernizing the NCD and offer the following recommendations to help ensure the policy continues to promote high-quality, evidence-based, and patient-centered care.

Our recommendations outlined focus on targeted clarifications to the proposed decision that will help ensure consistent implementation, preserve nationally standardized approaches to quality assessment and evidence generation, and maintain the multidisciplinary care model that has contributed to the success of TAVR in the Medicare population. The subsequent sections provide additional detail regarding these recommendations and the specific policy modifications needed to support high-quality, evidence-based care for Medicare beneficiaries.

Preserve a Targeted, Forward-Looking CED Pathway
The Societies agree that it is appropriate to sunset the existing CED framework designed to evaluate TAVR in high-risk patients with symptomatic severe aortic stenosis (AS) within a framework defined by hospital and operator volume requirements and programmatic quality standards. That framework has successfully achieved its intended purpose by generating substantial clinical trial and real-world evidence demonstrating the safety and effectiveness of TAVR in the Medicare population; and thereby supporting CMS’s determination that TAVR is reasonable and necessary for this population.

As TAVR expands into new and more complex patient populations, we support CMS's continued use of targeted CED and strongly recommend that CMS establish a clear process for incorporating future FDA-approved indications and emerging clinical evidence into the coverage framework. We support maintaining a targeted CED pathway for newly approved patient populations and other clinical circumstances where important evidence gaps remain, particularly where TAVR use continues to evolve beyond the populations studied in the original evidence base. This approach reflects the current evidence base, aligns with clinical consensus, and supports the Administration's goal of ensuring timely beneficiary access to innovative, FDA-approved technologies while maintaining appropriate safeguards for quality and safety.

Consistent with prior multisociety recommendations, CED should apply to the following populations:

• Patients with symptomatic severe bicuspid AS
  Use in bicuspid valve patients is expanding rapidly despite limited prospective evidence. Due to important anatomical differences, including calcification patterns and valve morphology, procedural risk, and valve durability, long-term outcomes may differ (Halim et al., Circulation 2020; Mehaffey JH et al., Ann Thorac Surg. 2025). Because bicuspid anatomy was excluded from the pivotal TAVR trials, continued prospective evidence generation remains particularly important as use expands in this population.
• Patients requiring prosthetic aortic valve reintervention
  Long-term registry data are needed to better understand patterns of repeat intervention, valve durability, and patient outcomes following prior surgical or transcatheter valve replacement (Makkar et Lancet. 2023; Bowdish et al., Ann Thorac Surg. 2024)
  
• Patients with asymptomatic severe AS
  While recent trials support expanded use in select patients, routine treatment of asymptomatic individuals remains evolving. CED enables systematic tracking of outcomes, including complications such as thrombosis, infection, and device-related failure (Lindman et al., J Am Coll Cardiol Img. 2020).
• Patients with aortic regurgitation (AR) requiring treatment by the Heart Team
  

  We strongly recommend including AR under CED. Historically, TAVR trials have focused on calcified aortic stenosis, and prospective evidence in AR remains limited. With the recent FDA approval of dedicated TAVR technologies for AR, including the JenaValve system, structured real-world evidence generation is essential to ensure appropriate adoption and patient safety (Makkar et al., Lancet 2025). CMS should also clarify that the final NCD does not exclude TAVR for AR and should avoid language that could be interpreted as limiting coverage pathways for conditions that fall outside the scope of the NCD.

In the absence of clear national coverage parameters under CED, newly approved indications, such as, AR, and potential future indications currently under investigation, such as moderate AS could result in inconsistent policies across Medicare contractors, geographic variability in access, and increased administrative burden for providers and health systems. Such fragmentation undermines both equitable access and systematic evidence generation. We therefore recommend that CMS explicitly include a prospective pathway for incorporating future FDA-approved indications and clinically evolving patient populations into the CED framework to ensure continued evidence generation, appropriate monitoring of outcomes, and alignment of coverage with the current level of evidence. A prospective, flexible CED framework is a more durable and efficient policy approach than repeatedly reopening the NCD as new technologies and indications are approved. By establishing a mechanism to align coverage with evolving FDA indications and evidence development, CMS can allow the NCD to adapt over time while maintaining national consistency. Such an approach would enable timely beneficiary access to newly approved therapies, support nationally consistent evidence development, and reduce administrative burden on CMS and stakeholders.

As additional evidence-based guidance is expected in the forthcoming 2026 ACC/AHA Valvular Heart Disease Guidelines and recent updates in international guidelines (Praz et al., Eur Heart J, 2025), we encourage CMS to ensure that the final NCD maintains sufficient flexibility to incorporate evolving clinical evidence and consensus recommendations.

Heart Team: Clarification and Safeguards Needed
The proposed language would benefit from additional clarification regarding the respective roles of the interventional cardiologist and a cardiac surgeon in the Heart Team evaluation process.
CMS proposes:

• An initial evaluation that may be conducted asynchronously using medical records
• An independent, in-person evaluation performed by a TAVR operator

• Initial review by a non-physician or mid-level provider, and
• Independent evaluation performed solely by an interventional cardiologist or cardiac surgeon

We recommend that CMS clarify that both an interventional cardiologist and a cardiac surgeon must participate in the Heart Team evaluation and treatment recommendation of eligible patients with severe aortic stenosis. This clarification preserves CMS's requirement for an in-person evaluation while providing flexibility for either an interventional cardiologist or cardiac surgeon to perform the initial evaluation. The second physician evaluation may occur separately through an appropriate mechanism, such as telehealth, provided both physicians participate in the Heart Team assessment and treatment recommendation. Additionally, CMS should reinforce the Heart Team as a required component of care and clarify that the treatment recommendation must reflect collaborative physician-led decision making rather than review by a single specialty or delegation to nonphysician personnel. The Heart Team model, which requires collaborative evaluation by both interventional cardiologists and cardiac surgeons, has been central to appropriate patient selection and optimal outcomes. This collaborative approach is particularly important in patients with more complex anatomy or procedural characteristics where clinical judgment and procedural planning are most challenging.

We are also concerned that the proposed NCD weakens expectations regarding multidisciplinary Heart Team composition. The proposed language states that the Heart Team "may include nurses, advanced practice clinicians, and administrators." This permissive language creates ambiguity regarding the personnel necessary to support patient evaluation, care coordination, registry participation, quality monitoring, and longitudinal follow up. We recommend that CMS revise this language to state that the Heart Team must include nurses, advanced practice clinicians, and administrators.
Coordinators and navigators play an essential role in managing the longitudinal patient journey, coordinating multidisciplinary care, supporting documentation and registry activities, and facilitating quality oversight (Otto et al., J Am Coll Cardiol., 2017; Nishimura et al., J Am Coll Cardiol., 2019; Otto et al., J Am Coll Cardiol., 2021). CMS has recognized the importance of dedicated care coordination personnel in other complex cardiovascular programs. For example, the recently finalized National Coverage Determination for Renal Denervation requires facilities to maintain a multidisciplinary hypertension program that includes a hypertension navigator. Additionally, CMS has consistently used mandatory language in other structural heart NCDs, which specify that the Heart Team must include defined multidisciplinary specialists rather than leaving participation optional. Consistent with the current TAVR and other structural heart coverage frameworks, specifying the essential members of the Heart Team helps ensure the personnel necessary to support patient care, policy implementation, registry participation, and quality oversight are maintained while allowing flexibility in how individual programs deploy these roles.

Finally, while the Societies recognize that procedural approaches may continue to evolve over time, we do not believe the final policy should create barriers to collaborative care models. Accordingly, CMS should clarify that the participation of two qualified operators does not require additional justification for coverage when a collaborative procedural approach is deemed appropriate by the Heart Team.

Facility and Operator Volume Requirements
We appreciate CMS's effort to incorporate contemporary evidence regarding operator experience into the proposed TAVR requirements. Recent analyses from the STS/ACC TVT Registry demonstrate a persistent association between lower operator procedural volumes and adverse short-term outcomes following TAVR. In a contemporary analysis of more than 350,000 TAVR procedures performed between 2020 and 2023, operators performing fewer than 15 TAVR procedures annually experienced modestly higher rates of 30-day mortality, procedural complications, and composite adverse outcomes compared with operators performing more than 37 procedures annually (Kumbhani et al., JAMA Cardiology, 2026) At the same time, the available evidence demonstrates a continuous relationship between procedural volume and outcomes rather than a clear inflection point that identifies a single evidence-based threshold for competency. The observed differences were modest, with numbers needed to harm ranging from 143 to 250, and the analyses do not establish a definitive volume threshold below which operators can no longer safely perform TAVR. Rather, they reinforce that operator experience should be considered as one component of a broader quality framework (Kumbhani et al., JAMA Cardiology, 2026).

A more recent analysis from the STS/ACC TVT Registry further suggests that procedural volume should be evaluated within the context of broader programmatic quality and institutional performance. These findings indicate that while operator experience remains important, longer-term outcomes are further influenced by multiple factors beyond individual procedural counts alone, including multidisciplinary team performance, institutional infrastructure, care coordination, and quality oversight (Kumbhani et al., J Am Coll Cardiol., in press, 2026).

CMS appropriately recognizes that procedural experience remains an important component of quality. However, the proposed threshold of 15 TAVR procedures annually may not fully reflect the complexity of the available data. Contemporary TVT Registry analyses found that approximately one-third of current TAVR operators performed fewer than 15 procedures annually, the threshold proposed by CMS (Kumbhani et al., JAMA Cardiology, 2026). As a result, the proposed requirement could have meaningful implications for workforce capacity and beneficiary access, particularly in regions served by otherwise well-established TAVR programs. The Societies support revisiting procedural volume thresholds with greater emphasis on outcome-based quality measures and registry performance rather than strict procedural minimums. However, recent evidence continues to demonstrate worse outcomes among lower volume programs and operators.

Accordingly, we recommend that CMS adopt a balanced framework that:

• Recognizes operator experience as an important component of quality.
• Emphasizes program-level performance supported through national registry participation and externally benchmarked outcomes assessment.
• Considers hospital experience, institutional infrastructure, multidisciplinary care, and quality oversight alongside individual procedural volume.
• Prioritizes quality outcomes and programmatic performance when evaluating TAVR programs.

Such an approach would better align with the available evidence, preserve beneficiary access to TAVR services, and maintain the quality framework that has supported the safe and successful expansion of TAVR in the Medicare population.

Registry Participation with CED
Under the current proposal, while certain indications remain contingent upon participation in CMS-approved CED studies, it is unclear how these requirements will be operationalized in practice. In particular, there is ambiguity regarding the role of national registries and how institutions are expected to meet CED requirements while ensuring consistent participation in standardized data collection.

Under prior NCDs, the STS/ACC TVT Registry functioned as a CMS-recognized CED pathway, supported by a formal study protocol, ClinicalTrials.gov registration, and explicit CMS approval. This model ensured consistent, nationwide participation in standardized data collection and was central to successful evidence development and quality monitoring for TAVR. The success of this model argues for continuity wherever feasible as CMS updates the TAVR coverage framework. The registry-based approach is familiar to facilities, clinicians, and patients, has established processes for data collection, quality oversight, and evidence generation, and has produced a substantial body of clinical and real-world evidence that has informed regulatory, clinical, and coverage decision-making. Significant changes to the operational structure of evidence development without clear implementation guidance may create confusion and variability among facilities and clinicians, potentially disrupting ongoing evidence generation efforts. While flexibility may be appropriate in certain circumstances, ambiguity regarding participation requirements, data collection expectations, or acceptable evidence development pathways can increase administrative burden on facilities by requiring local interpretation and development of operational processes that were previously standardized nationally. Accordingly, CMS should seek to build upon the existing registry-based infrastructure wherever possible while modernizing CED requirements to address evolving indications and evidence needs. Clear expectations regarding registry participation, data collection, and evidence development pathways will be essential to achieving this goal.

In the absence of clear expectations under the proposed framework, there is a risk that:

• Participation in national registry infrastructure may be interpreted as optional
• Institutions may pursue fragmented or study-specific approaches to meeting CED requirements
• CMS may not receive sufficiently accurate and comprehensive effectiveness and safety data to make fully informed decisions
• Nationally standardized evidence generation and longitudinal outcomes assessment may be significantly weakened

We also have concerns regarding how the proposed framework may function for new or expanding TAVR programs, particularly in the absence of uniformly applied CED expectations. The success of TAVR to date has been directly tied to the standards established in the NCD, including multidisciplinary care, institutional readiness, participation in structured national data collection, and ongoing quality oversight. Under the current proposal, variability in implementation may emerge. For example, a program could focus primarily on patients outside of CED-designated indications and thereby avoid participation in certain evidence development activities. This would result in incomplete national data collection, fragmented quality monitoring and uneven evidence generation across institutions, ultimately limiting the ability to consistently assess outcomes as TAVR continues to expand into new patient populations and care settings.

These concerns are further compounded by updated methodological requirements, such as the inclusion of an active contemporaneous comparator. As currently written, it is unclear how this requirement can be operationalized without access to:

• Comprehensive claims datasets or external real-world data sources
• Infrastructure beyond existing national registries

While registry-based studies can address many important clinical questions, the TVT Registry alone may not be sufficient to support all aspects of the proposed comparator framework. Without clear guidance, this requirement may create practical barriers to participation in CED and introduce additional variability in how evidence is generated across institutions.

At the same time, the success of the TVT Registry demonstrates the value of a standardized, registry-based approach to evidence development. Developed in collaboration with CMS, the TVT Registry has served as the foundation for post-market surveillance, outcomes assessment, and regulatory decision-making. Over the past decade, this model has enabled the safe and evidence-based expansion of TAVR across multiple patient populations.

Participation in a national, audited registry remains essential because it provides:

• Real-world clinical insight through detailed, procedure-specific data reflecting routine practice
• Standardization and data quality through uniform definitions, structured data collection, and rigorous auditing
• Comprehensive national benchmarking across institutions and patient populations

Movement away from this model risks fragmenting data collection, reducing transparency, and limiting CMS’s ability to evaluate outcomes as TAVR expands into new indications and care settings.

Accordingly, we recommend that CMS:

• Maintain mandatory participation in a national, audited registry, such as the STS/ACC TVT Registry
• Clarify how registry-based approaches may be used to fulfill CED requirements, including whether registries may be approved as CMS-recognized CED pathways
• Provide clear guidance on how requirements such as active contemporaneous comparators can be operationalized within existing infrastructure, including through hybrid models or linked data sources
• Ensure that any CED framework maintains expectations for standardized, nationally comparable data collection across all participating institutions Preserving and clarifying the role of registry-based CED will be essential to maintaining the programmatic quality framework that has supported TAVR outcomes to date.

Continuous Quality Improvement and Safeguarding Programmatic Quality
The proposed requirement for a “continuous quality improvement process” is an important component of the NCD. However, as currently written, it is insufficiently defined, with unclear expectations for implementation and accountability. Specifically, the proposal states that facilities must maintain:
“A continuous quality improvement process that assesses procedural outcomes and makes necessary programmatic adjustments to assure patient safety.”

In addition, the proposal references the use of quality measures and externally developed frameworks (e.g., those endorsed by a clinical measurement consensus-based entity [CBE] or aligned with nationally recognized quality measurement programs) to support quality assessment. However, it is unclear how these elements are intended to be operationalized in practice. It remains ambiguous whether this requirement is intended to represent a formal, standardized, and measurable process tied to validated quality measures, or whether it may be satisfied through routine institutional activities such as internal review conferences. In practice, all institutions could assert that they already meet this requirement through existing internal processes, such as morbidity and mortality conferences, without participating in standardized external benchmarking. Without additional clarity, this requirement could end up being inconsistently applied across institutions, difficult to measure in a meaningful way, and ultimately ineffective as a quality safeguard or in advancing optimal patient care delivery.

This issue becomes particularly important as the proposed NCD reduces or eliminates several long-standing programmatic requirements. The favorable outcomes achieved with TAVR to date were generated under a framework that included multidisciplinary Heart Team evaluation, national registry participation, institutional standards, and ongoing quality oversight. As the policy evolves away from certain structural requirements, nationally standardized quality measurement and externally benchmarked performance assessment become increasingly important mechanisms for monitoring outcomes, identifying variation in performance, and ensuring continued accountability across TAVR programs. Because the proposed policy continues to rely on nationally recognized quality frameworks, additional clarity regarding the role of externally benchmarked quality assessment programs would help ensure consistent interpretation and implementation across institutions. Current outcomes are strong in part due to structured benchmarking, registry participation, externally validated performance assessment, and the dedicated personnel responsible for coordinating these activities. Absent clear expectations, variation in care and outcomes may increase, particularly among newer or lower-volume programs.
The TAVR NCD represents a unique opportunity for CMS to advance a quality-based coverage framework, aligning with broader CMS efforts to incorporate national quality measures, transparency, and accountability into coverage policy. To achieve this, we recommend that CMS define minimum expectations for quality improvement that are objective, measurable, and linked to externally benchmarked data sources, including national registries and validated quality frameworks.

We recommend CMS adopt the following approach:
Facilities must ensure continuous quality improvement by assessing procedural outcomes through established mechanisms, such as national registry reporting or other externally benchmarked data systems aligned with national quality measurement frameworks, and making necessary programmatic adjustments to assure medical necessity and patient safety.

This approach would

• Reinforce quality improvement tied to validated measures
• Support consistent benchmarking across institutions
• Align with CMS’s emphasis on national quality frameworks and transparency
• Enhance accountability for hospitals and clinicians

We further recommend that CMS:

• Define minimum, measurable expectations for quality improvement processes
• Clarify how national quality measures (e.g., measures endorsed by a clinical measurement CBE or similar frameworks) should be incorporated into program evaluation
• Require linkage of quality improvement activities to externally benchmarked data sources
• Maintain clear institutional standards and oversight mechanisms to support programmatic quality

This clarification is essential to ensure that continuous quality improvement is implemented in a consistent, measurable, and meaningful way across all TAVR programs, and sustains high-quality outcomes achieved under prior NCDs.

Conclusion
The success of TAVR in the Medicare population is the result of a carefully constructed framework grounded in multidisciplinary Heart Team decision-making, national registry participation, and rigorous, data-driven quality oversight. These elements have not only ensured patient safety but have also enabled continuous quality improvement, evidence generation, and transparency across institutions.

Both the clinical community and industry share a unified commitment to ensuring equitable access to care while maintaining and advancing quality in TAVR care. The proposed decision includes many important steps toward modernization of the TAVR NCD. However, there is a risk that implementation may move away from the very mechanisms that have made TAVR one of the most successful examples of coordinated, evidence-based care in modern medicine. Weakening expectations around registry participation, Heart Team engagement, and standardized quality monitoring introduces unnecessary variability.

We appreciate CMS's efforts to modernize the TAVR NCD and support many aspects of the proposed decision. Our comments are intended to clarify key operational, quality, and evidence-development provisions to ensure consistent implementation across TAVR programs while preserving the quality framework that has supported successful patient outcomes. Without additional clarification, ambiguity regarding Heart Team participation, registry use, CED implementation, and quality oversight will create operational uncertainty, increase administrative burden, contribute to delays in care delivery, and ultimately introduce avoidable risks to patient safety. Greater clarity is essential to promote nationally consistent, high-quality care for Medicare beneficiaries.

We remain committed to working with CMS to develop a final NCD that reflects both the strength of the evidence base and the expert consensus of the clinical community. Thank you for the opportunity to comment. We respectfully urge CMS to give serious consideration to the recommendations and clarifications outlined above.
Please direct any questions or follow-up to Amanda Stirling, Regulatory Affairs Associate, at 202-375-6553 or astirling@acc.org.
Sincerely,

Roxana Mehran, MD, FACC
President, American College of Cardiology

J. Dawn Abbott, MD, MSCAI
President, Society for Cardiovascular Angiography & Interventions

Vinay Badhwar, MD
President, The Society of Thoracic Surgeons

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Dear Administrator Oz,

The Medical Device Manufacturers Association (MDMA), a national trade association representing hundreds of primarily small to mid-sized, innovative companies in the field of medical technology, appreciates the opportunity to provide comment on CMS's proposed decision regarding the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). MDMA thanks CMS for its consideration of the comments we submitted during the first comment period. We are pleased that the proposed decision reflects several of the points we raised, including termination of Coverage with Evidence Development (CED) for symptomatic severe aortic stenosis (AS) and a more streamlined approach to facility, operator, and heart team requirements.

We do believe that there is ambiguity in the scope of the proposed decision that warrants clarification before the NCD is finalized, as the ambiguity could create confusion for providers, contractors, and beneficiaries regarding two distinct patient populations.

(1) Moderate symptomatic AS. The current NCD does not limit coverage to severe AS; it covers “symptomatic aortic valve stenosis” under CED, without qualifying disease severity. The proposed decision, by contrast, defines both the non-CED and CED coverage pathways in terms of severe AS specifically. It is not clear from the proposed decision what happens to symptomatic patients with moderate AS who have been receiving coverage under the current CED framework. The proposed decision does not appear to discuss the evidentiary basis for this apparent narrowing, and members have raised the question of whether CMS intends to (a) continue CED coverage for moderate symptomatic AS, (b) leave such coverage to MAC discretion under §1862(a)(1)(A), or (c) end coverage for this population altogether. We urge CMS to clarify its intent and maintain coverage for moderate AS under CED, consistent with the current NCD, in the final decision.

(2) TAVR for aortic disease other than AS. The proposed decision states plainly that it “does not address TAVR for the treatment of other conditions like aortic regurgitation (AR).” At the same time, several other elements of the draft — including the proposed retitling of the NCD to specify “for Aortic Stenosis,” the elimination of the current NCD's general CED pathway for off-label uses, and the reference only to AS in Section I.C and Appendix A, Section D — create uncertainty as to whether the final decision will foreclose, preserve, or simply remain silent on coverage pathways for TAVR in aortic disease other than stenosis, including through the Investigational Device Exemption (IDE) pathway or MAC discretion. We ask CMS to state explicitly, in both the decision memo and the manual language, what coverage pathways (if any) remain available for aortic valve disease outside the scope of this NCD, so that the final decision cannot be misread by negative implication.

MDMA believes clear guidance on both points will reduce administrative confusion, support consistent claims adjudication, and avoid unintended coverage gaps or overlaps as this NCD is finalized. We appreciate CMS's continued engagement with stakeholders on this reconsideration and welcome the opportunity to provide additional detail if helpful.

Sincerely,

Dan Waldmann
EVP, Health Policy & Reimbursement
MDMA

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Re: Proposed Revision to National Coverage Determination for Transcatheter Aortic Valve Replacement

I am pleased to provide comments on the proposed revision to National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). Overall, I believe the proposed decision appropriately reflects the current evidence supporting TAVR, and I respectfully recommend that CMS finalize the proposed decision memorandum as written, except for the CED requirement for asymptomatic severe AS.

As an interventional cardiologist and clinician caring for Medicare patients with structural heart disease, I believe the proposed NCD appropriately aligns Medicare policy with current clinical practice while maintaining the high standards of care that have contributed to the excellent outcomes achieved with TAVR. The proposed revisions improve patient access while preserving rigorous clinical evaluation, physician collaboration, and institutional excellence.

In particular, the proposal appropriately (1) updates the Heart Team evaluation process, (2) provides standard Medicare coverage for symptomatic severe aortic stenosis without continued Coverage with Evidence Development (CED), (3) preserves appropriate hospital and quality standards, and (4) adopts a competency-based framework for operator qualification.
In regards to asymptomatic severe AS, I am recommending standard Medicare coverage similar to symptomatic severe AS, given the large burden of evidence supporting upstream treatment of AS in term of clinical benefits and cost-effectiveness, and the similarities of asymptomatic severe AS and symptomatic severe AS as clinical entities.

I. Heart Team Evaluation
The proposed Heart Team evaluation process appropriately reflects current structural heart practice.
Independent multidisciplinary review before the in-person physician evaluation allows Heart Team members to assess imaging, anatomy, frailty, comorbidities, and patient preferences in a coordinated and efficient manner while preserving comprehensive clinical decision-making. This approach reduces unnecessary clinic visits, minimizes travel and caregiver burden, and facilitates more timely treatment without compromising the quality of patient evaluation.
The required in-person assessment by a qualified TAVR operator preserves physician-patient interaction, shared decision-making, and clinical oversight while allowing additional consultations whenever clinically appropriate. This proposal improves efficiency while preserving the fundamental principles of the Heart Team.

II. Standard Coverage for Symptomatic Severe Aortic Stenosis
Standard Medicare coverage for symptomatic severe aortic stenosis is supported by a mature and comprehensive body of evidence.
Randomized clinical trials, together with extensive real-world registry experience, have consistently demonstrated the safety, effectiveness, durability, and reproducibility of TAVR across a broad Medicare population.
Coverage with Evidence Development played an important role during the early adoption of TAVR, when additional evidence was needed to better define patient selection, procedural outcomes, valve durability, and long-term clinical performance. Those objectives have now been achieved. Continuing CED for symptomatic severe aortic stenosis is no longer justified for a well-established therapy supported by robust clinical evidence.

That being said, some area may deserved CED, such as complex TAVR procedures including leaflet modifications (mechanical or electrosurgery), new indications such as TAVR for aortic regurgitation or moderate AS, and new TAVR platforms with new mechanism of action/anchoring and lack of long-term data.

III. Hospital Infrastructure and Quality Standards
The proposed hospital, ICU, operator competency, and continuous quality improvement requirements appropriately emphasize the institutional capabilities most closely associated with excellent patient outcomes.
Experienced structural heart programs, advanced rescue capability, dedicated post-procedural critical care, and ongoing performance assessment remain essential components of high-quality TAVR programs. These standards accurately reflect current clinical practice and should be finalized.

IV. Competency-Based Operator Qualification
The proposed competency-based operator qualification framework appropriately emphasizes demonstrated experience and procedural competency.
Operator qualification should be based on experience, technical competency, and active participation within an established Heart Team rather than specialty designation or a universal requirement that every TAVR procedure be performed by two attending physicians.
Although dual operators may be beneficial in selected complex procedures, current evidence does not support making this a national requirement irrespective of patient complexity or institutional expertise. The proposed policy appropriately allows individual Heart Teams to determine procedural staffing according to the clinical needs of each patient while preserving timely access to care.

Continued Coverage with Evidence Development for Asymptomatic Severe Aortic Stenosis
I politely disagree that continued Coverage with Evidence Development (CED) for asymptomatic severe aortic stenosis is required. Recent randomized trials have consistently demonstrated that early valve replacement, whether by TAVR or SAVR, improves clinical outcomes, including death, stroke, and heart failure hospitalization, and is cost-effective compared with a strategy of clinical surveillance.
Importantly, identifying truly asymptomatic patients remains challenging in routine clinical practice. A substantial proportion of patients initially considered asymptomatic are subsequently found to have symptoms following more detailed questionnaire, exercise testing or further clinical evaluation, while others have already developed subclinical cardiac damage that is associated with adverse outcomes. In addition, the natural history of severe asymptomatic aortic stenosis is characterized by rapid and unpredictable disease progression, with approximately half of patients developing symptoms within one year, and 40% presenting with acute and severe symptoms requiring hospitalization. Recent evidence also suggests that an early intervention strategy results in better procedural outcomes compared to a strategy of delayed AVR. From a procedural standpoint, there is little biological rationale to expect TAVR to perform less favorably in asymptomatic than symptomatic severe aortic stenosis. If anything, intervention at an earlier stage of disease may offer procedural and durability advantages because patients generally have less advanced valvular calcification, fewer secondary cardiac damage, and greater physiological reserve.
Taken together, these observations suggest that the remaining evidence gap between asymptomatic and symptomatic severe AS has narrowed considerably, and that these populations represent the same disease rather than 2 distinct clinical entities.

In conclusion, the proposed NCD appropriately aligns Medicare coverage with the current evidence supporting TAVR. It improves the Heart Team evaluation process, establishes standard coverage where the evidence is mature, preserves the high standards of care that support excellent patient outcomes, and adopts an operator qualification framework based on demonstrated competency and experience.
For these reasons, I respectfully recommend that CMS finalize the proposed decision memorandum as written, except for asymptomatic severe AS, where “Severe Aortic Stenosis” should be considered as one clinical entity, and not 2 based on the presence or absence of symptoms. CED should be preserved for new indications, such as TAVR with leaflet modifications, new TAVR platforms with lack of long term data, and new indications such as aortic regurgitation and moderate aortic stenosis. Thank you for the opportunity to provide these comments and for your thoughtful consideration of this important policy.

Philippe Genereux, MD
Director, Structural Heart Program
Morristown Medical Center
Morristown, New Jersey

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As an Executive of a health system serving Medicare beneficiaries with structural heart disease, I support CMS's proposed updates to the TAVR National Coverage Determination and encourage finalization of policies that expand access, reduce unnecessary barriers to care, and preserve high-quality outcomes.

Expanding coverage to patients with severe asymptomatic aortic stenosis is supported by a growing body of evidence demonstrating the clinical benefit of timely intervention. Recent randomized trials and meta-analyses have shown reductions in cardiovascular and heart failure hospitalizations, stroke, and adverse clinical events when valve replacement is performed before symptom progression. Delaying treatment may allow irreversible cardiac damage to develop and can lead to worse clinical outcomes and higher healthcare utilization. The evidence also suggests that earlier intervention is associated with lower resource utilization and meaningful healthcare cost savings.

I also support greater flexibility in patient evaluation requirements. While multidisciplinary Heart Team decision-making remains essential, requiring multiple in-person evaluations may create unnecessary burden for elderly Medicare beneficiaries, particularly those in rural or underserved areas. Streamlining evaluation pathways while maintaining appropriate clinical oversight can reduce travel, administrative complexity, and delays to treatment, helping patients access care more efficiently. Evidence suggests that delays to valve replacement are associated with higher mortality, increased hospitalizations, and higher overall costs of care.

Finally, I support the proposed operator flexibility provisions. Contemporary TAVR outcomes continue to improve, and experienced Heart Teams are well-positioned to determine the most appropriate procedural approach for individual patients. Allowing qualified interventional cardiologists or cardiac surgeons to perform procedures based on patient need and local expertise can help improve capacity, reduce treatment delays, and expand access while preserving quality and accountability. CMS's proposed changes appropriately maintain the Heart Team model while recognizing the evolution of clinical practice.

In summary, expanding asymptomatic coverage, streamlining patient evaluation requirements, and supporting operator flexibility represent thoughtful updates that can improve patient access, reduce unnecessary burden on patients and providers, and facilitate more timely treatment for Medicare beneficiaries without compromising quality of care

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We write as members of the multidisciplinary heart team at Mission Hospital (HCA) in Asheville, North Carolina, comprised of cardiac surgeons and interventional cardiologists who jointly direct our TAVR program. We appreciate the opportunity to comment on the proposed NCD changes published June 15, 2026. We enthusiastically support efforts to expand access to TAVR for appropriate patients (i.e. those with asymptomatic severe aortic stenosis) and recognize that easing the restrictions of CED for TAVR may alleviate administrative burdens for some TAVR centers, but we urge CMS to preserve four pillars that have been foundational to the exceptional quality and safety record of TAVR in the United States:
(1) mandatory participation in the STS-ACC TVT Registry
(2) the requirement for multidisciplinary heart team evaluation, including face-to-face preprocedural visits by both a cardiac surgeon and an interventional cardiologist
(3) the dual-operator model requiring both a cardiac surgeon and an interventional cardiologist as co-operators during TAVR procedures.
(4) the procedural volume requirements for TAVR institutions.

I. The Requirement for TVT Registry Participation Is Integral for TAVR Quality and Should be Maintained

We recognize that removing the CED classification for TAVR is CMS acknowledging that TAVR has become the standard of care for many patients with aortic stenosis; and that eliminating prescriptive registry-reporting mandates is in line with removing the CED classification. However, the STS-ACC TVT Registry represents one of the most successful examples of registry-based quality improvement in modern medicine and has helped to ensure TAVR program maturity and quality improvement processes at all participating centers. Multiple studies have demonstrated improvement in clinical outcomes with incorporation of TVT Registry reporting. These improvements did not occur by chance; they are the direct result of standardized data collection, national benchmarking, site-level performance feedback, and the quality improvement infrastructure that the Registry enables.
Eliminating the requirement for TVT Registry participation is counter to ensuring that national benchmarks and best medical practices for TAVR are maintained across all centers performing this important procedure, while the technology itself, patient populations, and indications continue to evolve.
Without mandatory registry participation, there will be no standardized national mechanism to monitor outcomes, identify underperforming sites, track complications, or ensure that the expansion of TAVR to new populations (including asymptomatic patients) is proceeding safely. We strongly urge CMS to maintain mandatory TVT Registry reporting for all TAVR indications or propose mandating another form of required quality metric monitoring that is publicly reported.

II. The Multidisciplinary Heart Team Is Essential to Optimal Patient Outcomes

The multidisciplinary heart team (MDT) consisting of interventional cardiologists and cardiac surgeons has been a stalwart example of the collaboration between specialties that has led to innovation with the TAVR procedure itself and improved outcomes.

The requirement for face-to-face evaluation by both a cardiac surgeon and an interventional cardiologist dramatically reduces biased assessments via a shared decision-making process. This was particularly important as TAVR expanded to lower-risk and younger patients, where the long-term implications of valve choice, durability considerations, and the potential need for future reintervention demand the combined expertise of both specialties. Replacing the requirement for two face-to-face encounters with "one in-person visit and one other assessment" risks diluting this critical safeguard and eroding the relationship that cardiac surgery and interventional cardiology has developed in the TAVR era.

III. The Dual-Operator Model Should Continue to Be an Option

We strongly support maintaining the requirement for both a cardiac surgeon and an interventional cardiologist to be present as co-operators in some capacity during every TAVR procedure. The proposed NCD changes would replace the dual-operator requirement with "heart team discretion," which we believe would compromise a critical patient safety mechanism.

The 2012 ACCF/AATS/SCAI/STS Expert Consensus Document established that "both a surgeon and an interventional cardiologist should be integrally involved with each procedure" and that "prior to the start of each procedure, a specific team leader should be identified, either the surgeon or the interventional cardiologist." The document further recognized that the multiple tasks involved in TAVR (vascular access, crossing the stenotic valve, balloon valvuloplasty, prosthesis positioning and deployment, vascular closure, and management of procedural complications) "often require different skill sets" that are complementary between the two specialties.

The 2018 Expert Consensus reaffirmed that "no one individual, group, or specialty possesses all of the necessary skills for optimal patient outcomes" and that "the success of these programs depends on a group of professionals, each with his or her own skillset, working together to provide the best possible patient-centered care." We could not agree more with this sentiment.
This collaborative model has been foundational to the outcome relationship documented in the TVT Registry.

Leaving the decision to include a surgeon to "heart team discretion" creates a potential incentive structure in which financial pressures could lead programs to eliminate surgical or interventional cardiology presence from the procedure room, precisely at the moment when it matters most. The current mandate ensures that every TAVR patient in the United States has the same safety net, regardless of institutional culture or financial considerations.

IV. Procedural Volume Requirements Should be Maintained

While we were relieved to see that on-site cardiac surgery is still proposed to be a requirement for structural heart programs performing TAVR, we were quite concerned to see the volume requirements for TAVR would be essentially eliminated. While we understand that there are market forces pushing for this change, eliminating the volume requirements creates an environment in which low volume centers, who would now also not be beholden to reporting to the TVT Registry, may be placing patients at risk for worse outcomes.

We respectfully urge CMS to:

1. Maintain mandatory TVT Registry participation (or simplify the metrics tracked and visits required) for all TAVR procedures, including the proposed new coverage for symptomatic severe AS (without CED) and asymptomatic severe AS. Registry reporting should continue for a minimum of 30 days post-procedure.
2. Preserve the requirement for multidisciplinary heart team evaluation, including face-to-face assessment by both a cardiac surgeon and an interventional cardiologist prior to TAVR. CMS should make clear that team consensus is required on each patient's course of therapy and that all preprocedural visits deemed necessary by the heart team are covered.
3. Maintain, or at least suggest as best practice, the dual-operator requirement that both a cardiac surgeon and an interventional cardiologist serve as co-operators during TAVR procedures. This requirement should not be replaced by "heart team discretion," as it provides a critical and non-negotiable patient safety mechanism that ensures immediate surgical capability for life-threatening complications. Even if the dual-operator requirement ultimately is eliminated, we urge CMS to maintain reimbursement for both operators as historically has been done.
4. Maintain institutional volume requirements for TAVR to ensure high quality, safe procedures.
5. Support the heart team concept by ensuring that CMS coverage policies reinforce, rather than weaken, the multidisciplinary infrastructure that has made TAVR one of the safest and most successful innovations in cardiovascular medicine.

Respectfully,

Michael S. Chenier, MD, MPH; interventional cardiology
Mark A. Groh, MD; cardiothoracic surgery
Thomas G. Gleason, MD; cardiothoracic surgery
Joshua P. Leitner, MD; interventional cardiology
William B. Abernethy, MD; interventional cardiology
Sara Evenson; structural heart coordinator
Deborah Provost; structural heart coordinator
Pamela Pierce; structural heart quality coordinator
Brad Kappalman; VP Heart Services

Mission Health/HCA
Asheville, NC

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I strongly support maintaining dual operators (cardiologist and cardiothoracic surgeon) for TAVR procedures as well as mandatory database reporting for the following reasons:

1) A heart surgeon is in the unique position to do a TAVR and a SAVR whereas a Cardiologist can only offer TAVR. In addition, the surgeon fixes the life-threatening short-term procedural complications of TAVR as well as the long-term complications of TAVR requiring TAVR Explant and SAVR. In this fiduciary position the surgeon may offer an unbiased medical opinion to the patient and act in the patient’s best interest. In 2026 TAVR is often the answer but there are patients and disease processes better suited for SAVR. Without a heart team approach and true multidisciplinary input, select patients will never hear the discomforting truth: they will be better served with SAVR in the long-term. Cardiologists control that pathways of patients. A patient sees a heart surgeon only after they are referred by a Cardiologist. If surgeons are removed from the preop and intraprocedure TAVR equation, they will never see these patients, and the patients will receive a limited and even biased perspective and thus not have the opportunity for true informed consent.

2) TAVR Explant has one of the highest mortalities of any cardiac surgery operation performed in 2026. The question of TAVR first or SAVR first is not answered in a straightforward approach; any given patient is a unique smorgasbord of their comorbidities, the morphology of their aortic valve disease, and the recognition that chronologic age does not always correlate with physiologic age. Surgeons fix the complications of TAVR. It is prudent to involve surgeons pre-procedure and intra-procedure to decrease the frequency of complications and to save lives. Surgeons can either be involved at the onset of aortic valve disease decisions, or they can be involved after complications occur. The former will result in better patient outcomes and decreased medical costs. Involving surgeons after complications occur will result in worse results and lives lost. If a surgeon is not standing at the table when complications such as perforation and rupture of the heart occur during TAVR (and these complications do occur), the patient is less likely to live. If a surgeon is not involved in the decision-making and a patient has a TAVR that ultimately requires explant when the patient would have had a SAVR if the surgeon had been involved, this patient will suffer higher complications and a significant risk of death during TAVR explant and the healthcare system will bear the higher financial cost.

3) Finally, CMS should continue to mandate participation in the STS/ACC TVT Registry. The registry is an incredible repository of real-time information. It allows clinician to adjust our decision-making as driven by the data. Ongoing analysis not only updates our understanding of the risks and benefits, who should receive TAVR and who should not, but also decreases costs to CMS. Ultimately, the goal of healthcare is to optimize patient outcomes and minimize unnecessary costs and burdens. Without tracking the data, TAVR will be performed at centers with poor results, higher complications and increased health costs to CMS.

4) To summarize, cardiac surgeons are uniquely suited to a fiduciary responsibility to the patient by being able to perform TAVR, SAVR and treat the complications of TAVR; no other heart team member has this role or unbiased perspective. Involving surgeons pre-procedure and intra-procedure will improve patient outcomes and survival and decrease healthcare costs. Upholding mandatory participation in the STS/ACC TVT registry will allow the United States to provide our citizens with the best outcomes and mitigate financial burdens by making data-based decisions.

Respectfully yours,

Lori K. Soni, MD
Cardiothoracic Surgeon

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CO-SIGNED EXECUTIVE SUMMARY

This executive summary accompanies and is co-signed in support of a public comment submitted by Dr. Elizabeth M. Perpetua, DNP, ACNP-BC, ARNP, FACC on the proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) CAG-00430R2. Implementation guidance and evidence, which are not yet part of the evidentiary record for this reconsideration of the TAVR NCD, are provided in support of Dr. Perpetua's four requests for the final NCD.

Since 2020, TAVR programs have had multi-professional society guidance, the current TAVR NCD 20.32, and empirical evidence for the roles needed for hospitals to justify essential, interprofessional Heart Team infrastructure to furnish TAVR: coordinators, advanced practice clinicians, and nurses. (Otto 2017, Bavaria 2018, Nishimura 2019, Perpetua 2019, Otto 2021)

The proposed NCD creates a mandatory and discretionary tier of Heart Team membership criteria, using the language "must include" for the interventional cardiologist and cardiac surgeon and "may include" for advanced practice clinicians and nurses, among others. To date, there is no evidence or guideline available, or provided in the CMS evidence review, to support changing the interprofessional Heart Team infrastructure of advanced practice clinicians and nurses from mandatory to discretionary.

REQUESTS FOR THE FINAL NCD

Request 1: Add a valve coordinator as a required criterion of the Heart Team / program facilities requirement, consistent with the ventricular assist device NCD (20.9.1) and renal denervation NCD (CAG-00470N), multi-professional society guidance, and evidence presented in the full public comment. (Otto 2017; Bavaria 2018; Nishimura 2019; Otto 2021)

Request 2: Restore the advanced practice clinician (nurse practitioner, clinical nurse specialist, or physician associate) as a required criterion of the Heart Team / program facilities requirement, consistent with the current TAVR NCD (20.32), multi-professional society guidance, and evidence presented in the full public comment. (Bavaria 2018; Nishimura 2019)

Request 3: Restore nurses as a required criterion of the Heart Team / program facilities requirement, consistent with the current TAVR NCD (20.32) and evidence presented in the full public comment.

Request 4: Convene a CMS meeting that includes valve coordinators and advanced practice clinicians. This workforce possesses deep knowledge and experience most proximal to patients and NCD implementation and should be heard directly before the Final NCD is issued.

Crosswalk:

Current NCD (20.32), Nationally Covered Indications A2: MUST INCLUDE (a) …cardiac surgeon, interventional cardiologist…, (b)…other physicians, advanced patient practitioners, nurses...

Proposed NCD (CAG-00430R2), Provision B2, Physician and Heart Team Criteria: (a) MUST INCLUDE cardiac surgeon, interventional cardiologist; (b) MAY INCLUDE other physicians, advanced practice clinicians, nurses...

Requested language for the Final NCD: MUST INCLUDE cardiac surgeon, interventional cardiologist, coordinator, advanced practice clinicians, and nurses…

RATIONALE

Harm in patients with severe aortic stenosis accrues in delay before treatment, not during it. Mortality while awaiting valve replacement reaches 11.6% at six months, and contemporary U.S. data show that evaluative encounters, cardiac specialist visits and imaging, explain approximately 83% of the excess time to treatment for TAVR compared to SAVR. (Malaisrie 2014; Stinis 2026) A national registry study corroborates that this is not hypothetical: investigators reported that "whether and when a multidisciplinary heart team evaluation occurred was sometimes difficult to ascertain due to the lack of an explicit process at many centers or confusion regarding which clinicians comprised the heart team." (Lindman 2023)

Professional society guidance has named valve coordinators and advanced practice clinicians as Heart Team members and institutional facilities requirements since 2017. (Otto 2017, Bavaria 2018, Nishimura 2019, Otto 2021) A national survey confirms who is responsible for the implementation that the NCD mandates: 82% of structural heart coordinators hold a nursing degree, and coordinators screen referrals, ensure completion of Heart Team evaluation, and coordinate care across the continuum. (Perpetua 2019) In the EVOLVE study, the first multicenter, mixed methods study of U.S. TAVR Heart Teams, physicians named coordinators and advanced practice clinicians as essential, central team members without prompting. Exemplar quotes included: from an interventional cardiologist, "The core members of the team are obviously my valve coordinator... that's pretty much the only way that we're able to do anything and get it done in a timely fashion" and, from a cardiac surgeon, "The nurse practitioners are actually absolute key, I think, more than really any of us, because all of us are interchangeable, but the advanced practice clinician and the people she works with are really central. It really is driven by them." (Coylewright 2026; Kolte 2026) When these roles are defined and deployed, outcomes improve: the BENCHMARK registry, isolating the coordinator role through propensity matching across 2,323 patients in 7 countries, found significantly shorter length of stay and fewer complications, without a safety penalty. (Lauck 2026)

Naming these roles as essential Heart Team membership and facilities requirements would align the Final NCD with CMS' own precedent. CMS already identifies "advanced practice clinicians, nurses" as mandatory Heart Team members in the current TAVR NCD (20.32). CMS already names a program coordinator in the ventricular assist device NCD (20.9.1) and a hypertension navigator in the renal denervation NCD (CAG-00470N).

WHO WE ARE

The undersigned are clinical valve coordinators, advanced practice clinicians, nurses, and physicians who operationalize TAVR programs and Heart Teams across the United States. We support Dr. Perpetua's public comment and its four requests, and ask that CMS name this Heart Team implementation infrastructure – valve coordinators, advanced practice clinicians, and nurses – as mandatory in the Final NCD.

CO-SIGNATORIES

The following colleagues join as co-signatories in these requests.

1. Jenna Abington, BSN, RN. Structural Heart Program Manager. Huntsville Hospital, Huntsville, AL.
2. Yousif Ahmad, MBBS, PhD, FACC, FSCAI. Structural Interventional Cardiologist and Director of Complex Coronary Intervention, Division of Cardiology, University of California San Francisco, UCSF Health, San Francisco, CA.
3. Russell Brandwein, MS, PA-C, AACC. Physician Associate. Executive Director, Columbia Interventional Cardiovascular Care and Columbia Structural Heart and Valve Center. Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, NY.
4. Marcus R. Burns, DNP, RCIS, AACC. Lead Advanced Practice Provider, Structural Heart. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN.
5. Christina Cantey, DNP, FNP-C, CCK, FACC. Structural Heart Program Nurse Practitioner. Huntsville Hospital, Huntsville, AL.
6. Richard Cheng, MD, FACC, FSCAI. Structural Interventional Cardiologist and Heart Failure Specialist. Associate Director of Interventional Cardiology, Director of Structural Interventional Cardiology Research, Division of Cardiology, Department of Medicine, University of California Los Angeles, UCLA Health, Los Angeles, CA.
7. David J. Cohen, MD, MSc. Structural Interventional Cardiologist. St. Francis Hospital and Heart Center, Roslyn, NY.
8. Megan Coylewright, MD, MPH, FACC, FSCAI. Structural Interventionalist/Interventional Cardiologist. Essentia Health, Duluth, MN.
9. Ashley Dacey, DNP, AGACNP-BC, CCK. Structural Heart Nurse Practitioner. Banner University Cardiovascular Institute, Phoenix, AZ.
10. Sammy Elmariah, MD, MPH, FACC, FSCAI. Chief, Interventional Cardiology and Director, Cardiac Catheterization Laboratory. Cardiology Division, Department of Medicine, University of California San Francisco, UCSF Health, San Francisco, CA.
11. Nathan Ferreira, MPAS, PA-C. Physician Associate. Interventional and Structural Program Manager, Interventional Program/Structural Heart Disease Program/Adult Congenital Heart Disease Program. Intermountain Health, Murray, UT.
12. John Frederick, MD. Cardiothoracic surgeon. Division Chief, Cardiothoracic Surgery, Sanger Heart and Vascular Institute, Charlotte, NC.
13. Kimberly A. Guibone, DNP, ACNP-BC, FACC. Cardiology Nurse Practitioner. Beth Israel Deaconess Medical Center, Boston, MA.
14. Marian Hawkey, RN. Nurse Project Lead, Structural Heart. Hackensack University Medical Center, Hackensack, NJ. Officer, Transcatheter Valve Research, Division of Cardiology. Columbia University Irving Medical Center. New York, NY.
15. Dhaval Kolte, MD, PhD, MPH, FACC, FSCAI. Structural Interventional Cardiologist, Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School, Boston, MA.
16. Brian R. Lindman, MD, MSc, FACC. Medical Director, Structural Heart and Valve Center. Vanderbilt University Medical Center, Nashville, TN.
17. Michael J. Mack, MD. Chair, Cardiovascular Governance Council and Medical Director, Cardiovascular Surgery, Baylor Scott and White Health, Dallas, TX.
18. Rebecca Marcantuono, MSN, CRNP, ACNP-BC. Acute Care Nurse Practitioner and Structural Heart Valve Coordinator. Jefferson Health, Philadelphia, PA.
19. Joan Michaels, MSN, RN, FACC. Washington, DC.
20. Rose Nguyen, MBA. Administrative Director. Empath Health Services, Seattle, WA.
21. Dianna Ramsey, BSN, RN. Clinical Director. Empath Health Services, Seattle, WA.
22. Michael J. Reardon, MD. Professor and Chief of Cardiac Surgery. Allison Family Distinguished Chair of Cardiovascular Research. Houston Methodist Hospital, Houston, TX.
23. Caitlin O'Callaghan Reen, CNP, FACC. Lead Advanced Practice Provider, Structural Heart Program. Massachusetts General Hospital, Boston, MA.
24. Cara C. Richardson. MSN, ACNP-BC, AACC. TAVR Program Coordinator. Tennessee Valley Healthcare System, US Dept of Veterans Affairs, Nashville, TN.
25. Michael Rinaldi, MD, FSCAI. Structural Interventional Cardiologist. Structural Heart Medical Director, Sanger Heart and Vascular Institute, Charlotte, NC.
26. Falin Schaefer, DNP, FNP-C. Nurse Practitioner, Transcatheter Heart Valve Program, Stanford Healthcare, Palo Alto, CA.
27. Susan J. Schnell, MSN, ACNP-BC. Chief Operating Officer, Columbia Heart Source. New York, NY.
28. Jonathan Schwartz, MD. Structural Cardiologist. Advocate Health Enterprise Medical Director of Innovation, Advocate Health, Charlotte, NC.
29. Catherine Shah, DNP, FNP-C, AACC. Nurse Practitioner/Structural Heart Clinical Program Lead Advanced Practice Provider, Sanger Heart and Vascular Institute, Atrium Health, Charlotte, NC.
30. Eric Skipper, MD. Cardiothoracic Surgeon, Structural Heart Surgical Director, Sanger Heart and Vascular Institute, Charlotte, NC.
31. Martina Kelly Speight, MS, FNP-BC. Transcatheter Valve Nurse Practitioner. Stanford Health Care, Stanford, CA.
32. Misty Theriot, BSN, RN, CPHQ, FACC. Valve Clinic Coordinator, STS/ACC TVT Registry Site Manager. Heart and Vascular Center, Cardiovascular-Thoracic Surgery. Lake Charles Memorial Hospital, Lake Charles, LA.
33. Melissa Todice, MSN, ARNP, FNP-BC, CCK. Lead Structural Heart Nurse Practitioner. Yale New Haven Hospital, New Haven, CT.
34. Evelyn H. Wilder, MSN, FNP-BC, CPHQ, AACC. Clinical Effectiveness Consultant IV, Clinician. Structural Heart, Sutter Health, Sacramento, CA.

REFERENCES

1. Malaisrie SC, McDonald E, Kruse J, et al. Mortality while waiting for aortic valve replacement. Ann Thorac Surg. Nov 2014;98(5):1564-70; discussion 1570-1. doi:10.1016/j.athoracsur.2014.06.040

2. Stinis C, Tunis S, Lauck S, et al. Impact of pre-procedural requirements on time to aortic valve replacement: Transcatheter AVR vs surgical AVR. Am Heart J Plus. Jan 2026;61:100698. doi:10.1016/j.ahjo.2025.100698

3. Lindman BR, Fonarow GC, Myers G, et al. Target Aortic Stenosis: A National Initiative to Improve Quality of Care and Outcomes for Patients With Aortic Stenosis. Circ Cardiovasc Qual Outcomes. Jun 2023;16(6):e009712. doi:10.1161/circoutcomes.122.009712

4. Otto CM, Kumbhani DJ, Alexander KP, et al. 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults with Aortic Stenosis. A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. 2017;doi:10.1016/j.jacc.2016.12.006

5. Bavaria JE, Tommaso CL, Brindis RG, 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, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. 2018;doi:10.1016/j.jacc.2018.07.002

6. Nishimura RA, O'Gara PT, Bavaria JE, et al. 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 Society of Thoracic Surgeons. 2019;73(20):2609-2635. doi:10.1016/j.jacc.2018.10.007

7. Otto CM, Nishimura RA, Bonow RO, 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. Feb 2 2021;77(4):e25-e197. doi:10.1016/j.jacc.2020.11.018

8. Perpetua EM, Clarke SE, Guibone KA, Keegan PA, Speight MK. Surveying the Landscape of Structural Heart Disease Coordination: An Exploratory Study of the Coordinator Role. Structural Heart. 2019/05/04 2019;3(3):201-210. doi:10.1080/24748706.2019.1581962

9. Coylewright M, Kolte D, Kruse G, Strong S, Elmariah S, Suri R, Perpetua EM. A Multicenter, Mixed Methods Study of United States Heart Teams and Health Policy: The EVOLVE Study Design and Protocol. Journal of the Society of Coronary Angiography and Interventions. 2026; in press.

10. Kolte D, Perpetua E, Kruse G, et al. EVolution Of heart vaLVe teams and the patient Experience (EVOLVE): A Multicenter, Mixed Methods Study of TAVR Programs Across the U.S. June 25, 2026. Invited late breaking science abstract for New York Valves. New York, NY.

11. Lauck SB, Saia F, Durand E, et al. Impact of a Clinical Valve Coordinator on Hospital Length of Stay and Patient Outcomes: Results From the BENCHMARK Registry. Struct Heart. Jan 2026;10(1):100740. doi:10.1016/j.shj.2025.100740

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Dear CMS Coverage and Analysis Group,

I appreciate the opportunity to comment on the proposed TAVR NCD. The proposed updates appropriately reflect TAVR's maturation as a standard of care, and I am broadly supportive of modernizing coverage policy to match contemporary practice. I offer the following thoughts:

The multidisciplinary Heart Team should remain a foundational requirement, as it drives appropriate patient selection, shared decision-making, and longitudinal management. Patient evaluation should include an independent, in-person assessment by a credentialed Heart Team TAVR operator, along with review in a multidisciplinary Heart Team forum to ensure collaborative oversight and appropriate treatment planning.

Local Heart Teams should be allowed to determine the appropriate composition of the procedural team that would preserve patient safety while allowing the flexibility needed to serve diverse patient populations, institutions, and practice settings. When two operators participate in a procedure, both should be credentialed TAVR operators from the established Heart Team.

Coverage should be updated to align with all current FDA-approved TAVR indications, while maintaining a targeted CED pathway for populations where meaningful evidence gaps remain — such as bicuspid aortic stenosis, valve reintervention, asymptomatic severe aortic stenosis, aortic regurgitation, and moderate aortic stenosis. Mandatory TVT Registry participation should be retained as a condition of coverage for all TAVR indications to support quality oversight and continuous outcomes monitoring.

Thank you for considering these comments.

Yours sincerely,
Pei-Hsiu

Pei-Hsiu Huang, MD, FACC, FSCAI
Interventional Cardiology & Adult Congenital Heart Disease
Medical Director, Cardiac Catheterization Laboratory
Medical Director, Adult Congenital Heart Disease Program
Sutter Medical Center, Sacramento

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15 July 2026

Joanna Baldwin
Interim Director, Coverage and Analysis Group (CAG)
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

Submitted electronically to: CAGInquiries@cms.hhs.gov

RE: CAG-00430R2 — Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR)

Dear Ms. Baldwin:

I congratulate CMS for this attempt to modernize CAG-00430R2 (2019), but feel compelled to point out worrisome deficiencies and unintended consequences in the June 15 draft proposal which potentially will jeopardize patient outcome and limit what can be learned about new TAVR indications in new patient subsets. The gist of my response has been previously read by Mehmet Oz, M.D., Administrator for the Centers for Medicare & Medicaid Services. I write as an individual cardiovascular surgeon with over 43 years of experience who was instrumental in launching the TAVR Program at Stanford University Medical Center in 2010; I served as the Stanford Co-PI of all 3 of the Edwards PARTNER randomized trials as well as the Medtronic intermediate risk SURTAVI RCT. I was a member of the Edwards PARTNER Trial Executive Committee from 2011 to 2019. I have no financial link with any corporation involved in surgical or transcatheter valve replacement. I was President of the American Association for Thoracic Surgery (AATS) in 2007-2008.

The CMS TAVR NCD has been a tremendous success story in the field of cardiovascular medicine. The NCD notion first applied by CMS in 2012 to TAVR was a stroke of genius- it is sad that it was not subsequently applied by CMS to other major new and expensive drugs and devices. Maybe even going so far as to mimic the manner which NICE operates in the UK, e.g., the manufacturer has pledged to refund costs to the NHS if the outcome effectiveness seen in real-world use did not live up to the expectations promised. For the first time for any new FDA-approved drug or medical device, CMS assumed responsibility to guide an experimental treatment into a mature therapy by mandating site and operator training standards, by accrediting TAVR institutions, by insisting on well-functioning multidisciplinary Heart Teams to decide collaboratively which patient is best served by which treatment (TAVR, SAVR, continued medical therapy, or palliative care), and using the STS/ACC TVT registry as a vehicle to measure outcome quality metrics, thereby providing patient safety guardrails. Conceptually, if individual institutions did not meet risk-adjusted national quality metric thresholds at 30 days and one- year, they would lose the ability to bill CMS for future TAVRs until remediation efforts and additional training demonstrated satisfactory clinical performance. Also Included was the pathway called “Coverage with Evidence Development” (CED), which has spawned regulatory and societal guidelines for dozens of new TAVR applications and a host of evidence and new knowledge. The unrivaled strengths of the TVT was that it was mandatory, auditable, risk adjusted, and captured nearly all TAVR procedures done in the United States in Medicare beneficiaries. The June 15 draft proposal seeks to eliminate the need for TVT participation in symptomatic AS patients, yet preserve it for future TAVR use in asymptomatic AS patients under CED guidelines. The proposed gutting of the TAVR NCD and elimination of the TVT registry by Edwards would be a tragedy; such would only spawn more TAVR abuse, overuse, fraud, and patient harm. Lamentably, one key element of the genius NCD did fail: Despite John Carroll's efforts over many years, CMS could never force the hospitals to submit the obligatory 1-year patient vital status and functional assessment (KCCQ) in enough patients to allow nationwide benchmarks to be established, which according to the initial NCD intent would be used to determine if each center would continue to be reimbursed going forward. Without the NCD and TVT registry we would have just been stumbling along blindly, which is what Edwards and the other THV manufacturers desire now.
Preservation of the multidisciplinary Heart Team in the preoperative patient evaluation is crucial in the future to provide reasonable patient safety guardrails, especially since so many younger patients are now being offered TAVR and newer indications are being explored. Indeed, perhaps the most important decision step in the entire Heart Team program is patient selection. The previous NCD which threatened stopping CMS reimbursement if a center’s 30-day and 1-year outcomes did not meet the national quality metric thresholds made the physicians accountable. The requirement that both an IC and a surgeon participate in the TAVR procedure is arguable, but even if a catastrophe arises less than <1% of the time this will be a death unless the surgeon can immediately open the chest and put the patient on CPB. As Hughes et al. showed, it is not the complication that kills the patient it is the inability of that center’s capability and preparedness to rescue the patient that kills (Bishawi M, Jensen C, Vekstein A, et al. Influence of Failure to Rescue on Mortality After Transcatheter Aortic Valve Replacement. Ann Thorac Surg Short Reports. 2025;3:617-623. doi:10.1016/j.atssr.2025.03.011).

The two attached papers provide detailed information regarding the evidence gaps, regulatory actions, and poorly defined unknown risks regarding TAVR that CMS is now facing: My 2025 ANN THOR SURG Op/Ed piece illustrates that the benefits of TAVR vs. SAVR remain unproven in many “off-label” patient subsets, which are expanding rapidly over time, where practice has exceeded the evidence. The other 2026 CIRCULATION paper by Mehaffey, Miller, Kaul, Badhwar, and Bowdish summarizes the nationwide relative usage of TAVR (36% in 2023), biological SAVR (42% in 2023), and mechanical SAVR (21% in 2023) across the country between 2017 and 2023 in patients under 65 years, the patient numbers were derived from the STS-ACC TVT registry for TAVR and the STS ACSD for isolated SAVR. Other California and New England multistate registries have shown even higher fractions upwards of 50% of young patients under 65 who have been treated with TAVR. It is glaringly clear that practice in the US has far exceeded the evidence available and has ignored the guidelines. Our Medicare patients desperately need continuation of the original TAVR NCD for both symptomatic and asymptomatic AS patients, which will ultimately provide the answers to the questions CMS is now asking. This must include specific patient subsets, e.g., AS patients with bicuspid aortic valves (BAV), those undergoing valve-in-valve TAVR (V-in-V) for failing THV’s or surgical bioprostheses, young patients under 70, TAVR for symptomatic AS with CED (as CMS currently proposes), and (when FDA approved) TAVR for symptomatic moderate AS or pure AR. Another often hidden example of TAVR use exceeding available evidence and violating FDA approval guidelines is that V-in-V TAVR was approved by the FDA only for inoperable or high surgical risk redo patients with failing aortic bioprosthetic valves; across the country today this restriction is widely ignored despite several centers who have demonstrated mortality and morbidity rates for redo (open) surgical AVR which are just as low as first-time surgical AVR. Continuing strict follow-up of all TAVR patients out to at least one year using a mandatory, external, nationwide, risk-adjusted, auditable registry, viz., the STS/ACC TVT, will provide safety and effectiveness guardrails for Medicare beneficiaries and eventually allow accurate analyses of what determines the best outcome for individual patients, such as generating ICER (incremental cost effectiveness ratio) and quality of life (QUALYs, estimated by functional assessment such as KCCQ) analyses. Conversely but equally important, such research will also reveal which techniques, THV device and model, center, operators, institutional care pathways and infrastructure, and patient selection are associated with no or marginal benefit. If the physicians on the Heart Team making the decision to proceed with TAVR are held accountable if TAVR provides no substantial extension of life expectancy or meaningful improvement in quality of life at one-year follow-up by risking cessation of CMS reimbursement for their TAVR program, the up-front decision-making process would be radically transformed. Putting this responsibility on the shoulders of the physicians obviously requires multidisciplinary input, including a surgeon. This sad situation is reminiscent of the PARTNER 2 trial “Cohort C”, where even if the patients received a TAVR they did not do well. Mike Mack and John Webb years ago vainly tried to educate us about the difference between an elderly patient with AS who was dying of multiple other diseases and one who was actually at risk of dying from AS. The former patient obviously will not benefit from a TAVR.

Thank you for your consideration of these principles. After a stellar and very successful 14-year impact using the CMS TAVR NCD, let’s try to avoid putting the transmission in reverse when crossing the creek. We collectively must put patient welfare first and foremost.

D. Craig Miller, M.D.

Thelma and Henry Doelger Professor of Cardiovascular Surgery (Emeritus), Stanford University Medical School, Stanford, CA 94305
dcm@stanford.edu

Miller, DC: Expanding Transcatheter Aortic Valve Replacement Use in Younger Patients and Bicuspid Valves: Risks, Evidence Gaps, and Regulatory Action. Ann Thorac Surg 2025;119:1166-74.

Mehaffey JH, Miller, DC, Kaul, S, Badhwar, V, Bowdish ME: Current incidence and modality of young aortic valve replacement in the United States. CIRCULATION 2026;153: 1520-1522.

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July 14, 2026

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

RE: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2)

On behalf of the American Heart Association, including the American Stroke Association and 35 million volunteers and supporters, we appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed decision memorandum updating Medicare coverage for transcatheter aortic valve replacement (TAVR). The Heart Association supports CMS’ efforts to improve timely access to evidence-based cardiovascular care, including appropriate access to TAVR for Medicare beneficiaries with severe aortic stenosis (AS).

TAVR outcomes have improved substantially over time, reflecting advances in device technology, procedural care, operator experience, and quality oversight. For example, an analysis of the STS/ACC TVT Registry found that 30-day mortality declined from 6.7% in 2012 to 2.4% in 2018, with improvements in short-term outcomes largely related to device and procedural factors and likely improved team-based technical care.(1)

As CMS modernizes the National Coverage Determination (NCD) for TAVR, it should expand access in a way that preserves patient safety, supports multidisciplinary decision-making, avoids arbitrary volume requirements, and maintains reporting of outcomes.

1. CMS should preserve a meaningful multidisciplinary heart team model.

The heart team model has been central to the development and success of TAVR. As proposed, CMS would no longer require evaluation by both an interventional cardiologist and a cardiac surgeon before TAVR. This proposed policy’s reduced expectations for surgical evaluation risks weakening the heart team and current collaborative decision-making process. The Heart Association urges CMS to maintain a multidisciplinary approach that includes both interventional cardiology and cardiac surgery.

A multidisciplinary assessment helps ensure that patients receive balanced counseling, individualized treatment recommendations, and shared decision-making that accounts for anatomy, procedural risk, lifetime valve management, durability, and patient preferences. Further, peer-reviewed evidence supports the value of multidisciplinary cardiovascular decision-making. A study evaluating implementation of a TAVR and multidisciplinary heart team program found an associated mortality benefit among patients with severe aortic stenosis, independent of expanded access to intervention.(2) A 2025 systematic review further found that heart team approaches were associated with improved outcomes in specialized cardiovascular interventions, including valve disease care, while emphasizing the need for structured implementation and outcome measurement.(3)

AHA recommends that CMS preserve a robust heart team model by maintaining the current requirement that both an interventional cardiologist and cardiac surgeon evaluate the patient. At minimum, CMS should require in-person evaluation by both specialties for intermediate- and low-risk patients.

2. CMS should consider maintaining the dual-operator requirement for TAVR.

CMS proposes to remove the requirement for joint operator participation during TAVR procedures. The Heart Association is concerned that this change could compromise patient safety, particularly given the current procedural demands of TAVR and the growing complexity of the patient population.

At present, TAVR requires coordinated procedural decision-making, including catheter positioning, valve deployment, hemodynamic assessment, and immediate management of complications. Many cases involve complex anatomy or heightened procedural risk, including bicuspid valves, valve-in-valve procedures, redo-TAVR, low left ventricular ejection fraction, high coronary obstruction risk, high aortic root injury risk, tortuous or complex access, and pure aortic regurgitation.

The Heart Association recommends that CMS retain a requirement for two qualified TAVR operators unless and until sufficient clinical trials and outcomes data demonstrate that a single-operator model is more effective and can be implemented safely without compromising outcomes or access. If CMS elects to permit single-operator procedures, these should be performed only in limited circumstances and CMS should define those clinical indications and circumstances narrowly, require appropriate backup and heart team infrastructure, and monitor outcomes closely through standardized reporting.

3. CMS should avoid volume requirements and evaluate access, quality, and program readiness directly.

CMS proposes to establish minimum operator thresholds of 15 TAVR procedures per year or 30 procedures over two years, while removing current facility volume thresholds for TAVR. Together, these changes would loosen facility requirements while retaining a minimum procedural threshold for individual operators. The Heart Association supports improving access to TAVR, particularly for rural and underserved communities, but does not support volume requirements when they function as arbitrary proxies for quality rather than evidence-based measures of patient outcomes, operator competency, and program performance.

Although procedural experience remains important, the evidence does not establish that a single minimum volume threshold reliably distinguishes high-quality from low-quality TAVR care. Rather than rely on volume alone, CMS should prioritize direct measures of quality and access. Recent modeling using Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry data found that shifting care based on historical outcomes could improve modeled TAVR outcomes more than shifting care based on a volume threshold.(4) Studies examining geographic access to TAVR suggest that patients in low-population-density areas may face longer travel times to TAVR-capable hospitals, lower TAVR utilization, and worse adjusted outcomes than patients in more densely populated areas.(5) These findings support CMS evaluating access barriers directly rather than relying on blunt procedural volume thresholds.

Access expansion should be accompanied by appropriate program safeguards. Some lower-volume programs may play an important role in improving access where patients otherwise face significant travel burdens or delays in care. However, TAVR programs require specialized personnel, imaging, procedural infrastructure, complication management capacity, multidisciplinary heart team support, and ongoing quality improvement. CMS should therefore consider not only whether additional programs could expand access, but also whether those programs can sustain the capabilities needed to deliver safe, effective, and patient-centered TAVR care.

The Heart Association recommends that CMS not adopt arbitrary volume requirements as a condition of coverage and instead evaluate access barriers using data-driven geographic, utilization, and outcomes analyses before finalizing changes to facility or operator requirements. If CMS finalizes policy changes intended to expand access—such as removing hospital volume requirements, lowering operator-volume thresholds, or otherwise making it easier for additional programs or operators to furnish TAVR—it should pair those changes with clear accountability standards, including baseline infrastructure requirements, meaningful heart team expectations, emergency backup capabilities, continuous quality improvement, and ongoing outcomes monitoring.

4. CMS should require continued reporting of standardized TAVR outcomes in many clinical scenarios.

The Heart Association supports CMS’ proposal to remove coverage with evidence development (CED) for symptomatic severe AS; however, we believe that some data collection or outcomes reporting is still needed for all Medicare-covered TAVR procedures. Reporting remains essential to monitor patient safety, care quality, access, and equitable outcomes as coverage expands.

CMS should require reporting sufficient to track performance over time, identify safety signals, assess variation across programs and patient populations, and determine whether access-related policy changes benefit rural and underserved communities.

At a minimum, reported outcomes should include mortality, stroke, major vascular complications, bleeding, acute kidney injury, readmissions, and other clinically meaningful measures needed to assess real-world TAVR performance. The Heart Association recommends that CMS require continued reporting of standardized TAVR outcomes for all Medicare-covered TAVR procedures, including symptomatic severe AS cases no longer subject to CED, through a CMS-approved reporting mechanism that meets uniform standards for data elements, outcomes measures, reporting frequency, and data validation.

For new programs—those without previous TAVR experience—CMS could consider temporarily requiring that services be provided under the existing CED requirements, such as for a two-year period.

Conclusion
In summary, the Heart Association supports CMS’ goal of improving access to TAVR for Medicare beneficiaries. CMS should finalize a policy that expands appropriate access while preserving the dual-operator model, maintaining the requirement for evaluation by both an interventional cardiologist and a cardiac surgeon, avoiding arbitrary procedural volume requirements, and requiring continued reporting of standardized outcomes. These safeguards will help ensure that broader access to TAVR is accompanied by continued accountability for patient safety, care quality, and equitable outcomes.

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

Sincerely,

Manesh Patel, MD, FAHA
President, American Heart Association

References

1. Kumbhani DJ, Girotra S, Dong H, et al. Contemporary Operator Procedural Volumes and Outcomes for TAVR and MTEER in the US. JAMA Cardiology. 2026.
2. Salemi A, Sedrakyan A, Mao J, et al. Individual Operator Experience and Outcomes in Transcatheter Aortic Valve Replacement. JACC: Cardiovascular Interventions. 2019;12(1):90–97.
3. Jones DR, Chew DP, Horsfall MJ, et al. Multidisciplinary Transcatheter Aortic Valve Replacement Heart Team Programme Improves Mortality in Aortic Stenosis. Open Heart. 2019;6:e000983.
4. Nelson AJ, Wegermann ZK, Gallup D, et al. Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US. JAMA Cardiology. 2023;8(5):492-502. doi:10.1001/jamacardio.2023.0477.
5. Damluji AA, Fabbro M II, Epstein RH, et al. Transcatheter Aortic Valve Replacement in Low-Population Density Areas: Assessing Healthcare Access for Older Adults With Severe Aortic Stenosis. Circulation: Cardiovascular Quality and Outcomes. 2020;13(8):e006245. doi:10.1161/CIRCOUTCOMES.119.006245.

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Dear CMS Coverage and Analysis Group,

Thank you for the opportunity to comment on the proposed National Coverage Determination for TAVR. I am an interventional and structural cardiologist, Director of the Interventional Cardiology Fellowship Program, and Director of Interventional Structural Heart Research at Brown University Health Cardiovascular Institute and Brown University. I commend CMS for undertaking a thoughtful, data-driven review, and I offer the following comments:

• TAVR has matured well beyond the point where CED remains necessary for symptomatic severe aortic stenosis. Multiple RCTs have consistently shown that TAVR produces outcomes comparable to surgery in death and disabling stroke, with durable results. CED served an essential purpose when TAVR was an emerging therapy; that purpose has been fulfilled for the typical symptomatic patient. Continuing to require it now diverts institutional resources toward regulatory compliance rather than direct patient care, without adding meaningful protection for patients. I support ending CED for symptomatic severe AS while appropriately maintaining it for asymptomatic disease.
• Procedural operator requirements should reflect clinical judgment rather than a fixed specialty mandate. Surgical bailout has become exceedingly rare, and when complications such as coronary obstruction, valve embolization, or vascular injury do occur, they are managed predominantly through percutaneous, catheter-based techniques. Mandating the presence of two operators of specific specialties (interventional cardiologist and cardiac surgeon) no longer reflects where that expertise adds the most value. A recent SCAI survey of 267 structural interventional cardiologists found that nearly 80% favored flexibility in using either one or two operators from any appropriate specialty, based on patient and procedural complexity. Two operators of different specialties would be better reserved for complex cases, at the discretion of the heart team. I encourage CMS to lift the requirement for a fixed interventional cardiologist–cardiac surgeon pairing and instead allow single or dual operators of either specialty, based on institutional expertise, availability, and local heart team judgment.
• Heart team evaluation should be preserved in principle but with flexibility in the mode of evaluation. The heart team remains valuable, and that value comes from collaborative judgment, not from a mandated number of in-person visits. I support CMS's proposal to allow asynchronous, record-based initial heart team review. Mandating in-person visits falls hardest on exactly the patients TAVR is meant to serve — rural, elderly, frail, and financially disadvantaged beneficiaries, for whom each additional trip imposes a significantly higher burden. Untreated severe symptomatic aortic stenosis carries a prognosis comparable to or worse than many metastatic cancers, with survival falling to roughly 50% at two years and well below that at five years. Despite this, only about one in five eligible patients receives timely valve replacement. Every additional mandatory visit, redundant physician review, or rigid staffing requirement adds friction to a pathway where delay has measurable consequences. I encourage CMS to permit telehealth and chart-based review for heart team evaluation whenever the treating team determines it is clinically appropriate.

Conclusion
I encourage CMS to finalize an NCD that ends CED for symptomatic severe aortic stenosis, gives heart teams real discretion over operator number and specialty, and removes the rigid requirement for in-person evaluation by both interventional cardiology and cardiac surgery — instead allowing single-operator TAVR evaluation with appropriate heart team discussion, supplemented by telehealth visits as needed.

Thank you for your consideration of these comments.

Respectfully,
Marwan Saad, M.D., Ph.D., FACC, FSCAI, FESC
Director, Interventional Cardiology Fellowship Program
Director, Interventional Structural Heart Research
Brown University Health Cardiovascular Institute
Assistant Professor of Medicine, Brown University

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I'm an interventional cardiologist who performs structural heart interventions at a community hospital in a far northwest suburb of Chicago. Overall, I support the position submitted by SCAI. I agree with the proposed changes to the TAVR NCD as outlined in the proposal with the following comments:

1. Patient Criteria
I would recommend the verbage state "TAVR is covered for the treatment of Medicare beneficiaries with Aortic Stenosis." Valvular heart disease is not black or white and there are several subtypes of severe aortic stenosis: high flow high gradient aortic stenosis, low flow low gradient, paradoxical low flow low gradient, surgical bioprosthetic aortic stenosis, transcatheter valve aortic stenosis, etc. Furthermore, patients who have mixed moderate aortic stenosis with severe aortic regurgitation, whom are not surgical candidates, would benefit from TAVR. The language should encompass FDA approved indications for TAVR rather than specifying "symptomatic or asymptomatic severe aortic stenosis"

2a. Heart Team
The heart team has been a very successful model for patient outcomes, program development and growth, and clinical innovation. Because of the structural heart team, this concept has been replicated in cardiogenic shock, heart failure, PE response teams, etc. TAVR has matured considerable and is being done in a safe an minimalistic approach nationwide. Coverage for reimbursement should be maintained for 2 operators, but the criteria should be broadened to 2 structural heart operators (2 IC, 1 IC + 1 CV surgeon, etc). Also, 1 operator should be allowed if the physician feels its appropriate

2b. Patient Evaluation
1 member of the heart team (IC or surgeon) should evaluate the patient in person before any intervention is undertaken. I do not believe both IC and surgeon need to evaluate pt beforehand. Both structural heart IC and modern era cardiac surgeons are in tune with discussing all the treatment options available and how to help patients decide which treatment option is best for them. Allowing 1 person to evaluate pt beforehand will help increase patient access and timeliness to intervention

2c. TAVR operator
Agree with the proposed TAVR operator volume requirements

3. Hospital criteria
Agree

4. CED study criteria
Ok to maintain CED for asymptomatic severe aortic stenosis. I would dissolve CED for symptomatic severe aortic stenosis. I would. Self reporting to TVT registry should be optional rather than required for symptomatic severe aortic stenosis.

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I am writing (from a COMMUNITY CARDIOLOGIST'S perspective) in strong support of the proposed changes to the TAVR National Coverage Determination, and I urge CMS to keep patient access, equity, and flexibility in implementation as central considerations in finalizing this decision. Severe aortic stenosis is a progressive and fatal disease, and delays in treatment have been shown time and again to be associated with worse outcomes, including death on waiting lists, heart failure decompensation, and avoidable hospitalizations. Every administrative requirement that adds weeks between diagnosis and treatment carries a real clinical cost for these patients.

TAVR is no longer a research or experimental therapy. With more than two decades of clinical experience and one of the most robust bodies of randomized trial and registry evidence in the history of medicine — spanning extreme-, high-, intermediate-, and low-risk populations — the questions that justified the original coverage restrictions have been answered. It is time for CMS to ease these restrictions and pave the way for timely access to TAVR and further minimize delays in therapy.

Specifically, I support revisiting the regulatory requirements around mandatory registry participation, mandatory in-person surgical consultations — particularly for patients in their 80s and beyond, for whom surgery is rarely a realistic option and for whom an additional required visit is a genuine burden — and facility surgical volume requirements. These safeguards were appropriate and necessary in the EARLY years of the technology, but after two decades of commercial use and consistently excellent real-world outcomes, they now function primarily as sources of difficulty and delay in patient access rather than as meaningful quality protections. The proposal to retain heart team infrastructure, operator experience requirements, and continuous quality improvement processes preserves the elements that actually protect patients, while removing mandates that add cost and time without commensurate benefit.

I would also respectfully ask CMS to make this decision with the full, diverse distribution of TAVR centers across the country in mind — NOT only a handful of large academic centers. The perspective of community programs serving rural areas, smaller cities, and underserved populations is essential, because that is where access barriers are felt most acutely.

Finally, one of the most important benefits demonstrated in the asymptomatic AS trials and the broader TAVR evidence base has been the reduction in the burden of congestive heart failure and CHF-related readmissions in the community. Many of the patients who stand to benefit most are elderly, frail, and residing in nursing facilities, with significant transportation challenges and related barriers to care. For these beneficiaries, each additional mandated evaluation, consultation, or trip to a distant center is not a neutral administrative step — it is an obstacle that can delay or entirely prevent them from receiving a therapy that would keep them out of the hospital. Adding or maintaining unnecessary barriers to therapy works directly against their treatment.

I commend CMS for this thoughtful proposal and urge the agency to finalize it with access, equity, and implementation flexibility at the forefront.

Thank you for your consideration.

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July 14,2026

Dr. Mehmet Oz
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00430R2 — Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR)

Dear Dr. Oz,

I am writing as an interventional and structural cardiologist and Structural Heart Disease Program Director to express my strong support for the proposed decision memo reconsidering the National Coverage Determination for TAVR, issued June 15, 2026.

Support for the Proposal as a Whole

I support the proposed decision in full. Expanding coverage to asymptomatic severe aortic stenosis, streamlining heart team and hospital criteria, and modernizing the coverage framework will simplify care delivery for patients and the multidisciplinary teams that treat them. These changes reflect the substantial body of clinical evidence that has accumulated since the 2019 NCD and will allow clinicians to spend more time on patient care and less on administrative requirements that no longer add proportionate value.

Support for Removing the Registry Requirement for Symptomatic Severe AS

I am particularly supportive of removing the Coverage with Evidence Development (CED) and associated TVT Registry submission requirement for symptomatic severe AS. While the registry served an important purpose in the early years of TAVR adoption, mandatory participation tied to publicly reported, risk-adjusted outcomes has had an unintended consequence; it has made some programs more reluctant to treat the highest-risk patients who stand to benefit most from the procedure, out of concern that poor outcomes in inherently sicker patients will lower the program's reported metrics.This concern is not merely anecdotal. A recent analysis published in JACC: Cardiovascular Interventions (Shah et al., November 2025) found a substantial, sustained decline in the number of high-risk patients receiving TAVR nationally since 2020, concentrated among hospitals that received lower outcomes-based ratings — a pattern the authors attribute to risk-averse case selection. This mirrors earlier, well-documented experience with public reporting in CABG and PCI, where multiple studies found that publicly reported, risk-adjusted outcome metrics led physicians and hospitals to forgo high-risk but clinically indicated procedures. A separate 2025 analysis using TVT Registry data itself (Kolkailah et al., Circulation: Cardiovascular Interventions) further found that systematically excluding the highest-risk TAVR patients did not even reliably improve a hospital's risk-adjusted performance metrics — meaning that risk-averse avoidance carries real cost to patients without a clear offsetting benefit to program ratings.

Removing the mandatory registry/CED requirement for an indication as well-established as symptomatic severe AS will reduce the incentive for this kind of defensive case selection and help ensure that appropriate, indicated patients — regardless of risk profile — are not denied a beneficial therapy because of concerns about how their case will affect a center's public-facing data.

Support for Single-Operator and Single-Visit Evaluation Models

I also encourage CMS to build greater flexibility into the heart team and pre-procedural evaluation requirements, specifically by permitting single-operator TAVR procedures and a single, consolidated pre-procedural visit rather than mandating separate, sequential evaluations by multiple specialists. For many Medicare beneficiaries, particularly those in rural or medically underserved areas, the current requirement to complete multiple in-person visits with different specialists before treatment can meaningfully delay care, increase travel burden on elderly and frail patients, and in some cases lead patients to forgo treatment altogether. Consolidating evaluation into a single coordinated visit, and allowing experienced, high-volume interventional cardiologists to perform straightforward transfemoral TAVR independently, would meaningfully expand access without compromising safety — an approach already well established in much of Europe and other parts of the world, where TAVR has matured into a primarily interventional cardiology-led procedure.

Finally, I would urge CMS to ensure that coverage policy treats surgical and transcatheter aortic valve replacement equivalently going forward. Both are now well-validated, guideline-recommended treatments for severe aortic stenosis across the risk spectrum, and imposing site, volume, or evaluation requirements on TAVR programs that are not similarly applied to surgical AVR programs risks distorting clinical decision-making and access in ways that are not justified by the comparative evidence base.

Conclusion

I appreciate CMS's effort to update this NCD to reflect current evidence and clinical practice, and I urge the agency to finalize the proposed decision as written with respect to both the expansion of coverage to asymptomatic severe AS and the removal of the CED/registry requirement for symptomatic severe AS. I would welcome the opportunity to provide further input as CMS finalizes this determination.

Respectfully,

Aref A. Bin Abdulhak, MD,MSc

References

Shah T, et al. Effect of Transcatheter Aortic Valve Replacement Program Ratings on Case Selection. JACC Cardiovasc Interv. 2025;18(22):2787-2789.

Kolkailah AA, et al. Will a Conservative Case Selection Strategy Improve Hospital-Level TAVR Performance Metrics? Circ Cardiovasc Interv. Published online December 4, 2025.

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Dear CMS Review Committee,

I appreciate the opportunity to provide comments regarding the proposed revisions to Medicare coverage for transcatheter aortic valve replacement (TAVR).

I strongly support CMS’s proposal to modernize the National Coverage Determination by eliminating Coverage with Evidence Development (CED) requirements for patients with symptomatic severe aortic stenosis. TAVR has evolved into a mature, well-established therapy supported by extensive randomized clinical trials and hundreds of thousands of patients enrolled in the STS/ACC TVT Registry. The current body of evidence demonstrates excellent safety, durability, and clinical outcomes. Continuing CED requirements for this population adds administrative complexity without providing meaningful additional protection for patients.

At the same time, I believe it is critical that CMS continue to uphold the quality standards that have made the United States TAVR program so successful. Multidisciplinary Heart Team evaluation, participation in the TVT Registry, ongoing quality reporting, and continuous outcomes monitoring remain essential components of high-quality structural heart care. These measures promote accountability while allowing experienced programs to provide timely treatment.

As the only active TAVR operator serving a referral population of approximately 300,000 people in a medically underserved region of northeast Texas and southwest Arkansas, I see firsthand how Medicare policy directly affects patient access. Many of my patients travel significant distances for evaluation and treatment, and alternative centers are often several hours away. Delays created by unnecessary administrative requirements can translate into additional hospitalizations for heart failure, worsening symptoms, or even preventable mortality in patients with severe aortic stenosis.

I also support the thoughtful expansion of coverage as evidence continues to emerge for selected patients with asymptomatic severe aortic stenosis. As this indication evolves, coverage decisions should remain grounded in high-quality clinical evidence, FDA-approved indications, and multidisciplinary Heart Team consensus while allowing physician judgment to guide individualized patient care.

Importantly, CMS policy should recognize that high-quality structural heart care is no longer limited to large academic medical centers. Many community-based structural heart programs now deliver outcomes that equal national benchmarks while providing care closer to home for Medicare beneficiaries. Coverage policies should encourage access to these established, high-quality programs rather than creating barriers that disproportionately affect rural and underserved populations.

Finally, I encourage CMS to preserve flexibility for physicians and Heart Teams to exercise sound clinical judgment. Every patient presents unique clinical circumstances—including frailty, prior cardiac surgery, porcelain aorta, radiation-associated heart disease, severe pulmonary disease, and other complex comorbidities—that cannot always be captured within rigid coverage language. Coverage policies should support individualized, evidence-based decision-making rather than inadvertently restricting appropriate care.

Thank you for your continued commitment to improving access to high-quality cardiovascular care for Medicare beneficiaries. I appreciate the opportunity to provide these comments and support CMS’s efforts to update the TAVR coverage policy in a manner that reflects contemporary evidence while maintaining the highest standards of patient care.

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Public Comment on the Proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR)

To the Centers for Medicare & Medicaid Services:

I appreciate CMS for its thoughtful proposed revisions to the National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR). These proposed changes appropriately recognize the remarkable evolution of TAVR over the past decade and represent an important step toward improving patient access, reducing unnecessary administrative barriers, modernizing physician workflows, and lowering healthcare expenditures without compromising quality or patient safety.

I am a practicing Structural Interventional Cardiologist who has personally performed several thousand TAVR procedures and participated in the care of many more patients with severe valvular heart disease. These comments represent my personal views and not those of my institution. They are based on more than a decade of clinical experience, participation in structural heart research and physician education, and the privilege of caring for Medicare beneficiaries every day.

Perhaps the greatest success story in structural heart disease has been the multidisciplinary Heart Team. The collaboration between interventional cardiologists, cardiac surgeons, imaging specialists, anesthesiologists, nurses, and advanced practice providers transformed TAVR from an investigational therapy into one of the safest and most effective cardiovascular procedures performed today. My recommendations are intended to preserve that collaborative model while allowing mature programs greater flexibility to deliver efficient, evidence-based care.

1. Modernize Procedural Staffing Requirements

I fully support CMS allowing either one operator or two operators of any appropriate specialty to perform TAVR based on physician judgment, procedural complexity, and patient-specific needs.

Current-generation TAVR bears little resemblance to the procedure that existed when the original NCD was developed. Advances in valve technology, cardiac CT planning, procedural techniques, cerebral protection, vascular closure, and operator experience have dramatically reduced procedural complications.

Emergent surgical conversion has become exceedingly uncommon. When complications do occur, including coronary obstruction, valve embolization, vascular injury, annular injury, or tamponade, the first and most critical management is overwhelmingly catheter-based. Successful rescue depends primarily on advanced structural interventional expertise.

Routine transfemoral TAVR should therefore no longer require a scrubbed cardiac surgeon for every procedure. This recommendation should not be interpreted as diminishing the critical role of cardiac surgeons. On the contrary, surgeons remain indispensable partners for complex surgical patients, hybrid procedures, root enlargement, valve repair, and patients best served with surgical valve replacement.

Likewise, many contemporary structural procedures, including redo TAVR, valve-in-valve interventions, BASILICA, coronary protection, coronary rescue stenting, alternative access procedures, and complex bicuspid anatomy, often benefit more from two experienced structural interventional operators than from a fixed specialty requirement.

CMS should allow experienced Heart Teams to determine the optimal procedural staffing based on patient complexity rather than regulatory mandate.

2. Eliminate Mandatory Second Physician Evaluations

Untreated severe symptomatic aortic stenosis carries one of the poorest prognoses in cardiovascular medicine. Every unnecessary delay increases the risks of heart failure hospitalization, syncope, ventricular dysfunction, and death.

Mandatory evaluation by two physicians has become one of the greatest sources of inefficiency in TAVR care. It frequently results in additional clinic visits, travel burden, copayments, scheduling delays, and frustration for elderly patients without demonstrable improvement in outcomes.

Perhaps most importantly, patients frequently ask why another physician evaluation is necessary. Too often our answer is simply:

"CMS requirement"

That answer no longer reflects contemporary patient-centered care.

Structural interventional cardiologists receive extensive training in echocardiography, cardiac CT, coronary angiography, hemodynamics, and comprehensive structural heart disease. Like every specialty in medicine, we routinely involve additional experts whenever their expertise benefits patient care.

The Heart Team remains essential. However, mandatory dual physician evaluations for every patient should no longer be required in mature, experienced programs with established quality oversight.

I appreciate CMS's proposal allowing electronic review in lieu of a second in-person evaluation. However, I respectfully question whether mandatory electronic review remains necessary. Experienced Heart Teams should determine when additional consultation improves care rather than requiring it universally.

Programs with quality concerns should be addressed through credentialing, hospital quality oversight, registry benchmarking, and professional accountability, not through administrative requirements imposed on every patient.

3. Coverage with Evidence Development (CED)

Coverage with Evidence Development has been extraordinarily successful.

It helped establish the evidence supporting TAVR through landmark randomized trials including PARTNER, CoreValve High Risk, SURTAVI, Evolut Low Risk, NOTION, and numerous real-world registries. For FDA-approved treatment of symptomatic severe tricuspid, aortic stenosis, CED has fulfilled its purpose.

I fully support CMS's proposal to sunset CED for these patients.

However, I respectfully encourage CMS to maintain national registry participation for off-label TAVR procedures and newly approved indications until their evidence base matures.

Nearly one in ten TAVR procedures today is performed outside the original FDA labeling. These patients include bicuspid aortic valve disease, cardiogenic shock, complex valve-in-valve procedures, leaflet modification (BASILICA), coronary protection strategies, and newly approved indications such as native aortic regurgitation. These procedures will continue to be performed because many patients have no reasonable alternative.

From a TVT registry perspective, maintaining registry participation for evolving indications protects patients while simultaneously supporting responsible innovation. Conversely, eliminating registry reporting for these populations risks losing one of our most valuable quality improvement tools precisely where it is needed most.

Conclusion

The proposed NCD appropriately recognizes that TAVR has evolved from an emerging technology into an established standard of care.

Our policies should evolve accordingly.

After caring for thousands of patients with severe valvular heart disease, I believe our greatest opportunity to improve outcomes is no longer making TAVR safer, it is ensuring that every appropriate patient receives timely, evidence-based treatment while preserving the quality infrastructure that continues to advance the field.

I respectfully encourage CMS to finalize an NCD that:

Allows flexibility in procedural staffing based on physician judgment and procedural complexity.
Removes mandatory second physician evaluations and mandatory electronic review requirements.
The goal should not be to regulate mature therapies the same way we regulate emerging therapies. Established indications should be allowed to benefit from streamlined, evidence-based care, while newer and evolving indications should continue generating the high-quality real-world data necessary to ensure patient safety and drive future innovation. Maintains national registry reporting for off-label and newly approved indications until sufficient evidence supports graduation from CED.

These recommendations preserve patient safety, strengthen the Heart Team model, reduce unnecessary administrative burden, and allow continued innovation while maintaining the rigorous quality standards that have made TAVR one of the greatest advances in modern cardiovascular medicine.

Thank you for your thoughtful consideration of these comments and for your continued commitment to improving cardiovascular care for Medicare beneficiaries.

Respectfully submitted,

Carlos E. Sanchez, MD
Structural Interventional Cardiologist

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I write as a cardiothoracic surgeon at Duke University Medical Center and as senior author of a national analysis of failure to rescue after TAVR conducted using the STS/ACC Transcatheter Valve Therapy (TVT) Registry (Bishawi M, Jensen C, Vekstein A, et al. Influence of Failure to Rescue on Mortality After Transcatheter Aortic Valve Replacement. Ann Thorac Surg Short Reports. 2025;3:617-623. doi:10.1016/j.atssr.2025.03.011). The findings of that analysis bear directly on four provisions of the proposed decision, and I submit them for the record.

Summary of position
1. The proposal eliminates the requirement that the heart team's cardiac surgeon and interventional cardiologist jointly participate in the intraoperative technical aspects of TAVR. This provision should be restored.
2. The proposal no longer requires the cardiac surgeon to independently evaluate the patient in person. This should be restored. Patients seen by both heart valve team members report the highest quality shared decision-making, and the decision at issue turns on outcomes that diverge years after the procedure.
3. The proposal deletes all hospital procedural volume criteria, including the open heart surgical volume minimum. Our data indicate that TAVR case volume does not predict a center's ability to rescue patients from complications. Surgical capability does. Hospital criteria oriented toward cardiac surgical capability should be retained.
4. The proposal ends mandatory registry participation for symptomatic severe aortic stenosis. This is the most consequential provision in the memorandum, and I discuss it last and at greatest length.

The evidence: what distinguishes high-mortality from low-mortality TAVR centers
We analyzed 61,804 transfemoral TAVR patients across 429 sites in the STS/ACC TVT Registry. Centers were stratified into tertiles by observed-to-expected procedural mortality. Procedural mortality across the lowest, middle, and highest tertiles was 1.8%, 3.3%, and 5.6% (P < .001). The threefold spread in mortality across American TAVR centers is not in dispute. What matters for this rulemaking is why it exists.
It is not because high-mortality centers have more complications. Risk-adjusted complication rates were nearly identical across tertiles: 22.2%, 24.5%, and 27.0%. The difference is statistically detectable in a sample of this size and is not clinically meaningful.
It is because high-mortality centers fail to rescue patients once complications occur. Risk-adjusted failure to rescue rates for the composite of all complications were 5.4%, 9.5%, and 14.6% across the lowest, middle, and highest mortality tertiles (P < .001). The pattern held for every complication examined.
The most consequential finding for this NCD concerns conversion to open surgery. This is a rare event, occurring in 0.4% to 0.6% of cases, and its incidence does not differ meaningfully between good and bad centers. But the risk-adjusted odds of dying after conversion to open surgery were 9.04 times higher (95% CI, 4.12 to 19.83; P < .001) at high-mortality centers than at low-mortality centers. Risk-adjusted failure to rescue after conversion to open surgery was 22.7% at the lowest-mortality centers and 64.6% at the highest.
Comparable gradients were observed for new dialysis requirement (OR, 6.16), major bleeding (OR, 3.83), cardiac arrest (OR, 3.54; 95% CI, 2.57 to 4.87), major vascular complications (OR, 3.35), stroke (OR, 3.15; 95% CI, 1.97 to 5.04), unplanned cardiac intervention (OR, 3.06), and the composite of all complications (OR, 3.16), all P < .001.
The complications happen everywhere. Patients survive them in some places and die from them in others. That difference, not procedural technique, is what the coverage criteria in this NCD should be built to protect.

1. The elimination of joint intraoperative participation should be reversed
The 2019 NCD provides that the heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TAVR. The proposed decision replaces this with a provision stating that joint participation of two TAVR operators is not required, and that where two operators do participate, both may be interventional cardiologists.
The effect of this change is that a Medicare beneficiary may undergo TAVR with no cardiac surgeon present.
Our data speak directly to what happens next. Conversion to open surgery is the clearest natural experiment available in the registry: a rare, unambiguous, time-critical event in which the ability to open the chest and institute cardiopulmonary bypass within minutes determines whether the patient lives. It occurs at essentially the same rate at every center. The nine-fold adjusted mortality difference after it occurs is a direct measurement of the value of immediate, competent surgical rescue. CMS should be clear-eyed about the mechanism. What differentiates a safe TAVR program from an unsafe one is not proficiency at implanting the valve, since complication rates are nearly uniform across centers. It is the program's capacity to recognize and reverse a catastrophe already in progress. That capacity is a property of the team in the room, not of the operator's implant technique. The plausible mechanisms behind the failure-to-rescue gradient we observed are speed of recognition and speed of deployment of secondary intervention. A provision permitting the surgeon to be absent from the procedure directly degrades both.
I would also note the practical dynamic that a local heart team determination standard creates. Where team function is already strong, the surgeon will remain engaged and nothing changes. Where team function is already marginal, and those are precisely the centers in the highest mortality tertile, the permissive standard will be used to remove the surgeon. The provision will have its largest effect exactly where the safety margin is thinnest.

2. The surgeon's independent in-person evaluation should be restored
The 2019 NCD requires that a cardiac surgeon and an interventional cardiologist each independently examine the patient face-to-face and each document the rationale for their clinical judgment. The proposed decision requires an initial heart team evaluation that may be asynchronous and conducted from the medical record, plus a single independent in-person evaluation by a heart team TAVR operator, who may be the interventional cardiologist.
Under the proposal, a patient may be evaluated for, and undergo, aortic valve replacement without ever being examined by a surgeon.
The requirement for two independent face-to-face evaluations was never about redundancy. It was a structural safeguard against single-modality decision making at the point where the treatment choice is actually made.
There is direct evidence that it works. In a randomized pilot study of patients with severe aortic stenosis choosing between TAVR and SAVR, patients who were seen by both heart valve team members, the cardiac surgeon and the interventional cardiologist, reported the highest shared decision-making quality scores. Exposure to both team members, rather than to one, was associated with greater shared decision-making (Valentine KD, Marques F, Selberg A, et al. Impact of Decision Aid on Decision-making of Patients With Severe Aortic Stenosis: Randomized Pilot Study. J Soc Cardiovasc Angiogr Interv. 2022;1(2):100025. doi:10.1016/j.jscai.2022.100025). This was a pilot and the comparison was not the randomized contrast, so I do not present it as definitive. But it is the direct evidence available on the question CMS is deciding, and it points one way: patients who meet both specialists make better-informed decisions than patients who meet one.
CMS's own proposal elevates shared decision-making and lifetime management as governing considerations in the evaluation. Those considerations cannot be adequately developed by a single operator who performs one of the two procedures under discussion. A patient choosing between TAVR and SAVR has an obvious interest in hearing from a physician who performs the operation being declined.
This matters more now than it did in 2019, not less, because of where TAVR is going:

• TAVR utilization among patients undergoing aortic valve replacement rose from 45% in 2015 to 2016 to 88% in 2021, with the largest relative increase, a 2.7-fold rise, among patients under age 65. By 2021, 48% of AVR patients under 65 received TAVR. (J Am Coll Cardiol 2022;80(21)]
• In California state discharge data, the proportion of patients under age 60 receiving TAVR rather than SAVR rose from 7% in 2013 to 46% in 2021. In a propensity-matched analysis of that cohort, 5-year survival was 89% after TAVR and 97% after SAVR (HR 2.5 for mortality, P = .02), despite no difference in 30-day mortality, stroke, readmission, or pacemaker requirement. (Alabbadi S et al. Ann Thorac Surg 2024)

3. Hospital criteria: TAVR volume is not the mechanism, cardiac surgical capability is.
I want to be direct about a finding in our data that does not conform to the usual advocacy framing, because I believe it is the most policy-relevant result we obtained. In risk-adjusted analysis, we found no significant association between institutional TAVR volume and failure to rescue. Nor was failure to rescue associated with teaching hospital status or hospital bed capacity. This contrasts with the volume-outcome relationship established for most major surgical procedures. Accumulated transcatheter repetitions do not appear to confer the ability to rescue a patient from a catastrophe.
This should not be misread as support for deleting hospital criteria. It is the opposite. It localizes where rescue capability actually resides. A center can perform a large number of TAVRs and still sit in the highest mortality tertile, because the capability that determines survival after a conversion to open surgery is not a transcatheter capability. It is a cardiac surgical capability. Some high-volume TAVR programs do not have cardiac surgical quality commensurate with their transcatheter quality, and those are the programs where a conversion becomes a death.
Two further lines of evidence complete the picture, and they are important precisely because they do not come from our failure-to-rescue analysis.
Surgical volume does predict surgical outcomes, even though TAVR volume does not predict rescue. In STS Adult Cardiac Surgery Database analyses of isolated SAVR, centers performing more than 100 SAVR per year achieve superior risk-adjusted mortality, while centers performing fewer than 40 per year have observed-to-expected mortality ratios above 1. (Mehta CK et al. Ann Thorac Surg 2024;118:30-9) These two findings are not in tension. They are the same finding viewed from two angles. Transcatheter repetition does not build rescue capability. Surgical repetition builds surgical capability, and surgical capability is what rescue requires. A coverage rule that deletes the surgical volume floor while retaining a nominal on-site surgery requirement severs exactly the link that matters.
Centers with balanced surgical and transcatheter practice achieve the best outcomes for both procedures. In an analysis of the National Readmissions Database, hospitals were stratified by their TAVR-to-SAVR ratio, and overall aortic valve replacement outcomes were best at centers with a balanced ratio. Notably, both TAVR outcomes and SAVR outcomes were better at those centers. (Marghitu T et al. JTCVS Open November 7, 2024) A center that has allowed its surgical practice to atrophy does not merely perform worse SAVR. It performs worse TAVR.
The proposed decision deletes every hospital procedural volume criterion in the 2019 NCD, including the open heart surgical volume minimum, the aortic valve procedure minimum, and the requirement for two physicians with cardiac surgery privileges. What remains is a requirement for an on-site cardiac surgery program, an intensive care unit, and a continuous quality improvement process.
The foreseeable failure mode is a center that satisfies the letter of the NCD by maintaining a nominal cardiac surgery program existing primarily to enable TAVR billing, without the case volume, surgical staffing, perfusion coverage, or intensive care depth required to actually execute an emergency conversion, and without the capability to offer SAVR as a genuine alternative. Our data describe what happens to patients in such centers: risk-adjusted failure to rescue after conversion to open surgery of 64.6%.
An on-site cardiac surgery requirement is only as protective as the surgical program behind it. A requirement that can be satisfied by a program incapable of performing the rescue is not a safety provision. It is a formality. I urge CMS to retain meaningful hospital criteria anchored on cardiac surgical capability.

4. Ending mandatory registry participation removes the only instrument capable of answering CMS's own question
The 2019 NCD requires that the heart team and hospital participate in a prospective, national, audited registry that consecutively enrolls TAVR patients, accepts all devices, and follows patients for at least one year, and it specifies that the registry must permit identification and analysis of patient, practitioner, and facility level variables that predict outcomes. The proposed decision retains registry-grade data collection only inside the CED pathway, which now applies solely to asymptomatic severe aortic stenosis. For symptomatic severe aortic stenosis, which is the overwhelming majority of TAVR performed in the United States, mandatory participation ends. I would ask CMS to weigh the following. The analysis I have described to you could not have been performed under the NCD you are proposing.
Our study required consecutive, audited, nationally complete, facility-identified data on 61,804 patients across 429 sites, with STS predicted risk of mortality available for observed-to-expected standardization and complication and mortality data complete enough to compute failure to rescue at the institution level. Those properties are not incidental. They are the direct product of a mandatory, audited registry. A voluntary registry, subject to selection bias and incomplete enrollment, cannot support institution-level quality measurement, because the centers whose outcomes most need measuring are precisely the centers least likely to volunteer. This matters acutely because of a question CMS itself poses in the proposed CED criteria: whether longer term, risk-standardized, patient-centered health outcomes can replace volume criteria for TAVR operators.
That is the right question, and I believe the answer is yes. Risk-standardized failure to rescue is exactly such a metric. It is patient-centered, it is risk-adjusted, it is computable at the institution level, it discriminates powerfully between centers, and unlike volume it appears to capture the mechanism that actually kills patients. A coverage framework built on measured rescue performance rather than on case counts would be a genuine advance, and I would support it.
But the proposal deletes the volume criteria and the mandatory data collection before the outcome-based replacement exists. It asks whether outcomes can replace volume, and in the same document removes both the volume requirement and the data infrastructure required to develop, validate, and eventually apply the outcome measure. The sequence is inverted. CMS should retain mandatory registry participation for all TAVR, retain hospital criteria in the interim, and use the registry to build the risk-standardized outcome metric it has correctly identified as the better instrument. Once that metric exists and is validated, the volume criteria can be retired on the strength of evidence rather than in advance of it.
The proposed decision also requires each hospital to maintain a continuous quality improvement process that assesses procedural outcomes. Without mandatory participation in a national audited registry, hospitals will have no external benchmark against which to assess those outcomes. A center in the highest mortality tertile does not know it is in the highest mortality tertile. That was, in effect, the finding of our study.

5. Coverage with Evidence Development should be retained for contested indications
I support retaining CED for the populations in which the evidence base remains immature: low surgical risk patients, bicuspid severe aortic stenosis, moderate trileaflet aortic stenosis, pure aortic regurgitation, and bioprosthetic valve reintervention.
The proposal removes CED for symptomatic severe aortic stenosis on the basis of randomized trial evidence showing outcomes comparable to SAVR. Two features of that evidence base deserve CMS's attention.
First, the comparability is time-dependent. A phase-specific meta-analysis of the eight randomized trials comparing TAVR with SAVR (n = 8,885, mean age 79 years) found that TAVR survival was superior in the very short term (0 to 1 year), equivalent at 1 to 2 years, and inferior to SAVR in the mid-term (2 to 5 years), with SAVR also superior in mid-term cardiovascular survival and in short- and mid-term rehospitalization. (Yokoyama Y et al. J Thorac Cardiovasc Surg 2024;168:796-8080) A coverage decision that treats the trials as settling the question is reading only the early portion of the curves. The trials have not yet reached the horizon that matters for the patients into whom TAVR is now expanding.
Second, the trials do not generalize to the patients now receiving TAVR. Fewer than 10% of patients in the low-risk trials were under age 65. Bicuspid valves were excluded. Mean age in PARTNER 3 and Evolut Low Risk was 73 to 74 years. Yet these are precisely the populations, younger patients and bicuspid anatomy, in which TAVR use is growing fastest. Extending unconditional national coverage on the strength of trials that excluded these patients, while simultaneously ending the data collection that would reveal how they fare, is not an evidence-based sequence.
Our own analysis illustrates the same gap from a different direction. It necessarily excluded valve-in-valve procedures, because this population is not adequately characterized in the available registry data. We cannot tell CMS what failure to rescue looks like in those patients. Neither can anyone else. That is an argument for continued mandatory data collection, not for its removal.
________________________________________

Respectfully submitted,
G. Chad Hughes, MD
Professor and Chief, Section of Aortic Disease
Department of Surgery, Duke University Medical Center
Surgical Director, Duke Center for Structural Heart Disease
Director, Duke Center for Aortic Disease

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Thank you for the opportunity to comment on the proposed TAVR National Coverage Determination. As a Vice President and Chief Operational Transformation Officer at a large academic medical center, I oversee the quality and efficiency across the organization. Overall, I am supportive of the proposed direction and believe these updates appropriately balance patient access, quality, and operational realities across diverse healthcare settings.

I support extending coverage to patients with severe asymptomatic aortic stenosis. Emerging evidence, including findings from the EARLY TAVR trial, demonstrates that earlier intervention can reduce death, stroke, and unplanned cardiovascular hospitalizations compared with clinical surveillance alone. For patients and health systems alike, treating disease earlier may help avoid clinical deterioration, urgent admissions, and the higher costs associated with delayed care.

I also support CMS's proposal to end Coverage with Evidence Development (CED) requirements for symptomatic severe aortic stenosis. TAVR is now a mature therapy supported by more than a decade of clinical trials, registry data, and real-world experience demonstrating excellent safety and effectiveness. While the TVT Registry has played a critical role in advancing quality and transparency, maintaining extensive evidence-generation requirements for a well-established therapy creates administrative burden that could be better directed toward patient care and program operations.

The proposed evaluation flexibilities are particularly important. Across our health system, many Medicare beneficiaries travel significant distances to access specialty cardiovascular care. Multiple in-person evaluations can add substantial burden through travel expenses, parking costs, copayments, coinsurance, caregiver coordination, and scheduling delays. Allowing Heart Teams to tailor evaluation pathways based on patient complexity while maintaining multidisciplinary oversight can improve efficiency, reduce administrative burden, and help patients receive treatment more quickly.

I also support maintaining operator flexibility. Our programs operate in varied environments with different staffing models and workforce realities. Allowing qualified Heart Teams to determine the most appropriate operator approach based on patient needs and available expertise enables programs to use highly specialized resources more effectively while maintaining excellent outcomes and costs. This flexibility is especially important for urgent or non-elective patients, where treatment delays can adversely impact outcomes. Experience during the COVID-19 Public Health Emergency demonstrated that cardiovascular programs could successfully implement more flexible care pathways while maintaining high standards of quality and safety.

Finally, workforce sustainability should be an important consideration in the final policy. Current and projected shortages of cardiothoracic surgeons and other specialized clinicians are affecting health systems nationwide, particularly in rural and underserved communities. Policies that preserve the Heart Team model while allowing operational flexibility will help ensure that scarce clinical resources can be deployed where they add the greatest value, both now and in the future.

In summary, I believe the proposed updates will improve patient access, reduce operational and administrative burden, support workforce sustainability, and allow health systems to deliver timely, high-quality care while maintaining appropriate oversight and accountability. I encourage CMS to finalize these provisions.

Thank you for your consideration.

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July 14, 2026

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: NCA CAG-00430R2 Transcatheter Aortic Valve Replacement (TAVR)

Dear Administrator Oz,

Abbott welcomes the opportunity to comment on the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR, CAG-00430R2), which was requested by Edwards Lifesciences. Abbott believes National Coverage Determination (NCD) policies should be revised in a timely manner as therapies mature and become standard of care. We applaud the Centers for Medicare & Medicaid Services (CMS) for proposing a more flexible, future-proof coverage policy framework that empowers heart teams to make patient-centered decisions, fosters innovation, and ensures equitable access to life-saving therapies such as TAVR.
Abbott supports the proposal to maintain the concept and composition of the multidisciplinary Heart Team in TAVR programs coupled with the streamlining of several criteria within the NCD.
Summary

Specifically, Abbott requests that CMS consider the following when finalizing the NCD:

1. Preservation of Heart Team framework. Abbott strongly supports the successful Heart Team framework to ensure collaborative, patient-centered decisions are made considering multiple perspectives.

2. Support clinical flexibility in patient management. This will allow local Heart Teams to make the best decisions for individual patients and procedures.

3. Support clarity in coverage for indications not addressed in the NCD. Abbott appreciates the clarity in the proposal that Medicare Administrative Contractors (MACs) may make reasonable and necessary determinations for other indications of TAVR.

4. Support streamlined volume requirements. Abbott supports the proposed streamlining of institutional volume requirements and hospital staffing as these may create unintended barriers to care—particularly in rural or underserved areas. Abbott requests CMS strongly consider the proposed 15 annual TAVR procedures per year for operators and whether reported outcome differences are appropriately balanced with practical outcome differences and access impact.

5. Remove clinical study trial coverage criteria section B. Abbott supports the proposed update to the TAVR NCD for clinical trial coverage through NCD 310.1 or through the Investigational Device Exemption (IDE) Policy as it allows for flexibility in trial design and streamlined review under existing review processes.

1. Preservation of Heart Team Framework

Abbott agrees with CMS and many stakeholders that the Heart Team framework has been extremely successful in ensuring collaborative, multi-disciplinary care for structural heart patients. The continuation of a Heart Team that includes both an interventional cardiologist and a cardiothoracic surgeon should remain in the final coverage policy, as proposed. Abbott supports the continuation of requirements that patients are under the care of the Heart Team both pre- and post-procedurally, as proposed.

CMS could consider a clarifying edit to the proposed NCD that would require the initial evaluation from the Heart Team to include agreement on which specialists should conduct an independent patient evaluation (e.g., interventional cardiologist only, cardiothoracic surgeon only, or both interventional cardiologist and cardiothoracic surgeon). Similarly, CMS could clarify that during the evaluation, the Heart Team should agree on the appropriate TAVR operator(s) (e.g., joint participation and medical necessity / specialties required, rationale for single operator).

2. Flexibility in Patient Management

Abbott fully supports the Heart Team concept as a core model for the treatment of valvular heart disease when there are multiple treatment options dependent on patient disease state, comorbidities, and preferences. After more than a decade of clinical practice for TAVR in the real-world setting and outside of closely controlled clinical trials, Abbott agrees with the proposed streamlining of pre-procedural patient assessments and intraoperative requirements. Abbott notes that while the Proposed NCD does not contain as many specific requirements as the current NCD 20.32[1], this does not suggest a mandatory broad shift in how patients are managed but instead allows Heart Teams to self-govern and decide the appropriate pathway for each patient.

For the same reason, Abbott supports the proposal to remove the requirement for both an interventional cardiologist and a cardiothoracic surgeon participating in every TAVR procedure. The number of physicians and the required specialties should be left to Heart Team discretion based on the patient circumstances. Abbott appreciates the clarity CMS provided in the proposal Decision Memo that TAVR could be performed with one operator, or two operators from any combination of interventional cardiologists and cardiothoracic surgeons as determined by the Heart Team.

3. Clarity in Covered Indications

In general, Abbott supports covered indication language that preserves policy agility and reduces the need for frequent NCD reconsiderations due to expanding proven therapies into new patient populations. Abbott appreciates the clarity in the proposal that Medicare Administrative Contractors (MACs) may make reasonable and necessary determinations for other indications of TAVR for aortic stenosis and supports finalization of this wording.

4. Streamlined Volume Requirements

Abbott supports the proposal to streamline and update requirements within the TAVR NCD, including removal of proxy procedure volumes. While ensuring quality outcomes is important, CMS should be sure to carefully consider the impact of any volume requirements on patient access. As reported by Kumbhani et al.[2], there were statistically significant differences in 30-day mortality and procedure complications for low-volume (<15 TAVR per year) and high-volume (>37 TAVR per year) operators. While differences in TAVR mortality were observed between volume categories, the absolute differences in mortality and procedural complications were modest and should be weighed alongside the potential impact on patient access, particularly for rural and underserved populations. For 30-day mortality rate, the difference in 30-day mortality was 2.0% for high-volume TAVR operators and 2.4% for low-volume TAVR operators (procedural complications were 6.4% and 7.1% respectively). The low-volume TAVR operators comprise 1/3 of total TAVR operators, and 6% of TAVR volume. That 6% was reported as more likely to occur at rural hospitals (11.5% for low-volume vs. 7.7% for high-volume). Removing eligibility for the low-volume operators would restrict access for rural patients. Given the small practical differences, CMS should consider whether the threshold of 15 annual TAVR per year is appropriately balanced against TAVR access.

It is also important to acknowledge that for underserved populations, the decision may not be between travelling to a higher volume center or being treated at a lower volume center in the community. The decision may be between treatment at the center in the community and no treatment at all. For untreated patients with severe or moderate-to-severe aortic stenosis, the mortality risk is over 10% within 6 months.[3] This high mortality risk for delay in treatment or non-treatment must be included in the balance when setting TAVR operator – or any – volume maintenance requirements.

Abbott believes that by requiring a qualified heart team in TAVR programs and a site-level quality monitoring and improvement process, the NCD policy sufficiently balances ensuring quality care with patient access. Physician skill is needed to perform the procedure effectively and safely, and this is best managed locally considering all factors relevant to patient care. Continued advances in device technology, imaging integration, procedural planning, and operator training will contribute to improvements in procedural consistency and outcomes over time. Limiting the ability for low-volume TAVR operators to perform procedures would limit the patient access impact of these improvements.

However, if CMS comes to the decision that procedure volume requirements must be included in the NCD, then Abbott recommends allowing additional flexibility in meeting TAVR Operator volume requirements. Specifically, given that several studies have examined the TAVR overall learning curve, we believe career volume would also be an appropriate criterion to ensure adequate procedure experience. Ideal inflection points for the learning curve vary across studies[4],[5], however a career requirement of 100 TAVR procedures is above reported learning curve inflection points and compares to more than 6 years of experience at the rate of 15 TAVR procedures per year. Abbott believes that if the 15 annual TAVR procedures criterion is maintained, CMS should consider adding an alternative (“OR”) criterion of approximately 100 career TAVR procedure experience.

5. IDE Study Requirements

Abbott supports the proposed update to the TAVR NCD to allow clinical trial coverage through NCD 310.1 or through the IDE Policy as it promotes efficient generation of clinical evidence while allowing flexibility in trial design and streamlined review under existing review processes.

In summary, Abbott broadly supports the finalization of the proposed update to the TAVR NCD, with minor suggested changes:

• Remove or reduce the requirement for 15 annual TAVR procedures for TAVR Operators given the potential impact on access, the clinical cost of delayed treatment or non-treatment, and the expected future developments improving TAVR ease-of-use and procedure consistency over time.
• Consider addition of a lifetime TAVR volume to be a qualified TAVR Operator.

Thank you for your consideration of our comments.
Sincerely,

Peter Kelly
DVP Corporate Reimbursement Government Affairs
Abbott

1. NCD 20.32 Transcatheter Aortic Valve Replacement (TAVR) Version 2 Effective 6/21/2019
2. Kumbhani DJ, Girotra S, Dong H, et al. Contemporary Operator Procedural Volumes and Outcomes for TAVR and MTEER in the US. JAMA Cardiol. 2026;11(3):268–280. doi:10.1001/jamacardio.2025.5645
3. Généreux, P, Sharma, R, Cubeddu, R. et al. The Mortality Burden of Untreated Aortic Stenosis. JACC. 2023 Nov, 82 (22) 2101–2109. https://www.jacc.org/doi/10.1016/j.jacc.2023.09.796
4. Istrate M, Dregoesc MI, Bolboaca SD, et al. The Influence of the Learning Curve on Clinical Outcomes in Balloon-Expandable versus Self-Expandable Transfemoral Transcatheter Aortic Valve Implantation. Cardiology. 2023;148(4):335-346. doi:10.1159/000531401 https://pubmed.ncbi.nlm.nih.gov/37279710/
5. Miyoshi H, Kamiya S, Ikeda T, et al. Impact of proficiency in the transcatheter aortic valve implantation procedure on clinical outcomes: a single center retrospective study. BMC Anesthesiol. 2024;24(1):209. Published 2024 Jun 21. doi:10.1186/s12871-024-02594-7 https://pubmed.ncbi.nlm.nih.gov/38907200/

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I strongly support CMS's efforts to modernize the TAVR National Coverage Determination while preserving the STS/ACC TVT Registry as the foundation for evidence generation, quality oversight, and continuous quality improvement. The success of TAVR has been driven not only by technological innovation, but also by a national framework built on multidisciplinary Heart Team care, standardized data collection, rigorous outcomes assessment, and transparent performance benchmarking. In many respects, the ecosystem established through the current NCD has been as important to the success of TAVR as the technology itself.

The STS/ACC TVT Registry has been central to this success, providing standardized, audited clinical data, longitudinal follow-up, national benchmarking, and high-quality real-world evidence that have informed FDA regulatory decisions, CMS coverage policy, clinical guidelines, and quality improvement initiatives. As TAVR expands into new patient populations and indications, preserving this national quality infrastructure will become even more important.

To ensure Medicare beneficiaries continue to receive safe, evidence-based, high-quality care, I encourage CMS to:

- Maintain participation in a prospective, national, audited registry for TAVR performed under Coverage with Evidence Development (CED).
- Explicitly recognize registry participation as an appropriate mechanism for satisfying CED requirements.
- Continue using registry-derived outcomes to support nationally standardized quality measurement, benchmarking, and continuous quality improvement.

The TVT Registry is far more than a database—it is the national quality infrastructure that has enabled the safe, evidence-based expansion of TAVR and should remain a cornerstone of the final NCD.

I also strongly support preserving the multidisciplinary Heart Team as a required component of TAVR care. Shared decision-making is optimized when both an interventional cardiologist and a cardiac surgeon participate in evaluating patients and determining the most appropriate treatment strategy, whether those evaluations occur synchronously or asynchronously.

Finally, I encourage CMS to clarify that the final NCD should not discourage the participation of two qualified operators when the multidisciplinary Heart Team determines that a collaborative procedural approach is appropriate. While some routine transfemoral TAVR procedures can be safely performed by a single operator (with appropriate back-up), more complex cases, including alternative access procedures, valve-in-valve interventions, challenging anatomy, intraprocedural complications, or physician training, may benefit from two operators. Decisions regarding one versus two operators should remain within the clinical judgment of the multidisciplinary Heart Team rather than be dictated by coverage policy. Preserving this flexibility will support patient safety, procedural quality, physician training, and optimal patient outcomes without creating unnecessary barriers to care.

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Thank you for the opportunity to comment on the proposed changes to the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). As a Nurse Practitioner and Administrative Director of the Cardiovascular and Thoracic Surgery Services at Baptist Hospitals of Southeast Texas, I support CMS's proposed updates to the TAVR NCD. Our program serves a large Medicare population across Southeast Texas and the surrounding areas, timely access to specialized valve care remains critically important.
I support CMS's proposal to remove Coverage with Evidence Development (CED) requirements for patients with symptomatic severe aortic stenosis. TAVR is a well-established therapy supported by substantial clinical evidence and years of real-world experience.

I also support CMS's efforts to provide greater flexibility within the Heart Team model. Cardiac surgeons and interventional cardiologists each play an essential role in delivering high-quality valve care, and multidisciplinary collaboration should remain the standard. However, experienced Heart Teams should have the ability to determine the most appropriate evaluation process based on the clinical needs of each patient rather than being required to follow a prescriptive pathway from CMS in every case. Streamlining the pre-procedure process can reduce delays and improve access while preserving clinical oversight and shared decision-making.

Similarly, I support allowing appropriately qualified Interventional Cardiologists or Cardiac Surgeons to serve as the TAVR operator rather than requiring both specialists to act as procedural operators in every case. This change recognizes the experience of established Heart Teams while maintaining the important partnership between cardiology and cardiac surgery that is fundamental to successful patient outcomes.

I also support CMS's proposal to provide coverage for appropriately selected patients with asymptomatic severe aortic stenosis. As evidence continues to evolve, physicians should have the flexibility to intervene earlier when clinically appropriate rather than waiting for patients to progress to more advanced disease.
Overall, I believe the proposed NCD preserves patient safety, maintains the Heart Team approach, and improves access to evidence-based care for Medicare beneficiaries. I encourage CMS to finalize the proposed policy.

Michael Moore, DNP, FNP-C, AGACNP-BC
Director of Cardiovascular and Thoracic Surgery Services
Baptist Hospitals of Southeast Texas
Beaumont, Texas

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July 14, 2026

Mehmet Oz, MD
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00430R2 – Proposed Decision for the National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR)

Dear Dr. Oz,

Pi-Cardia appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services' (CMS) proposed reconsideration of the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). As a company dedicated to advancing transcatheter solutions for structural heart disease, we commend CMS for undertaking a thoughtful review of coverage policy that reflects the continued evolution of TAVR and the changing needs of the patients it serves.

Pi-Cardia offers the following observations on how TAVR has matured and how coverage policy can support the next phase of structural heart care.

The Evolution of TAVR
Over the past decade, TAVR has transformed the treatment of aortic stenosis and fundamentally changed the practice of structural heart disease. As clinical experience has grown and technologies have advanced, physicians are caring for increasingly diverse patient populations while confronting new considerations related to lifetime valve management, future coronary access, and repeat intervention. These changes have reshaped contemporary TAVR care and provide an important opportunity for coverage policy to keep pace with clinical practice.

The proposed reconsideration reflects the remarkable progress achieved since the original TAVR NCD was established. Once reserved for a limited population of patients at prohibitive or high surgical risk, TAVR has become an established therapy supported by extensive clinical evidence, technological advancement, and real-world experience. (1,2,3,4) Today, physicians routinely treat patients across a broad spectrum of clinical presentations, and the discussion has naturally shifted beyond demonstrating procedural success toward optimizing care over the course of a patient's lifetime. (1,2,3,4,8)

This progress is reflected in the patients now being considered for transcatheter therapy. Longer life expectancy and expanding experience with valve-in-valve procedures have introduced new clinical considerations that extend well beyond the index procedure. Contemporary TAVR planning increasingly includes anticipating future repeat valve interventions, preserving coronary access, and selecting procedural strategies that maintain future treatment options over the course of a patient's lifetime. (3,7,8) As a result, treatment decisions are informed by a broader understanding of the patient's anticipated clinical journey rather than the immediate procedural outcome alone.

The maturation of TAVR has also expanded the scope of innovation supporting structural heart care. Advances in pre-procedural imaging, procedural planning, and complementary transcatheter technologies have enabled physicians to safely treat patients who were previously considered poor candidates for transcatheter intervention. Contemporary TAVR therefore represents considerably more than a valve platform alone; it reflects an integrated approach to patient evaluation, procedural planning, and long-term management.

CMS's proposed reconsideration appropriately recognizes that contemporary TAVR differs substantially from the environment in which the original NCD was developed. As clinical practice continues to advance, coverage policy should similarly recognize the changing realities of structural heart care and the increasingly individualized decisions that accompany a mature therapy.

Individualized Care for Complex TAVR Patients
One important consequence of TAVR’s maturation is the growing diversity of patients now undergoing TAVR. While many procedures have become increasingly efficient and standardized, others present unique anatomical and clinical considerations that require substantially greater planning, coordination, and procedural expertise. Contemporary TAVR should therefore be viewed not as a uniform procedure, but as a spectrum of clinical scenarios requiring individualized treatment strategies. Recognizing this spectrum allows physicians to tailor procedural planning, multidisciplinary involvement, and adjunctive technologies to the individual patient rather than applying a uniform treatment approach.

Patients undergoing valve-in-valve procedures and those at increased risk for coronary obstruction or compromised long-term coronary access frequently require more extensive imaging, careful procedural planning, and thoughtful evaluation of both immediate procedural success and long-term treatment options. (5) For these patients, procedural complexity extends beyond technical execution and begins well before entering the catheterization laboratory.

Through our ongoing collaboration with structural heart physicians, Pi-Cardia has observed a consistent evolution in how experienced physicians approach these challenging cases. Across practice settings, experienced physicians increasingly describe contemporary TAVR as requiring individualized procedural strategies tailored to each patient's anatomy, prior interventions, and anticipated lifetime management. As routine procedures become increasingly standardized, physician expertise is increasingly focused on the subset of patients whose care demands more nuanced planning, multidisciplinary collaboration, and individualized treatment strategies.

As clinical decision-making becomes more individualized, multidisciplinary collaboration remains an important part of contemporary TAVR care. Although procedural workflows have appropriately become more efficient over time, patients with the greatest anatomical and procedural complexity continue to benefit from multidisciplinary evaluation by an experienced multidisciplinary team. Interventional cardiologists, cardiac surgeons, cardiac imaging specialists, and other members of the multidisciplinary team each contribute distinct perspectives that inform patient selection, procedural planning, risk assessment, and long-term treatment strategy. The exceptional outcomes achieved with TAVR have been built upon this collaborative model of care, and preserving the flexibility for multidisciplinary evaluation when patients present with complex anatomy or procedural risk remains an important consideration as coverage policy continues to evolve. (3,4)

Innovation in Contemporary TAVR Care
The maturation of TAVR has also reshaped the role of innovation within structural heart care. During the early years of TAVR, innovation focused primarily on the development and refinement of transcatheter valve platforms. As those technologies have matured, innovation has increasingly shifted toward technologies that complement TAVR by addressing specific procedural challenges, expanding treatment options, and enabling physicians to safely treat patients with more complex anatomy and clinical needs.

This next generation of innovation includes technologies that enhance procedural planning, improve intraprocedural imaging, preserve future coronary access, mitigate procedural risk, and facilitate treatment in patients with challenging anatomy. (8) Rather than replacing TAVR, these innovations extend their reach by providing physicians with additional tools to tailor treatment strategies to individual patients. As structural heart disease continues to evolve, these complementary technologies have become an increasingly important part of contemporary TAVR care.

Leaflet modification technologies illustrate this broader trend. (6) For carefully selected patients at risk for coronary obstruction during valve-in-valve TAVR, preemptive leaflet modification may provide an important strategy to facilitate safe transcatheter intervention while preserving future treatment options. Like other complementary technologies, leaflet modification expands the treatment options available to experienced physicians caring for patients whose anatomy or procedural risk requires a more individualized approach.

As coverage policy continues to advance alongside clinical practice, it should continue to support responsible innovation that addresses emerging clinical needs. A policy environment that encourages the development and appropriate adoption of technologies that complement established therapies will help ensure that physicians have access to the tools necessary to care for increasingly diverse patient populations while continuing to advance the field of structural heart disease.

Preserving the Foundations of TAVR
While continued innovation will remain essential, the extraordinary success of TAVR reflects more than advances in technology alone. It is also the result of a care model founded on multidisciplinary collaboration, rigorous clinical evidence, continuous quality improvement, and an unwavering commitment to patient-centered care. (3,4) Together, these principles have enabled the structural heart community to expand access to TAVR while maintaining consistently high standards of safety and clinical outcomes.

As CMS modernizes the NCD, we believe these foundational principles should continue to guide the delivery of TAVR, even as the field itself continues to advance. Multidisciplinary care has become more efficient over time, but it remains particularly valuable for patients whose anatomy or clinical circumstances require individualized treatment planning. Similarly, national outcomes assessment and ongoing evidence generation have played a central role in advancing best practices, refining patient selection, and ensuring that innovation is introduced responsibly. Preserving these principles will help sustain the collaborative culture that has driven the remarkable progress of TAVR over the past decade while allowing physicians the flexibility to adapt to changing clinical needs.

Conclusion
Pi-Cardia commends CMS for undertaking this important reconsideration of the TAVR National Coverage Determination and for recognizing that coverage policy should continue to evolve alongside advances in structural heart disease. The proposed decision reflects the remarkable progress achieved by physicians, hospitals, researchers, and industry working together to transform the treatment of aortic stenosis, while acknowledging that the next phase of TAVR will present new clinical opportunities and challenges.

As TAVR continues to mature, the conversation is no longer defined solely by the procedure itself, but by how physicians optimize care for increasingly diverse patient populations over the course of a lifetime. The next chapter of TAVR will depend on preserving multidisciplinary collaboration, supporting thoughtful clinical judgment, and fostering innovations that enable physicians to safely expand the benefits of transcatheter therapy to increasingly diverse patient populations. Pi-Cardia appreciates the opportunity to provide these comments and looks forward to continuing to work with CMS to ensure that coverage policy keeps pace with the continued evolution of structural heart care.

Respectfully,
Erez Golan
Founder & CEO
Pi-Cardia, Inc.

References 1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1695-1705. doi:10.1056/NEJMoa1814052
2. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1706-1715. doi:10.1056/NEJMoa1816885
3. Otto CM, Nishimura RA, Bonow RO, 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. Circulation. 2021;143(5):e72-e227. doi:10.1161/CIR.0000000000000923
4. Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020;76(21):2492-2516. doi:10.1016/j.jacc.2020.09.595
5. Khan JM, Babaliaros VC, Greenbaum AB, et al. Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: Results From the Multicenter International BASILICA Registry. JACC Cardiovasc Interv. 2021;14(9):941-948. doi:10.1016/j.jcin.2021.02.035
6. Dvir D, Tchétché D, Leon MB, et al. Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study. Eur Heart J. 2024;45(33):3031-3041. doi:10.1093/eurheartj/ehae303
7. Généreux P, Leon MB, Dar RD, et al. Predicting Treatment of Bioprosthetic Aortic Valve Failure in the United States: A Proposed Model. Struct Heart. 2024;9(2):100339. Published 2024 Jul 10. doi:10.1016/j.shj.2024.100339
8. Beerkens FJ, Tang GHL, Kini AS, et al. Transcatheter Aortic Valve Replacement Beyond Severe Aortic Stenosis: JACC State-of-the-Art Review. J Am Coll Cardiol. 2025;85(9):944-964. doi:10.1016/j.jacc.2024.11.051

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The European Association for Cardio-Thoracic Surgery (EACTS), as an international scientific society dedicated to advancing the quality of care for patients with cardiovascular disease through clinical excellence, education, research, and evidence-based practice, welcomes the opportunity to provide comments on the proposed revisions to the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). Although this proposal pertains to Medicare and Medicaid coverage within the United States, its implications extend beyond national borders. CMS coverage decisions have historically influenced clinical practice, regulatory policy, research priorities, and reimbursement frameworks internationally. For this reason, modifications to the current evidence-based framework governing TAVR warrant careful consideration.

Our main concern with the CMS proposal is the decreasing role of cardiac surgery within the TAVR decision-making process and periprocedural care. TAVR represents a paradigm shift in the management of patients with AS, particularly in elderly and higher risk patients. The encouraging results in these patient populations, since TAVR was first approved by the Food and Drug Administration almost 15 year ago, have been the direct result of the regulatory restrictions that are currently in place. However, we are now entering an era where TAVR is being increasingly performed in younger and lower risk patients with longer life expectancy. Such a development necessitates high quality medical care that focuses on both periprocedural and long-term patient outcomes, goals that require the presence of an active, involved and informed cardiac surgeon with the Heart Team.

TAVR has always been performed within the context of a multidisciplinary Heart Team, and valvular heart disease guidelines have emphasized the principal role of the cardiac surgeon within this Heart Team. The proposed CMS memorandum decreases the role of cardiac surgery during TAVR procedures and therefore undercuts the basic concept of the Heart Team in two ways. Firstly, it would eliminate the need for a cardiac surgeon operator during the TAVR procedure. This will not only lead to a decreased ability to treat life-threatening complications of TAVR that require immediate surgical intervention, but may also lead to preferential use of TAVR in patients who may benefit more from the known long-term benefits of surgical aortic valve replacement (SAVR). Secondly, the elimination of the hospital open-heart surgical volume minimum requirement will degrade the quality of the on-site cardiac surgery capabilities. It is quite conceivable that extremely small cardiac surgery programs will be established with the sole purpose of fulfilling the requirements for performing TAVR, without being able to treat life-threatening TAVR complications and, even more importantly, not being able to offer high quality SAVR as an alternative to TAVR. Numerous studies have demonstrated a close association between cardiac surgery volumes and outcomes, with important effects on even uncommon, but highly relevant, events like perioperative mortality. With the establishment of cardiac surgical programs without institutional volume requirements, it is quite possible that many patients with AS will suffer inappropriate and inadequate medical care in small volume surgical centers.

Furthermore, the decision to allow a single TAVR operator to perform these procedures will lead to a diminished capability to recognize, diagnose and treat life-threatening complications of TAVR. Although such complications are uncommon, they continue to occur in the modern TAVR era – even in very experienced centers with well-functioning Heart Teams – and require the rapid action of several skilled team members to avoid catastrophic consequences for the patient. In addition, we would note that the individual operator threshold of fifteen TAVR procedures per year is far below the minimum volume requirements shown to be associated with optimal TAVR outcomes in multiple studies from around the world.

We are also concerned by the decision to remove the Coverage with Evidence Development (CED) requirement for symptomatic AS patients undergoing TAVR. Cardiovascular specialists and referring physicians everywhere have benefited enormously from the information gained on over 500,000 TAVR patients recorded thus far within the STS/ACC TVT Registry. Because it is comprehensive and mandatory, this real-world registry has supplied us with numerous invaluable insights into the management of patients with AS, making its data of much higher quality than voluntary TAVR registries limited by selection bias and incomplete enrollment. Such ongoing data aggregation will be critical to further assess the role of TAVR in symptomatic AS patients with controvertible indications such as: (1) bicuspid aortic valve disease, (2) low surgical risk, (3) younger age, (4) previous SAVR or TAVR procedures, and (5) moderate AS. Eliminating the CED requirement in symptomatic AS patients falling into these categories would markedly limit our ability to assess the appropriateness of TAVR in such contested patient populations. Furthermore, CED elimination may lead to upcoding of symptoms in “asymptomatic” AS patients, particularly when extensive stress testing is performed, thereby circumventing the CED mandate.

The resultant lack of long-term data would be of significant concern for any class III medical device, but particularly for TAVR devices in an era in which they are being increasingly implanted in patients with longer life expectancy. The most recently published data on current generation TAVR devices have demonstrated accelerated valve failure patterns in certain prostheses, exceeding even those of SAVR bioprostheses that have been removed from the market due to premature valve failure. Furthermore, the current TAVR devices are now reaching the known critical time span of 7-10 years post-implantation – when bioprosthetic valve failure is known to increase exponentially – in younger and lower risk patients who will live long enough to experience such valve failure. Stopping follow up of these patients in a comprehensive and mandatory manner would do a great disservice to AS patients everywhere, leaving clinicians without the critical data to assess proper management strategies in patients with longer life expectancy.

Finally, we must express our surprise at the decision to approve TAVR coverage for patients with asymptomatic AS. Although two small randomized controlled trials (RCTs) have previously demonstrated survival benefit for early SAVR compared to conservative therapy in patients with asymptomatic AS, the current evidence supporting TAVR in this patient population is based almost entirely on a single, large RCT demonstrating a decreased incidence of unplanned cardiovascular hospitalization (with no effect on survival), in a study whose conclusions are markedly limited by the very high crossover rate in the conservative treatment group.

We would like to thank the CMS for allowing us to express our opinions on the Proposed TAVR Decision Memorandum. We strongly believe that the continued active involvement of cardiac surgeons in the TAVR Heart Team ensures the best possible outcomes for patients with AS, particularly in an era of rapid TAVR expansion into patients with longer life expectancy.

On behalf of the EACTS:
Michael A. Borger (Councillor-at-Large)
Patrick Myers (Secretary General)
Rafael Sádaba (President)
Volkmar Falk (Past President)

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Public Comment on the Proposed National Coverage Determination (NCD) for TAVR
To the Centers for Medicare & Medicaid Services,

On behalf of the Michigan Structural Heart Consortium (MISHC), we appreciate the opportunity to comment on the proposed revision of the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).

The Michigan Structural Heart Consortium (MISHC) is a statewide quality collaborative jointly led by cardiac surgeons and interventional cardiologists that brings together structural heart programs across Michigan to measure outcomes, benchmark performance, identify variation in care, and develop collaborative quality improvement initiatives. Founded on a model of multidisciplinary collaboration, MISHC reflects the Heart Team approach that has been central to the success of TAVR programs. Our comments reflect more than a decade of experience using clinical registry data to improve the quality and safety of structural heart interventions.

Most importantly, MISHC’s mission is patient-driven. Our work is rooted in improving outcomes that matter to patients and families: survival, symptom relief, functional recovery, quality of life, maintenance of independence, avoidance of preventable complications, timely access to appropriate care, and care aligned with each patient’s goals and preferences. For MISHC, registry participation, benchmarking, Heart Team review, imaging excellence, and quality improvement are not administrative exercises. They are tools that allow health systems to learn from every patient’s experience and improve care for the next patient beyond the walls of their hospital and across the State. Our experience has taught us that variation in care is common, often unrecognized by individual institutions. It is best addressed through transparent benchmarking, collaborative learning, and continuous quality improvement driven by a shared purpose to make a difference for every structural heart patient.

We support CMS's efforts to modernize the NCD and expand access to this transformative therapy for appropriate Medicare beneficiaries. We also recognize CMS's goal of reducing unnecessary regulatory burden as the evidence supporting TAVR continues to mature.

The current NCD has been one of CMS's most successful quality initiatives. It created a national quality framework built on three complementary pillars: the multidisciplinary Heart Team, participation in the TVT Registry with continuous quality improvement, and program competency supported by reasonable experience standards. Together, these elements have created a learning health system for structural heart disease that has improved patient safety, accelerated scientific discovery, promoted transparency, and supported outstanding clinical outcomes.

The multidisciplinary Heart Team remains fundamental to high-quality TAVR care. Appropriate patient selection requires integration of clinical assessment, multimodality imaging, surgical expertise, interventional cardiology, anesthesiology, and shared decision-making with an informed patient. The Heart Team also provides multidisciplinary review of complex cases, procedural outcomes, and complications, creating an ongoing opportunity to improve care.

Successful TAVR programs also depend on experienced multidisciplinary teams and well-developed institutional systems of care. Reasonable program competency standards, including procedural experience and clinical outcomes, help ensure that hospitals maintain the expertise and infrastructure needed to provide consistently safe and effective care. Experience standards should be viewed as one component of a broader commitment to quality.

The TVT Registry has evolved from a Coverage with Evidence Development requirement into the national quality infrastructure for structural heart disease. It supports benchmarking, continuous quality improvement, patient safety surveillance, longitudinal outcomes assessment, patient-reported outcomes, and clinical research.

As Co-Directors of MISHC, we have seen firsthand how registry-based quality collaboratives improve patient care. MISHC uses standardized TVT Registry data to evaluate outcomes across Michigan. Our statewide experience has shown that meaningful variation in care exists, even among experienced centers. Registry analyses have identified opportunities to improve stroke reporting, patient selection, procedural outcomes, and clinical follow-up. Ongoing MISHC projects evaluating stroke and quality of life, conduction disturbances and pacemaker implantation, alternative access, and treatment patterns for low-gradient aortic stenosis are intended to reduce unnecessary variation and improve patient care throughout the state.

A key example is MISHC’s recent publication, “The Relationship Between Hospital Stroke Center Designation and TVT Reported Stroke: The Michigan TAVR Experience,” in JACC: Cardiovascular Interventions. Stroke is an uncommon but devastating complication after TAVR. For patients and families, stroke is not merely a procedural endpoint or registry variable; it may determine whether a patient maintains independence, cognition, communication, mobility, and quality of life.

This MISHC analysis demonstrates the practical importance of registry-based quality improvement. By using statewide TVT Registry data, MISHC investigators were able to examine the relationship between hospital stroke center designation and TVT-reported stroke after TAVR. This type of work highlights how registry data can identify variation in event reporting and clinical outcomes, improve understanding of patient safety events, and focus collaborative quality improvement efforts on complications that matter deeply to patients.

Without robust and consistent registry participation, this type of statewide learning would be limited. Individual sites may not have sufficient case volume to identify trends in uncommon events such as stroke, and administrative claims alone cannot provide the clinical granularity necessary to understand procedural risk, event timing, care processes, and reporting variation. MISHC allow hospitals to move from isolated institutional experience to shared learning, benchmarking, and coordinated improvement across Michigan and beyond.

Structural heart disease is entering a new era that includes younger patients, lifetime valve management, repeat interventions, valve durability, and expanding transcatheter therapies. These advances increase the need for high-quality clinical data and multidisciplinary collaboration. National registries and regional quality collaboratives provide the infrastructure needed to evaluate new technologies, detect emerging safety concerns, monitor long-term outcomes, and improve care as innovation continues.

The original TAVR NCD should be viewed as one of CMS's greatest quality success stories. As CMS modernizes the NCD, it should align the revised TAVR NCD with the principles of value-based, patient-centered care by preserving mandatory TVT Registry participation, requiring a comprehensive Heart Team, and maintaining reasonable program competency standards. This approach will expand patient access while supporting safe, equitable, high-value, and patient-centered TAVR care..

We respectfully urge CMS to:

• Continue to require participation in the TVT Registry as a condition of Medicare coverage.
• Maintain reasonable program competency standards that include procedural experience together with clinical outcomes.
• Preserve the multidisciplinary Heart Team as a core component of every TAVR program.
• Continue supporting registry-based quality collaboratives and national benchmarking as essential tools for continuous quality improvement.

Thank you for the opportunity to provide these comments. MISHC welcomes continued collaboration with CMS, patients, and other stakeholders to ensure that TAVR care remains safe, evidence-based, equitable, and centered on outcomes that matter to patients.

Respectfully submitted,

Co-Directors
Michigan Structural Heart Consortium (MISHC)

Raed Alnajjar, MD
Stanley Chetcuti, MD
P Michael Grossman, MD
Himanshu Patel, MD

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Centers for Medicare & Medicaid Services
Coverage and Analysis Group
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis for Transcatheter Aortic Valve Replacement CAG 00430R2

To the Coverage and Analysis Group:

I write in strong support of the proposed revision to National Coverage Determination 20.32 for Transcatheter Aortic Valve Replacement for aortic stenosis, and I respectfully urge CMS to finalize the proposed decision as written.

I submit these comments as a practicing cardiologist involved in the care of Medicare beneficiaries with aortic stenosis and structural heart disease. My comments reflect direct clinical experience with heart team evaluation, patient selection, procedural planning, and the operational realities of delivering timely TAVR care in a large integrated health care system. I have no financial relationship that bears on these comments.

In my view, the proposed NCD is clinically sound, evidence based, administratively workable, and consistent with the Medicare reasonable and necessary standard. It recognizes that TAVR for symptomatic severe aortic stenosis is now an established therapy supported by a mature evidence base, while preserving appropriate safeguards for patient selection, heart team review, operator experience, hospital infrastructure, and quality oversight.

Summary of recommendations

I respectfully urge CMS to:

1. Finalize coverage of TAVR for symptomatic severe aortic stenosis under section 1862(a)(1)(A) of the Social Security Act, without continuing Coverage with Evidence Development, because the evidence supports standard coverage under the proposed heart team, operator, hospital, ICU, and quality criteria;
2. Finalize the proposed modernized pre TAVR evaluation pathway, including asynchronous heart team review and an independent in person evaluation by one heart team TAVR operator;
3. Adopt the proposed competency based, specialty neutral operator standard, and decline to require two attending operators for every covered procedure;
4. Finalize the proposed heart team, hospital, ICU, operator volume, and continuous quality improvement requirements; and
5. Maintain Coverage with Evidence Development for asymptomatic severe aortic stenosis.

I. The evidence supports standard coverage for symptomatic severe aortic stenosis without CED

CMS should finalize coverage of TAVR for symptomatic severe aortic stenosis under section 1862(a)(1)(A) of the Social Security Act without continuing Coverage with Evidence Development. This is the appropriate coverage pathway for an established therapy when the evidence is sufficient and the procedure is furnished under defined patient, heart team, operator, hospital, ICU, and quality criteria.

Coverage with Evidence Development served an important purpose when TAVR was earlier in its development. At that time, structured evidence development was needed to answer questions about patient selection, procedural safety, outcomes, durability, and generalizability to Medicare beneficiaries outside pivotal trials. Those questions have now been sufficiently answered for on label symptomatic severe aortic stenosis. CMS’s own evidence review identifies 17 randomized trials including approximately 10,686 TAVR patients, supplemented by seven large registry based studies with data on more than 450,000 patients. That evidence base supports standard coverage without continuing to condition coverage on evidence development.

Ending Coverage with Evidence Development for symptomatic severe aortic stenosis also aligns with the purpose of evidence development. Coverage with Evidence Development is appropriate when evidence is insufficient for ordinary coverage and additional evidence is needed to support a future coverage determination. It should not become a continuing coverage condition after the relevant evidentiary questions have been answered. Continuing it for symptomatic severe aortic stenosis would no longer add proportionate beneficiary protection. It would instead keep an established therapy tied to research and registry infrastructure designed to resolve earlier uncertainty.

This distinction matters for patients. Symptomatic severe aortic stenosis is progressive and life threatening. Medicare beneficiaries with this condition are often older, frail, dependent on caregivers, and vulnerable to deterioration while awaiting treatment. Once the evidence supports standard coverage, access should turn on clinical need, FDA approved device use, heart team evaluation, operator qualification, hospital capability, ICU readiness, and continuous quality improvement, not on continued evidence development requirements that are no longer necessary for this indication.

Importantly, ending Coverage with Evidence Development does not reduce accountability. CMS’s proposed NCD preserves the safeguards that directly protect beneficiaries, including multidisciplinary heart team review, one independent in person TAVR operator evaluation, defined operator experience standards, on site structural heart and cardiac surgery programs, post procedure ICU capability, and continuous quality improvement. That is the right policy balance: end evidence development as a coverage condition where the evidence is sufficient, while maintaining the clinical and institutional safeguards that support safe, appropriate care.

II. CMS should finalize the modernized pre TAVR evaluation pathway

I strongly support CMS’s proposal to modernize the pre TAVR evaluation process by allowing the initial heart team evaluation to be performed asynchronously through medical record review, while still requiring an independent in person evaluation by a heart team TAVR operator before the procedure.

This is an important and necessary improvement. The current model can require multiple sequential visits, often with surgical and interventional evaluations scheduled separately, even when the essential clinical information has already been obtained. For Medicare beneficiaries with symptomatic severe aortic stenosis, those extra steps are not benign. They can delay treatment, increase travel burden, require additional caregiver time, duplicate clinical review, and create avoidable barriers for frail patients, patients with limited mobility, patients in rural or underserved areas, and patients recently hospitalized for heart failure or syncope.

Asynchronous heart team review is not a reduction in clinical rigor. It is a modern and efficient way to use the full multidisciplinary record, including echocardiography, CT imaging, coronary assessment, frailty assessment, comorbidities, surgical risk, anatomic suitability, life expectancy, and patient goals. It allows the cardiac surgeon, interventional cardiologist, imaging specialists, valve coordinators, and other team members to review the same information and reach a coordinated recommendation without requiring every beneficiary to attend duplicative in person visits.

The requirement for one independent in person evaluation by a heart team TAVR operator is also appropriate. It preserves direct physician assessment, confirms symptoms and functional status, allows final review of procedural risk and alternatives, and supports shared decision making. It also creates clear physician accountability before the procedure. The proposed NCD does not prevent additional in person evaluations when the heart team believes they are needed. Complex anatomy, uncertainty about SAVR versus TAVR, severe frailty, limited life expectancy, or patient preference may all justify additional evaluation. CMS should not require multiple in person specialist visits for every beneficiary as a national condition of coverage when one qualified operator evaluation, combined with multidisciplinary heart team review, is sufficient in many cases.

This modernized evaluation pathway is patient centered, administratively feasible, and clinically appropriate. It preserves the heart team while reducing avoidable delay and burden. It should be finalized as written.

III. The proposed operator standard is competency based, specialty neutral, and the better policy

I strongly support CMS’s proposed operator language. The proposed NCD defines a TAVR operator by demonstrated transcatheter valve experience and heart team participation, rather than by a categorical requirement that two attending physicians from two specialties jointly perform every procedure. A qualified interventional cardiologist or a qualified cardiac surgeon who is a member of the heart team, and who meets the proposed transcatheter cardiac valve and TAVR volume thresholds, may serve as the operator. That is the correct national coverage standard: competency based, specialty neutral, and focused on beneficiary safety.

The standard is specialty neutral in both directions. It neither privileges nor disadvantages either specialty. What it removes is only the requirement that both specialists jointly perform the technical procedure in every case, even when the local heart team judges one qualified operator sufficient.

Concerns about catastrophic complications, including annular rupture, coronary occlusion, and aortic or vascular injury, are legitimate and deserve consideration. In the earliest era of TAVR, mandatory joint participation by an interventional cardiologist and a cardiac surgeon was a reasonable safeguard. Operator experience was limited, devices and imaging were less refined, and bailout pathways were not yet well established. Contemporary practice has changed the setting in which those risks are managed. Complication management now depends on careful patient selection, imaging, procedural planning, qualified operators, on site structural heart interventional cardiology and cardiac surgery programs, ICU capability, and continuous quality improvement. These are the protections the proposed NCD preserves.

A national coverage determination should not impose a rigid procedural staffing model unless the evidence demonstrates that such a model is necessary for every covered case. Two operators may be appropriate in selected cases. Some patients have complex anatomy, challenging vascular access, high risk coronary anatomy, difficult hemodynamics, or other features that may warrant two attending operators. The appropriate policy question is whether CMS should require two attending TAVR operators for every covered TAVR procedure regardless of patient complexity, operator expertise, institutional experience, and local heart team judgment. The proposed NCD correctly answers no.

This approach is also consistent with CMS’s existing mitral TEER NCD, which permits an interventional cardiologist or cardiac surgeon from the heart team to perform the procedure, with joint participation as clinically appropriate rather than mandated for every case. Finalizing parallel language for TAVR promotes coherence across comparable structural heart NCDs and reflects the same principle applied to a mature transcatheter valve therapy.

A universal two operator mandate also carries access costs that are not benign in this disease. It can create scheduling bottlenecks and reduce program capacity. In symptomatic severe aortic stenosis, where delay risks heart failure, syncope, hospitalization, and death, those constraints can translate into avoidable harm. The proposed standard, which requires a qualified operator and permits a second when the heart team deems it appropriate, is more clinically precise and more administratively feasible than a blanket requirement. It matches procedural resources to patient risk while protecting timely access.

IV. The proposed hospital, ICU, volume, and quality requirements should be finalized

I support the proposed hospital, ICU, volume, and quality criteria. They focus on the protections that matter most: appropriate patient selection, qualified operators, rescue capability, post procedure critical care, and continuous outcome review. The proposed NCD requires on site structural heart interventional cardiology and cardiac surgery programs, a post procedure ICU staffed by personnel experienced in open heart valve care, and a continuous quality improvement process. These are meaningful contemporary safeguards and are more relevant to current TAVR quality than older proxy measures.

I also support the proposed operator volume criteria because they tie qualification to actual TAVR and transcatheter valve experience, which is the relevant measure of operator competency.

V. CED remains appropriate for asymptomatic severe aortic stenosis

CMS is also correct to require Coverage with Evidence Development for asymptomatic severe aortic stenosis. Unlike symptomatic severe aortic stenosis, this population still presents important unresolved questions regarding patient selection, comparison with structured surveillance and SAVR, valve durability, reintervention, and lifetime management strategy. Recent randomized data support continued evidence development rather than unrestricted national coverage. These results are promising but not yet definitive for broad Medicare coverage without evidence development.

Coverage with Evidence Development is therefore the appropriate pathway for asymptomatic severe aortic stenosis. It allows beneficiary access to promising care while requiring additional evidence to answer the questions that remain.

VI. Conclusion

The proposed NCD is superior to the current policy. It aligns coverage with contemporary evidence and FDA approved indications, ends Coverage with Evidence Development where the relevant questions have been answered, preserves Coverage with Evidence Development where evidence gaps remain, modernizes pre-procedure evaluation, maintains the heart team and hospital safeguards, and allows the local heart team to determine whether one operator or two is appropriate for a specific patient and procedure.

For these reasons, I respectfully and strongly urge CMS to finalize the proposed decision memorandum as written.

I appreciate the opportunity to comment and CMS’s thoughtful review of this important coverage issue.

Sincerely,

Somjot S. Brar, MD, MPH
Los Angeles, CA

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As a long term Valve Clinic Coordinator, I support CMS's proposed updates to the TAVR NCD, particularly the flexibilities related to patient evaluation, coverage for asymptomatic severe aortic stenosis, and reducing administrative requirements for a well-established therapy. The proposed evaluation changes will help reduce delays in treatment and lessen the burden on Medicare patients. Most of our patients are elderly, live on fixed incomes, and many travel long distances for specialty care. Requiring multiple in-person evaluations can result in additional travel costs, copays, caregiver coordination, and scheduling delays. For straightforward patients with a clear treatment plan, a more streamlined evaluation process would certainly improve efficiency while maintaining appropriate Heart Team oversight.

I also support expanding coverage to patients with severe asymptomatic aortic stenosis. In clinical practice, we often see patients progress while under surveillance, leading to worsening disease, urgent hospitalizations, and increased anxiety for patients and families. Earlier intervention, when supported by clinical evidence, provides an opportunity to improve outcomes and avoid unnecessary delays in care. The EARLY-TAVR trial demonstrated that early treatment reduced death, stroke, and unplanned cardiovascular hospitalizations compared with clinical surveillance.

Finally, reducing registry-related administrative requirements for symptomatic severe aortic stenosis would allow valve clinic staff to spend more time coordinating patient care and less time on data entry for a therapy that has already demonstrated extensive safety and effectiveness through years of clinical studies and real-world experience. The TVT Registry has been invaluable in establishing the evidence base for TAVR, but the administrative burden associated with ongoing reporting for proven indications can divert resources from direct patient care activities.

These proposed changes would improve timely access to care, reduce patient and administrative burden, and allow valve programs to focus resources where they have the greatest impact—caring for patients.

References
EARLY-TAVR Investigators. New England Journal of Medicine. 2024. Early TAVR versus clinical surveillance in asymptomatic severe aortic stenosis.
Elbaz-Greener G, et al. Circulation. 2018. Association between TAVR wait times and patient outcomes.
Barbash IM, et al. JACC Cardiovascular Interventions. 2020. Impact of treatment delays on TAVR outcomes and healthcare utilization.
Carroll JD, et al. JAMA. 2020. STS/ACC TVT Registry outcomes demonstrating the safety and effectiveness of contemporary TAVR practice.

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I applaud CMS for taking another thoughtful look at the TAVR National Coverage Determination. Clinical practice should evolve as new evidence emerges, and our policies should evolve with it. The current NCD served an important purpose when TAVR was in its infancy, but it no longer reflects where the field is today. Updating it is both appropriate and necessary.

1. Expand coverage for asymptomatic severe aortic stenosis.
The evidence supporting earlier intervention in carefully selected patients with asymptomatic severe aortic stenosis continues to grow. Waiting for symptoms to develop is not always a benign strategy and may allow irreversible myocardial damage or clinical deterioration to occur. Delayed intervention also increases downstream healthcare utilization. Coverage should allow physicians to treat patients based on the best available evidence rather than requiring them to become sicker before they qualify.

2. Preserve the Heart Team while reducing unnecessary administrative burden.
The Heart Team remains essential to appropriate patient selection. Multidisciplinary evaluation helps ensure treatment recommendations are centered on the patient's best interests rather than the preferences of a single specialty. This safeguard should remain.

However, the documentation requirements can be simplified. One comprehensive Heart Team note should satisfy coverage requirements, rather than multiple redundant notes.

The requirement for a mandatory in-person surgical evaluation should also be removed. Many TAVR patients are elderly, frail, or travel long distances for evaluation. In my practice, patients and their families frequently prefer telehealth because it reduces unnecessary travel while still allowing meaningful consultation. In-person evaluations should remain available when clinically necessary but should not be universally required.

3. Reassess procedural volume requirements carefully.
While improving access is important, quality must remain the priority. Evidence consistently demonstrates a learning curve for both operators and institutions performing TAVR, with greater experience associated with fewer procedural complications and better outcomes. Competency and volume requirements should be periodically reassessed as technology and experience evolve, but eliminating them entirely may unintentionally compromise patient outcomes. Expanding access should not come at the expense of maintaining high-quality care.

4. Support flexibility in operator requirements.
Allowing physicians greater flexibility in determining whether procedures are performed by one or two operators, and by operators from the same or different specialties, appropriately preserves physician judgment. These decisions should be guided by patient complexity, institutional expertise, and clinical circumstances rather than rigid administrative requirements.

5. Reconsider mandatory long-term registry participation.
Clinical registries have played an important role in improving TAVR outcomes, particularly during the early development of new programs. However, they also create substantial administrative burden. Mandatory participation is reasonable during the first several years of a new program to establish quality and monitor outcomes. Once a center has consistently demonstrated high-quality performance, continued participation should become optional. This approach maintains accountability while reducing unnecessary administrative requirements for established programs.

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There is ample rigorous and peer-reviewed evidence demonstrating the health benefits of TAVR for patient populations with severe symptomatic aortic stenosis (SSAS). Compared to clinical surveillance and medical management (CSMM), TAVR significantly improves survival rates and quality of life for SSAS patients [1,2]. And compared to the more invasive SAVR procedure, which some patients are ineligible to receive and others elect to forego, TAVR is less costly and followed by faster post-procedure recovery times and comparably favorable health outcomes [3–7].

Rigorous and peer-reviewed research has also demonstrated that there is a strong economic case for using TAVR to treat SSAS patients. Relative to both CSMM and SAVR, TAVR offers strong value-for-money for SSAS patients, with attractive incremental cost-effectiveness ratios, benefit-cost ratios, and rates of return [8–13]. While much of the evidence on TAVR’s value-for-money among SSAS patients adopts a narrow definition of its benefits (i.e., the monetary value of its benefit to patient health and of its impact on medical costs), [9,10] research led by Dr. JP Sevilla and coauthored with various colleagues also indicates that the broader economic benefits are sizeable [8,14]. These broader benefits reflect the fact that SSAS patients can spend more time being productive at work and at home, and they can engage in more and higher quality leisure than they would otherwise be able to if TAVR was not available.

That study found that the average SSAS patient essentially receives over $200,000 in (net) benefits from the health value of the TAVR procedure’s availability (compared to it not being available) and over $50,000 in broader (net) benefits associated with the value of the quantity and quality of their active time [8,14]. The findings implied that across all SSAS patients in the US in 2020, TAVR availability produced net benefits in excess of $53 billion. The ICER produced by these results is equal to $8,533, which is well below any conventional cost-effectiveness threshold, and the rate of return is an impressive 395%. Most of the value of TAVR’s availability derives from its positive impact on treatment rates among operable patients who would have otherwise foregone the SAVR procedure.

The strength of the evidence on the full benefits of TAVR’s availability to SSAS patients was made possible by years of careful data collection. The evidence for asymptomatic severe aortic stenosis (ASAS) patients is currently thinner, but there are already some promising data and results with respect to the sizeable health benefits and economic value of TAVR for ASAS patients [15,16]. We express support for the CMS proposal to cover TAVR for ASAS patients, including the CED requirement, which will help enable the collection of the data needed to robustly assess the health and economic benefits of TAVR for such patients.

Signed,
David E. Bloom and Joseph S. Knee

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I appreciate and commend CMS for proposing a meaningful modernization of the TAVR NCD that preserves the Heart Team concept while reducing barriers to timely care; with targeted refinements, the final policy can better support patient-centered decision-making, timely access, and outcomes-based quality across aortic stenosis treatment options. Ending the requirement for CED for the patients with symptomatic is a reasonable decision, because TAVR is now a mature, well-established therapy supported by extensive randomized trial, long-term follow-up, real-world registry, durability, and quality-measure evidence.

CMS should expand coverage for patients with severe asymptomatic AS who meet FDA-approved indications, without imposing unnecessary evidence-generation requirements where randomized clinical evidence, FDA review, and Heart Team evaluation already support prompt access to treatment. CMS should also show a clear pathway to coverage for appropriate patients with moderate AS demonstrating evidence and FDA-approved indications evolve. If one were to reflect on the development of criteria for carotid stenting, similar coverage for asymptomatic patients with severe carotid stenosis was approved. These patients, as well as those with asymptomatic AS, still need to receive treatment to prevent a catastrophic event.

I feel that the Heart Team should remain the foundation of high-quality care, but the final policy should allow local teams to tailor evaluation pathways, staffing, and workflows based on patient complexity, available ability, and local resources. At my organization, the Heart Team has been instrumental in deciding the ideal procedure for the patient that would drive the best possible outcome for the patient.

CMS should be supported for proposing to empower Heart Teams with the flexibility to decide the most appropriate procedural approach for each patient. Specifically, by clarifying that joint participation of two TAVR operators is not needed, while preserving and supporting joint participation when the Heart Team decides it is clinically called for. This flexibility will allow facilities to develop a structural heart program, as well as grow an established program, without compromising quality of care to the patient.

My facility serves a broad geographic area across the Mid-South, and many of our providers virtually connect with patients and take part remotely in our Valve Conference. CMS should allow in-person, virtual, asynchronous, or hybrid Heart Team evaluations when clinically appropriate and properly documented. This flexibility would support informed, individualized treatment decisions without unnecessary delays. Reducing the time from disease identification to treatment can improve patient outcomes. Timely treatment should be recognized as a quality priority because delays in aortic stenosis care can lead to clinical deterioration, urgent or emergent admissions, higher use, worse outcomes, and avoidable patient risk.

Maintaining the right hospital infrastructure and quality standards should be a major priority for CMS to focus on. Avoiding overly restrictive site requirements that could limit access in regions where hospitals can offer proper capabilities, outcomes monitoring, and continuous quality improvement. Ultimately ensuring that the TAVR Operators are professionally trained and have the experience to perform these procedures should be a focus for the individual hospitals and CMS.

In ideal situations, using the Heart Team approach to properly evaluate patients should be the norm, however CMS should preserve the emergency-use exception so that patients requiring urgent or emergent TAVR can receive immediate care without being delayed by evaluation requirements intended for elective cases.

CMS should move toward coverage equipoise across aortic stenosis therapies so that treatment selection is driven by clinical appropriateness, patient goals, anatomy, procedural risk, and lifetime management considerations rather than differential Medicare coverage requirements.

I urge CMS to finalize a modernized TAVR NCD that preserves the Heart Team, aligns with FDA-approved indications, retires outdated evidence-generation and process requirements where appropriate, supports outcomes-based quality, and reduces unnecessary delays so Medicare beneficiaries can receive timely, high-quality treatment for aortic stenosis.

Thank you for allowing the opportunity for public comments on this especially important topic. I trust that CMS will make the best decision possible that affects this population of patients.

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Glad that CMS gave revised guidelines. This is what I understand from this.
1. Heart team must include a CT Surgeon and an international Cardiologist with Structural expertise. Any other member inclusion into Heart team is just optional.

2. It sounded like TAVR can be performed by a single operator. Do they mean CT Surgeon or a Structural Interventionalist can do the procedure with a Tech or another assistant? We need a clarification here.

3. Volumes of 15 TAVRs a year or 30 TAVRs in two years for an operator to keep privileges is appropriate given the TAVR numbers are going down now.

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July 14, 2026
Re: CMS National Coverage Analysis (NCA CAG-00430R2): Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR)
To the Centers for Medicare & Medicaid Services:
I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). Overall, I strongly support CMS's proposal to remove Coverage with Evidence Development (CED) requirements for symptomatic severe aortic stenosis, expand coverage for asymptomatic severe aortic stenosis under CED, and modernize physician, Heart Team, and hospital requirements. These changes appropriately reflect the substantial evolution in clinical evidence, procedural safety, and national experience with TAVR over the past decade.
The proposal appropriately recognizes that TAVR has become the predominant treatment for symptomatic severe aortic stenosis and that multiple randomized trials have demonstrated outcomes comparable or superior to surgical aortic valve replacement across low-, intermediate-, and high-risk populations. Long-term follow-up from the PARTNER, Evolut Low Risk, SURTAVI, and NOTION trials confirms excellent survival, sustained valve performance, and meaningful improvements in quality of life. Accordingly, eliminating the CED requirement for FDA-approved indications is supported by a mature evidence base and reflects current standards of care.
I also support the continued emphasis on multidisciplinary Heart Team evaluation. Shared decision-making remains essential, particularly for younger patients, those with bicuspid anatomy, longer life expectancy, or complex coronary disease, where individualized lifetime valve management strategies are critical. The proposed flexibility allowing an initial asynchronous Heart Team review while maintaining an in-person evaluation by a qualified TAVR operator appropriately balances patient access with high-quality clinical assessment.
The proposed revision of operator competency requirements is similarly appropriate. Contemporary structural heart practice increasingly encompasses transcatheter therapies involving the aortic, mitral, tricuspid, and pulmonic valves. Recognizing total transcatheter valve experience, while maintaining minimum annual TAVR procedural volumes, better reflects current practice patterns and operator expertise than historical procedure-specific thresholds alone. As CMS correctly notes, future transition toward validated outcome-based quality metrics should ultimately supersede arbitrary volume requirements as additional evidence becomes available.
Finally, I support the expansion of CED for asymptomatic severe aortic stenosis. Recent randomized studies, including EARLY TAVR, suggest that selected asymptomatic patients may derive meaningful benefit from earlier intervention; however, important questions remain regarding long-term durability, optimal patient selection, valve lifetime management, and outcomes in younger and bicuspid valve populations. Restricting this expanded indication to carefully designed CED studies is therefore an appropriate and evidence-based approach.
In summary, the proposed NCD appropriately modernizes Medicare coverage to reflect the current scientific evidence while preserving rigorous evaluation of emerging indications. I commend CMS for developing a balanced policy that expands patient access, maintains high-quality standards through the Heart Team model, and continues evidence generation where uncertainty remains.
Thank you for considering these comments.
Sincerely,

Santiago Garcia, MD
Director, Structural Heart Program
The Christ Hospital, Cincinnati, OH

Suggested references
1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients at 5 Years. N Engl J Med. 2025.
2. Forrest JK, Deeb GM, Yakubov SJ, et al. Five-Year Outcomes After Self-Expanding Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients. J Am Coll Cardiol. 2023.
3. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease. Circulation. 2021;143:e72-e227.
4. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019.
5. Leon MB, Mack MJ, Hahn RT, et al. EARLY TAVR Trial: Transcatheter Aortic Valve Replacement in Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2024.

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I support CMS’s intent to expand appropriate access to TAVR, particularly for patients in rural and underserved areas where travel distance and limited local access may delay evaluation and treatment. I also support the proposed continuation of the heart team model, operator volume requirements, and the streamlined patient evaluation process, including an initial heart team review and an independent in-person evaluation by a heart team TAVR operator prior to the procedure.

However, I'm concerned with the proposed removal of mandatory registry participation. Under the current NCD, registry participation provides a defined mechanism to track outcomes, evaluate real-world performance, and better understand variation at the patient, operator, and facility level. If site volume requirements are removed and registry participation is no longer mandatory, it's unclear how CMS will continue to monitor whether outcomes are impacted, particularly at lower-volume or newly expanding centers.

I respectfully request that CMS clarify what replacement mechanism, if any, will be used to track outcomes and verify compliance with the remaining NCD requirements, including heart team composition, operator volumes, patient evaluation, hospital infrastructure, and continuous quality improvement processes. I also request clarification regarding the audit process and potential consequences when these requirements are not met.

Expanding access and maintaining quality should not be competing priorities. I recommend that CMS either retain mandatory participation in a national audited registry or establish an equivalent standardized reporting and oversight process to ensure continued transparency, accountability, and patient safety as TAVR access expands.

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Dear Members of the Coverage and Analysis Group:

I write as an structural heart interventional cardiologist at an academic heart center, and have an active role in a multidisciplinary heart team. I appreciate CMS's commitment to a transparent, evidence-based review and offer the following targeted comments on three policy areas where I believe focused refinements will best serve Medicare beneficiaries.

1. Operator Requirements: Discretion Should Rest with the Heart Team

TAVR has matured substantially since the original NCD was written. Standardized delivery systems, high-resolution imaging, and accumulated operator experience have transformed the procedure's risk profile, and the rare complications that do arise are now managed almost exclusively through advanced catheter-based techniques rather than emergent surgical intervention. National registry data and outcomes across high-volume international programs consistently reflect this evolution.

I urge CMS to adopt language permitting heart teams to determine whether one or two operators are appropriate for each individual case, and to allow both operators to be from the same subspecialty when team composition and patient complexity so warrant. This approach preserves scheduling flexibility, reflects real-world program structures, and does not compromise safety—outcomes across programs that exercise this flexibility support that conclusion.

2. Evaluation Modality: In-Person by the Primary Operator; Flexibility for the Broader Heart Team

I support a model in which the primary TAVR operator conducts an in-person evaluation of every patient. Direct examination is essential for informed consent, accurate frailty and vascular access assessment, and the shared decision-making that defines patient-centered care. This requirement is both clinically sound and operationally achievable.

For the remainder of the heart team, however, a categorical in-person mandate is not supported by evidence and imposes disproportionate burden on rural, elderly, and frail patients—precisely the population TAVR is designed to serve. Telemedicine preoperative evaluation in complex cardiac populations has demonstrated equivalent procedural and one-year outcomes compared with in-person assessment, with meaningful reductions in patient travel time and cost. Multidisciplinary conference review mirrors workflows already standard in surgical AVR evaluation and leverages the same imaging and clinical data the team would review in person.This framework protects clinical rigor, expands equitable access, and aligns with the telehealth capabilities CMS has appropriately sought to preserve.

3. Coverage with Evidence Development (CED): Preserve Registry-Based Oversight

While CED should be streamlined where the evidence base is mature, I respectfully urge CMS to maintain registry-based CED for indications where evidence continues to evolve—including lower-risk populations, bicuspid aortic valve anatomy, valve-in-valve procedures, and patients with complex comorbid conditions. The STS/ACC TVT Registry has demonstrated that high-quality, longitudinal data collection is feasible at scale and imposes manageable institutional burden. Continued participation supports quality improvement, informs future guideline development, and provides the evidence infrastructure needed to responsibly evaluate expanding indications. This approach honors CED's original intent while focusing its requirements where they add genuine value.

Conclusion

These three recommendations—operator flexibility per the local institution and allow two heart team operators from the same speciality, a hybrid in-person/remote evaluation model, and targeted continuation of registry-based CED—are practical, evidence-grounded, and designed to advance both patient safety and access.

Respectfully,

Apurva Patel, MD FACC FSCAI

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To the Centers for Medicare & Medicaid Services:

I strongly support the proposed revisions to the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).

I commend CMS for conducting a comprehensive, transparent, and data-driven review of the available evidence. The proposed decision thoughtfully aligns Medicare coverage with FDA-approved indications and the extensive body of randomized clinical trial and real-world evidence. It appropriately balances patient safety, quality, innovation, and timely access to care and reflects the remarkable maturation of transcatheter valve therapies over the past two decades.

The continued emphasis on multidisciplinary Heart Team decision-making is an important strength of the proposal. Collaborative care remains the cornerstone of contemporary structural heart disease programs. At the same time, while the principles of the Heart Team should remain constant, its structure and implementation should remain flexible. Team composition, patient evaluation pathways, and procedural workflows may appropriately vary across hospitals and health systems based on local expertise, patient needs, and system resources. CMS should define the expectations of multidisciplinary care while allowing programs the flexibility to operationalize those principles in the manner that best serves their patients. The Heart Team should be defined by its function rather than its form. High-performing teams are built on collaboration, communication, shared accountability, and patient-centered decision-making—not by a prescribed organizational structure. Likewise, unnecessary redundancy and delays in evaluation should be avoided, as timely treatment is itself an important component of quality care.

I also support CMS's approach to Coverage with Evidence Development (CED). As technologies mature and the evidence becomes sufficiently robust, it is appropriate for CMS to determine when CED has fulfilled its purpose. As CMS appropriately sunsets CED for mature technologies, the responsibility for continued evidence generation should transition to our professional societies and the structural heart community. The STS/ACC TVT Registry has become the benchmark for post-market evidence generation, informing regulatory decisions, expanding indications, improving patient selection, and strengthening clinical practice guidelines. Continued investment in comprehensive, longitudinal registry data remains essential to responsibly advance patient care, support future innovation, inform FDA approvals, strengthen future clinical practice guidelines, and guide subsequent coverage decisions.

Finally, the continued evolution of structural heart disease underscores the need for formal investment in physician training. Despite the remarkable growth and complexity of the field, there are currently no ACGME-accredited training pathways in structural heart disease. As structural heart disease has matured into a distinct subspecialty, our training infrastructure should mature with it. Contemporary structural interventions require advanced expertise in multimodality imaging, catheter-based therapies, multidisciplinary decision-making, and longitudinal patient care. As structural heart therapies continue to expand, dedicated, accredited training programs supported by sustainable funding are essential to develop the next generation of structural heart specialists and ensure the highest quality care for our patients.

I commend CMS for developing a thoughtful, balanced, and evidence-based proposal that appropriately aligns Medicare coverage with the best available scientific evidence while improving access to FDA-approved therapies for Medicare beneficiaries. This proposed NCD recognizes that the future of structural heart disease depends not only on evidence-based coverage decisions, but also on continued collaboration, responsible evidence generation, and investment in the next generation of structural heart specialists. Together, these efforts will continue to improve patient outcomes, strengthen future clinical practice guidelines, and ensure that Medicare beneficiaries have access to the highest-quality, evidence-based structural heart care.

I respectfully encourage CMS to finalize the proposed National Coverage Determination.

Respectfully,

Chad A. Kliger, MD, MS, FACC, FSCAI
Director, Structural Heart Disease
Northwell Health - Lenox Hill Hospital

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As an interventional cardiologist involved in the evaluation and treatment of patients with severe aortic stenosis (AS), I support CMS's proposed National Coverage Determination (NCD) updates that expand coverage to include asymptomatic severe AS under Coverage with Evidence Development (CED) while maintaining the Heart Team model and providing greater flexibility regarding for procedural operators.
Coverage for asymptomatic severe AS under CED is particularly important given the growing body of evidence demonstrating that earlier intervention can improve patient outcomes and prevent disease progression. The recently published EARLY TAVR trial showed that treatment of patients with asymptomatic severe AS resulted in a significant reduction in the composite endpoint of death, stroke, or unplanned cardiovascular hospitalization compared with clinical surveillance. Patients treated with early TAVR experienced substantially fewer cardiovascular hospitalizations and maintained better quality of life, supporting an earlier treatment strategy before irreversible cardiac damage or clinical deterioration occurs. [pubmed.ncb...lm.nih.gov], [acc.org]

Maintaining CED for asymptomatic patients is an appropriate and evidence-based approach. It allows Medicare beneficiaries access to an FDA-approved therapy while enabling continued collection of real-world outcomes data to further refine patient selection and optimize care. This targeted use of CED reflects the evolving evidence base and focuses data collection efforts where important clinical questions remain. [acc.org], [scai.org]

I also strongly support the proposed operator flexibility provisions. The modern TAVR procedure has evolved substantially over the past decade, with the vast majority of cases now performed via transfemoral access using minimalist approaches and excellent safety outcomes. Heart Teams should retain the flexibility to determine which qualified physician member is best suited to perform the procedure based on patient-specific clinical needs, procedural complexity, and local expertise.

I do think there should be an emphasis on the Heart Team requirements based on age. I do think that a patient must be seen by a surgeon who is under the age of 60 in order to make sure the patient has been thoroughly offered a mechanical aortic valve replacement option. Additionally, a patient greater than the age of 75 may not necessitate a surgical evaluation and in forcing them to do so adds to the burden required on the patient both from a time, distance and financial perspective.
Additionally, a patient over the age of 70 must be seen by an interventional cardiologist prior to being offered open heart surgery to make sure they have been fully consented (understand the alternative that is TAVR).

I do agree that TVT registry requirements for established populations should not be required but maintaining star ratings will help promote centers to voluntarily submit their data analogous to STS. CED for still at question populations (bicuspid valve, asymptomatic, moderate symptoms AS patients) should be mandatory.

Thank you
Fredy El Sakr

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Dear CMS,

Thank you for the opportunity to comment on the proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). With approximately 800K procedures performed globally since commercialization almost 15 years ago, buoyed by randomized trial data in thousands of patients across surgical risk categories and device platforms in real-world settings, TAVR now epitomizes a mature technology. As such, revisions to a regulatory framework that is not required in comparable risk procedures (SAVR, PCI, CABG) are warranted and probably past-due. The proposed changes are thoughtful, and I believe they will improve patient access to care and substantially modernize and streamline TAVR coverage. Below are a few personal comments and opinions on the key issues:

1) The advent of the Heart Team has been largely driven by TAVR and has tremendously benefited patients. It should be preserved, but focused where it adds value. Collaboration amongst different specialties is essential, but that doesn’t need to be prescribed by an NCD and is not for any other disease condition. A frail patient in their late 80s with prior sternotomy does not need an in-person surgical evaluation to be told they are high risk for SAVR. As ethical, responsible, and well-trained physicians we should be trusted to evaluate gray-zone cases, complex anatomies, lifetime planning decisions, and other nuanced clinical situations together as a heart team – ICs, cardiac surgeons, imagers, general cardiologists, and APPs. The proposed NCD changes do not “dissolve” the Heart Team, but rather put the onus on us as physicians to engage other physicians in different specialties as we do for every other disease condition.

2) Access to care is a real issue. Severe aortic stenosis is a lethal condition with a prognosis comparable to or worse than many metastatic cancers and delays in treatment lead to substantial increases in mortality with some estimates that under 20% of severe symptomatic AoS patients get timely treatment[1,2]. I’ve performed TAVRs and been involved with TAVR program building since 2013 in a large academic program, a rural fledgling program, and now a large private program and have seen every iteration of delayed care and can specifically remember patients who died before being treated (as many TAVR operators likely can). Streamlining access by allowing telehealth visits and eliminating mandatory in-person visits will improve access to TAVR, especially for rural, financially disadvantaged, elderly, and urgent patients.

3) Procedural operator requirements are unnecessary and outdated. Mature programs should have the flexibility to perform TAVR with dual operators from either specialty or single operators at the discretion of the program if the operator is very experienced, the anatomy is straightforward, etc. Mandating that a surgeon be present for every procedure un-necessarily constrains efficient TAVR workflow. The reality is that complex TAVRs and TAVR bailout have become largely catheter-based as TAVR has evolved, and these are techniques mastered by structural interventional cardiologists at the vast majority of centers. The need for surgical bailout has become exceedingly rare (<1% in contemporary trials)[3] so while having surgical backup available is still reasonable, having it on stand-by for every case is not.

4) The CED for symptomatic severe aortic stenosis has served its purpose well and can be allowed to sunset. This is not to say we close our eyes to any new data or don’t seek to investigate less well-defined patient groups (asymptomatic, very young, bicuspid), but this is already being done through randomized controlled trials like EARLY TAVR, BELIEVERS, NOTION-2. In my opinion, participation in ACC/STS TVT Registry should become voluntary along the lines of the STS and the NCDR CATHPCI registries which have high participation rates, capture upwards of 90% of cases, and provide benchmarks of quality and mechanisms for identifying deficiencies and improving. These are all goals of any good program. The administrative and cost burdens to mandatory collection of a host of low-impact data in every symptomatic severe AoS patient are real and do limit use of those resources in a more effective manner.

In summary, I’m supportive of the proposed changes to the NCD for TAVR. I view them as needed modernization and removal of constraints from a mature procedure. They in no way destroy the Heart Team or blind us to further research, but place TAVR on an equal footing with comparable cardiovascular procedures. I appreciate the opportunity to give input and am encouraged that a process like this is in place for Medicare beneficiaries.

[1] Li et al. Trends in Utilization of Aortic Valve Replacement for Severe Aortic Stenosis. J Am Coll Cardiol. 2022
[2]Tanguturi et al. Timely Treatment of Severe Aortic Stenosis. Circulation. 2025
[3] Aarts et al. Surgical Bailout in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, and Clinical Outcomes. JACC: Cardiovascular Interventions, Jan 2025

Sincerely,
Jim Stewart, MD
Structural Interventional Cardiologist
Piedmont Heart Institute, Atlanta, GA

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To the Centers for Medicare & Medicaid Services:

Overall, I support CMS's efforts to modernize the NCD to reflect the evolution of TAVR practice, advances in operator experience, and the maturation of multidisciplinary structural heart programs. I offer the following comments for consideration.

1. Support for a Single Credentialed Operator Model While Preserving Flexibility for Two-Operator Programs

I support CMS's proposal to permit TAVR to be performed by a single credentialed operator, whether that operator is an interventional cardiologist or a cardiac surgeon. This change appropriately recognizes the substantial experience that has been accumulated over the past decade and reflects contemporary practice at many high-volume centers. However, I strongly encourage CMS to explicitly preserve institutional flexibility to continue using a two-operator model when that approach best serves the needs of the program, the patients, and the physicians involved. Different institutions have developed successful care models based on their local expertise, staffing, and workflow, and a single national procedural model should not be mandated. Importantly, CMS should also maintain the current reimbursement structure that allows both credentialed operators to be reimbursed when they jointly perform a TAVR procedure. The decision to use one or two operators should remain a clinical and operational decision made by the local Heart Team rather than one driven by reimbursement policy. Providing this flexibility offers several important advantages:

• It improves procedural scheduling by reducing the requirement for simultaneous physician availability when a single operator is appropriate.
• It allows cardiac surgeons whose primary focus is operative valve surgery to dedicate more time to surgical care while still remaining active members of the multidisciplinary Heart Team.
• It allows cardiac surgeons with a strong interest and expertise in transcatheter valve therapies to continue participating directly in TAVR procedures.
• It preserves collaborative multidisciplinary care without creating unnecessary operational barriers.

2. Support a Single Required In-Person Operator Evaluation

I also support the proposal requiring only one in-person evaluation by a credentialed TAVR operator.
The current requirement for separate in-person evaluations by both procedural specialties often creates scheduling challenges without consistently adding meaningful clinical value, particularly in mature multidisciplinary programs where imaging, clinical data, and treatment recommendations are routinely reviewed by the Heart Team. Requiring one comprehensive in-person evaluation while allowing the remainder of the Heart Team to participate through multidisciplinary review maintains high-quality decision-making while substantially improving efficiency. This approach reduces unnecessary patient visits, expedites treatment, and allows the second operator to devote additional time to other important aspects of patient care, including operative procedures, clinic responsibilities, and inpatient consultation. The multidisciplinary Heart Team remains essential; however, its effectiveness should not be defined by requiring duplicate in-person evaluations. Again, individual programs may continue to decide to maintain joint evaluations for all patients or perhaps devise local criteria that would prompt a joint evaluation based on age, valve anatomy (i.e, bicuspid aortic valve), etc.

3. Routine Coverage Should Be Extended to Patients with Asymptomatic Severe Aortic Stenosis

I encourage CMS to provide routine Medicare coverage for TAVR in appropriately selected patients with asymptomatic severe aortic stenosis rather than limiting coverage solely to Coverage with Evidence Development (CED) studies. Several contemporary randomized trials have demonstrated that earlier intervention in carefully selected patients with severe aortic stenosis may improve clinical outcomes compared with watchful waiting. While ongoing studies will continue to refine patient selection, the available evidence increasingly supports intervention before the development of irreversible myocardial damage or clinical decompensation. Restricting coverage exclusively to CED studies may unintentionally limit access for Medicare beneficiaries who could derive meaningful benefit from treatment but do not have access to participating research centers. Such an approach may also create geographic disparities in care. Coverage decisions should continue to emphasize careful patient selection through a multidisciplinary Heart Team, but appropriately selected patients with asymptomatic severe aortic stenosis should have access to TAVR outside the setting of clinical trials.

In conclusion, the proposed NCD appropriately modernizes many aspects of TAVR coverage. By preserving flexibility for either one- or two-operator procedural models, maintaining reimbursement when two credentialed operators participate, simplifying evaluation requirements through a single required in-person operator visit, and expanding routine coverage to appropriately selected patients with asymptomatic severe aortic stenosis, CMS can further improve patient access while supporting efficient, high-quality structural heart programs.

Thank you for considering these comments and for your continued efforts to ensure that Medicare beneficiaries have access to safe, evidence-based, and patient-centered cardiovascular care.

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Dear CMS,

I support CMS's proposed updates to the TAVR National Coverage Determination and believe they represent an important step toward improving patient access, streamlining care, and reducing unnecessary Medicare costs. As a structural interventional cardiologist who performs TAVR on a daily basis, I have seen firsthand how advances in technology and operator experience have transformed the treatment of severe aortic stenosis. The proposed revisions appropriately recognize that current Medicare policy should reflect contemporary practice while maintaining high standards of patient care.

1. Streamline the Pre-Procedural Evaluation
Severe symptomatic aortic stenosis is a progressive, life-threatening condition, and avoidable delays in treatment can lead to worsening heart failure, declining ventricular function, syncope, and death. Requiring every patient to undergo evaluation by two physicians often adds clinic visits, travel, expense, and scheduling delays without providing clear clinical value.
Structural interventional cardiologists are specifically trained to evaluate TAVR candidates using advanced imaging, invasive hemodynamics, and comprehensive clinical assessment. As with all areas of medicine, additional specialists should be involved whenever their expertise will improve patient care, not because of a universal regulatory requirement.

The mandatory Heart Team evaluation was an important safeguard during the early implementation of TAVR. However, after more than a decade of experience and well-established quality programs, this requirement should no longer apply to every patient. While permitting electronic review is a positive step, a mandatory secondary review still creates unnecessary administrative burden without evidence of improved outcomes. Decisions regarding additional consultation should remain with the treating Heart Team, while program quality should continue to be ensured through credentialing, institutional oversight, and established quality measures.

2. Streamline Procedural Operator Requirements
I support allowing TAVR to be performed by either one or two qualified physicians, regardless of specialty. The procedural environment has changed dramatically since the original NCD was established. Improvements in device technology, imaging, patient selection, and operator experience have reduced the need for emergent surgical intervention to an exceptionally uncommon event. When procedural complications arise, they are most often treated successfully with catheter-based techniques that depend on advanced interventional skills.

For standard transfemoral TAVR procedures, a requirement for a scrubbed cardiac surgeon is no longer warranted in most cases. Cardiac surgeons remain indispensable for patients requiring complex surgery, hybrid approaches, and operative rescue when needed, but routine cases should allow greater staffing flexibility. Experience from other countries has demonstrated that excellent outcomes can be achieved without a mandatory scrubbed surgeon. Likewise, in particularly challenging catheter-based cases, a second structural interventional cardiologist may offer greater procedural benefit. CMS should allow each Heart Team to determine the appropriate procedural staffing based on the patient's needs rather than physician specialty.

3. Remove Coverage with Evidence Development (CED)
Coverage with Evidence Development (CED) played an important role in the early introduction of TAVR by ensuring that outcomes were systematically evaluated as the technology matured. That objective has now been achieved. Over the past decade, multiple randomized trials—including PARTNER 1–3, CoreValve High Risk, SURTAVI, Evolut Low Risk, and NOTION—have established the safety and effectiveness of TAVR across all surgical risk categories.

Given the strength and consistency of the available evidence, continued CED requirements are no longer justified. Maintaining these mandates consumes significant institutional time and resources without providing meaningful additional clinical value. Ending CED appropriately acknowledges that TAVR is now a well-established standard of care rather than an emerging technology.

Conclusion
These comments are intended to support policies that reflect the current state of TAVR rather than the environment in which the original National Coverage Determination was developed. The evidence supporting TAVR, the experience of Heart Teams, and advances in procedural safety have fundamentally changed how this therapy is delivered.

I encourage CMS to finalize an NCD that provides flexibility in procedural staffing, eliminates unnecessary physician review requirements, removes outdated Coverage with Evidence Development provisions, and allows experienced Heart Teams to make patient-centered clinical decisions without unnecessary administrative barriers.

Thank you for your consideration of these comments and for your continued efforts to ensure that Medicare beneficiaries have timely access to high-quality structural heart care.

Respectfully,
Vivek Rajagopal, MD
Operator, Structural Heart Interventions
Piedmont Heart Institute, Atlanta, GA

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Dear Coverage/Analysis Team:

As a cardiovascular service line administrator responsible for multiple cardiovascular programs, I support CMS’s proposed updates. These revisions appropriately recognize TAVR’s evolution into a mature, evidence-based therapy while preserving the essential role of multidisciplinary Heart Team decision-making.

From a large health system perspective, the proposed operator and evaluation flexibilities will improve efficiency, reduce unnecessary resource utilization, and expand timely access to care without compromising quality. TAVR programs face significant workforce shortages, increased capacity constraints, and cost increases that impact growing demand. Allowing care sites to align resources with patient needs is essential to high-quality care.

The proposed operator and volume flexibilities are particularly valuable. We remain committed to a Heart Team model. Allowing the Heart Team to determine when co-operator involvement is clinically necessary enables more effective physician resource utilization, reduces scheduling complexity, increases procedural capacity, and lowers unnecessary staffing costs. These efficiencies are increasingly important as we face mounting financial/workforce pressures.

Similarly, the streamlined patient evaluation process reflects the realities of modern TAVR care. Current requirements can result in duplicative consultations, scheduling delays, and administrative burden without improving clinical decision-making. Greater flexibility will eliminate unnecessary steps, accelerate treatment, reduce operational demands on physicians, nurse coordinators, and support staff, and lower the overall cost of care while improving the patient experience.

Most importantly, these changes will improve access and reduce treatment delays. For patients with severe aortic stenosis, delays can lead to worsening symptoms, avoidable hospitalizations, increased healthcare utilization, and significantly poorer outcomes. By updating evaluation pathways and operator requirements, hospitals can reduce wait times, and expand therapy access and capacity, particularly in rural and underserved communities.

These proposed flexibilities do not diminish quality. The success of contemporary TAVR programs is driven by experienced multidisciplinary Heart Teams, robust registry participation, continuous quality monitoring, and evidence-based patient selection-not by prescriptive requirements that may no longer be necessary for every case. The proposal preserves foundational safeguards while allowing hospitals to apply clinical expertise and resources more effectively.

Overall, these revisions enable programs to deliver care efficiently, reduce unnecessary costs and administrative burden, expand access, and maintain best in class outcomes. I encourage CMS to finalize these directional updates with prudent safeguards, as an important step toward modernizing coverage policy in a way that benefits our patients, providers, and systems alike.

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I support the proposed modernization of the TAVR National Coverage Determination and appreciate CMS's recognition that TAVR has evolved into an established standard of care. The proposed removal of procedural volume requirements and increased flexibility in program structure appropriately reflect the maturity of contemporary TAVR programs.

My primary concern is the proposed elimination of the requirement for participation in a national audited registry. While I agree that Coverage with Evidence Development (CED) is no longer necessary for symptomatic severe aortic stenosis, I believe continued participation in a national outcomes registry remains an important component of ensuring high-quality patient care.

As CMS reduces prescriptive structural requirements and provides greater flexibility in how TAVR programs are organized and staffed, objective measurement of patient outcomes becomes even more important. Comprehensive registry participation supports continuous quality improvement, meaningful national benchmarking, post-market surveillance, and early identification of trends that may impact patient safety or clinical outcomes.

Additionally, broad participation is essential to maintaining the integrity and value of national benchmark reports. If registry participation becomes voluntary and participation declines, the ability to generate accurate risk-adjusted comparisons and representative national performance data will be diminished for all participating programs.

I encourage CMS to consider maintaining a requirement for participation in a national audited TAVR registry while removing the Coverage with Evidence Development requirement. Doing so would preserve the benefits of robust national quality measurement while allowing TAVR programs the operational flexibility envisioned by the proposed NCD.

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As a health system executive responsible for ensuring patient access, operational efficiency, and high-quality cardiovascular care, I strongly support CMS's proposed updates to the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).

The draft NCD appropriately recognizes the significant advances in TAVR technology, operator experience, and clinical evidence that have occurred since the original coverage determination was established. These proposed changes are an important step toward aligning Medicare policy with contemporary practice while preserving the multidisciplinary heart team approach that has been integral to the success of TAVR programs nationwide.

I am supportive of the proposed flexibilities related to patient evaluation and procedural staffing. Healthcare systems across the country continue to face workforce shortages, including projected shortages of cardiothoracic surgeons and other cardiovascular specialists. Allowing programs greater flexibility in determining the appropriate clinician involvement based on patient needs, physician competency, and local resources will help reduce unnecessary barriers to care while maintaining appropriate clinical oversight and quality standards.

From an operational perspective, these changes have the potential to improve access to care, reduce administrative burden, and enhance patient throughput within established TAVR programs. Delays in treatment for severe aortic stenosis are associated with increased hospitalizations, higher healthcare utilization, and worse patient outcomes (Elbaz-Greener et al., Circulation, 2018; Barbash et al., JACC Cardiovascular Interventions, 2020). By enabling more efficient evaluation and treatment pathways, the proposed policy changes can help patients receive timely intervention while also reducing avoidable healthcare expenditures.

I also applaud CMS for proposing updates that better reflect current evidence and the evolution of TAVR indications. TAVR has become the standard of care for many patients across the surgical risk spectrum, and emerging evidence continues to support earlier intervention in appropriately selected patients. The EARLY-TAVR trial demonstrated improved outcomes with early treatment compared with clinical surveillance among patients with asymptomatic severe aortic stenosis (NEJM, 2024). Aligning Medicare coverage with contemporary evidence will help ensure beneficiaries have access to appropriate therapies as the field continues to advance.

Importantly, maintaining flexibility in operator requirements will be essential to supporting patient access in rural, community-based, and underserved settings where specialist resources may be limited. Allowing hospitals and heart teams to determine the most appropriate procedural staffing model based on patient complexity and program capabilities reflects current practice realities while preserving accountability for outcomes and quality.

Overall, I commend CMS for proposing changes that modernize the TAVR NCD and better align coverage policy with today's evidence, workforce realities, and care delivery models. These updates have the potential to improve patient access, reduce unnecessary administrative burden, support healthcare system efficiency, and ensure Medicare beneficiaries continue to receive timely, evidence-based care.

I encourage CMS to finalize the proposed flexibilities and continue supporting policies that enable heart teams to deliver the right care to the right patient at the right time.

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Dear Dr. Hutter and Ms. Fulton:
The Global Coalition on Aging (GCOA) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services' (CMS) proposed decision memo updating the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR), released June 15, 2026.¹ This comment builds on GCOA's submission earlier this year, when we urged CMS to modernize NCD 20.32 to reflect the clinical evidence, the realities of an aging Medicare population, and the need for long-term program sustainability.
We commend CMS for the direction of this proposal. After fourteen years, CMS is recognizing TAVR as reasonable and necessary for the treatment of severe, symptomatic aortic stenosis (AS) without a Coverage with Evidence Development (CED) requirement. For a Medicare population that is growing older and more dependent on timely, evidence-based intervention, this is a meaningful and overdue step. It also reflects what GCOA has argued throughout this process: Medicare coverage policy should keep pace with clinical evidence and ensure that Americans everywhere can benefit from biomedical innovation that can extend not just years, but also quality of life, functional ability, and independence.
One gap remains, and it is the most consequential one. CMS's proposal would extend TAVR coverage to patients with asymptomatic severe AS, an indication the FDA approved in April 2025, but would keep this population under CED. We do not believe that half measure is justified. The evidence for early intervention in asymptomatic severe AS has moved past the exploratory stage: the EARLY TAVR trial, published in the New England Journal of Medicine, along with a growing body of randomized and observational data, consistently shows that deferring treatment until symptoms appear allows avoidable, and often irreversible, cardiac damage.^2-5 Continuing to require evidence development for this population does not protect patients. It delays care for people who, by CMS's own recognition, already qualify for the therapy, and undermines the promise of future innovation. We urge CMS to extend the same national coverage determination, without CED, to asymptomatic severe AS.
We also support the proposal's broader shift toward outcomes-based Heart Team and quality measurement requirements, which move the focus from rigid procedural counts to how patients actually fare. As CMS finalizes these provisions, we would encourage continued attention to access in underserved communities, where fewer than half of eligible AS patients currently receive treatment.⁶ Finally, we encourage CMS, once this NCD is finalized, to take a harder look at how CED is used across Medicare more broadly. CED has a legitimate purpose when real evidence gaps exist.⁷ It is a poor fit once the evidence has caught up, as it has here. As America ages, and as more of Medicare's coverage decisions touch conditions that disproportionately affect older adults, CMS has an opportunity to build a coverage framework that retires CED on a predictable timeline rather than indefinitely, so that America’s older adults are not left waiting on policy to catch up with biomedical innovation.
GCOA urges CMS to finalize this proposal, and to extend the same evidence-based, no-CED approach to asymptomatic severe AS. We would welcome the opportunity to serve as a resource to CMS as this policy moves toward finalization.

Respectfully submitted,

Michael W. Hodin
CEO
Global Coalition on Aging

Citations

1. Centers for Medicare & Medicaid Services. Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2, NCA-CAL-321). June 15, 2026.
2. Généreux, P., et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med, 2024.
3. Kang, D.H., et al. Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis. N Engl J Med, 2020;382(2):111-119.
4. Loganath, K., et al. Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis: The EVOLVED Randomized Clinical Trial. JAMA, 2024.
5. Généreux, P., et al. Aortic Valve Replacement Versus Clinical Surveillance in Asymptomatic Severe Aortic Stenosis: A Systematic Review and Meta-Analysis. J Am Coll Cardiol, 2024.
6. Brennan, J.M., et al. Racial Differences in the Use of Aortic Valve Replacement for Treatment of Symptomatic Severe Aortic Valve Stenosis in the Transcatheter Aortic Valve Replacement Era. J Am Heart Assoc, 2020;9(16):e015879.
7. Centers for Medicare & Medicaid Services. Coverage with Evidence Development, in Ending CED. 2024.

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Dear CMS
As a practicing structural interventional cardiologist at an academic center, I appreciate CMS for proposing thoughtful updates to the TAVR National Coverage Determination. These changes appropriately recognize the evolution of TAVR over the past decade and represent an important step toward improving patient access, reducing unnecessary administrative burden, and modernizing policy to reflect contemporary practice.

1. Procedural Operator Requirements
I strongly support allowing either one or two qualified operators, regardless of specialty, based on patient and procedural complexity.

TAVR has evolved into a safe structural heart procedure due to advances in device technology, procedural planning, and operator experience. Emergent surgical bailout is now rare, and most procedural complications are managed with advanced catheter based techniques. For complex procedures such as redo TAVR, valve-in-valve interventions, coronary protection, or alternative access, a second structural interventional cardiologist may provide complementary expertise. Providing Heart Teams with the flexibility to determine the most appropriate procedural staffing for each patient, rather than prescribing operator specialty, would better reflect contemporary practice.

2. Pre-Procedural Evaluation
I support replacing the mandatory in-person second physician evaluation with electronic review, but I also encourage consideration of eliminating the mandatory second review altogether.

Mandatory second evaluations often lead to additional clinic visits, increased costs, and delays in treating patients with symptomatic severe aortic stenosis without clear evidence of improved outcomes. Allowing experienced Heart Teams to determine when additional consultation is clinically warranted would reduce unnecessary barriers while maintaining high quality patient care.

3. Coverage with Evidence Development
I strongly support eliminating Coverage with Evidence Development requirements.
CED fulfilled its purpose during the early adoption of TAVR. Today, TAVR is supported by robust randomized trial data and extensive real world experience and is an established standard of care. Retiring these requirements would appropriately recognize the maturity of the evidence while reducing unnecessary administrative burden.

Thank you for your thoughtful consideration of these comments and for your continued commitment to improving care for Medicare beneficiaries.

Sincerely,
Abdallah El Sabbagh, MD

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EXECUTIVE SUMMARY
This public comment provides implementation guidance and evidence not yet part of the evidentiary record for reconsideration of the TAVR NCD. CMS's evidence review addresses which patients should receive TAVR and through which device; it does not yet address who performs the evaluation, coordination, and continuous quality improvement functions the proposed rule requires. This comment presents multi-professional society guidance, empirical evidence on coordinators and Heart Teams, and outcomes studies to support that clinical valve coordinators, advanced practice clinicians, and nurses are the workforce infrastructure that operationalizes these functions in current practice. This is role specification of Heart Team criteria and facilities requirements, which is not a new burden and is consistent with similar CMS policies. Four requests follow this summary, with supporting rationale and evidence, to name these roles accordingly in the Final NCD.

To Lead Analyst Sarah Fulton, MHS; Lead Medical Officer, Joseph Hutter, MD, MA; and CMS:

The multidisciplinary Heart Team is the foundation of contemporary care for patients with aortic stenosis, and I support CMS' stewardship of that standard and the direction of the proposed national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR). This public comment aims to address one provision: Heart Team criteria in the proposed rule. The current NCD lists the Heart Team as including a cardiac surgeon, an interventional cardiologist, and providers from other physician groups, advanced practice practitioners, nurses, research personnel, and administrators (CMS 2020).(1) The proposed NCD introduces a tiered distinction of mandatory and discretionary roles for the first time in TAVR NCD history, stating that the required tier “must include” an interventional cardiologist and cardiac surgeon, and creating a tier of optional interprofessional roles that “may include” advanced practice clinicians, nurses, research personnel, and administrators (CMS 2026).(2)

Now, consider what happens without coordinated, patient-centered team-based care. A patient with severe aortic stenosis is referred for evaluation. No one is designated to own that referral. It sits unclaimed for weeks. Diagnostic images are not requested, so tests are repeated. No one asks the patient about goals of care or treatment preferences before the Heart Team meets. Pre-procedure labs and medication instructions are missed, so TAVR is rescheduled. After the procedure, no one confirms that prescriptions were filled. The one month follow-up visit is never scheduled. This is not catastrophizing; Heart Teams must routinely avert these failures, which do not require a proceduralist to prevent (Hawkey 2014; Perpetua 2019).(3,4) What connects these failures is not a lack of knowledge or skills, but a lack of specified resources for role clarity and designated ownership. Closing this gap aims to prevent avoidable consequences that patients and the program would otherwise absorb.

Thus, in response to this proposed change, this comment addresses CMS' Evidence Question 3: whether specific treatment conditions are necessary to achieve the health outcomes demonstrated in the reviewed studies (CMS 2026).(2) Building upon this premise, I make 4 requests to specify the interprofessional Heart Team roles necessary for NCD implementation infrastructure as a treatment condition. This aligns with CMS’ specification of Heart Team functions including evaluation for all treatment options (surgical aortic valve replacement, TAVR, close surveillance/medical therapy, and palliative care), facilities requirements such as on-site structural heart interventional cardiology and cardiac surgery programs, and a continuous quality improvement process that assesses procedural outcomes and makes necessary programmatic adjustments to assure patient safety.(2) Each request specifies who performs the functions the proposed NCD requires, and who is essential for TAVR programs to operationalize the flexibility CMS introduces to support patient access and outcomes. I provide these 4 requests with supporting rationale and evidence for inclusion into the Final NCD.

REQUESTS
Request 1: Add a valve coordinator as a required criterion of the Heart Team / program facilities requirement, consistent with the ventricular assist device NCD (20.9.1) and renal denervation NCD (CAG-00470N), multi-professional society guidance (Otto 2017; Bavaria 2018; Nishimura 2019; Otto 2021), and presented evidence.(5-10)

Request 2: Restore the advanced practice clinician (nurse practitioner, clinical nurse specialist, or physician associate) as a required criterion of the Heart Team / program facilities requirement, consistent with the current TAVR NCD (20.32), multi-professional society guidance (Bavaria 2018; Nishimura 2019), and presented evidence.(1,8,9)

Request 3: Restore nurses as a required criterion of the Heart Team / program facilities requirement, consistent with the current TAVR NCD (20.32) and presented evidence.(1)

Crosswalk:

Current NCD: MUST INCLUDE cardiac surgeon and interventional cardiologist; providers from other physician groups, advanced practice practitioners, nurses…
Proposed NCD: MUST INCLUDE cardiac surgeon and interventional cardiologist; MAY INCLUDE other physicians, advanced practice clinicians, nurses…
Requested for the Final NCD: MUST INCLUDE cardiac surgeon and interventional cardiologist; MUST INCLUDE a coordinator (new, clarifying language), advanced practice clinicians, and nurses (restored language used in the current TAVR NCD)

4. Convene a CMS meeting that includes valve coordinators and advanced practice clinicians. This workforce possesses deep knowledge and experience most proximal to patients and NCD implementation and should be heard directly before the Final NCD is issued.

RATIONALE

Delayed, Uncoordinated Care Puts Patients at Risk
Harm in patients with severe aortic stenosis accrues in delay before treatment rather than during the treatment itself. Mortality while awaiting valve replacement has been reported at 3.7% at one month and 11.6% at six months (Malaisrie 2014).(11) Delay independently predicts wait-list death and heart failure hospitalization in population-level cohorts (Albassam 2020), with a linked cohort separately reporting cumulative wait-list mortality of 4.3% and heart-failure hospitalization of 14.7% (Elbaz-Greener 2018).(12,13) Contemporary U.S. data locate this delay in the pre-procedural pathway; after adjustment for specialist and imaging encounters, evaluative encounters explained approximately 83% of the excess time to treatment for TAVR as compared to SAVR (Stinis 2026).(14) While the proposed NCD permits Heart Teams to determine the “how” of patient evaluation (asynchronous, one in-person TAVR operator consultation) for all treatment options (surgical aortic valve replacement, TAVR, close surveillance/medical therapy, and palliative care), the number of guideline directed, clinically indicated encounters to coordinate does not change (Heart Team consultation asynchronous and in-person; transthoracic echocardiogram, CT angiography) (Otto 2021).(10) This evaluative process requires complex coordination for patients, families, and Heart Teams (Hawkey 2014).(3) Specifying who clinically operationalizes the Heart Team approach and provides stewardship for patients throughout this process is critical; clear roles, shared goals, effective communication, and measurable processes and outcomes are core principles of effective team-based care (Mitchell 2012).(15) This is not a hypothetical concern: a national registry study of severe aortic stenosis found that "whether and when a multidisciplinary heart team evaluation occurred was sometimes difficult to ascertain due to the lack of an explicit process at many centers or confusion regarding which clinicians comprised the heart team" (Lindman 2023).(16)

Patients themselves rank trust in the team above all other considerations when evaluating treatment (Col 2022), and in making decisions for undergoing TAVR, patients evaluate logistical barriers and facilitators as well as the healthcare system and support alongside symptom burden (Lauck 2016a).(17,18) These patient-stated values of trust and support extend well beyond the TAVR procedure itself; individual risk tolerance for TAVR varies widely, underscoring the need for individualized, longitudinal engagement rather than a single standardized encounter (Heen 2021).(19) The consequence of an uncoordinated pathway is felt directly by patients and families, as the daughter of one TAVR patient described the discharge:
"It was sort of like, 'Yeah, off you go.'"
- Daughter of a TAVR patient, on post-discharge information gaps (Straiton 2026)(20)

Professional Society Guidance on the Required Infrastructure for TAVR Programs: An Interprofessional Heart Team
A defined, interprofessional workforce performs the patient care and clinical coordination that moves a patient through the pathway from referral to follow-up.
Professional society guidance has named valve coordinators and advanced practice clinicians Heart Team members and as an institutional facilities requirement, and this comment asks CMS to specify it through whichever mechanism it judges appropriate. Specification of these roles began with the 2017 American College of Cardiology (ACC) Expert Consensus Decision Pathway for TAVR, which named “valve clinic care coordinators” alongside interventional cardiologists and cardiac surgeons as Heart Team members (Otto 2017).(7) The Heart Team interprofessional infrastructure is also made explicit in the 2018 American Association of Thoracic Surgery (AATS)/ACC/American Society of Echocardiography (ASE)/Society of Coronary Angiography and Intervention (SCAI)/Society of Thoracic Surgeons (STS) TAVR Operational and Institutional Requirements, which also named these members alongside the interventional cardiologist and cardiac surgeon: “nurse practitioner/physician assistant for pre- and peri-procedure care and multidisciplinary team consults, TAVR administrative coordinator/program navigator, institutionally supported data manager for STS/ACC Transcatheter Valve Therapies Registry, and hospital administration representative” (Bavaria 2018).(8)

The 2019 AATS/ACC/ASE/SCAI/STS Expert Consensus Systems of Care Document to Optimize Care for Patients with Valvular Heart Disease echoed these facilities requirements: “a formalized role/position for a dedicated valve coordinator who organizes care across the continuum and system of care” and “nurse practitioner/physician assistant for pre- and periprocedural care and multidisciplinary team consults” (Nishimura 2019).(9) The 2020 ACC/American Heart Association (AHA) Guidelines for the Management of Patients with Valvular Heart Disease also specify “a formalized role/position for a dedicated valve coordinator who organizes care across the continuum and system of care” alongside the physician multidisciplinary team (Otto 2021).(10) Accordingly, the current TAVR NCD specified Heart Team interprofessional roles – “advanced patient practitioners, nurses, research personnel, and administrators” – as a condition of coverage for TAVR (CMS 2020).(1)

Who Performs the Essential Work of Operationalizing the Heart Team: Empirical Evidence
Empirical data confirm who does the work the proposed NCD requires for patient care across the continuum and system of care, initiating and documenting shared decision making, and continuous quality improvement: clinical valve coordinators and advanced practice clinicians. In a national cross-sectional survey of structural heart coordination in the U.S. (N=219 respondents), 82% had a degree in nursing and 96% provided direct patient care and coordination for patients undergoing TAVR; nurse practitioners, clinical nurse specialists, and physician associates comprised 39% of the respondents (Perpetua 2019).(4) Primary responsibilities of greater than 75% of the respondents included screening new patient referrals (94%), ensuring completion of the Heart Team evaluation (93%), communicating patient goals and social needs to the Heart Team (89%), serving as primary contact for outpatients (87%), coordinating tests with local providers (85%), verifying procedural readiness prior to procedure scheduling (86%), interacting with patients during multidisciplinary team visits (85%), serving as primary contact for referring providers (84%), educating patient prior to on-site evaluation (84%), performing frailty evaluation (84%), communicating to patient and family for medication changes (83%), managing all patient referrals (83%), presenting patients to the multidisciplinary team physicians in clinic (82%), performing quality of life/Kansas City Cardiomyopathy Questionnaire evaluation (82%), obtaining patient records and study images (81%), and collecting data for the national registries (75%) (Perpetua 2019).(4)

Thus, since 2020 TAVR programs have had multi-professional society guidance, a national mandate, and a data-driven description of the roles needed for hospitals to justify the resources for this essential, interprofessional Heart Team infrastructure – coordinators, advanced practice clinicians, and nurses. To date, there is no evidence or guideline available, or provided in the CMS evidence review, to support changing this implementation infrastructure from mandatory to discretionary.(2)

What Physicians Say: Empirical Evidence from Contemporary U.S. TAVR Programs
Empirical evidence demonstrates the interprofessional Heart Team is fundamental to contemporary U.S. TAVR programs. The EVolution Of heart vaLVe teams and the patient Experience (EVOLVE) study was a large, multicenter, mixed methods study which characterized the composition, workflow, and care delivery strategies in 26 U.S. TAVR sites: 54% academic, 50% in the South, 35% low-volume, and 15% were newly established TAVR programs after 2020 (Coylewright 2026; Kolte 2026).(21,22) Notably, this study was completed before the TAVR NCD opened and presented as late breaking science at New York Valves on June 25, 2026 (Kolte 2026).(22) From quantitative surveys and qualitative interviews of 111 Heart Team members – interventional cardiologists, cardiac surgeons, valve coordinators, advanced practice clinicians, and administrative leaders – a primary, major theme that emerged from this study was “Heart Teams today have a highly interprofessional structure in which the advanced practice clinicians and valve coordinators are essential members in central roles” (Kolte 2026).(22) Without prompting, physicians explicitly named valve coordinators and advanced practice clinicians as core Heart Team members comprising critical infrastructure.
"The core members of the team are obviously my valve coordinator. I mean, that's pretty much the only way that we're able to do anything and get it done in a timely fashion."
- Interventional cardiologist (EVOLVE study; Kolte 2026)
"The nurse practitioners are actually absolute key, I think, more than really any of us, because all of us are interchangeable, but the advanced practice clinician and the people she works with are really central. It really is driven by them."
- Cardiothoracic surgeon (EVOLVE study; Kolte 2026)

Outcomes Improve When These Requested Roles are Defined
When these interprofessional roles are defined and deployed, the outcomes that CMS prioritizes improve. The Vancouver 3M study is the primary, prospective multicenter study to demonstrate that a structured pre-procedural selection-and-management pathway is safe and reproducible across low-, medium-, and high-volume centers (Wood 2019).(23) This pathway positioned a nurse coordinator and clinic as central to the Heart Team across referral, case selection, and the full peri-procedural pathway; a clinical nurse specialist, nurse practitioner, and nursing and allied health across the care continuum were also specified (Lauck 2016b Circ Quality).(24) The impact of the clinical valve coordinator role was evaluated in the BENCHMARK registry, which isolated the coordinator as a variable through propensity matching across 2,323 patients in 7 countries and found significantly shorter total and critical-care length of stay, and reduced pacemaker rates and vascular complications, without a safety penalty (Lauck 2026; Frank 2024).(25, 26) Two randomized controlled trials of nurse-led care showed reduced readmissions: a nurse-led transitional care program significantly lowered rehospitalization (Akbaba 2025), and an intensified transcatheter valve nurse-involved follow-up strategy significantly reduced cardiovascular-specific rehospitalizations, though not all-cause 90-day readmission (Bække 2025).(27, 28) This role also matters to patients: a patient-experience study of 100 TAVR patients found that 96% would recommend the procedure and 93% agreed the TAVI nurse's support across the pathway was important for their tranquility, information, and problem-solving (González-Cebrián 2025).(29)

In the AHA Target: Aortic Stenosis implementation science initiative, structured multidisciplinary evaluation rose from 78% to 84% between 2023 and 2024 (p=0.008) (Lindman 2026).(30) A learning collaborative of Target: AS sites share implementation best practices (model shares), which are largely represented by a coordinator- and advanced practice clinician-led interprofessional structure (AHA Target: Aortic Stenosis Model Shares, 2024-2026).(31) These roles lead continuous quality improvement efforts to improve vascular complications (Theriot 2025a), hospital readmission (Theriot 2025b), and utilization and documentation of guideline-directed cardiac rehabilitation referral (Wilder 2025).(32-34) Further, coordinators and advanced practice clinicians are well positioned to help close the shared decision-making gap CMS itself names (Perpetua 2024), functioning as an important part of team-based shared decision making workflow that reduces decisional conflict (Coylewright 2024).(35,36)

Consistency with CMS Policies
Specifying these roles would align the Final NCD with CMS’ own precedents rather than depart from them or create new burdens. CMS already names a program coordinator in the ventricular assist device NCD (20.9.1) and a hypertension navigator in the renal denervation NCD (CAG-00470N).(5,6) Both the current TAVR NCD (20.32) and the mitral TEER NCD (20.33) also expressly name advanced practice clinicians and nurses among the Heart Team.(1,37) In current billing policies, CMS also already classifies care coordination as clinical work requiring minimum licensure as a registered nurse, who may bill incident-to advanced practice clinicians or physicians (Medicare Learning Network 2025).(38)

A practical reality bears on why the distinction matters: hospitals allocate resources in alignment with national policy on conditions of coverage per the TAVR NCD, which bears on healthcare system sustainability. Nurses and physicians in Magnet-recognized hospitals identify staffing as the single most modifiable variable in studies of burnout drivers (Aiken 2023).(39) Roles that become discretionary are difficult to sustain against competing budget priorities, not through any lack of institutional commitment. With a focus on sustainability, the European Association of Percutaneous Cardiac Interventions and the Association of Cardiovascular Nursing and Allied Health Professions of the European Society of Cardiology issued a Clinical Consensus Statement on the Role of the Clinical Valve Coordinator, which provides a roadmap for the development, implementation, and evaluation of a pan-European initiative to improve care delivery for valvular heart disease and the experiences of patients and families (Lauck 2026).(40)

Relevance to the Medicare Population
This population of Medicare beneficiaries is one for whom coordination matters greatly. TAVR is furnished predominantly to older adults often with multiple chronic conditions, who require multiple evaluative encounters, are most exposed to the time-dependent risks of delayed care and depend most on longitudinal navigation across the continuum (Stinis 2026; Lindman 2023).(14,16) The coordinator and advanced practice clinician sit at the entry to that pathway, at referral, detection, and evaluation, where severe aortic stenosis remains underdiagnosed and undertreated (Lindman 2023).(16) Physicians provide the complex evaluation and medical decision making, procedural judgment, and intervention; the coordinator and advanced practice clinician are central to operationalizing and optimizing the Heart Team's capacity to deliver that care reliably and on time (Brush 2015; Rodgers 2020; Batchelor 2023).(41-43) Naming the coordinator and advanced practice clinician Heart Team roles as mandatory infrastructure in the Final NCD is consistent and aligned with evidence, guidelines, and CMS’ current policies, and provides the safeguard required to support the patient access, equity, and flexibility CMS aims to ensure. Heart Teams remain empowered to self-regulate how to best deploy these roles.

I have cared for patients and families living with severe aortic stenosis and undergoing TAVR since 2007, and have programmatically implemented the TAVR NCD since May 2012. In 2018, as a member of the public, I provided testimony during the Medicare Evidence Development and Coverage Advisory Committee Panel for this same NCD (CMS 2018).(44) I was Principal Investigator of the first national study of the structural heart disease coordinator role (Perpetua 2019), which received no external funding, and I am Co-Principal Investigator of the EVOLVE study (Coylewright 2026; Kolte 2026), supported by an investigator-initiated research grant from Edwards Lifesciences with no funder role in study design, data collection, analysis, interpretation, or publication of findings. This clinical, programmatic, and research experience is the basis for the requests and evidence presented in this comment. Innovation in technology must be matched with innovation in care delivery: processes alone do not transform care – people do, one patient at a time.

To continue supporting Medicare beneficiaries as this therapy evolves, I greatly appreciate your consideration of the 4 requests above, and your corresponding review of the multi-professional society guidance, CMS policies, and the evidence presented in this comment. A list of references follows. An evidence table that accompanies the literature in this review, along with relevant financial disclosures, are available upon request.

Sincerely,
Elizabeth M. Perpetua, DNP, ACNP-BC, ARNP, FACC

References

1. Centers for Medicare and Medicaid Services. National Coverage Determination for Transcatheter Aortic Valve Replacement 20.32. 2019. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=293. Accessed June 15, 2026.
2. Centers for Medicare and Medicaid Services. Proposed Decision Memo for Transcatheter Aortic Valve Replacement CAG-00430R2. 2026. Available: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=321. Accessed June 15, 2026.
3. Hawkey MC, Lauck SB, Perpetua EM, et al. Transcatheter aortic valve replacement program development: Recommendations for best practice. Catheterization and Cardiovascular Interventions. 2014;84(6):859-867. doi:10.1002/ccd.25529
4. Perpetua EM, Clarke SE, Guibone KA, Keegan PA, Speight MK. Surveying the Landscape of Structural Heart Disease Coordination: An Exploratory Study of the Coordinator Role. Structural Heart. 2019/05/04 2019;3(3):201-210. doi:10.1080/24748706.2019.1581962
5. Centers for Medicare and Medicaid Services. Ventricular Assist Device National Coverage Determination 20.9.1. 2020. Available: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=360. Accessed June 15, 2026.
6. Centers for Medicare and Medicaid Services. Renal Denervation National Coverage Determination CAG-00470N. 2026. Available: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=318. Accessed June 15, 2026.
7. Otto CM, Kumbhani DJ, Alexander KP, et al. 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults with Aortic Stenosis. A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. 2017;doi:10.1016/j.jacc.2016.12.006
8. Bavaria JE, Tommaso CL, Brindis RG, 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, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. 2018;doi:10.1016/j.jacc.2018.07.002
9. Nishimura RA, O’Gara PT, Bavaria JE, et al. 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 Society of Thoracic Surgeons. 2019;73(20):2609-2635. doi:10.1016/j.jacc.2018.10.007
10. Otto CM, Nishimura RA, Bonow RO, 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. Feb 2 2021;77(4):e25-e197. doi:10.1016/j.jacc.2020.11.018
11. Malaisrie SC, McDonald E, Kruse J, et al. Mortality while waiting for aortic valve replacement. Ann Thorac Surg. Nov 2014;98(5):1564-70; discussion 1570-1. doi:10.1016/j.athoracsur.2014.06.040
12. Albassam O, Henning KA, Qiu F, et al. Increasing Wait-Time Mortality for Severe Aortic Stenosis: A Population-Level Study of the Transition in Practice From Surgical Aortic Valve Replacement to Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. Nov 2020;13(11):e009297. doi:10.1161/circinterventions.120.009297
13. Elbaz-Greener G, Masih S, Fang J, et al. Temporal Trends and Clinical Consequences of Wait Times for Transcatheter Aortic Valve Replacement. Circulation. 2018;138(5):483-493. doi:doi:10.1161/CIRCULATIONAHA.117.033432
14. Stinis C, Tunis S, Lauck S, et al. Impact of pre-procedural requirements on time to aortic valve replacement: Transcatheter AVR vs surgical AVR. Am Heart J Plus. Jan 2026;61:100698. doi:10.1016/j.ahjo.2025.100698
15. Mitchell P, Wynia, R., Golden, B., McNellis, S., Okun, C. E. for the Institute of Medicine, et al. Core principles and values of effective team-based health care. 2012. Available: https://nam.edu/wp-content/uploads/2015/06/VSRT-Team-Based-Care-Principles-Values.pdf. Accessed June 15, 2026.
16. Lindman BR, Fonarow GC, Myers G, et al. Target Aortic Stenosis: A National Initiative to Improve Quality of Care and Outcomes for Patients With Aortic Stenosis. Circ Cardiovasc Qual Outcomes. Jun 2023;16(6):e009712. doi:10.1161/circoutcomes.122.009712
17. Col NF, Otero D, Lindman BR, et al. What matters most to patients with severe aortic stenosis when choosing treatment? Framing the conversation for shared decision making. PLoS One. 2022;17(8):e0270209. doi:10.1371/journal.pone.0270209 18. Lauck SB, Baumbusch J, Achtem L, et al. Factors influencing the decision of older adults to be assessed for transcatheter aortic valve implantation: An exploratory study. Eur J Cardiovasc Nurs. Dec 2016;15(7):486-494. doi:10.1177/1474515115612927
19. Heen AF, Lytvyn L, Shapiro M, et al. Patient values and preferences on valve replacement for aortic stenosis: a systematic review. Heart. Aug 2021;107(16):1289-1295. doi:10.1136/heartjnl-2020-318334
20. Straiton N, Gallagher R, Gullick J. A Descriptive Qualitative Study of Patient and Carer Perspectives on the Acceptability of Transcatheter Aortic Valve Implantation. J Adv Nurs. May 2026;82(5):5305-5318. doi:10.1111/jan.70180
21. Coylewright M, Kolte D, Kruse G, Strong S, Elmariah S, Suri R, Perpetua EM. A Multicenter, Mixed Method Study of United States Heart Teams and Health Policy: The EVOLVE Study Design and Protocol. Journal of the Society of Coronary Angiography and Interventions. 2026; in press.
22. Kolte D, Perpetua E, Kruse G, et al. EVolution Of heart vaLVe teams and the patient Experience (EVOLVE): A Multicenter, Mixed Methods Study of TAVR Programs Across the U.S. June 25, 2026. Invited late breaking science abstract for New York Valves. New York, NY.
23. Wood DA, Lauck SB, Cairns JA, et al. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers. The 3M TAVR Study. 2019;12(5):459-469. doi:10.1016/j.jcin.2018.12.020
24. Lauck SB, Wood DA, Baumbusch J, et al. Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway: Minimalist Approach, Standardized Care, and Discharge Criteria to Reduce Length of Stay. Circ Cardiovasc Qual Outcomes. May 2016;9(3):312-21. doi:10.1161/circoutcomes.115.002541
25. Lauck SB, Saia F, Durand E, et al. Impact of a Clinical Valve Coordinator on Hospital Length of Stay and Patient Outcomes: Results From the BENCHMARK Registry. Struct Heart. Jan 2026;10(1):100740. doi:10.1016/j.shj.2025.100740
26. Frank D, Durand E, Lauck S, et al. A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study. Eur Heart J. Jun 1 2024;45(21):1904-1916. doi:10.1093/eurheartj/ehae147
27. Akbaba A, Mert H. Effects of nurse-led transitional care program on patient outcomes following transcatheter aortic valve implantation: a randomized controlled trial. Geriatr Nurs. Nov-Dec 2025;66(Pt B):103620. doi:10.1016/j.gerinurse.2025.103620
28. Bække PS, Jørgensen TH, Bieliauskas G, Sondergaard L, De Backer O. Impact of Intensified Outpatient Follow-Up on Rehospitalization After Transcatheter Aortic Valve Implantation: Results From the HOSPITAVI Trial. Am J Cardiol. Jun 15 2025;245:17-24. doi:10.1016/j.amjcard.2025.01.031
29. González-Cebrián M, García JLM, Cruz-González I, et al. Patient reported experience measures in TAVI procedures: VALVEX study. J Geriatr Cardiol. Jul 28 2025;22(7):638-647. doi:10.26599/1671-5411.2025.07.009
30. Lindman BR, Gillam LD, Perpetua EM, et al. Advancing Quality in the Evaluation, Surveillance, and Management of Aortic Stenosis: A Report From the AHA Target: AS Registry. Circulation. Jun 26 2026;doi:10.1161/circulationaha.126.081405
31. American Heart Association Target: Aortic Stenosis Model Shares. 2026. Available: https://www.heart.org/en/professional/quality-improvement/target-aortic-stenosis/tas-model-shares. Accessed June 30, 2026.
32. Theriot ML, Bergen EC, Lugo JG, Graham WM. Reducing TAVR Vascular Complications Through Multidisciplinary Process Optimization. JACC Case Rep. Nov 12 2025;30(36):105614. doi:10.1016/j.jaccas.2025.105614
33. Theriot ML, Bergen EC, Lugo JG, Fuselier JE. Reducing Readmissions After Transcatheter Aortic Valve Replacement Through Enhanced Transitional Care. JACC Case Rep. Nov 12 2025;30(36):105711. doi:10.1016/j.jaccas.2025.105711
34. Wilder EH, Dellise NR, Dhaliwal G, et al. Transcatheter Heart Valve Postprocedural Care : Improving the Cardiac Rehabilitation Referral Process Before Discharge. JACC Case Reports. 2025;30(36)doi:https://doi.org/10.1016/j.jaccas.2025.105898
35. Perpetua EM, Palmer R, Le VT, et al. JACC: Advances Expert Panel Perspective: Shared Decision-Making in Multidisciplinary Team-Based Cardiovascular Care. JACC Adv. Jul 2024;3(7):100981. doi:10.1016/j.jacadv.2024.100981
36. Coylewright M, Otero D, Lindman BR, et al. An interactive, online decision aid assessing patient goals and preferences for treatment of aortic stenosis to support physician-led shared decision-making: Early feasibility pilot study. PLoS One. 2024;19(5):e0302378. doi:10.1371/journal.pone.0302378
37. Centers for Medicare Services. National Coverage Determination for Mitral Transcatheter Edge to Edge Repair. 2021. Available: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=363. Accessed June 15, 2026.
38. Centers for Medicare and Medicaid Services. Chronic Care Management Services Medicare Learning Network MNL090188. 2025. Available: https://www.cms.gov/files/document/chroniccaremanagement.pdf. Accessed June 30, 2026.
39. Aiken LH, Lasater KB, Sloane DM, et al. Physician and Nurse Well-Being and Preferred Interventions to Address Burnout in Hospital Practice: Factors Associated With Turnover, Outcomes, and Patient Safety. JAMA Health Forum. Jul 7 2023;4(7):e231809. doi:10.1001/jamahealthforum.2023.1809
40. Lauck SB, Kirk BH, McCalmont G, et al. The role of Clinical Valve Coordinators: a clinical consensus statement of the European Association of Percutaneous Cardiac Interventions and the Association of Cardiovascular Nursing & Allied Professions of the ESC, European Heart Journal - Valvular and Structural Heart Disease, 2(1), January 2026, xwag008, https://doi.org/10.1093/ehjvshd/xwag008
41. Brush JE, Handberg EM, Biga C, et al. 2015 ACC Health Policy Statement on Cardiovascular Team-Based Care and the Role of Advanced Practice Providers. Journal of the American College of Cardiology. 2015;65(19):2118-2136. doi:10.1016/j.jacc.2015.03.550
42. Rodgers GP, Linderbaum JA, Pearson DD, et al. 2020 ACC Clinical Competencies for Nurse Practitioners and Physician Assistants in Adult Cardiovascular Medicine: A Report of the ACC Competency Management Committee. J Am Coll Cardiol. May 19 2020;75(19):2483-2517. doi:10.1016/j.jacc.2020.01.005
43. Batchelor Wayne B, Anwaruddin S, Wang Dee D, et al. The Multidisciplinary Heart Team in Cardiovascular Medicine. JACC: Advances. 2023/01/01 2023;2(1):100160. doi:10.1016/j.jacadv.2022.100160
44. Centers for Medicare and Medicaid Services. Medicare Evidence Development and Coverage Advisory Committee Meeting for TAVR. July 25, 2018. Transcript. Available: https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/downloads/id75c.pdf Accessed June 30, 2026.

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Dear Administrator Oz,

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 National Coverage Decision (NCD) proposed decision memo for Transcatheter Aortic Valve Replacement (TAVR).

We commend CMS for proposing significant updates that reflect the maturity of TAVR’s evidence base and the evolution of real-world clinical practice. We strongly support many elements of the proposal, including:

• Providing national coverage for symptomatic severe aortic stenosis (AS) without Coverage with Evidence Development (CED);
• Eliminating facility volume requirements;
• Clarifying operator volume requirements;
• Streamlining patient evaluation requirements;
• Providing greater flexibility regarding Heart Team participation during TAVR procedures.

These changes represent important steps toward reducing barriers to care and improving access for Medicare beneficiaries with AS, a progressive and life-threatening condition.

We are particularly encouraged by CMS's proposal to sunset CED for symptomatic severe AS. The evidence supporting TAVR has matured substantially over the past decade, and the procedure is firmly established as a standard-of-care treatment. [1] As TAVR has become widely and safely adopted across diverse patient populations, continued CED no longer reflects the realities of contemporary practice. Eliminating CED appropriately aligns Medicare policy with current clinical evidence and will reduce administrative burdens that can delay care and limit patient access.

We also strongly support the removal of facility volume requirements. Expanding the number of hospitals able to offer TAVR can help improve geographic access to care, particularly for patients in rural, underserved, and socioeconomically disadvantaged communities. Evidence shows that patients living in low-population-density areas face disproportionate barriers to accessing TAVR, and that increasing the number of hospitals offering the procedure significantly reduces geographic access inequality. [2] Access to life-saving therapies should not be determined by a patient's proximity to a high-volume center when quality care can be delivered closer to home.

We also appreciate CMS’s proposal to reduce operator volume requirements, which meaningfully modernizes the NCD and supports broader patient access to TAVR while maintaining a strong emphasis on quality and outcomes. By moving from legacy surgical metrics to standards based on recent transcatheter valve experience, CMS focuses operator expectations on the skills most associated with safe, high quality TAVR performance. This update also removes structural barriers that have disproportionately affected emerging and underserved programs, helping ensure that capable operators can meet standards through active engagement in transcatheter valve care rather than historical surgical caseloads.

We further support CMS’s proposal to modernize the patient evaluation process by allowing greater flexibility in how patients are assessed for TAVR. Under the proposed NCD, the longstanding requirement that both a cardiac surgeon and an interventional cardiologist conduct separate in-person evaluations would be replaced with a more streamlined approach: a single in-person evaluation by either specialist, supplemented by remote review of medical records for the second assessment. This update reflects contemporary clinical practice, reduces unnecessary burdens on patients, particularly those with mobility limitations or who live far from specialty centers, and preserves the rigor of multidisciplinary decision-making. Recent analyses also show that mandated specialist visits and imaging requirements are major contributors to treatment delays, independent of patient risk. [3] By enabling initial screening to occur remotely while still ensuring an in-person evaluation by a qualified specialist, CMS appropriately balances patient access, safety and efficiency.

While we appreciate CMS's efforts to modernize the NCD, we remain concerned that the proposed policy continues to require CED for patients with asymptomatic severe AS. We are encouraged that CMS recognizes this patient population within the NCD; however, requiring participation in a CMS-approved study may continue to create barriers to timely treatment.

Emerging evidence suggests that earlier intervention in appropriately selected patients with asymptomatic severe AS may prevent irreversible cardiac damage, reduce downstream morbidity, and improve long-term outcomes.[4] Coverage policies that rely on symptom onset alone risk delaying care until disease progression has already occurred. As additional evidence becomes available, we encourage CMS to establish a pathway toward broader national coverage for asymptomatic severe AS and ensure that patients do not experience unnecessary delays in receiving evidence-based treatment.

Thank you for the opportunity to provide these comments. We appreciate CMS's commitment to modernizing coverage policy and look forward to continued collaboration to improve outcomes for patients with aortic stenosis.

Sincerely,
The Heart Valve Disease Policy Task Force

Alliance for Aging Research
Alliance for Patient Access
American Society of Echocardiography
Conquering CHD
Heart Valve Voice US
Hypertrophic Cardiomyopathy Association
The Mended Hearts, Inc.
National Hispanic Health Foundation
Partnership to Advance Cardiovascular Health
Preventive Cardiovascular Nurses Association
RetireSafe

[1] Carroll, J. D., Mack, M. J., Vemulapalli, S., Herrmann, H. C., Gleason, T. G., Hanzel, G., … Bavaria, J. E. (2020). STS-ACC TVT Registry of transcatheter aortic valve replacement. Journal of the American College of Cardiology, 76(21), 2492–2516. https://doi.org/10.1016/j.jacc.2020.09.595

[2] Bergman, A., David, G., Nathan, A., Giri, J., Ryan, M., Chikermane, S., Thompson, C., Clancy, S., & Gunnarsson, C. (2024). Measuring hospital inpatient Procedure Access Inequality in the United States. Health Affairs Scholar, 2(11). https://doi.org/10.1093/haschl/qxae142

[3] Stinis, C., Tunis, S., Lauck, S., Gupta, A., Murphy, S., Chikermane, S., Clancy, S., & Russo, M. (2025). Impact of pre-procedural requirements on time to aortic valve replacement: Transcatheter AVR vs surgical AVR. American Heart Journal Plus: Cardiology Research and Practice, 61, 100698. https://doi.org/10.1016/j.ahjo.2025.100698

[4] Philippe Généreux, Schwartz, A., J. Bradley Oldemeyer, Philippe Pibarot, Cohen, D. J., Blanke, P., Lindman, B. R., Vasilis Babaliaros, Fearon, W. F., Daniels, D. V., Chhatriwalla, A. K., Kavinsky, C., Gada, H., Shah, P., Szerlip, M., Dahle, T., Goel, K., O’Neill, W., Sheth, T., & Davidson, C. J. (2024). Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2405880

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Thank you for the opportunity to submit comments on the proposed NCD changes. Our program believes that the reason our patients have good outcomes and that our program can perform hundreds of successful TAVRs on complex patients, is due to the heart team collaboration between the cardiac surgeon and cardiologist. This is critical.

The heart team makes all of us better and results in good patient care. I have performed over 6,000 TAVRs as an interventional cardiologist but I still believe my surgical partner makes our practice better. Having both of us involved allows us to treat more complex patients with good outcomes. It would be a step in the wrong direction if CMS no longer covers and reimburses both operators as equals. Additionally, the heart team should continue to involve a surgeon and a cardiologist seeing the patient before the procedure for planning and discussion of the best treatment options. As the Program Director for Interventional and Structural Fellows, I believe that volume requirements and training matters and these elements are paramount for patient safety with this procedure.

I am surprised that CMS wishes to reduce the volume requirements for TAVR programs - as a plethora of data has suggested, volume drives superior outcomes and higher volume equates to better quality. It is concerning to think that an operator with minimal TAVR experience could potentially be performing TAVR on patients independently. This coupled with the recommendation to stop registry reporting seems to be a concerning combination for patients who trust us with making the best treatment decisions based on real world data. While this treatment has become much more mainstream, there is still a significant amount to be learned and changed from the real-world data provided by the registry. Without this requirement, not only will patients not know which centers are high performing, the centers themselves will not know. This is a step backwards. We’ve come too far with developing both the science and our clinical practice for TAVR for CMS to let patients down like this.

Finally, I do not think it is a good idea to move too quickly to provide asymptomatic aortic stenosis patients with TAVR. This is especially true in the US where if a patient develops symptoms they can quickly and readily obtain access to a TAVR. The potential of complications and the continued learning that we are all doing about the durability of TAVR devices make waiting for symptoms seem more beneficial for patients.

Respectfully Submitted,
Tanvir Bajwa, MD on behalf of the St Luke's Heart Team
Medical Director of Structural Heart Program
Director of Interventional and Structural Heart Fellowship Program
Aurora St Luke's Medical Center
Milwaukee, WI

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I support the STS-recommended changes to the TAVR NCD and CED, which provide an evidence-based approach to expanding access while preserving patient safety.

The STS opposes eliminating the requirement for cardiac surgeon involvement during TAVR, emphasizing that rare but catastrophic complications may require immediate surgical intervention. Maintaining a cardiac surgeon as an active co-operator ensures timely decision-making and patient protection.

The STS also recommends preserving CED requirements and continued participation in national registries, such as the STS/ACC TVT Registry, to support quality oversight, transparency, and ongoing evaluation of outcomes and device durability.

Additionally, the STS strongly supports preservation of the multidisciplinary Heart Team model, ensuring patients receive balanced, individualized recommendations based on both surgical and interventional expertise.

Finally, the STS urges caution with expanding TAVR indications to asymptomatic patients, advocating that any broader use be supported by strong evidence and careful Heart Team evaluation.

In summary, the STS recommends that CMS maintain surgeon participation, robust data collection, and Heart Team decision-making to ensure that expanded access to TAVR does not come at the expense of patient safety.

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To Centers for Medicare & Medicaid Services (CMS)

To Whom It May Concern,

Thank you for the opportunity to comment on the proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR).

I am an interventional cardiologist specializing in structural heart disease and have been involved in TAVR clinical care, research, and physician education throughout the evolution of this field. I welcome the proposed modernization of the National Coverage Determination because I believe it appropriately reflects how both the evidence and clinical practice have evolved over the past decade while preserving Coverage with Evidence Development (CED) as a focused mechanism for addressing important unanswered clinical questions.

When the original CED policy was established, there were legitimate uncertainties regarding the safety, durability, and broader applicability of TAVR. Requiring prospective data collection through a national registry was an appropriate response that allowed evidence to accumulate alongside expanding clinical use.

That approach has been highly successful. Over the past decade, randomized clinical trials, registry analyses, and longer-term follow-up have answered many of the questions that originally justified Coverage with Evidence Development. The TVT Registry has been central to this progress and has also become an invaluable resource for ongoing quality improvement. These are distinct accomplishments. Coverage with Evidence Development is intended to resolve important evidentiary uncertainty regarding Medicare coverage, whereas quality programs exist to measure outcomes, benchmark performance, and support continuous improvement. Both are essential, but they serve different purposes. As the evidence matures, Medicare coverage policy should evolve accordingly, while ongoing quality improvement continues through complementary processes designed for that purpose.

The proposed updates to the Heart Team requirements appropriately recognize how contemporary structural heart programs function. Multidisciplinary evaluation remains one of the defining strengths of structural heart care and should continue to guide treatment decisions. At the same time, the Heart Team is best understood as a collaborative clinical process rather than a rigid set of required encounters. Allowing experienced programs flexibility in how that collaboration occurs reflects contemporary practice without diminishing the central role of multidisciplinary decision-making.

Similarly, allowing the Heart Team to determine when participation by more than one procedural operator is appropriate recognizes the realities of modern TAVR practice. Contemporary TAVR depends on multidisciplinary expertise before, during, and after the procedure. Whether one or two attending physicians are scrubbed for a particular case should be determined by the needs of the individual patient and the judgment of the treating Heart Team rather than by a universal procedural requirement.

One important aspect of the proposed NCD deserves consideration. The proposed coverage language is now explicitly tied to severe aortic stenosis rather than to FDA-approved indications for TAVR. While this accurately reflects current indications, the evidence base and FDA labeling will continue to evolve. I encourage CMS to consider whether structuring the final NCD around FDA-approved indications would provide a more durable framework, preserving alignment between FDA approval and Medicare coverage while reducing the need for repeated NCD reconsideration as indications expand.

In summary, I believe the proposed National Coverage Determination appropriately reflects the current state of evidence supporting TAVR while modernizing several aspects of the original policy that were developed during the early adoption of the technology. In particular, I encourage CMS to preserve the distinction between evidence generation and quality improvement, maintain flexibility in implementation of the Heart Team model, and consider structuring the final NCD around FDA-approved indications so that coverage can evolve efficiently as new evidence emerges.

Thank you for considering these comments.

Respectfully,
Toby Rogers, MD, PhD

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I support the proposed revisions to the operator requirements for TAVR procedures. While there are many cases in which the involvement of two operators is appropriate and beneficial, there are also procedures where, based on the patient’s clinical profile, procedural complexity, and the operator’s experience and skill set, a single clinician can safely perform the procedure.

Allowing programs the flexibility to determine the appropriate operator staffing for each case acknowledges the diversity of patient needs and institutional expertise while maintaining the heart team approach with high standards of patient care. This approach enables sites to tailor care to the individual patient without imposing unnecessary procedural requirements.

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I would like to voice my support of the STS recommended changes to the TAVR NCD and CED as are summarized below. These recommendations represent a thoughtful evidence based response to the desire to expand access without sacrificing patient safety.

1. Opposition to Single-Operator Procedures

The STS strongly opposes CMS's proposal to remove the requirement for a cardiac surgeon to be present during TAVR procedures.

Safety Concerns: The STS argues that while TAVR is safe, it still carries the risk of catastrophic, life-threatening complications (such as annular rupture, coronary obstruction, valve embolization, or cardiac/vascular perforation).

Need for Immediate Surgical Intervention: Because these rare but severe events require immediate open-heart surgical intervention and decision-making, the STS maintains that a cardiac surgeon must remain an active co-operator alongside an interventional cardiologist to ensure patient safety.

2. Objection to Rolling Back CED Requirements

While CMS proposed ending the Coverage with Evidence Development (CED) mandate for symptomatic patients, the STS expressed disappointment with this rollback.

Preserving Quality and Oversight: The STS argues that ongoing engagement with national registries (like the STS/ACC TVT Registry) has been the cornerstone of quality, transparency, and the overall success of TAVR in the United States.

Continued Evidence Generation: They suggest that abandoning these requirements could disrupt safety and optimal case adoption, advocating for continued robust data collection to monitor long-term outcomes and device durability.

3. Protecting the Multidisciplinary Heart Team

The STS emphasizes that the multidisciplinary Heart Team model—which ensures patients are evaluated from both an interventional and a surgical perspective—must be fully preserved. They argue against policies that might weaken the collaborative shared decision-making process between cardiac surgeons and cardiologists, ensuring that patients receive unbiased recommendations tailored to their specific anatomical and clinical needs (whether that is TAVR or traditional open-heart surgery).

4. Caution Regarding Asymptomatic Patients

While CMS proposed expanding coverage to asymptomatic patients under CED, the STS (and aligned surgical voices) urged caution. They emphasized that any expansion of indications should be strictly tied to careful evaluation by a full Heart Team and require strong, independent scientific evidence. They warned against policies that might encourage early, lifelong device implantation in asymptomatic patients without a clear survival or disability benefit.

In summary, the STS is urging CMS to walk back the "loosened operator language" to keep cardiac surgeons in the procedure room, maintain strong registry reporting mandates for quality control, and ensure that the NCD does not compromise patient safety in the pursuit of expanded access.

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I am an Echocardiographer and Imaging cardiologist with 22 years of independent practice experience.

I would wholeheartedly support the CMS proposed rule of removing the requirement of joint participation of both the interventional cardiologist and cardiac surgeon in intraoperative technical aspects of TAVR. I would agree that this practice-pattern change reflecting the reality that most TAVR is now performed by a single interventional cardiologist operator at many high-volume centers including ours.

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I appreciate the opportunity to comment on the proposed revisions to the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR).

I strongly support maintaining the requirement that TAVR be performed at centers with on-site cardiac surgery and by a true multidisciplinary Heart Team consisting of both interventional cardiologists and cardiac surgeons. The Heart Team model has been a major contributor to the outstanding outcomes achieved with TAVR in the United States. It ensures comprehensive patient evaluation, balanced decision-making, appropriate selection between surgical and transcatheter therapies, and the ability to manage rare but potentially catastrophic procedural complications without delay.

The revised NCD should more clearly define the role of the cardiac surgeon throughout the patient's care, including pre-procedural evaluation, shared treatment planning, procedural participation when appropriate, and longitudinal management. This is not simply a matter of professional representation but of ensuring that every patient receives the most appropriate valve intervention based on anatomy, operative risk, expected valve durability, future coronary access, lifetime management strategy, and the potential need for future reinterventions.

I am particularly concerned by the proposal to eliminate Coverage with Evidence Development (CED). CED has been one of the greatest strengths of the U.S. TAVR program. Through the STS/ACC TVT Registry, it has generated an unparalleled body of real-world evidence that has improved patient selection, enhanced quality, identified procedural complications, refined best practices, and informed national and international guidelines. The registry has become a model for evaluating new cardiovascular technologies.

While TAVR has matured into an established therapy for many patients with severe symptomatic aortic stenosis, important evidence gaps remain. These include younger and low-surgical-risk patients, bicuspid aortic valve disease, pure native aortic regurgitation, moderate aortic stenosis, valve-in-valve and bioprosthetic valve interventions, and long-term valve durability. As indications continue to expand into populations with decades of anticipated survival, continued prospective data collection becomes increasingly—not less—important. Eliminating CED at this stage risks slowing the generation of high-quality evidence precisely when long-term clinical outcomes, structural valve durability, repeat intervention strategies, and lifetime management questions remain unanswered.

Rather than eliminating CED, CMS should consider maintaining a streamlined evidence-development framework that preserves comprehensive participation in the STS/ACC TVT Registry while minimizing unnecessary administrative burden. Continued national data collection will ensure that coverage decisions evolve in parallel with high-quality scientific evidence and will ultimately benefit patients, physicians, and the healthcare system.

The United States has become the international leader in TAVR not only because of technical innovation but also because of its commitment to multidisciplinary care and rigorous evidence generation. The revised NCD should preserve these foundational principles by clearly defining the role of the Heart Team, ensuring meaningful participation of cardiac surgeons, and continuing the systematic collection of outcomes data that has made the TVT Registry one of the world's most valuable cardiovascular quality initiatives.

Thank you for the opportunity to provide these comments.

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I appreciate CMS’s willingness to expand coverage for asymptomatic severe aortic stenosis under Coverage with Evidence Development. This is a reasonable and patient-centered step, and I support CMS’s recognition that earlier intervention may benefit select patients with preserved LVEF and low procedural risk. The memo correctly identifies the need to answer critical evidence questions about surveillance vs early intervention, especially in younger and lower-risk patients.

However, I must express strong opposition to the proposed weakening of structural safeguards around TAVR — specifically, the reduction of required surgeon involvement and the removal of mandatory registry participation. These changes are not only premature; they are dangerous.

1. Long-term data increasingly favor surgery in lower-risk patients — this is not the time to weaken oversight
CMS’s own evidence review acknowledges that while early outcomes may favor TAVR, **long-term mortality differences “attenuate and become non-significant,” potentially reflecting later mortality in the TAVR group**. This late catch-up is driven by well-documented issues:

- Higher permanent pacemaker rates
- Higher moderate-to-severe paravalvular leak
- Structural valve deterioration over time

These concerns matter most in younger, lower-risk, and asymptomatic patients — precisely the population CMS is newly expanding coverage to.

If anything, **surgeon involvement should increase**, not decrease, as TAVR moves into populations with longer life expectancy and more complex lifetime valve management considerations.

2. Surgeons are the built-in safeguard against inappropriate TAVR — weakening their role directly harms patients
The proposed memo requires that the heart team include a cardiac surgeon, yet simultaneously states that **joint participation of two TAVR operators is not required**. This effectively removes surgeons from the procedure.

This is a profound mistake.

Surgeons are not simply technical backup. They are the **primary safeguard** ensuring that TAVR is used appropriately, safely, and ethically. Surgeons routinely:

- Identify patients who are being steered toward TAVR despite better long-term outcomes with SAVR
- Prevent inappropriate TAVR in patients with anatomy unsuitable for transcatheter therapy
- Advocate for lifetime valve management strategies that interventionalists may undervalue
- Provide immediate conversion capability during catastrophic complications
- Ensure that younger patients are not funneled into a therapy with known durability limitations

When CMS diminishes the surgeon’s intraoperative role, it **weakens their voice** in advocating for patients. It shifts the balance of decision-making toward procedural volume incentives rather than lifetime outcomes. It undermines the heart-team model that CMS itself claims to uphold.

Surgeons are the built-in watchdogs of the TAVR program. Removing them from the procedure removes the watchdog — and patients will pay the price.

3. Eliminating mandatory registry participation removes the backbone of national quality oversight**
The proposed NCD no longer requires hospitals to submit data to the STS/ACC TVT Registry, despite the registry being foundational to:

- Detecting safety signals
- Monitoring real-world outcomes
- Ensuring operator accountability
- Supporting future FDA and CMS decisions

Replacing this with a vague “continuous quality improvement process” is not a substitute. It is unenforceable, inconsistent, and inadequate.

At the exact moment CMS is expanding TAVR to asymptomatic patients under CED, **removing the primary national registry contradicts the stated goal of evidence development.

4. CMS cannot expand indications while simultaneously dismantling the safety infrastructure
CMS proposes to:

- Expand TAVR to asymptomatic severe AS under CED
- Reduce surgeon involvement
- Remove registry reporting
- Loosen intraoperative requirements
- Rely on operator volume alone as a quality proxy

This combination is reckless.

Younger, healthier, asymptomatic patients have **more to lose** from complications, durability issues, and suboptimal lifetime valve planning. They deserve **more oversight**, not less.

Recommendations

I strongly urge CMS to revise the proposed NCD as follows:

A. Maintain mandatory surgeon participation in every TAVR procedure
Surgeons are the built-in safeguard against inappropriate TAVR use. Their presence is essential for patient advocacy, safety, and lifetime valve planning.

B. Preserve mandatory TVT Registry participation
Registry data is essential for safety, quality, and future coverage decisions.

C. Do not weaken structural safeguards while expanding indications
Asymptomatic patients require *more* protection, not less.

D. Align coverage expansion with strengthened—not weakened—oversight**
CMS should not expand TAVR into younger, lower-risk populations while simultaneously dismantling the mechanisms that protect them.

CMS’s willingness to expand coverage for asymptomatic severe AS is commendable. But the accompanying reductions in surgeon involvement and registry reporting represent a serious threat to patient safety and program integrity.

These changes would shift TAVR away from the multidisciplinary, evidence-driven model that made it successful — and toward a fragmented, less accountable system that will harm patients.

I urge CMS to reconsider these elements of the proposal and restore the safeguards that Medicare beneficiaries deserve.

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Re: Public Comment on Proposed Updates to the National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR)

Dear CMS Coverage and Analysis Group,

Thank you for the opportunity to comment on the proposed revisions to the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). I strongly support the proposed updates, including removal of Coverage with Evidence Development (CED) for symptomatic severe aortic stenosis, expansion of coverage for asymptomatic severe aortic stenosis within a CED framework, elimination of hospital procedural volume thresholds, and increased flexibility in Heart Team, operator, and patient evaluation requirements [6].

As a cardiovascular administrator leading Structural Heart and cardiovascular service line operations across a multi-site health system, I have witnessed TAVR evolve from an emerging therapy into the standard of care for appropriately selected patients with severe aortic stenosis [1–3]. Today’s programs are supported by experienced multidisciplinary teams, established quality processes, mature care pathways, and an extensive body of clinical evidence [1,4,5]. The proposed revisions appropriately align Medicare policy with contemporary clinical practice [1,4,5].

Removing CED requirements for symptomatic severe aortic stenosis reflects the strength of the existing evidence and will reduce unnecessary administrative burden while improving timely access to treatment [1–3]. Similarly, extending coverage for asymptomatic severe aortic stenosis within a CED framework appropriately balances innovation with continued evidence generation [1,6]. As CMS finalizes this policy, participation requirements should remain practical for programs of varying size and structure to ensure equitable patient access [4–6].

I also support eliminating hospital procedural volume thresholds. Quality is better demonstrated through multidisciplinary expertise, robust infrastructure, continuous quality improvement, participation in national registries, and transparent outcomes reporting than by procedural volume alone [4,5]. Removing arbitrary volume requirements will help improve access for patients in community and underserved settings without compromising quality [4,5].

The proposed flexibility in Heart Team evaluations is another important modernization. Allowing chart review, telehealth, and other appropriate evaluation methods better reflects current practice while preserving multidisciplinary decision-making [1,5]. Given ongoing cardiothoracic surgeon workforce shortages, reducing duplicative evaluation requirements can improve efficiency without diminishing patient safety or clinical oversight [5].

Likewise, increased flexibility in operator requirements is essential. Allowing qualified interventional cardiologists or cardiac surgeons to serve as the primary operator, when clinically appropriate, enables programs to respond more efficiently to urgent or inpatient cases, reduces unnecessary delays, and supports optimal use of highly specialized clinical resources [1,4,5].

I also encourage CMS to explicitly recognize the critical role of Advanced Practice Providers (APPs) within Structural Heart programs. Nurse Practitioners and Physician Assistants have become integral members of the multidisciplinary Heart Team, leading patient evaluations, coordinating care, facilitating shared decision-making, educating patients and families, managing longitudinal follow-up, and supporting quality improvement initiatives [5]. As demand for structural heart interventions continues to grow, APPs are essential to expanding access, improving care coordination, and maintaining a patient-centered care model [4,5].

Overall, these proposed revisions modernize Medicare coverage policy by reducing unnecessary administrative barriers while maintaining rigorous standards for quality and patient safety [1,4–6]. They support clinical judgment, improve operational efficiency, and expand timely access to life-saving therapy for Medicare beneficiaries [1–3,6].

Thank you for your consideration and for your continued commitment to improving cardiovascular care.

Respectfully,

Jasmina Katinic DNP, APRN, CCRN-K, AACC
Division Assistant Vice President, Structural Heart and Vascular Programs

References:

1. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease. Circulation. 2021;143:e72–e227.
2. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380:1695–1705.
3. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019;380:1706–1715.
4. Carroll JD, Mack MJ, Vemulapalli S, et al. STS/ACC TVT Registry of Transcatheter Aortic Valve Replacement. Journal of the American College of Cardiology.
5. Writing Committee Members. 2025 ACC/AHA Clinical Performance and Quality Measures for Adults With Valvular Heart Disease.
6. Centers for Medicare & Medicaid Services. Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination.

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I am an interventional cardiologist practicing in the Chicago area since 2009. I have been performing structural heart interventions since 2012. During that time period, I have had the opportunity to be a founding medical director for TAVR programs at a number of hospitals. In that time, I have noted the variance of volume and expertise of the implanting physicians (cardiologists and surgeons). Of note, previous NCDs have focused on center volume and not operator volume.

Therefore, in response to the current NCD proposal, I strongly believe:
1). The ongoing registry data should continue and be mandatory for hospital TAVR programs. Though, seeing that is self-reported data, it is frusterating to see a level of "expertise" in practice that rivals or is better than the high volume programs in the low risk TAVR trials. We need to be comfortable to address not only the data but the ACCURACY of the data entered into these registries.
2). The focus should be on operator volume. At a high volume center that does 250 TAVR procedures a year, how can we ethically suggest to our patients that an operator who does 249 TAVRs is the same that does 1 TAVR? We do, and that is an issue with hospital administration, hospital credentialing and physician ego. This must be addressed with increased annual minimum requirements as OPERATORS and not PROGRAMS.
3). It is reasonable to have the changes address and allow 2 TAVR operators (including 2 cardiologists or 2 surgeons) if the center believes they are trained to safely perform the procedures. However, it must define that surgical backup is immediate as necessary (and not in an adjacent room tied up with a surgical on-pump case). 4). Asymptomatic Aortic Stenosis should be added to the coverage plan based on recent data.

If we REFOCUS our attention on patient outcomes and NOT just patient access (and we are comfortable addressing minimum operator volume and the accuracy of data registries), then the field can continue to move forward in a safe and exciting way for our patients.

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As System Chief Executive of Baptist Heart & Vascular Care, I oversee cardiology and cardiac surgery service lines across 12 hospitals in South Florida. I also serve as Professor and Chair of Cardiovascular Sciences at Florida International University's Herbert Wertheim College of Medicine. I appreciate the opportunity to comment on the proposed reconsideration of NCD 20.32 (CAG-00430R2).

We support many elements of the proposed decision, including termination of CED for symptomatic severe AS and the recognition that TAVR technology and operator experience have matured substantially since 2012. However, we write to urge CMS to reconsider three specific elements of the proposal before finalization, drawing on our experience operating heart valve programs across a large, multi-hospital system with varying levels of program maturity, and on the published evidence base underlying each of these standards.

1) CMS should require continued, mandatory participation in the STS/ACC TVT Registry:
The proposed NCD removes the current requirement that TAVR be furnished only in the context of a prospective, national, audited registry (the STS/ACC TVT Registry) for symptomatic patients, replacing it with a general requirement that hospitals maintain an unspecified continuous quality improvement process. We believe this change is a significant step backward and should not be finalized as written.
The TVT Registry is the single dataset that has allowed CMS, professional societies, and individual programs to track real-world TAVR outcomes against the pivotal trials at a national scale, including the very data CMS itself relies upon in this proposed decision memo. CMS cites Vekstein et al. (Circulation, 2025), which used TVT Registry data on 108,407 low-risk patients to show that real-world 1-year mortality (4.6 percent in heart-team-designated low-risk patients) meaningfully exceeds the 1 to 2 percent mortality observed in the low-risk trials, a divergence the authors attribute to comorbidity burden and care fragmentation. CMS also cites Arnold et al. (JAMA Cardiology, 2024), a TVT Registry analysis of over 200,000 patients showing that adjusted 30-day mortality risk actually increased between 2019 and 2022 even as unadjusted rates held steady. Neither finding would have been possible without mandatory, standardized, national registry participation, and neither would be detectable under a locally defined quality improvement process. Vemulapalli et al. (New England Journal of Medicine, 2019), also built on TVT Registry data, similarly demonstrated a persistent volume-mortality relationship across U.S. TAVR programs, with more variable outcomes at lower-volume hospitals.
Across our 12 hospitals, participation in a single, standardized, externally audited registry is what allows us to benchmark newer or lower-volume programs against national norms, identify outlier performance early, and give our patients and referring physicians confidence that outcomes are tracked consistently regardless of which of our hospitals they are treated at. An undefined, institution-specific quality improvement process, without a mandatory national data source, will produce exactly the kind of inconsistent, non-comparable local efforts that the original 2012 and 2019 NCDs were designed to avoid.
We recommend that CMS retain mandatory participation in the CMS-approved national registry as a condition of coverage for symptomatic patients, in addition to, not instead of, a local continuous quality improvement process. We further recommend that any CED studies approved under Section B4 be required to report through the same registry infrastructure, so that asymptomatic-AS evidence development remains comparable to the existing symptomatic-AS dataset rather than fragmenting across ad hoc study platforms.

2. CMS should not permit single-operator TAVR as a default; the proposal should require, or at minimum strongly favor, dual-specialty participation
The proposed NCD eliminates the requirement that two TAVR operators jointly perform each procedure, instead making joint participation optional and leaving the composition of the operating team entirely to the discretion of the local heart team. In principle, we understand CMS's stated rationale, that a mature field with better-trained fellows may not need mandatory dual staffing at every case. In practice, across a 12-hospital system with programs at very different stages of maturity, we do not believe this flexibility will preserve safety and quality uniformly, and we are concerned it will accelerate a drift toward single-operator, interventional-cardiology-only TAVR programs, particularly at newer or lower-volume sites where referral and scheduling control tends to sit with cardiology rather than surgery. This concern is grounded in published evidence, not merely operational anecdote. Gandjian et al. (JTCVS Open, 2022), analyzing a national cohort of TAVR hospitalizations from 2012 to 2018, found that institutional SAVR volume, a proxy for ongoing surgical engagement, remained independently associated with lower TAVR mortality and perioperative complications even in the modern era, and the authors concluded that continued collaboration between cardiologists and surgeons is needed to maximize patient safety. CMS's own proposed decision memo relies on Kumbhani et al. (JAMA Cardiology, 2026) to justify individual operator volume thresholds, finding a statistically significant difference in outcomes between high-volume and low-volume operators. That same evidentiary logic, that hands-on experience and case-specific judgment materially affect outcomes, supports retaining two experienced heart-team operators, drawn from complementary specialties, rather than assuming a single operator can substitute for the judgment both bring to unanticipated intraoperative events.
We also note that CMS's original 2012 TAVR coverage decision (CAG-00430N) required that the heart team's interventional cardiologist and cardiac surgeon jointly participate in the intraoperative technical aspects of every TAVR procedure. That requirement was not arbitrary. It was adopted as an explicit patient-safety safeguard during the introduction of a novel, technically demanding procedure with a real risk of emergent conversion to open surgery. Nothing in the clinical evidence reviewed in this proposed decision memo demonstrates that the risk of a catastrophic intraoperative event requiring immediate surgical judgment has been eliminated. It has been managed well precisely because a surgeon has, until now, always been an active operator in the room.
We recognize the proposed language technically permits two heart-team TAVR operators, including two cardiac surgeons or a surgeon-cardiologist pair. But permission is not the same as protection. Left as a local option, the default at many programs, including some within larger, well-resourced systems, will drift toward a single operator over time, driven by scheduling efficiency and reimbursement pressure rather than patient-specific clinical need. We ask CMS to reconsider a default requirement for dual-specialty participation (one cardiac surgeon and one interventional cardiologist, or in select cases two heart-team surgeons or two heart-team interventional cardiologists) for TAVR procedures, with a narrowly defined exception process for programs that can demonstrate, through registry-reported outcomes, sustained proficiency with single-operator cases. At minimum, we ask CMS to require that any new TAVR program operate under a dual-operator model for a defined minimum period (e.g., its first 12 months or first 50 cases) before a single-operator model is permitted, consistent with the position taken by AATS in its comments on this proposal. This kind of graduated standard would protect patients at newly established or lower-volume programs, which are disproportionately represented among our system's community-serving hospitals, without preventing our most mature, high-volume centers from exercising clinical judgment about when single-operator cases are appropriate.

3. CMS should be explicit that the multidisciplinary heart team, and not simply an individual operator, remains the coverage standard
We appreciate that CMS states its intent to maintain the concept and composition of the heart team. However, we do not believe the proposed regulatory text achieves that intent with sufficient clarity, and we are concerned that ambiguous language will be read by individual hospitals and physician groups as a license to functionally dismantle heart team practice, even where CMS did not intend that result.
The evidence supporting the heart team is not merely theoretical. Jones et al. (Open Heart, 2019), in a retrospective cohort of 3,399 patients with severe AS at Flinders Medical Center, found that implementation of a formal multidisciplinary heart team program was associated with a significant mortality benefit that was independent of, and additive to, the expansion of access to TAVR itself. This is one of the only studies to isolate the heart team process, separate from the intervention it selects, as an independent driver of survival. The ACC/AHA 2020 valvular heart disease guideline (Otto et al., Journal of the American College of Cardiology, 2021), cited extensively throughout CMS's own proposed decision memo, assigns a Class 1 (strong) recommendation to multidisciplinary heart team evaluation for severe valvular heart disease patients being considered for intervention. The 2019 AATS/ACC/ASE/SCAI/STS multi-society consensus document (Nishimura et al., Journal of the American College of Cardiology, 2019) likewise calls for an integrated, multidisciplinary model of valve center care built around shared decision-making between surgery and cardiology, not sequential or single-specialty review.
Specifically, the proposed Patient Evaluation criteria permit the initial evaluation to be performed asynchronously via chart review by trained heart team staff, and permit the single mandatory in-person evaluation to be performed by only one heart-team TAVR operator, with no requirement that a cardiac surgeon be part of that evaluation at all. As written, it is possible for a Medicare beneficiary to be evaluated, scheduled, and treated for TAVR without ever being seen by a cardiac surgeon, so long as an interventional cardiologist who qualifies as a heart-team TAVR operator performs the single required in-person evaluation. We do not believe this reflects genuine multidisciplinary, shared decision-making, particularly for the more complex or borderline patients, such as younger patients, those with longer life expectancy, bicuspid anatomy, or those in whom SAVR may in fact be the better long-term option, where the risk of a single-specialty perspective driving the recommendation is highest.
We ask CMS to revise the Physician and Heart Team Criteria to state explicitly that both a cardiac surgeon and an interventional cardiologist must document engagement in the pre-procedural evaluation of every patient, whether that engagement occurs synchronously or asynchronously, and that hospitals must be able to demonstrate, through documentation and registry participation, that both specialties are meaningfully involved in patient selection, not merely nominally listed as heart team members. Without this clarification, the heart team concept CMS says it intends to preserve risks, becoming a formality rather than an operational reality, particularly at hospitals where patient flow and scheduling are controlled by one specialty.

Conclusion
We respectfully urge CMS to (1) retain mandatory participation in a national, audited TAVR registry, (2) preserve a strong presumption in favor of dual-specialty operator participation, particularly for new and lower-volume programs, and (3) make explicit, rather than implicit, the requirement that both cardiac surgery and interventional cardiology be meaningfully engaged in every patient's heart team evaluation.
Thank you for your consideration of these comments.

Respectfully submitted,
Tom C. Nguyen, MD, FACS, FACC
System Chief Executive, Baptist Heart and Vascular Care
Professor and Chair, Department of Cardiovascular Sciences, Florida International University Herbert Wertheim College of Medicine

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As a member of the Heart Team and someone who cross-trained in structural heart interventions with Interventional Cardiologists for a dedicated year, I have the following statements. The establishment of the heart team represents one of the most significant advancements in the evolution of TAVR procedures. This collaborative approach emerged primarily within the framework of the original NCD, which mandated comprehensive assessments from both cardiology and cardiac surgery specialists. However, with the introduction of the newly proposed NCD, I have serious concerns that the heart team's integral role might be compromised, ultimately undermining patient care.

1. Continued Heart Team evaluation by Cardiologists and Cardiac Surgeons
While the updated NCD purports to support the continuation of the heart team, it is important to recognize that the previous framework was essential to its mandated inclusion across all TAVR programs. The removal of this framework raises alarming possibilities, particularly the risk that surgical evaluations may be overlooked in favor of early referrals and optimization strategies dictated by program politics. The collaborative input from both cardiology and surgical experts is crucial to delivering optimal patient therapy, a principle that underpins the heart team’s effectiveness. I am deeply concerned that this change could lead some programs to make unilateral decisions about patient management, which may inadvertently jeopardize patient outcomes. Therefore, I strongly suggest that the dual evaluation of patients be kept in the new NCD.

2. Continuation of NCDR STS/ACC TVT Registry Reporting
Furthermore, the elimination of the hospital volume requirement, coupled with the anticipated proliferation of TAVR centers, underscores the necessity for robust oversight through mandatory reporting to the NCDR STS/ACC TVT Registry. Previous studies have demonstrated a correlation between procedure volume and patient outcomes. As we move forward with expansion into smaller-volume centers, it is imperative that we rigorously monitor the care provided to patients. Additionally, given the scarcity of long-term evidence pertaining to low-risk patients, patients with aortic regurgitation, and those presenting with bicuspid aortic valves, the registry’s data will be invaluable in enhancing our understanding of TAVR's effects.

In conclusion, although the newly proposed NCD claims to uphold the heart team model, I harbor significant reservations regarding its implications for the heart team's structural integrity. I strongly favor the dual evaluation of TAVR patients by cardiologists and cardiac surgeons to continue to ensure patient care. The discontinuation of CED could profoundly impact the essential collaborative framework that ensures the best outcomes for our patients. It is critical that we advocate for a system that maintains the heart team's collaborative spirit and emphasizes rigorous oversight to safeguard patient care.

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Dear CMS,

I appreciate CMS for thoughtful changes as these proposed changes appropriately recognize the remarkable evolution of TAVR over the past decade and reflect an important commitment to improving patient access, reducing unnecessary delays in care, and eliminating administrative requirements that no longer add value while reducing unnecessary Medicare expenditures.

I am a practicing Structural Interventional Cardiologist and Director of the Structural Heart Program for a large integrated healthcare system. During my career, I have personally performed few thousand TAVR procedures and have participated in the care of many more patients with severe aortic stenosis. My comments (personal and not institutional) are based on more than a decade of firsthand clinical experience, leadership of a multidisciplinary structural heart program, and the privilege of caring for Medicare beneficiaries every day. Our structural heart program has been built on a close collaborative partnership between interventional cardiologists, cardiac surgeons, cardiac imaging specialists, anesthesiologists, and multidisciplinary heart team members. My recommendations are intended to strengthen—not diminish—that collaborative model by allowing experienced programs greater flexibility in how contemporary TAVR care is delivered.

1. Procedural Operator Requirements
Fully agree with 1 or 2 operators of any specialty performing procedure. Current-generation TAVR procedures are fundamentally different from those performed when the original NCD was written. At that time, immediate surgical bailout was an important consideration. However, advances in TAVR technology, procedural planning, operator experience have transformed TAVR into one of the safest structural heart procedures performed today. The incidence of complications requiring emergent surgical intervention has become exceedingly rare. When complications do occur—including coronary obstruction, valve embolization, vascular injury, tamponade, or annular complications—the initial management is overwhelmingly percutaneous and requires advanced interventional expertise. The ability to rapidly perform complex catheter-based interventions determines successful management in nearly all of these situations.

For routine transfemoral TAVR, the routine requirement for a scrubbed cardiac surgeon may no longer provide additional clinical benefit for most patients. At the same time, cardiac surgeons provide enormous value caring for patients who require complex surgical intervention, hybrid procedures, and advanced operative therapies. Allowing flexibility would enable both specialties to contribute where their expertise has the greatest impact.
Importantly, TAVR programs throughout Europe, Canada, and many other countries routinely perform TAVR without requiring a cardiac surgeon to be scrubbed while achieving outcomes comparable to those reported in the United States.

In many of the most technically challenging procedures—including redo TAVR, valve-in-valve procedures, leaflet modifications, coronary protection, alternative access, or highly complex anatomy, a second structural interventional cardiologist may provide complimentary expertise because these procedures frequently require simultaneous complex catheter-based steps.

CMS should allow teams to determine whether one or two operators are appropriate for each individual patient. When two operators are needed, Medicare policy should not restrict participation based on specialty, provided both physicians possess the expertise required for the procedure.
This recommendation is strongly supported by the practicing structural heart community. In a recent SCAI survey of 267 structural interventional cardiologists, 79% favored flexibility allowing either a single operator or two operators from any appropriate specialty based on patient and procedural complexity.

2. Simplify the Pre-Procedural Evaluation
Untreated severe symptomatic aortic stenosis carries an exceptionally poor prognosis. Every unnecessary delay increases the risk of heart failure hospitalization, progressive ventricular dysfunction, syncope, and death.

The current requirement for mandatory evaluation by two physicians has become one of the greatest sources of inefficiency in TAVR care. It often results in unnecessary clinic visits, prolonged wait times, increased travel burdens, additional copayments, and delayed treatment for an elderly and frequently frail patient population. Perhaps most telling is that we often cannot provide patients with a meaningful medical explanation for why they must see a second physician. The answer is frequently, "Because CMS requires it," rather than because it improves their care.

Structural interventional cardiologists are extensively trained in echocardiography, cardiac CT, coronary angiography, hemodynamic assessment, and patient selection for structural interventions. We routinely seek consultation from other specialists whenever additional expertise is clinically warranted. This is how modern medicine functions. As part of “healthcare team”, physicians consult infectious disease, nephrology, pulmonology, gastroenterology, cardiac surgery, or other specialists when clinically appropriate—not because regulation mandates it, but because patient care requires it.

The Heart Team concept was invaluable during the early adoption of TAVR, when patient selection and procedural outcomes were still evolving. Today, however, mandatory dual physician evaluations for every patient no longer appear necessary in mature TAVR programs with established quality processes.

While I appreciate CMS's proposal to replace mandatory in-person evaluation with electronic review (for 2nd physician), I respectfully question whether even mandatory electronic review remains necessary. Any additional required review as such has the potential to introduce delays without demonstrable benefit for the majority of patients. Experienced Heart Teams should be trusted to determine when additional consultation adds value to an individual patient's care. Programs or individuals providing substandard care should be addressed through hospital quality oversight, credentialing processes, and professional accountability—not through universal administrative requirements that affect every patient and every physician.

3. Coverage with Evidence Development (CED)
Coverage with Evidence Development was appropriately implemented during the early adoption of TAVR, but it was never intended to be permanent. Today, TAVR is supported by one of the strongest evidence bases in cardiovascular medicine. Randomized trials including PARTNER 1, PARTNER 2, PARTNER 3, CoreValve High Risk, SURTAVI, Evolut Low Risk, and NOTION have consistently demonstrated the safety and efficacy of TAVR across the spectrum of surgical risk.

CED has fulfilled its intended purpose. Continuing these requirements diverts substantial institutional resources toward regulatory compliance rather than direct patient care. Eliminating CED appropriately recognizes that TAVR has transitioned from an investigational therapy to an established standard of care.

Conclusion
I want to emphasize that these recommendations are not intended to diminish the essential role of cardiac surgeons within structural heart programs. The success of TAVR over the past decade has been built upon close collaboration between interventional cardiologists, cardiac surgeons, imaging specialists, anesthesiologists, and multidisciplinary teams. Rather, these recommendations recognize that as TAVR has matured, the operational requirements established during its early adoption should evolve to reflect contemporary practice. Modernizing the NCD will allow every member of the Heart Team to contribute where his or her expertise provides the greatest value for patients.

After caring for thousands of patients with severe aortic stenosis, I believe our greatest opportunity to improve outcomes is no longer making TAVR safer—it is ensuring that appropriate patients receive timely treatment without unnecessary administrative barriers.

I commend CMS for recognizing the evolution of TAVR and respectfully encourage you to finalize an NCD that:

• Allows flexibility regarding procedural staffing based on physician judgment and patient complexity.
• Removes mandatory second physician evaluations and mandatory electronic review requirements.
• Reduces unnecessary administrative barriers that delay treatment.
• Eliminates outdated Coverage with Evidence Development requirements.

Thank you for your thoughtful consideration of these comments and for your continued commitment to improving cardiovascular care for Medicare beneficiaries.
Respectfully,

Pradeep Yadav, MD, FSCAI
Director, Structural Heart Interventions
Piedmont Heart Institute, Atlanta, GA

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The reopening of the TAVR NCD and its current new proposals are ill-advised for a number of reasons:

1) The reopening of the NCD was primarily at the behest of Edwards LifeSciences, not any cardiac surgery or interventional cardiology professional society. The purported reasoning being to increase access to care is not supported by any data. In fact, current data would continue to suggest an explosion of TAVR in application to severe trileaflet aortic stenosis (AS), as well as other areas still under investigation including bicuspid AS, bioprosthetic valve failure, severe asymptomatic AS, moderate AS, and pure aortic regurgitation. The assertion that the NCD needs to be reopened to improve access to care is simply a farce, not supported by data. However, Edwards LifeSciences has clear monetary gain from further expansion of TAVR, particularly in an unregulated fashion as the new NCD proposes.
2) The pressure from industry to reopen the NCD and expand TAVR into areas that remain controversial, WITHOUT coverage with evidence development (CED) is simply irresponsible. Asymptomatic AS, moderate AS, pure AI, and valve-in-valve (ViV) TAVR remain areas of controversy requiring additional data to best inform decision-making for patients, interventional cardiologists, and surgeons. The phrase "nothing ruins an operation like some follow-up" comes to mind.
3) Single-operator TAVR is not in line with how the procedure was designed. No single operator can safely manage valve position, wire depth, and actively deploy the device. Furthermore, involvement of both cardiac surgeons and interventionalists is critical for safety and best patient outcomes.
4) Dissolution of the surgeon's role in the heart team is unsafe, and will likely lead to wider expansion of TAVR in younger and lower risk patients who are virtually certain to outlive their TAVR prosthesis, setting them up for future TAVR explantation. There is no data that TAVR explant is anything other than a high risk and generally avoidable procedure. These patients are best served instead at comprehensive valve centers which offer the full spectrum of aortic valve and root replacement, root enlargement, and Ross operations.

Simply put, the planned NCD changes are poorly-conceived, heavily influenced with pressure/bias from industry absent supporting data, and in many instances will compromise the long-term survival and health of our patients. If you believe the messaging from Edwards LifeSciences on this subject, you are likely either (1) uninformed on the topic, or (2) influenced by lobbying from industry that has a clear monetary interest in TAVR expansion, no matter the human cost.

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Dear CMS Coverage and Analysis Group,

I am writing as a cardiologist and interventional echocardiographer involved in the evaluation, procedural planning, intraprocedural imaging, and longitudinal care of patients undergoing transcatheter aortic valve replacement.

I support efforts to expand appropriate access to TAVR and to reduce administrative requirements that do not meaningfully improve patient care. However, I urge CMS to retain coverage with evidence development requirements, including standardized registry reporting, for TAVR procedures.

TAVR is now widely performed, but it remains a complex structural heart intervention with clinically important risks, including death, stroke, vascular complications, bleeding, conduction-system injury, paravalvular regurgitation, prosthesis-patient mismatch, acute kidney injury, and the need for repeat intervention. Outcomes also depend on patient selection, procedural volume, multidisciplinary decision-making, imaging expertise, device selection, and postprocedural follow-up. Expansion to new sites and less-experienced programs makes systematic outcomes surveillance more important, not less.

The national TAVR registry infrastructure has been central to the safe growth of this therapy. Standardized reporting allows programs, physicians, patients, regulators, and payers to evaluate outcomes consistently across institutions. It supports risk-adjusted benchmarking, identifies emerging safety signals, and allows hospitals to recognize performance gaps that may not be apparent from internal case review alone.

CED should therefore be maintained at least for clinically meaningful short-term outcomes, including 30-day mortality, stroke, rehospitalization, vascular complications, bleeding, pacemaker implantation, valve performance, and patient-reported health status. The reporting burden should be streamlined where possible, but elimination of the requirement would weaken one of the principal mechanisms that has supported quality assurance in TAVR.

Continued evidence development is particularly important as CMS considers broader coverage, including asymptomatic severe aortic stenosis and other populations in whom the balance of benefit and risk is still evolving. Coverage expansion without standardized registry reporting would make it more difficult to determine whether outcomes observed in clinical trials are reproduced in routine practice, especially among older adults, patients with frailty, complex anatomy, multiple comorbidities, or limited life expectancy.

I also support preservation of the multidisciplinary Heart Team model. Decisions regarding TAVR should reflect genuine clinical consensus among qualified clinicians, including interventional cardiology, cardiac surgery, cardiovascular imaging, anesthesia when appropriate, and other specialists relevant to the individual patient. Coverage policy should recognize and support all evaluations considered necessary by the Heart Team to determine whether intervention is appropriate and aligned with the patient’s goals.

For these reasons, I respectfully recommend that CMS:

1. Retain CED and standardized registry reporting for TAVR.
2. Require reporting of core clinical and patient-reported outcomes through at least 30 days.
3. Maintain enhanced evidence-development requirements for new indications and populations in which long-term benefit remains uncertain.
4. Preserve the multidisciplinary Heart Team and explicitly require documented consensus regarding treatment strategy.
5. Streamline duplicative administrative requirements without removing the national quality infrastructure that has supported safe TAVR expansion.

Broad access and rigorous outcomes assessment are not competing priorities. Continued CED is a practical mechanism for ensuring that expansion of TAVR remains accompanied by accountability, transparency, and protection of Medicare beneficiaries.

Thank you for considering these comments.

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JoAnna Baldwin
Interim Director
Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR) CAG-00430R2 Published 6/15/26

Dear Ms. Baldwin:

1. I applaud and support the proposal to extend coverage to Asymptomatic Severe Aortic Stenosis (Section A 2.) The data from the Early TAVR and Recovery Trials make coverage for this indication reasonable and necessary. While not every asymptomatic aortic stenosis patient may need (or want) intervention, treatment choices are best made as part of a multi-disciplinary team (MDT) lead, patient centric, shared decision-making (SDM) process.

2. I believe CED for Asymptomatic Severe AS (Section B 1.b.) is reasonable as a means of data gathering for this new indication. The CED should come with an automated sunsetting mechanism – to be triggered after a certain time period or once the needed information has been gathered.

3. I support sunsetting the CED for Severe Symptomatic Aortic Stenosis. TAVR is by far the best researched Aortic Stenosis treatment modality. Considering only the Partner 1, 2, 3 and equivalent Medtronic trials, more than 7500 patients were randomized to TAVR vs. SAVR and rigorously followed up. Every year, additional patients are enrolled in randomized, controlled TAVR clinical trials (PMID: 36990558, 38587261, NCT07194265, NCT06680427 etc), a level of evidence gathering unprecedented in the development of any prior valvular replacement modality. The numbers above dwarf the number of patients enrolled in the three major randomized studies of Biological versus Mechanical Surgical Aortic Valves (PMID: 32023258, 19892237, 11028464). It is worth nothing that the shift away from mechanical valves that occurred in the first decade of this century took place in the absence of ANY randomized controlled trials to support it, despite a survival and durability deficit for bioprosthetic valves and without the scrutiny of a CED. The TAVR CED has been in place since 2012 and is one of the longest such programs in existence (PMID: 35981123). The 1-year safety of TAVR has been well demonstrated in a wide range of populations and pathologies (TAV-in-TAV PMID: 33413929, TAV-in-SAV PMID:28473128, Bicuspid PMID: 37487404). Even when valve teams recommend TAVR in patients under age 65, one-year outcomes appear to be commensurate with patient comorbidities and risk (PMID: 39475333). As treatment is extended to lower risk, longer life expectancy patients, extended follow up becomes more important. Nonetheless, the durability issues of the Abbott Trifecta (PMID: 41502003) and Medtronic Evolute valves (PMID:41697183) were not detected through CEDs or even the TVT/STS registries but through active post-market surveillance and clinical trial follow-up. The data needed to detect long term issues will not be obtained from continuing the CED but rather robust post-market surveillance mechanisms (https://doi.org/10.1016/j.jacc.2026.02.5062). Furthermore, there is no reason for which new developments in transcatheter therapies be subject to any more scrutiny than similarly exciting developments in surgical techniques. As novel root enlargement techniques, TAVR explant and complex surgeries such at the Ross are growing rapidly and take their rightful place as critical lifetime management solutions, they should not receive a lesser (or higher) level of scrutiny than novel transcatheter therapies. The burden for gathering this type of information cannot rest on resource-poor hospitals already struggling to comply with a wide range of reporting requirements, but will need to be obtained through other means, more in line with current technological advances. Importantly, CED sunsetting should not be expected to lead to the demise of the TVT registry – the largest and most prestigious database of its kind in the world. Despite participation in the STS registry being voluntary, the benchmarking value of the registry ensures essentially universal participation of US cardiac surgical programs.

4. I am worried by the change in verbiage between the current proposal and the prior iteration of the NCD. The shift from “Aortic Stenosis” to “Severe Symptomatic” and “Severe Asymptomatic” Aortic Stenosis is unnecessary and does not recognize the complex decision-making process required for the management of AS patients. Even before the results of the Progress Trial (NCT03042104) are reported this fall, it is important to acknowledge that patients with Aortic Stenosis exhibit a wide variety of phenotypes (based on cardiac output, gradients, ejection fraction etc.) MDT involving surgeons, interventional cardiologists and imagers are best equipped to analyze the multiple imaging modalities, tests and patient characteristics required to choose the treatment modality and timing of intervention. The distinction between Symptomatic and Asymptomatic makes sense (see above) but I would recommend maintaining the “Aortic Stenosis” verbiage as opposed to the “Severe Aortic Stenosis”.

5. I believe the “Physician and Heart Team Criteria” (Section B. 2.) are reasonable and reflect the mature status of TAVR and low complication rates in the current era. While many programs (including our own), continue to use a dual-operator model with meaningful participation of an interventional cardiologist and surgeon, this is no longer the case in many other programs where the participation of one of the mandated operators is perfunctory and more akin to a standby that a true co-surgeon role. There is no evidence that this compromises safety. When the surgical conversion rate for TAVR is lower than that of primary PCI (PMID 33213729, 19555835), the cost of maintaining full, immediate backup with an OR team, perfusionist, perfusion circuit and open surgical trays is hard to justify for under-staffed and under-resourced hospitals (PMID: 25086843). Minimalistic TAVR (PMID: 30846085), MAC anesthesia (PMID: 38454917), conscious sedation (PMID: 32023258) and even local anesthesia (PMID: 38454917) are safe and can be used to increase access to care and decrease costs. Pulling this thread, it is hard to understand how mandatory surgeon participation in TAVR increases safety for a procedure that has an exceedingly low open conversion rate and is now often performed in the cath lab, under conscious sedation or MAC and where the resources necessary for surgical conversion are not immediately available. While there will always be cases where a 2nd operator and more resources are needed, this decision and the choice of operator should be left to the MDT (PMID: 34425952). It is worth noting that TAVR remains (to my knowledge), the only procedure requiring a -62 modifier every time it is performed (different from NCD 20.37 TTVR, 20.34 LAAC, 20.33 TEER). For comparison, the incidence of retrograde aortic dissection with TEVAR is much higher (PMID: 38953000) than the rate of open conversion with TAVR, however a cardiac surgeon is not required to scrub into every TEVAR case.

6. I support the simplified evaluation pathway for AS patients (Section B. 2, Patient Evaluation). Especially in underserved areas the current mandates can lead to unnecessary delays in care which could be avoided under this proposal. In this high acuity population delays in care can be fatal (PMID: 25240781) and dramatically increase health care costs (PMID: 42281844).

7. I believe the volume requirements for TAVR operators are reasonable (section B. 2, TAVR Operator). Multiple publications have demonstrated that low volume sites and operators can have excellent outcomes and any volume requirements should be balanced against access to care considerations (PMID 40376776, 33234781). It is important to note that the volume-outcome relationship for TAVR sites (Odds Ratio 1.21) is considerably less prominent than that for SAVR sites (Adjusted Odds Ratio 2.24) (see PMID: 34785247, 34785247) and that there are no mandatory volume requirements for cardiac surgical programs.

8. I believe the requirement for a post procedure ICU (Section B. 3.b Hospital Criteria) is redundant and should be removed. All hospitals with a cardiac surgical program have a “post-procedure ICU with personnel experienced in managing patients who have undergone open-heart valve procedures”, but using this unit for the care of TAVR patients is rarely needed and no longer the standard of care in the US.

9. The creation of the MDT Valve Team has been a (and in my view the) signal achievement of TAVR development. The management of patients with aortic stenosis is vastly more complex today than it was before the advent of TAVR. Cases requiring consideration of surgical versus percutaneous therapies should continue to be discussed in Valve Conference before choices are presented to patients and families. Interaction with both a surgeon and a cardiologist is extremely valuable in such situations – giving patients and families an opportunity to ask questions specific to each treatment modality’s durability, risks, benefits and burdens. To increase access to care, the form of consultation (in person or virtual) should be left to the discretion of the MDT. For patients traveling long distances to obtain treatment, and in situations where the MDT determines that in person consultation can be deferred until the day of procedure - this option should be available.

10. Given the importance of the MDT in the lifetime management of Aortic Stenosis, I believe this bedrock principle should be applied to ALL patients with aortic stenosis, regardless of age and treatment modality (TAVR and SAVR). Just as there are patients in the 9th decade of life who can benefit from SAVR, there are younger patients who may benefit from TAVR. More complex and potentially higher risk procedures – both surgical and transcatheter (Ross procedure, root enlargement, leaflet modification etc.) are perfect examples of situations where the input of the valve team is invaluable in guiding patient choice. Such advanced techniques are more likely to see increased adoption when their implementation is backed by a MDT rather than a single operator.

11. Acknowledging the continued importance of surgical therapies for the lifetime management of aortic stenosis, and to incentivize surgical participation in the MDT, I recommend providing a payment for surgeon standby during TAVR procedures in which the surgeon is not actively participating.

12. Please consider establishing a mechanism for the coverage decision to automatically update, should additional FDA indications for Aortic Stenosis be approved. The results of the Progress Trial are expected at this year’s TCT meeting. Should the study show a benefit for the treatment of Moderate Aortic Stenosis patients, and an FDA indication be approved, a mechanism should be available to allow coverage for this patient population without needing to re-open the NCD.

I commend CMS for a thoughtfully written proposal and look forward to a final document whose adoption improves access to care, brings coverage equipoise at the disease level and helps maintain and expand the primacy of the valve team to all aortic stenosis patients.

Sincerely,

Andrei Pop MD, FACC, FSCAI, RPVI Interventional Cardiology,
System Structural Director, Ascension Illinois
Cardiac Cath Lab Director, Ascension Alexian Brothers Medical Center.

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To start, as an advanced practice clinician, I am concerned that the changes in wording regarding the heart team composition to "May include" could set a precent for healthcare organizations to "trim the fat" and put pressure on structural heart teams already functioning within best practice (ie. with non-physician personnel) to eliminate essential members to meet a bottom line. Face to face time with patients is already limited due to a number of reasons and the more touchpoints we have with the patient the better. Similarly, we often relay critical patient information to the heart team that sometimes influences a patient's course and options.

I also believe that although TVT registry participation may not be required, best practices should be emphasized and reflected in hospital policy despite changes in coverage requirements.

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I applaud the continued reevaluation of TAVR criteria by CMS to increase access to the procedure for patients, however I am concerned by the conclusions that are drawn to increase this access.

Asymptomatic aortic stenosis is not a benign disease process. This leads to diastolic dysfunction, enlargement of the LV mass, and is related to sudden death. Treatment of asymptomatic critical aortic stenosis, either by TAVR or SAVR, is a progressive move in the positive direction. Four previous studies have examined early intervention on critical aortic stenosis with mixed outcomes, but they were small studies with mixed results. Despite the European guidelines, more research is needed to confirm this, though in low risk patients, I believe there will be a long term benefit.

I am concerned about the other proposed changes and I do not believe they will alter the concerns of access to care. Removing the cardiac surgeon from patient evaluation creates a scenario where the cardiologist who performs TAVR unilaterally decides that a patient is a TAVR candidate without the input of a surgeon other than a chart review during a heart team meeting. There are many technical aspects of both SAVR (such as concomitant procedures and root enlargement) that a surgeon is more qualified to judge this rather than a cardiologist. The current functioning heart team has actually dramatically improved the care of these sick patients. TAVR outcomes are as good as they are because of the collaborative nature of surgeons and cardiologists in patient selection, team based procedural implementation, and team based postopertive management. Removing guardrails set up to minimize complications is not a benefit to the patient. The surgeons participation in the procedure is not the limiting factor in the access to the patients (especially since a surgery program is required to have a TAVR program).

I have read multiple comments that a single cardiologist can do the procedure by themselves and I would challenge that statement. I would say in a straightforward case, a single surgeon or cardiologist could do the procedure by themselves. The benefit of the heart team approach to this disease process is that both a surgeon and cardiologist are able to manage both the straightforward and the complex cases together. We have all been involved in these cases that initially were thought to be straightforward but became complex.

Why are we trying to change a process and system that has given us such amazing results?

My final point is also to point out research over the past few years that has highlighted inappropriate use of TAVR in patients younger than 65. The average age of patients in the low risk trials was 74yo. As we discuss lifetime management of aortic stenosis, TAVR at a young age is likely inappropriate for a low risk patient because they will require a TAVR explant and surgery at a later age. TAVR in TAVR outcomes are clearly not as promising as first procedure TAVR. TAVR explant still has an exceedingly high risk of periprocedural mortality. Keeping the heart team intact and present for all aspects of the care of these patients ensure we treat patients correctly and keeping in mind the lifetime management of this disease. Patients may want TAVR for the short term benefits, but we need to educate patients on the long term treatment strategy of aortic stenosis. As surgeons, we need to also focus on minimally invasive valve surgery and optimizing prosthesis size and strong discussions on the benefits of mechanical valves in the correct population.

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In 2026, both the surgical and transcatheter procedural treatments for aortic stenosis (AS) are mature and performed at the vast majority of centers with low complication rates for most patients. With numerous randomized trials, thousands of patients enrolled, and many hundreds of thousands of patients treated commercially with TAVR, TAVR for AS is not an experimental treatment in any meaningful way. Variation in outcomes after TAVR (Vemulapalli et al. NEJM 2019;380:2541-2550) is already less than variation in outcomes after surgical AVR (Thourani et al. Ann Thorac Surg 2022;114:1299-306). Most studies point to comparable durability data between TAVR and SAVR. As such, there is not a strong rationale for why the requirements and mandates for performing TAVR should be meaningfully different than they are for performing SAVR.

This NCD update offers an opportunity to recognize how the field and TAVR procedure have evolved and now introduce greater flexibility, thereby minimizing the disparity between the requirements to perform TAVR vs. SAVR. Relevant to this, the time from identification of clinically significant AS to treatment with TAVR is longer than for treatment with SAVR due, in part, to the greater burdens of the evaluation process (Stinis et al. American Heart Journal Plus: Cardiology Research and Practice 61, 2026, 100698).

While it is understandable that the focus of prior TAVR NCDs was on ensuring the safe dispersion of a novel technology, the safety of the procedure and reproducibility of results has been broadly established through evolution of the technology and dissemination of best practices. It is now time to recognize that the requirements and mandates put in place to ensure peri-procedural safety have had some unintended consequences and collateral damage.

Variation in procedural mortality between high-volume and low-volume TAVR centers is statistically significant, but only 0.5% at 30 days (Vemulapalli et al. NEJM 2019;380:2541-2550). In comparison, the mortality on a waiting list to get an AVR performed is almost 4% at 30 days (~8-fold higher) (Malaisrie et al. Ann Thorac Surg 2014;98:1564–71). So, from a patient-centered perspective, our focus should now be on minimizing the barriers in place to timely treatment. The 2024 ACC/AHA Clinical Performance and Quality Measures report has a performance goal of treatment of symptomatic severe AS within 90 days (Jneid et al. Circ Cardiovasc Qual Outcomes. 2024;17:e000129). The AHA Target AS initiative has a timely treatment quality metric to treat those with a Class I indication with AVR within 90 days (Lindman et al. Circulation 2026). Recognizing the mortality and quality of life cost that accrues from under and delayed treatment (Li et al. J Am Coll Cardiol 2022;79:864–877; Benfari et al. Eur Heart J. Jun 1 2024;45(21):1877–1886), our focus needs to shift/expand to timely treatment as the barometer of quality care for AS.

The centrality of the multidisciplinary heart team for the evaluation of patients with aortic stenosis is maintained in this NCD revision and should be championed. All patients with AS (preoperatively and postoperatively) undergoing TAVR or SAVR should be under the care of a heart valve team. The proposed revision to the patient evaluation process is the right move insofar as it allows flexibility and the development of triaging protocols guided by the multidisciplinary heart valve team to facilitate the right evaluation for the right patient that minimizes wasted effort and unnecessary delays for all stakeholders. For context, a patient could undergo surgical AVR without any multidisciplinary evaluation occurring and without any discussion of a TAVR option. In most circumstances, that practice would be highly inappropriate as it runs counter to guidelines, patient-centered care, and true informed consent, but there is no mandate or requirement in place prohibiting it. Without overly onerous mandates and requirements, it is now time for centers and multidisciplinary heart valve teams to self-regulate and monitor so that all patients with AS undergoing TAVR or SAVR are under the care of a multidisciplinary heart valve team to ensure the right match of patient to procedure (considering anatomy, procedural risk, lifetime management, local expertise, and patient goals and preferences), genuine informed consent of the patient regarding all options, and shared decision-making. How those principles are operationalized in various settings may differ and there should be flexibility to allow for it.

The proposed revision to the TAVR operator and procedural requirements is the right move. At this point, many straightforward cases can be safely performed with a single operator. Functionally, this probably occurs for many cases already in which a co-proceduralist will come in at the last minute and help blow up the balloon (participating for a couple minutes). The conversion rate of TAVR cases to open surgery is now exceedingly low (<1%), providing insufficient rationale to mandate surgical presence in every case. As long as the operator (whether IC or surgeon) has the experience and skills to reliably perform the procedure safely, allowing for a single operator is anticipated to reduce delays in scheduling/performing TAVR related to alignment of schedules between both an IC and surgeon without sacrificing safety. Allowing for 2 TAVR operators (without specifying specialty type) allows appropriate flexibility for more challenging cases while minimizing the potential impact on scheduling delays.

Removing the coverage with evidence development requirement/mandate for symptomatic severe AS is the right move. The TVT registry plays an important accountability and transparency role to help ensure optimal peri-procedural outcomes consistently across sites and provides a mechanism to see when that is not the case. But, just like participation in the STS registry is not required, participation in the TVT should not be required at this point. There should be a carrot to encourage participation rather than a stick; this provides warranted consistency between TAVR and SAVR.

Suggested changes:

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Dear CMS,

Thank you for the opportunity to provide feedback regarding the proposed CMS modifications related to single-operator TAVR.

I support modernization of the current requirements while preserving the multidisciplinary principles that have been fundamental to the success of TAVR programs. My recommendations are as follows:

These modifications would preserve the multidisciplinary decision-making process while reducing unnecessary barriers to care, improving efficiency, and allowing programs to tailor evaluations according to individual patient characteristics rather than applying a one-size-fits-all approach.

Thank you for considering these comments.

Sincerely,

Pedro Villablanca, MD

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To the Centers for Medicare & Medicaid Services:

Thank you for the opportunity to comment on the proposed National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR). The proposal advances the field forward with additional support for asymptomatic aortic stenosis. I support CMS's proposals permitting chart-based triage and telehealth evaluation. However, I urge CMS to remove the requirement that at least one heart team evaluation be conducted in person. The decision regarding whether evaluations occur in person, by telehealth, or through chart-and-image review should be left to the clinical judgment of the heart team. The evidence on outcomes, safety, and patient access supports a model in which the heart team, not a fixed visit-modality rule, determines how each patient is evaluated.

The comments below address five points, with supporting data where available.

1. Aortic stenosis is a life-threatening condition, and patients are too often treated too late.

Severe aortic stenosis carries a prognosis comparable to or worse than many metastatic cancers once symptoms appear.¹ Without valve replacement, survival for symptomatic severe aortic stenosis falls to roughly 50% at two years and 20% at five years, and untreated severe disease is associated with a five-year mortality of approximately 67%.^1,2 Despite the availability of effective, durable therapy, a substantial share of eligible patients never receives valve replacement, and as few as 19% of symptomatic severe AS patients undergo timely AVR within 90 days of diagnosis.^3,4

Undertreatment persists for several converging reasons: symptoms are frequently under-recognized or attributed to normal aging, and nearly half of patients with echo-confirmed moderate or severe AS lack a formal diagnosis within a year;⁵ patients in rural and underserved communities face meaningful geographic and travel-related barriers to reaching a structural heart program;^6?8 and the logistical burden of in-person evaluation requirements can itself deter patients from completing the evaluation pathway. For this population, every administrative step that adds delay is a step that can contribute to preventable clinical deterioration — and, too often, to lives lost.

2. Mandating in-person visits will delay care and fall hardest on rural, disadvantaged, and clinically urgent patients.

A requirement that more than one heart team evaluation occur in person would disproportionately harm the patients who already face the greatest barriers.^6-10 Here are three examples:

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To whom it may concern,

I appreciate the opportunity to weigh in on proposed changes to guidelines related to the use of TAVR as well as decision making surrounding this. It is clear that there are short term benefits not only to patient quality of life, but as well as peri-procedural risk to undergo TAVR, however the evidence is not out yet to the long-term impact. If we were to stop researching now, and to dissolve the majority of heart teams by no longer requiring the participation of cardiac surgeons in these procedures, the downstream impacts are unknown at best, but potentially disastrous at worst. There is, unfortunately, no perfect solution to the disease process of aortic stenosis, and many surgeons have treated tavr technology with disdain, but clearly it serves an important role. There does appear to be an inflection point about 8 years after implantation where TAVR is trending clearly towards higher failure when compared to surgical AVR. Additionally, taking away the heart team approach removes for many patients the option of mechanocal valves and the clear mortality benefit seen at least into patients 60s. To conclude, I fear the changes made will turn aortic stenosis into a hammer and nail situation, when there is far more subtlety to aortic valve stenosis, the complexity of explant of a tavr device can dramatically increase mortality, and valve in valve will not be an option for everyone. I do agree with the majority of changes made, but a requirement for a heart team approach and discussion of both options with a patient is tremendously important, and it fosters collegiality at a level not otherwise seen in these fields. By having patients we routinely treat together there is tremendous opportuinity to grow as clinicians and continue to see beyond our own skillsets. To abandon the research components of TAVR will certainly leed to younger and younger patients receiving this, and certainly preventable mortality from multiple valve procedures and complex explants of valves that will not remain durable for life.

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Re: CMS Proposed Decision Memorandum for Transcatheter Aortic Valve Replacement for Aortic Stenosis, CAG-00430R2

Dear CMS Coverage and Analysis Group,

Thank you for the opportunity to comment on the proposed National Coverage Determination for Transcatheter Aortic Valve Replacement for aortic stenosis. I commend CMS for issuing a proposal that is timely, data driven, objective, and appropriately centered on the needs of patients. The proposed changes recognize the maturity of the evidence base for TAVR in symptomatic severe aortic stenosis while preserving the safeguards necessary to ensure high-quality, patient-centered care.

I support CMS’s effort to modernize the TAVR coverage framework. The original NCD was appropriate when TAVR was an emerging therapy requiring coverage with evidence development. However, for symptomatic severe aortic stenosis, the field has now matured substantially, and the coverage framework should evolve accordingly. In my view, the proposed policy appropriately balances access, safety, clinical judgment, and quality oversight.

At a high level, there is substantial agreement among clinicians and stakeholders that the heart team remains central to high-quality valve care. The relevant question is not whether the heart team should be preserved; rather, it is how it should be implemented in a modern, evidence-based, efficient, and patient-centered manner.

1. Support for Ending Coverage With Evidence Development for Symptomatic Severe Aortic Stenosis

I support CMS’s proposal to terminate coverage with evidence development for symptomatic severe aortic stenosis. The original TAVR coverage framework was appropriately developed at a time when TAVR was an emerging therapy and additional evidence was needed. The use of CED was justified in that historical context. However, the field has now moved well beyond the initial evidence-generating phase for the typical patient with symptomatic severe aortic stenosis.

CMS recognizes in the proposed decision memorandum that the current evidence base includes 17 randomized controlled trials involving approximately 10,686 TAVR-treated patients, as well as seven large registry-based studies including more than 450,000 patients. CMS further notes that the evidence spans a broad range of surgical risk profiles, symptom status, valve platforms, and follow-up durations from short-term to long-term outcomes. This mature evidence base demonstrates that the central CED questions for symptomatic severe AS have been sufficiently answered.

The safety and effectiveness of TAVR are now well established for appropriately selected patients with symptomatic severe aortic stenosis. Across randomized trials, TAVR has consistently demonstrated outcomes comparable to surgery in key safety endpoints, including death and disabling stroke, while offering important procedural advantages for many patients. In intermediate-risk patients, PARTNER 2 five-year data showed no significant difference between TAVR and surgery in death or disabling stroke at five years, particularly in the transfemoral-access cohort. In low-risk patients, PARTNER 3 five and seven-year outcomes demonstrated no significant between-group difference between TAVR and surgery in the primary composite outcomes, with similar rates of bioprosthetic valve failure. Similarly, the Evolut Low Risk trial has shown durable safety through longer-term follow-up, with comparable rates of death or disabling stroke between TAVR and surgery.

Real-world data also support the safety of contemporary TAVR practice. Large STS/ACC TVT Registry analyses demonstrate low contemporary 30-day mortality and provide important national surveillance of outcomes including stroke, bleeding, vascular complications, acute kidney injury, paravalvular regurgitation, pacemaker implantation, and valve reintervention. These real-world outcomes are particularly important because they reflect contemporary practice outside the confines of randomized trials.

Taken together, the randomized and registry evidence supports the conclusion that TAVR is no longer investigational for symptomatic severe AS. It is a mature, well-studied, safe, and effective therapy when performed in appropriate patients. Accordingly, routine coverage for symptomatic severe AS should no longer depend on evidence development as a condition of payment.

2. Preserve the Heart Team, but Focus It Where It Adds Value

I strongly support preservation of the heart team model. The heart team is valuable in ensuring that the right decision is being made for the right patient. Its purpose is to support collaboration, thoughtful patient selection, and shared decision-making.

The heart team is especially important in gray-zone situations: patients with complex anatomy, uncertain durability considerations, competing risks, concomitant coronary or valve disease, bicuspid anatomy, frailty, or circumstances in which both TAVR and SAVR are reasonable and appropriate. In these cases, collaboration between interventional cardiology and cardiac surgery, general cardiology, advanced practice clinicians, and other relevant team members is not merely procedural; it is central to good patient care.
At the same time, heart team participation should not become a rigid mandate that creates unnecessary visits or delays without improving clinical decision-making. Requiring a 90-year-old patient with straightforward symptomatic severe AS to see a surgeon solely because of a coverage mandate adds burden without meaningful value.

For this reason, I support CMS’s effort to streamline the pre-procedural evaluation process while maintaining the heart team concept. CMS’s proposal to allow an initial heart team evaluation to occur asynchronously through medical record review is appropriate. This approach preserves multidisciplinary oversight while avoiding unnecessary delays and duplicative encounters.

3. TAVR Should Not Be Regulated More Rigidly Than Comparable Cardiovascular Procedures Without a Clear Rationale

I do not believe there is anything inherent to TAVR, when compared with PCI or surgical valve replacement, that warrants a fundamentally different or more burdensome regulatory framework.
Other complex cardiovascular procedures rely on professional standards, registry participation, accreditation, hospital privileging, quality reporting, and continuous quality improvement processes without requiring an NCD to prescribe every operational element. Surgical valve replacement is not governed by an analogous NCD requirement, yet outcomes are monitored and quality is supported through the STS registry and related professional standards. PCI similarly relies on registry participation, institutional oversight, appropriateness criteria, and quality programs rather than a highly prescriptive NCD structure. The same principle should apply to TAVR.

4. Concerns About Widespread Poor-Quality TAVR Expansion Are Likely Overstated

Some stakeholders have expressed concern that loosening requirements will lead to inappropriate proliferation of TAVR programs and poor outcomes in low-volume or less-experienced centers. While patient safety must remain the highest priority, I believe this concern may be overstated.

TAVR programs do not develop in isolation. A credible program requires structural heart expertise, imaging, anesthesia support, vascular and surgical backup, postoperative care pathways, intensive care capability when needed, and a continuous quality improvement infrastructure. CMS’s proposed hospital criteria appropriately require on-site structural heart interventional cardiology and cardiac surgery programs, a post-procedure intensive care unit with personnel experienced in managing open-heart valve patients, and a continuous quality improvement process that assesses outcomes and makes programmatic adjustments.

These infrastructure requirements are meaningful safeguards that help to ensure patients being evaluated for surgical AVR appropriately have access to transcatheter options as well. Relaxing selected procedural or documentation requirements does not automatically result in unsafe programs, just as the absence of an NCD for surgical valve replacement does not mean that surgical valve programs are created without infrastructure, expertise, or oversight.

5. The STS/ACC TVT Registry Remains Highly Valuable, Particularly if Other Criteria Are Streamlined

I strongly support continued use of the STS/ACC TVT Registry as a tool for quality assessment, benchmarking, self-evaluation, and continuous improvement. The registry has been central to the responsible development of the TAVR field and remains one of the most important mechanisms for monitoring real-world outcomes.

If the CMS coverage criteria for TAVR are loosened as is proposed, the importance of robust quality monitoring increases rather than decreases. That said, the value of the TVT Registry does not necessarily mean that registry participation must remain embedded in the NCD as a condition of coverage for all symptomatic severe AS cases. The STS registry captures >95% of cardiac surgical cases across the United States without an NCD mandating participation. The NCDR CATHPCI registry similarly captures more than 90% of PCI procedures despite the absence of a mandate for participation. There is no clear reason why TAVR should be treated differently. It will be incumbent upon us as a multidisciplinary structural community, not CMS, to ensure a high degree of participation within the ACC/STS TVT Registry.

6. Support for CED in Asymptomatic Severe Aortic Stenosis

I support CMS’s proposal to distinguish symptomatic severe AS from asymptomatic severe AS. CMS appropriately notes that more data are needed for asymptomatic patients, including questions related to TAVR versus SAVR versus surveillance, long-term valve reintervention, durability, and outcomes in patients with longer life expectancy or lower surgical risk.

Conclusion

The TAVR NCD was originally designed for an era in which TAVR required structured evidence development. That approach was appropriate and successful. More than a decade later and with nearly 800,000 TAVRs performed in the US, the field has generated a robust body of randomized and real-world evidence for symptomatic severe aortic stenosis. The policy should now evolve accordingly.

The safety of contemporary TAVR is supported by randomized trial data across surgical risk groups and by large real-world registry experience. This does not mean that TAVR is appropriate for every patient, nor does it eliminate the need for careful heart team evaluation. It does mean, however, that routine TAVR for appropriately selected patients with symptomatic severe AS should no longer be treated as investigational or dependent on CED.

CMS should preserve what matters: the heart team, patient-centered decision-making, appropriate infrastructure, and continuous quality improvement. At the same time, CMS should streamline or eliminate requirements that no longer meaningfully improve care and may instead create unnecessary burden for patients and clinicians. The goal should be a modernized coverage policy that supports access and maintains quality. CMS’s proposed changes are consistent with that goal, appropriately balancing patient access, clinical judgment, evidence-based care, and continued quality oversight.

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[PHI Redacted]

I strongly support CMS's proposed updates to modernize the National Coverage with Evidence Development (CED) for severe disease. Relying on symptoms as a gatekeeper for TAVR is a lethal policy. [PHI Redacted]

My experience navigating this condition highlights three critical areas for system-wide improvement:

Administrative Inconsistency: Even with an exceptional care team at Emory, the system remains opaque. Patients can leave an appointment feeling confident, only to log into MyChart at home to find unexpected, conflicting financial surprises. This administrative inconsistency causes real physical stress and anxiety that patients should not have to manage.
Equity and Geography: We must remove geographical roadblocks to care. Systemic barriers continue to dictate health outcomes, and we cannot continue to echo these exclusionary trends.
Empowering the Next Generation: My advocacy work is driven by the need to empower, not restrict. We must support student athletes with congenital heart conditions by ensuring universal access to AEDs and comprehensive, proactive cardiac screening. Every young athlete deserves the chance to pursue their potential—whether that is the Olympics or the Paralympics—without being arbitrarily benched by outdated policies.

Federal policy must be driven by Science, Empathy, and Action.

Sincerely,
Kim Klatt
Patient Advocate, Heart Valve Voice US

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On behalf of the Association of Black Cardiologists (ABC), we appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services' (CMS) Proposed Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR) and thank the agency for its consideration of our input and recommendations.

About ABC

Founded in 1974, the Association of Black Cardiologists (ABC) is a nonprofit organization with a global membership of over 2,000, including health professionals, community health advocates, and institutional members. ABC's mission is to promote the prevention and treatment of cardiovascular disease, including stroke, in Black populations and other minority groups, striving for health equity through the elimination of disparities. ABC’s inclusive membership welcomes all who align with its mission and vision. Through advocacy, education, research, and partnerships, ABC advances cardiovascular health and improves outcomes in communities nationwide. Learn more at www.abcardio.org.

ABC Comments on Proposed Decision

ABC strongly supports CMS's proposed reconsideration of the TAVR National Coverage Determination (NCD) and commends the agency for advancing policies that better reflect current clinical evidence, expand patient access to life-saving therapy, and modernize Medicare coverage criteria.

Support for Coverage Expansion to Asymptomatic Patients with Severe Aortic Stenosis

ABC commends CMS for proposing to expand coverage to appropriately selected asymptomatic patients with severe aortic stenosis. As we noted in our prior comments, severe aortic stenosis is a progressive and potentially fatal disease for which timely intervention is critical. Emerging evidence demonstrates that earlier treatment in carefully selected asymptomatic patients can prevent irreversible cardiac damage, reduce the risk of acute decompensation, and improve long-term outcomes.

The proposed coverage expansion, under Coverage with Evidence Development (CED), represents an important step toward facilitating earlier intervention and reducing treatment delays that can contribute to avoidable complications and death. This policy change may be particularly helpful to patients who face barriers to specialty care and are at risk of seeking treatment only after the disease has significantly progressed.

Therefore, we urge CMS to finalize expanding coverage to asymptomatic patients in the final decision memorandum.

Support for Retirement of CED for Beneficiaries with Symptomatic Severe Aortic Stenosis

ABC applauds CMS's proposal to retire the longstanding CED framework for beneficiaries with symptomatic severe aortic stenosis.

When the original CED requirements were established, TAVR was an emerging technology with a limited evidence base. In contrast, today, more than a decade of clinical experience and clinical trial data demonstrate that TAVR is a safe and effective therapy. Furthermore, removing the CED framework will help align Medicare coverage policy with current clinical practice and eliminate barriers to patients receiving the care they need.

As such, we agree with CMS that the evidence supporting TAVR has matured sufficiently to justify routine Medicare coverage for symptomatic severe aortic stenosis without the additional restrictions imposed through CED and encourage CMS to finalize this policy change in the final decision memorandum.

Support for Modernization of Heart Team, Operator, and Facility Requirements

We appreciate CMS's efforts to modernize physician, heart team, and facility requirements to better reflect current standards of care.

The proposed changes appropriately preserve clinical oversight while providing greater flexibility in the patient evaluation process. ABC supports CMS's recognition that quality should be measured through patient outcomes and evidence-based standards rather than procedural volume thresholds alone. The proposed revisions maintain important patient protections while reducing unnecessary administrative and operational burdens that may limit access to care.

We appreciate CMS's willingness to reconsider historical assumptions regarding procedural volume and quality, and we support continued evaluation of patient-centered outcomes as a more meaningful measure of program performance.

Access, Utilization, and Health Equity Considerations

We continue to recognize the potential access implications of the proposed policy changes in this proposed decision memorandum. As we stated in our previous comments, Black and Hispanic beneficiaries continue to be significantly underrepresented among TAVR recipients despite higher prevalence of cardiovascular disease. Delayed diagnosis, failure to follow-up, limited access to specialty care, and geographic barriers continue to contribute to disparities in the utilization of available heart therapies and contribute to differences in outcomes. While coverage policy alone cannot eliminate these disparities, the proposed expansion of coverage and removal of unnecessary coverage restrictions represent important steps toward improving access for medically underserved populations.

We note that CMS’ CED Guidance Document cited in the Proposed Decision Memorandum outlines scientific standards to which CMS-approved CED studies must adhere. We note that among these requirements are one that the study population must reflect “the demographic and clinical diversity among the Medicare beneficiaries who are the intended population of the intervention” and that the study protocol explicitly address “beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion requirements effect [sic] enrollment of these populations, and a plan for the retention and reporting of said populations in the trial.” We appreciate this important recognition of the need to ensure CED studies are inclusive and that sponsors/investigators provide details regarding “plans for analyzing demographic subpopulations as well as clinically-relevant subgroups as identified in existing evidence.” Ensuring that CED studies involving asymptomatic patients with severe aortic stenosis meet these criteria will help further the body of knowledge regarding TAVR access and outcomes for all beneficiaries, particularly those from rural and underserved communities. As CMS finalizes this NCD, ABC encourages the agency to continue monitoring the impact of these policy changes on access to care among rural, minority, and historically underserved patient populations.

Conclusion

Overall, ABC strongly supports the direction of the Proposed Decision Memorandum and urges CMS to finalize the proposal. We thank CMS's continued leadership in modernizing Medicare coverage policies and look forward to working with the agency to improve cardiovascular outcomes for all beneficiaries.

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I have been following closely along with many of my colleagues, the proposed changes to NCD for TAVR. I am in full support of expanding coverage to "asymptomatic severe AS patients based on our institutional outcomes as well as results from Early TAVR study that showed definite benefit to TAVR even in asymptomatic patients. I also strongly support the concept and composition of the heart team and feel consensus opinion for patient therapy, ie, TAVR versus SAVR, should be documented between the interventional cardiologists and CT surgeons.

However I am not in support of ending CED requirements for TVT-R reporting. The high quality of care expected of TAVR patients driven by comprehensive and standardized data must not be compromised, especially as we are just now getting reliable long term outcomes for low risk patients.
I am also very concerned with the proposal of eliminating volume requirements and replacing the dual operator requirement. I believe this would result in competition instead of collegiality between interventional cardiac physicians and CT surgeons. I have performed over 1500 TAVR procedures in the last 10 years and feel that the procedure is definitely a two physician procedure during the deployment of the TAVR bioprosthesis, and that it is also critical to have the skill sets of both an interventional cardiologist and CT surgeon to be present in the event a major complication occurs. Complications are unpredictable for a lot of patients but a team of an interventional cardiologist and CT surgeon is definitely needed and necessary to best treat the complications that can arise during this procedure.

Thank you in advance for your consideration of these views.

Respectfully
Dr. Duane Berkompas

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Dear CMS Coverage and Analysis Group,

Thank you for the opportunity to comment on the proposed revisions to the National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR). As an interventional cardiologist with experience caring for patients with structural heart disease, I appreciate CMS's efforts to update the policy in response to the expanding evidence base and evolution of TAVR practice.

Overall, I support the majority of the proposed changes, including the removal of Coverage with Evidence Development (CED) for symptomatic severe aortic stenosis and the modernization of the Heart Team and hospital requirements. I would, however, like to offer several recommendations for consideration.

1. Encourage dual-operator participation in appropriate TAVR procedures.

The proposal appropriately states that two TAVR operators are not required for every case. However, CMS should recognize that dual-operator participation can improve procedural efficiency, facilitate management of unexpected complications, enhance education and mentorship, and support optimal patient care, particularly for anatomically or clinically complex cases. When two qualified operators actively participate in a procedure, reimbursement policies should appropriately recognize the contributions of both physicians rather than creating a financial disincentive for collaborative care.

2. Refine the role of the Heart Team.

The Heart Team model has been instrumental in the safe adoption of TAVR and remains valuable for complex decision-making. However, for many patients with symptomatic severe aortic stenosis, the appropriate treatment strategy is straightforward based on current evidence and guideline recommendations. In these situations, mandatory multidisciplinary review often becomes an administrative exercise with limited impact on clinical decision-making.

CMS should consider allowing Heart Team discussions to focus primarily on patients with complex anatomy, multiple treatment options, uncertain procedural risk, or other factors where multidisciplinary input is most likely to influence management. This approach would preserve the strengths of the Heart Team model while improving efficiency and reducing unnecessary administrative burden.

Furthermore, if CMS continues to require formal Heart Team evaluation for patients undergoing TAVR, consideration should be given to applying a comparable multidisciplinary evaluation process for patients undergoing surgical aortic valve replacement (SAVR). Patients should receive consistent standards of multidisciplinary evaluation regardless of the treatment modality ultimately selected.

3. Increase the minimum operator volume requirements.

I am concerned that the proposed operator threshold of 20 transcatheter valve procedures annually, including 15 TAVR procedures, is too low to ensure maintenance of procedural proficiency. Lower thresholds may unintentionally increase the number of low-volume operators, which could adversely affect patient outcomes.

I recommend increasing the requirement to at least 30 transcatheter valve procedures annually, including a minimum of 25 TAVR procedures. These thresholds would better reflect the technical complexity of TAVR, promote continued operator expertise, and more closely align with the philosophy underlying CMS procedural volume expectations for percutaneous coronary intervention (PCI) programs.

While procedural volume should not be the sole measure of quality, maintaining adequate annual experience remains an important component of operator competency, particularly as TAVR expands into younger and lower-risk patient populations where procedural excellence and long-term outcomes are paramount.

4. Strengthen training requirements for new TAVR operators.

As TAVR has become a standard component of interventional cardiology fellowship training, it is important to recognize that participation during fellowship does not necessarily confer independent procedural competency. Graduates who have observed or assisted with TAVR procedures may still require additional structured training, proctoring, or dedicated structural heart fellowship experience before independently performing TAVR.

Alternatively, CMS could require substantially higher procedural experience before recently trained physicians qualify as independent TAVR operators. Such measures would help ensure that newly credentialed operators have achieved sufficient technical proficiency and clinical judgment to safely perform these complex procedures.

In summary, I believe the proposed NCD represents a significant and appropriate modernization of Medicare coverage for TAVR. Incorporating the recommendations outlined above would further strengthen the policy by promoting high-quality collaborative care, preserving procedural expertise, supporting rigorous operator training, and maintaining excellent outcomes for Medicare beneficiaries.

Thank you for your consideration of these comments and for your continued commitment to evidence-based cardiovascular care.

Sincerely,

Kapildeo Lotun, MD, FACC, FSCAI
Interventional Cardiologist

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To: Centers for Medicare & Medicaid Services (CMS)

Re: Public Comment on Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR) in Asymptomatic Severe Aortic Stenosis

Subject: Evidentiary Deficiencies, Patient Safety Concerns, and the Standard of "Reasonable and Necessary" Coverage

From: Eugenio Mulero-Portela, MD, FACS, FCCP. Director of Cardiovascular Surgery. Mayaguez Medical Center, Mayaguez, Puerto Rico.

To Whom It May Concern,

I am writing to formally submit a public comment expressing deep concern regarding the proposed Decision Summary to expand National Coverage for Transcatheter Aortic Valve Replacement (TAVR) to include asymptomatic patients with severe aortic stenosis. The Centers for Medicare & Medicaid Services (CMS) is urged to reconsider this expansion, as the current proposed Decision Summary relies on structurally flawed, industry-funded clinical trial data that fails to demonstrate a true clinical benefit for this patient population. Expanding coverage at this juncture removes critical safeguards, ignores profound long-term anatomical risks, and fails to protect vulnerable Medicare beneficiaries from premature, unmonitored interventions.

As detailed below, the proposed policy fails to meet the standard of "reasonable and necessary" under Section 1862(a)(1)(A) of the Social Security Act [NCT03042104, healthaffairs.061126] for the following critical reasons:

-Misleading evidentiary basis and absence of hard endpoint data: The summary mischaracterizes the efficacy of early intervention by relying on the industry-funded EARLY TAVR trial [NCT03042104, mddionline.012826]. This trial exhibited severe performance and design biases, and most importantly, demonstrated an absence of hard endpoint data, showing no statistical difference in all-cause mortality or stroke between groups [NCT03042104].

-Flawed extrapolation of surgical data to transcatheter platforms: The decision mistakenly relies on historical data from trials like RECOVERY or AVATAR. Applying those results here represents a dangerous extrapolation of surgical data to transcatheter platforms, completely ignoring TAVR-specific long-term complications [acc.052626.1315].

-Severe clinical risks of early implantation (and explantation), a 5- to 7-years horizon: Implanting a TAVR valve too early essentially "starts a ticking clock" on valve decay while a patient is still perfectly healthy, introducing several serious long-term consequences when the patient outlives the valve:

-Incentivizing real-world overutilization and systemic abuse: By broadening coverage without strict, objective clinical guardrails, CMS is opening the door to widespread commercial overutilization and daily clinical abuse of TAVR in patients who are far more safely managed via rigorous, non-invasive clinical surveillance [NCT03042104].

-Total lack of national registry data transparency: The reliance on existing registry frameworks to protect patients is deeply flawed. To date, there has been no open disclosure of the national TAVR registry data regarding long-term real-world outcomes and catastrophic complications to the broader medical community [acc.061726, healthaffairs.061126]. Doctors are being asked to approve a massive expansion of coverage while the actual real-world failure and complication rates of these devices remain hidden behind closed industry doors.

-Failure of regulatory oversight and non-compliance: Even worse, the current system allows for severe tracking failures. There are active clinical centers completely bypassing data tracking and not participating in or generating any registry reporting at all [cms.070126, healthaffairs.061126]. Allowing a premature expansion of TAVR into healthy, asymptomatic populations while simultaneously failing to mandate or police universal registry compliance is a profound regulatory failure.

-Absence of Coverage with Evidence Development (CED) enforcement: If CMS intends to permit access to early TAVR for asymptomatic patients [beckerscardiology.061726], doing so without a highly restrictive, fully transparent Coverage with Evidence Development (CED) mandate is a severe oversight [healthaffairs.061126]. Without an audited, registry-bound CED framework that forces open data sharing, CMS cannot protect beneficiaries from hidden, long-term, high-risk redo-TAVR complications [acc.052626.1315, healthaffairs.061126].

For these reasons, CMS must reject the broad expansion of coverage as currently written to protect vulnerable beneficiaries from premature, unmonitored, and inappropriate interventions.

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I am writing in support of the proposed updates to the TAVR National Coverage Determination. As a board-certified interventional cardiologist with advanced structural heart disease training and significant TAVR procedural volume, I believe these changes represent a meaningful step forward for patients and for the rational evolution of coverage policy.

On Streamlining Evaluation Requirements
The existing requirement for a mandatory surgical evaluation prior to TAVR imposes a real burden on the patients it is meant to protect. Elderly and frail patients, the very population most likely to benefit from transcatheter intervention, often face significant logistical, physical, and emotional challenges with each additional clinical visit. Moreover, this requirement disproportionately burdens rural, low-income, and medically underserved patients who lack reliable transportation or local access to a cardiothoracic surgeon. Removing it aligns directly with CMS's stated health equity priorities. The appropriate model already exists in the management of complex coronary artery disease, where the treating interventional cardiologist exercises independent clinical judgment and refers selectively to surgery when indicated. TAVR decision-making should operate under the same framework.

On Intraoperative Surgeon Presence
In current practice, the mandatory co-operator requirement for cardiac surgeons during TAVR does not reflect the operational reality of the procedure. TAVR has matured into a well-defined transcatheter technique, and in the vast majority of cases, the cardiac surgeon's intraoperative contribution is minimal. Contemporary national data show surgical conversion rates of approximately 1%. This arrangement creates logistical strain for both programs and surgical colleagues without meaningfully contributing to procedural safety or outcomes.
Furthermore, this dynamic places surgical colleagues in an uncomfortable professional position, present as nominal participants in a procedure that is primarily operator-dependent on the interventional cardiologist at many centers. This underutilizes their expertise and, paradoxically, directs their time and attention away from the surgical competencies that will matter most as TAVR volumes grow. An on-call backup model preserves rapid response capability without this cost.

On Surgical Training and the Growing Explant Burden
Perhaps the most important reason to redirect surgical involvement away from routine TAVR co-operation is this: the cardiac surgery community faces an urgent and growing need to develop expertise in TAVR valve explantation. As transcatheter valves are now being implanted in younger, lower-risk patients with longer life expectancies, valve explantation, the complex open surgical removal and replacement of a failed TAVR device, is the fastest-growing category of cardiac surgery in the United States by procedural rate. These operations are technically demanding, carry substantial risk, and require a distinct surgical skill set that many centers have not yet developed. Requiring surgeons to serve as nominal co-operators during routine TAVR cases does not build this competency. It occupies their time with a largely passive role while the true surgical need, explant training and volume, goes unmet. CMS coverage policy should encourage a model that frees cardiac surgeons to focus on developing and maintaining the operative skills that will protect TAVR patients over the long arc of their care: complex redo surgery, explantation, and management of transcatheter valve failure. Surgical societies should likewise be encouraged to prioritize explant training as a core competency in cardiac surgery programs.

Conclusion
The proposed changes appropriately recognize the procedural maturity of TAVR, the strength of the existing evidence base, and the importance of reducing unnecessary barriers to access, particularly for vulnerable Medicare beneficiaries. The appropriate model is a robust multidisciplinary heart team that deliberates on case selection and treatment strategy, supported by on-call surgical backup, without requiring intraoperative surgical presence as a default condition of coverage. I strongly support finalization of these proposals and encourage CMS to adopt a coverage framework that places clinical judgment, heart team collaboration, and patient-centered decision-making at the center of TAVR care.

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Some of the proposed changes need to be reconsidered.

First, we should maintain a focus on quality. Therefore programs performing TAVR need to continue to participate in a national registry which tracks patient data and outcomes. This allows the TAVR programs to continue to evaluate outcomes and institute quality improvement measures. I think mandatory participation should be maintained as, in order to ensure excellent patient outcomes, this should not be an optional process.

Second, the multidisciplinary heart team should be maintained. The patient should be evaluated by both an interventional cardiologist and a cardiothoracic surgeon. Furthermore, it makes sense that the procedures would also be performed by an interventional cardiologist and cardiothoracic surgeon. Logistically, it takes 2 operators to deploy the currently available TAVR systems. Given that the 2 specialists have already developed a relationship with the patient and possess expertise from 2 different fields, required participation by both specialists in the procedure itself should be maintained. Furthermore, if a severe complication occurs, expertise from both specialties may be required in order to save the patient's life.

I agree with coverage for TAVR for patients with asymptomatic AS, however, it should be utilized in select cases in which the multidisciplinary heart team feels that it will benefit the patient.

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July 8, 2026

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

Dear Administrator Oz,

On behalf of Heart Valve Voice US, a national nonprofit patient advocacy group dedicated to enhancing the lives of individuals affected by heart valve disease, we appreciate the opportunity to comment on the National Coverage Decision (NCD) proposed decision memo for Transcatheter Aortic Valve Replacement (TAVR).

As an organization representing patients and families living with heart valve disease, we see every day how timely access to treatment can change lives. One such patient is Mary, who was diagnosed with asymptomatic aortic stenosis more than 15 years ago. Through years of careful monitoring, subtle changes in her mobility and imaging revealed disease progression even before she experienced severe symptoms. Her physicians recognized the importance of intervening before irreversible damage occurred and recommended TAVR. Mary underwent the procedure in March 2026, returned home the next day and quickly experienced improvements in her energy, sleep, physical activity, and overall quality of life. Her experience underscores why flexibility in coverage is essential for patients whose disease progresses before symptoms become severe.

We commend CMS for proposing meaningful updates that reflect how TAVR is practiced today. We strongly support eliminating Coverage with Evidence Development (CED) for patients with symptomatic severe aortic stenosis, removing unnecessary facility requirements, modernizing operator standards, and streamlining patient evaluations. These updates meaningfully reduce barriers to care while preserving high-quality treatment standards.

Ending CED for symptomatic patients is particularly important. TAVR has been supported by years of clinical evidence and is now an established standard of care. [1] Patients with severe symptomatic aortic stenosis should not face administrative requirements that may delay access to this proven, life-saving therapy.

We also appreciate CMS's efforts to improve access by modernizing both facility and operator requirements, replacing outdated volume metrics with more flexible, evidence-aligned standards that better reflect how TAVR is practiced today. Patients should be able to receive high-quality care as close to home as possible. Mary was fortunate to undergo TAVR at a hospital just 20 miles from her home, allowing her to receive timely treatment without the burden of traveling a long distance. However, for the millions of Americans who do not live near a facility meeting historic volume thresholds, these requirements may unintentionally limit access to timely care. [2]

Mary was fortunate to receive care at a center where she was evaluated by both an interventional cardiologist and a cardiothoracic surgeon. We support preserving this multidisciplinary Heart Team approach whenever feasible, while appreciating CMS's updated standards that allow patients to meet Heart Team evaluation requirements with only one in-person visit and modernize operator requirements by allowing a single operator to perform the procedure – providing needed flexibility for those who live far from specialty centers. This modernization of operator and evaluation requirements helps ensures that patients can receive timely, high quality care close to home while maintaining the collaborative decision making that is central to TAVR.

While we applaud these important improvements, we remain concerned that the proposed policy continues to require CED for patients with asymptomatic severe aortic stenosis. Under CED, Medicare coverage may be limited to patients treated at certain hospitals or participating in approved clinical studies while additional evidence is collected. As a result, otherwise eligible beneficiaries may face barriers or delays in accessing timely treatment, even when their physicians determine that early intervention is the most appropriate course of care.

Mary's experience illustrates why this issue matters. Although she did not have severe symptoms, careful monitoring revealed disease progression, and her physicians recommended intervention before significant decline occurred. Today, she believes that acting earlier is what enabled her rapid recovery and the dramatic improvement in her quality of life. As evidence supports earlier intervention for appropriately selected patients with asymptomatic severe aortic stenosis [3], we encourage CMS to establish a pathway toward broader national coverage. Patients should not have to wait until their disease has progressed to experience the benefits of treatment.

Heart Valve Voice US appreciates CMS's commitment to modernizing coverage policy in a way that reflects today's evidence and the experiences of patients. Mary's story is just one example of how timely access to TAVR can preserve independence, improve quality of life, and help patients continue living full, active lives. We look forward to continuing to work with CMS to ensure that every patient has access to the care they need in a timely manner.

Sincerely,
Berkeley Barnett
Director, Policy & Advocacy
Heart Valve Voice US

[1] Carroll, J. D., Mack, M. J., Vemulapalli, S., Herrmann, H. C., Gleason, T. G., Hanzel, G., … Bavaria, J. E. (2020). STS-ACC TVT Registry of transcatheter aortic valve replacement. Journal of the American College of Cardiology, 76(21), 2492–2516. https://doi.org/10.1016/j.jacc.2020.09.595
[2] Bergman, A., David, G., Nathan, A., Giri, J., Ryan, M., Chikermane, S., Thompson, C., Clancy, S., & Gunnarsson, C. (2024). Measuring hospital inpatient Procedure Access Inequality in the United States. Health Affairs Scholar, 2(11). https://doi.org/10.1093/haschl/qxae142
[3] Philippe Généreux, Schwartz, A., J. Bradley Oldemeyer, Philippe Pibarot, Cohen, D. J., Blanke, P., Lindman, B. R., Vasilis Babaliaros, Fearon, W. F., Daniels, D. V., Chhatriwalla, A. K., Kavinsky, C., Gada, H., Shah, P., Szerlip, M., Dahle, T., Goel, K., O’Neill, W., Sheth, T., & Davidson, C. J. (2024). Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2405880

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Centers for Medicare & Medicaid Services Coverage and Analysis Group:

Boston Scientific Corporation (BSC) appreciates the opportunity to comment on CMS’s proposed update to the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination (NCD). BSC is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We develop and supply medical devices in numerous clinical areas, including cardiology, which serve the needs of patients, including Medicare beneficiaries.

BSC agrees with the overall direction of CMS’s proposed decision. Specifically, BSC supports covering TAVR for symptomatic severe aortic stenosis (AS) without Coverage with Evidence Development (CED), expanding coverage to asymptomatic severe AS under CED to align Medicare coverage with updated FDA labeling and generate clinical evidence to answer targeted research questions, and increasing flexibility in the facility, operator, and heart team requirements.

Since CED was first established, the clinical evidence base for TAVR in symptomatic severe AS has expanded significantly (1,2) and continues to strengthen (3-6). BSC agrees continued CED is no longer necessary for this population.

For asymptomatic severe AS, the evidence base is still emerging (7). Targeted evidence generation can help address remaining questions related to patient selection, timing of intervention, long-term outcomes, and durability. We support CMS's approach to removing CED for symptomatic severe AS, while applying targeted CED requirements to the asymptomatic population to address the remaining evidence gaps.

The proposed revisions to the facility, operator, and heart team requirements also appropriately reflect contemporary TAVR practice. In particular, we support CMS’s efforts to reduce volume requirements that may no longer serve as meaningful proxies for quality, while maintaining appropriate safeguards for patient safety and program accountability (8-10). Greater flexibility in patient evaluation, care coordination, and procedural staffing can help preserve access to timely care without compromising quality.

BSC recognizes the importance of clinician-patient shared decision-making in selecting the most appropriate treatment for patients with severe AS. CMS appropriately recognizes no fully developed decision tool is currently available to support shared decision-making for TAVR for AS. We therefore agree it is appropriate to encourage shared decision-making but not require it as a condition of coverage.

BSC requests CMS clarify the applicable benefit categories for TAVR to include outpatient hospital services, in addition to inpatient hospital services and physicians’ services. As clinical practice and Medicare payment policy continue to evolve, including potential changes to the Inpatient-Only List, the NCD should preserve flexibility for TAVR to be covered in any clinically appropriate site of care payable under the Medicare program. Including outpatient hospital services as an applicable benefit category would support alignment between coverage and potential future payment policy while preserving patient access across clinically appropriate hospital settings.

At the same time, BSC requests CMS explicitly exclude ambulatory surgical centers (ASCs) as an appropriate site of service for TAVR procedures. ASCs do not have access to the appropriate infrastructure, such as on-site structural heart interventional cardiology and cardiac surgery programs and post-procedure intensive care units, which remain important safeguards for patients undergoing TAVR.

BSC appreciates CMS’s efforts to update the TAVR NCD in a manner that reflects the current evidence base, supports targeted evidence generation where appropriate, and preserves access to high-quality care. Thank you for your consideration of these comments.

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

1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1695-1705.
2. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1706-1715.
3. Jørgensen TH, Thyregod HGH, Ihlemann N, et al. Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement. Eur Heart J. 2021;42(30):2912-2919.
4. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. N Engl J Med. 2023;389(21):1949-1960.
5. Leon MB, Mack MJ, Pibarot P, et al. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med. 2026;394(8):773-783.
6. Forrest JK, Yakubov SJ, Deeb GM, et
al. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2025;85(15):1523-1532. 7. Genereux P, Schwartz A, Oldemeyer JB, et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2025;392(3):217-227.
8. Desai ND, O'Brien SM, Cohen DJ, et al. Composite Metric for Benchmarking Site Performance in Transcatheter Aortic Valve Replacement: Results From the STS/ACC TVT Registry. Circulation. 2021;144(3):186-194.
9. Kumbhani DJ, Manandhar P, Bavry AA, et al. National Variation in Hospital MTEER Outcomes and Correlation With TAVR Outcomes: STS/ACC TVT Registry Analysis. JACC Cardiovasc Interv. 2024;17(4):505-515.
10. Russo MJ, McCabe JM, Thourani VH, et al. Case Volume and Outcomes After TAVR With Balloon-Expandable Prostheses: Insights From TVT Registry. J Am Coll Cardiol. 2019;73(4):427-440.

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As a practicing interventional cardiologist, I strongly support CMS's proposal to expand coverage for patients with asymptomatic severe aortic stenosis under Coverage with Evidence Development (CED). The draft policy appropriately recognizes the growing body of evidence supporting earlier intervention in carefully selected patients before irreversible cardiac damage, heart failure, hospitalization, or symptom progression occurs. The inclusion of asymptomatic patients under CED creates an important pathway for Medicare beneficiaries to access potentially beneficial therapy while continuing to generate high-quality evidence through ongoing study participation. The draft NCD specifically expands coverage to include asymptomatic severe AS patients under CED while maintaining Heart Team oversight.

From a patient perspective, severe aortic stenosis is a progressive disease, and many patients classified as "asymptomatic" have already begun to reduce their activity levels or adapt their lifestyle to avoid symptoms. Waiting for overt symptom development may result in missed opportunities to intervene before deterioration occurs. The proposed policy allows physicians and Heart Teams to apply clinical judgment and emerging evidence to identify appropriate patients who may benefit from earlier treatment, potentially preserving functional status, independence, and quality of life. The draft NCD's inclusion of asymptomatic severe AS under CED reflects this opportunity to improve access while continuing evidence generation.

Equally important, the proposed flexibility in the evaluation process helps remove unnecessary barriers that can delay treatment. While I strongly support the multidisciplinary Heart Team model, requiring multiple mandated in-person evaluations can create scheduling bottlenecks, increase travel burden for elderly patients and caregivers, and prolong the time from diagnosis to treatment. The draft policy's streamlined evaluation process—which allows an initial Heart Team assessment through chart review or asynchronous evaluation and requires one independent in-person evaluation by a TAVR operator—maintains appropriate clinical oversight while reducing unnecessary logistical burden.

This change would be particularly valuable for straightforward patients. For example, a 90-year-old patient with severe aortic stenosis who is clearly appropriate for transfemoral TAVR based on imaging, anatomy, comorbidities, and Heart Team review may derive little additional benefit from a separate in-person surgical approval visit. The cardiac surgeon remains a critical member of the Heart Team and should continue to participate in patient selection and treatment planning; however, the team should have flexibility to determine the most appropriate evaluation pathway based on the patient's clinical presentation rather than being required to satisfy a prescriptive administrative process.

For hospitals and health systems, these changes have the potential to improve operational efficiency, reduce appointment duplication, decrease resource utilization, and accelerate patient access to therapy. Earlier treatment of appropriate asymptomatic patients may also help avoid future emergency department visits, heart failure admissions, and other downstream complications associated with disease progression. Overall, the proposed policy appropriately balances patient safety, evidence generation, Heart Team collaboration, and timely access to care, while allowing clinicians to tailor evaluation and treatment pathways to the individual needs of each patient. The draft NCD emphasizes streamlined patient evaluation, greater flexibility for Heart Teams, and improved patient access while maintaining quality oversight.

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Re: Public Comment on CMS Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR), CAG-00430R2

Dear CMS Coverage and Analysis Group,

I am submitting this comment in support of the proposed changes to the TAVR National Coverage Determination, specifically the removal of Coverage with Evidence Development for symptomatic severe aortic stenosis, the expansion of coverage for asymptomatic severe aortic stenosis under CED, the removal of hospital procedural volume requirements, and the modernization of physician, heart team, and evaluation requirements.

I write as a healthcare executive responsible for advancing access, outcomes, clinical integration, and community-based care. For health systems serving diverse communities, Medicare coverage policy is not abstract. It determines whether patients receive timely care close to home, whether clinicians can move efficiently from diagnosis to treatment, and whether hospitals can organize cardiovascular services around patient need rather than administrative complexity.

TAVR is no longer an emerging therapy for symptomatic severe aortic stenosis. It is a mature, evidence-supported intervention that is central to contemporary valve care. Removing CED for symptomatic severe AS is an overdue step. Continued CED requirements in this population delay care without proportionate benefit to patients, clinicians, or the Medicare program.

I support the proposal to expand coverage for asymptomatic severe AS under CED. This is a responsible bridge between emerging evidence and Medicare coverage. CMS should ensure that CED requirements answer meaningful clinical questions while remaining operationally feasible, so that community-based and regionally integrated programs can participate without infrastructure burden that functions as a barrier to the beneficiaries the policy intends to help.

I support the movement away from hospital procedural volume requirements. Volume thresholds can concentrate care, extend travel times, and delay treatment for older adults, rural patients, and underserved communities, without reliably predicting patient-centered outcomes. Quality is better protected through heart team expertise, appropriate on-site infrastructure, continuous quality improvement, outcomes monitoring, and transparent accountability.

I also urge CMS to preserve, and where feasible extend, the proposed flexibility in how heart team evaluation is conducted. In many regions, cardiac surgery capacity is concentrated in a small number of surgeons per program, against the backdrop of a documented and worsening cardiothoracic surgery workforce shortage. Requirements that mandate duplicative, in-person surgeon evaluation for every candidate convert a national workforce constraint into a patient access barrier, delaying care without measurable outcome benefit. The proposed allowance for chart-based triage, and for a secondary evaluation conducted in person, by telehealth, or through additional review, directly addresses this constraint and should be retained. Scarce surgical capacity should be directed toward operative care and complex clinical decision-making, not toward administrative evaluation steps that do not change the clinical recommendation. The heart team, supported by outcomes monitoring, remains the appropriate safeguard.

From an executive standpoint, the objective is alignment. Coverage requirements should reinforce safe, high-quality care while allowing health systems to build access where patients live. Prescriptive requirements consume clinical and administrative capacity that could otherwise coordinate care, reduce wait times, support valve clinics, improve follow-up, and address disparities. Administrative burden is not neutral. It has consequences for patients, clinicians, and communities.

The proposed revisions are directionally correct. I encourage CMS to finalize a policy that:

1. Covers TAVR for symptomatic severe AS without CED;
2. Expands access for appropriate asymptomatic severe AS patients under a feasible CED framework;
3. Removes unnecessary hospital volume requirements;
4. Preserves heart team based, patient-centered decision-making, including the cardiac surgeon’s role on the team;
5. Preserves the proposed flexibility in evaluation modality so that scarce surgical and clinical capacity is directed to care rather than redundant administrative steps;
6. Uses outcomes-based quality oversight rather than blunt structural proxies; and
7. Enables communities to receive advanced cardiovascular care closer to home.

Medicare beneficiaries deserve timely access to evidence-based valve care without unnecessary administrative friction. Health systems need a coverage framework that supports quality, accountability, and community access simultaneously. The proposed changes move policy in that direction, and I respectfully urge CMS to finalize them with continued attention to reducing burden, improving outcomes, and expanding equitable access.

Respectfully submitted,

Gordon Wesley
Chief Strategy & Clinical Integration Officer
UChicago AdventHealth
gordon.wesley@adventhealth.com

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I am a young surgeon, but even in my short career I have seen the profound role and necessity to preserve the Heart Team model for TAVR. The multidisciplinary Heart Team model has been fundamental to the safe and appropriate adoption of TAVR, and removing cardiac surgeons from this process would represent a step backward in patient-centered care. While TAVR has transformed the treatment of aortic stenosis, the decision between transcatheter and surgical intervention extends far beyond technical feasibility. Cardiac surgeons provide essential expertise in identifying patients who would derive greater long-term benefit from surgical aortic valve replacement, including younger patients for whom mechanical prostheses offer superior durability, patients requiring annular enlargement to avoid patient-prosthesis mismatch, and those with concomitant pathology—such as coronary artery disease, aortopathy, or multivalve disease—that can be addressed definitively during a single operation.

Excluding surgeons from procedural planning while expecting them to manage catastrophic complications during TAVR relegates them to a rescue role rather than recognizing them as equal partners in clinical decision-making. This model creates an imbalance in accountability, whereby surgeons assume responsibility for procedural failures without having had meaningful input into patient selection or treatment strategy. Optimal outcomes are achieved when both interventional cardiologists and cardiac surgeons share responsibility for patient evaluation, procedural planning, and longitudinal outcomes. The Heart Team is not an administrative formality—it is a safeguard that ensures every patient receives the right procedure, by the right team, at the right time.

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Dear administrators,

I appreciate the opportunity to comment on the proposed changes to the National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR). As a practicing interventional cardiologist who has helped establish a new TAVR program at my institution, I fully support the recommendations made by CMS.

Over the past decade, TAVR has undergone remarkable evolution. The early requirement for direct surgical involvement was appropriate during the initial adoption of this transformative technology, when procedural techniques, device design, and operator experience were still developing. However, today’s practice is fundamentally different.

Advances in valve technology, imaging, procedural planning, vascular access techniques, and operator experience have made TAVR one of the safest and most predictable structural heart interventions. Contemporary outcomes demonstrate low complication rates, and in experienced centers many aspects of TAVR are now less technically demanding and associated with lower procedural risk than several complex coronary interventions routinely performed by interventional cardiologists without the requirement for a second physician from another specialty.

I support the proposed flexibility allowing appropriately credentialed interventional cardiologists to perform TAVR as a single operator when clinically appropriate and consistent with institutional policies. Importantly, this proposal does not eliminate the essential role of the cardiac surgeon or diminish the value of the multidisciplinary Heart Team. Rather, it preserves the Heart Team approach while allowing physician staffing to reflect the realities of modern practice and the needs of individual patients.

Maintaining a mandatory two-operator requirement may create unnecessary logistical barriers, particularly in community hospitals and underserved regions where access to cardiac surgeons may be limited despite the presence of experienced structural heart programs. Greater flexibility can improve patient access, reduce scheduling delays, enhance procedural efficiency, and expand the availability of life-saving therapy without compromising quality or safety.

Cardiac surgeons remain indispensable partners in patient selection, management of complex anatomy, treatment of patients requiring surgical intervention, and the rare circumstance of procedural complications requiring emergent surgery. The proposed policy appropriately recognizes that collaboration does not necessarily require the physical presence of two operators for every routine TAVR procedure.

CMS should allow institutions to determine, through their credentialing processes, when a single experienced operator is appropriate while continuing to uphold rigorous standards for training, quality monitoring, and Heart Team collaboration. This approach promotes high-quality, patient-centered care while preserving access and encouraging continued innovation in structural heart disease treatment.

Thank you for considering these comments

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Dear Administrator Mehmet Oz,

On behalf of Access for All, a project of my organization, Survivors for Solutions, I am writing to express strong support for your proposal that would remove the Coverage with Evidence Development (CED) mandate for transcatheter aortic valve replacement (TAVR) for symptomatic patients. This change is a vital step forward that will meaningfully expand treatment options for patients who have been left behind by an outdated policy. We applaud CMS for taking this proactive approach to improve patient care.

For over a decade, CED requirements have functioned as senseless bureaucratic hurdles. They have kept rural and mobility restricted patients, who cannot easily navigate the demands of mandatory registries, from securing Medicare coverage for a potentially lifesaving, minimally-invasive alternative to open-heart surgery. Having navigated similar obstacles myself, I know firsthand the frustration of facing such barriers when seeking critical, time-sensitive care. I have lived with [PHI Redacted] for more than 30 years and have relied on access to several breakthrough treatments that have given me the life I have today. Every patient, regardless of geography or mobility, deserves that same fighting chance.

Removing this mandate will help save lives by streamlining the path to essential care. Evidence shows that TAVR is a proven, life-changing procedure that should not be locked behind a wall of mandatory paperwork that impedes access and creates gaps in care. Coverage determination policies should be rooted in scientific evidence and must prioritize safe, reliable access to medical innovation and treatment breakthroughs. The agency’s proposal to remove CED requirements for symptomatic patients acknowledges the well-established benefits of TAVR, reflects a necessary commitment to clinical results, and prioritizes equitable access to care.

Access for All applauds this proposal and commends the agency for its dedication to ensuring all patients can fully benefit from advancements and innovation in the medical landscape. We appreciate your leadership in prioritizing patient needs and look forward to seeing this positive change finalized.

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I fully support and commend CMS for its thoughtful and meaningful proposed update to the National Coverage Determination (NCD) for TAVR.

For programs such as ours that serve large rural and underserved populations, these proposed changes will have a meaningful impact by improving timely access to evaluation and treatment for patients with severe aortic stenosis while preserving the fundamental principles of the Heart Team model.

Importantly, the proposal also provides programs with greater flexibility to determine the most appropriate procedural approach based on the individual needs of each patient. As our group previously reported, the temporary liberalization of operator requirements during the COVID-19 Public Health Emergency was not associated with any significant difference in major clinical outcomes. Those changes enabled programs with limited co-surgeon availability to continue providing timely, safe, and effective care to patients who otherwise may have experienced unnecessary delays.

Prompt treatment of severe symptomatic aortic stenosis should remain the highest priority, as appropriately emphasized throughout this proposed NCD. I believe these updates strike the right balance between maintaining high standards of quality and expanding access to life-saving care, and I strongly support their implementation.

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Hello,

I would like to express my STRONG support of adjusting the single-operator model for TAVR's procedures. Here's why:

1) TAVR's have been done for many years now, and providers who have been doing them for several years in programs with volume are extremely proficient. They do not require two specialized physicians to deploy the valve, but especially not needing the expertise of a cardiac surgeon to be one of them. Access does not require the expertise unique to a cardiac surgeon - this could be done by either the interventional cardiologist (IC) by themselves, or with the assistance of another IC if deemed necessary. As long as a cardiac surgeon has provided input in the workup phase such as reviewing with the IC the anatomy and appropriateness of the TAVR, there is no reason that this demands the specialized skills or limited availability of a cardiac surgeon.

2) Mitral TEER's are arguably a more complex procedure, and are far newer, and these are done as a single operator. Thus, having TAVR's as a single operator is an outdated requirement, with poor utilization and allocation of resources, and poor use of funds to be financially supporting cardiac surgeons that do not provide any of their top-of-license skill set in their role in a TAVR. Yes, I agree they should be in house should the need for conversion to surgery be needed, but not in the room.

3) From a patient access perspective, cardiac surgeons are limited, and TAVR's do not take much time to complete - as long as scheduling is not at the mercy of the cardiac surgeon. This applies both to scheduling cases several weeks away, as well as the day-of schedule. We have had several issues at our facility where the surgeon holds up the IC waiting in the cath lab, waiting to do the time out because the surgeon was called an hour ago to say that we're waiting for them and they are still finishing up their morning rounds or are in house but in a meeting.

As long as the cath lab has the ability to convert to open heart surgery, and the surgeon could be available in an emergency to present immediately, I think moving to a single operator is very reasonable, and eliminates the double-standard of mitral TEER procedures.

I am not necessarily in support of removing the registry all together for symptomatic severe AS patients, but transitioning from CED to fully approved does seem reasonable. The data obtained from the registry is a valuable to measure outcomes and continue to uphold a high standard for such procedures, and may help continue to develop the field to where fewer patients need to undergo open heart surgeries in the future as TAVR valves develop further. Cardiac surgeons may be bothered by this sentiment, but on a human level, no one wants to have their chest cracked up when they could have a catheter in their groin. Plus the recovery is so much faster. From a financial perspective, insurances could save so much money but supporting TAVR's and decreasing open heart surgeries. There should almost be a push from CMS that if a patient has amenable anatomy to undergo TAVR, even if low risk for surgery, they should be REQUIRED to under TAVR instead of SAVR. Surgeons are so eager to cut that they are sometimes demanding that the low-surgical risk AS cases go to SAVR and taking these from the IC's, but it is simply unethical. If a TAVR can be done, and patient does not need a root enlargement, and their lifetime valve predictions are fine to have a valve-in-valve down the road and buy them plenty of life, I think CMS should demand TAVR be chosen over SAVR.

Thank you for your thoughtful consideration.

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Thank you for the opportunity to comment on the proposed update to the National Coverage Determination for Transcatheter Aortic Valve Replacement. As a hospital administrator responsible for supporting cardiovascular service line operations, quality, access, and resource planning, I support CMS’s effort to modernize the TAVR coverage framework so that it better reflects contemporary evidence, current care delivery, and the capabilities of experienced multidisciplinary valve programs.
From an administrative and operational perspective, the proposed policy is an important step toward improving timely access for Medicare beneficiaries with severe aortic stenosis. TAVR programs today are supported by mature clinical pathways, imaging protocols, scheduling processes, quality infrastructure, and post-procedure follow-up systems. Removing unnecessary Coverage with Evidence Development requirements for symptomatic patients can reduce avoidable delays, decrease administrative burden, and allow clinical teams to focus more directly on getting appropriate patients to treatment in a timely manner.
I also support CMS’s proposal to continue focused evidence development for asymptomatic severe aortic stenosis. As health systems expand access to innovative therapies, it is important that coverage policy continue to support responsible evidence generation, patient safety, and thoughtful adoption in areas where clinical questions remain. This approach appropriately balances access with accountability.

At the same time, I believe it is important that modernization of the NCD not be interpreted as reducing the role of cardiac surgeons. From a hospital leadership perspective, successful valve programs depend on strong collaboration between cardiac surgery, interventional cardiology, imaging, anesthesia, nursing, advanced practice providers, quality teams, and administration. Cardiac surgeons bring essential expertise in operative risk assessment, SAVR candidacy, complex anatomy, lifetime valve management, surgical backup planning, and program governance. Their involvement strengthens both clinical decision-making and institutional confidence in the program.
For that reason, I support a flexible Heart Team model that preserves multidisciplinary accountability while allowing hospitals to design workflows that fit their program maturity, staffing model, geography, and patient population. A rigid, one-size-fits-all structure can create scheduling bottlenecks and unnecessary administrative complexity without necessarily improving patient outcomes. Flexibility, when paired with quality oversight and clear internal governance, can support safer, more efficient, and more patient-centered care.
I encourage CMS to finalize a balanced policy that recognizes the maturity of TAVR programs, improves patient access, supports appropriate evidence development, and reinforces the ongoing importance of the multidisciplinary Heart Team. From a hospital administrator’s perspective, this should not be viewed as shifting ownership of TAVR from one specialty to another. It should be viewed as an opportunity to align coverage policy with modern, team-based care so that patients receive the right therapy, from the right team, at the right time.

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I am writing as a practicing interventional and structural cardiologist and cath lab director to offer comments on the proposed decision memo for the TAVR National Coverage Determination. I appreciate CMS's effort to modernize this policy and offer the following recommendations organized by the proposal's major sections.

Heart Team

Collaboration between interventional cardiology and cardiac surgery remains essential to safe, high-quality TAVR care, and I support preserving the Heart Team model as the foundation of this NCD. Initial patient evaluation should continue to require input from both an interventional cardiologist and a cardiac surgeon member of the Heart Team, ensuring that surgical and transcatheter risk are jointly assessed before a treatment pathway is selected. CMS should build in explicit flexibility for how these initial evaluations occur.

Operator Requirements

I support CMS's proposal to remove the mandatory two-operator requirement for the intraoperative technical performance of TAVR. This change appropriately reflects the maturation of TAVR as a procedure. I recommend CMS clarify the operative language to specify that TAVR may be performed by one or two qualified operators, who may include interventional cardiologists and/or a cardiac surgeons, rather than defaulting to language that implies a cardiologist-plus-surgeon pairing is the standard configuration.

The composition of the operative team for a given case should be determined by the local Heart Team based on patient complexity and institutional expertise, not dictated at the national policy level.

When a local Heart Team determines that two operators are clinically appropriate for a given case, that determination should be sufficient on its own. CMS should not impose an additional documentation or medical-necessity justification burden on teams that choose to use two qualified operators. Adding such a requirement would functionally undo the flexibility this proposal is intended to create, and would penalize the collaborative, multidisciplinary care model CMS has spent over a decade encouraging.

CMS should ensure this coverage change does not disturb existing Medicare Physician Fee Schedule (MPFS) treatment of co-surgeon billing for TAVR codes (CPT 33361–33365). The -62 modifier allows co-surgery claims from an interventional cardiologist and cardiac surgeon to be paid without additional documentation when the two-specialty requirement is met. This should be expanded to any 2 qualified operators as above.

Removing the NCD's mandatory two-operator requirement should not be construed as grounds to downgrade this. Doing so would penalize Heart Teams that continue to use two qualified operators by clinical judgment, and would create a disincentive to collaborative care at odds with the intent of this proposal.

I recommend the final decision memo state clearly that this is a coverage policy change only, and does not alter co-surgery payment treatment for TAVR codes with CMS preserving in the next Physician Fee Schedule cycle and expanding to two qualified operators.

I thank CMS for the opportunity to comment on this proposed decision memo. Modernizing operator requirements while preserving the collaborative Heart Team framework will improve patient access without compromising the quality and safety standards that have defined the TAVR program since its inception.

Thank You,

Chad Rammohan, MD FACC
Palo Alto Medical Foundation/El Camino Hospital
Mountain View, CA

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As a practicing Interventional Cardiologist performing Structural Heart Procedures, I fully support the proposed TAVR NCD coverage changes:

1. Coverage for symptomatic severe aortic valve stenosis without the coverage with evidence development (CED) requirement. The timing of this change is long overdue as the TAVR procedure was first approved over 15 years ago. The unnecessary administrative burden puts financial pressure on hospitals without any further clinical benefits.
2. Coverage for TAVR must be expanded to asymptomatic severe aortic valve stenosis patients. This change is supported by clinical trials. Similarly to other medical conditions with severe stages of illness, patients with asymptomatic severe aortic stenosis have a very high risk of morbidity and mortality. For example, Medicare covers surgical repair for an asymptomatic abdominal aortic aneurysm if the diameter generally reaches >5-5.5 cm. Watchful waiting for asymptomatic severe aortic valve stenosis lacks common clinical sense, therefore TAVR coverage should be expanded to these patients.
3. The Heart Team is essential for coordinating appropriate patient care but should not a be a burden and a barrier to providing a lifesaving treatment.
   1. One operator evaluation in person is sufficient for evaluation of appropriateness. Eliminating extra consultations and travel for patients will shorten the evaluation for TAVR and speed up the scheduling of a lifesaving procedure in a very frail patient population.
   2. Expanding the procedure to allow multiple options for operators: one operator TAVR (IC or CT), two operators TAVR (IC and IC, IC and CT, CT and CT). The TAVR procedure has undergone multiple improvements of the procedure: including smaller catheters, better valves, improved imaging, better techniques. It is clearly time to allow an option of a single experienced operator to perform the procedure, but at the same time not to eliminate the dual operator option for challenging cases and low volume operators. Reimbursement should double to reflect the extra work and responsibility of a single operator.

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Re: Proposed Changes to the National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR)

I submit this comment as a board-certified cardiothoracic surgeon with 27 years of clinical practice dedicated to cardiac, thoracic, and vascular surgery. My training encompasses open cardiac surgery, thoracic surgery, vascular surgery, and endovascular interventions, providing a comprehensive understanding of both surgical and catheter-based treatment of cardiovascular disease.

I have been actively involved in the evolution of transcatheter aortic valve replacement (TAVR) since its early development. I participated as an investigator in the Medtronic Low Risk Trial and other Medtronic TAVR clinical trials. I therefore have firsthand knowledge of how these devices were introduced, the rationale behind the original Heart Team model, and the safeguards that were intentionally built into TAVR programs to protect patients while this transformative technology matured.

The remarkable success of TAVR in the United States did not occur by chance. It resulted from a carefully designed system created by CMS in collaboration with the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). That system required multidisciplinary Heart Teams, independent patient evaluation, national registry participation, institutional standards, and continuous quality oversight. These safeguards have produced one of the safest and most successful structural heart programs in modern medicine.

I am deeply concerned that the proposed changes weaken these very safeguards.

The Heart Team is More Important Today Than Ever

When TAVR was first introduced, it was largely reserved for elderly patients who were inoperable or at prohibitive surgical risk. Today, TAVR is increasingly offered to younger and lower-risk patients. As indications expand, the clinical decision-making has become substantially more complex.

The question is no longer simply whether a patient is technically eligible for TAVR.

The question is how to manage that patient’s aortic valve disease over an entire lifetime.

Patients in their 50s, 60s, and early 70s require careful consideration of valve durability, future valve-in-valve procedures, coronary access after TAVR, subsequent surgical complexity, pacemaker risk, prosthesis-patient mismatch, and the sequence of interventions that will provide the best long-term outcome.

These are lifetime management decisions.

As a practicing cardiac surgeon, an increasing proportion of my consultations involve educating patients regarding the long-term consequences of choosing TAVR versus surgical aortic valve replacement. These discussions have become more—not less—important as younger patients enter the treatment population.

Weakening mandatory surgical participation at precisely this stage is contrary to the best interests of patients.

Independent Surgical Evaluation Protects Patients

The Heart Team was created because no single specialty should function as the sole gatekeeper for treatment of severe aortic stenosis.

The multidisciplinary evaluation ensures that every patient receives an objective assessment of all appropriate treatment options.

The United States physician reimbursement system remains largely based upon procedural productivity through Relative Value Units (RVUs). Whenever one procedural specialty evaluates the patient, determines candidacy, and performs the procedure without mandatory independent surgical participation, there is an inherent potential for conflicts of interest or the appearance of conflicts of interest.

This is not a criticism of individual physicians.

It is recognition of a fundamental principle of healthcare policy: systems should be designed to minimize financial conflicts and encourage independent clinical judgment.

The Heart Team has successfully accomplished exactly that.

Surgical Expertise is Complementary—Not Replaceable

Cardiac surgeons and interventional cardiologists bring different but complementary expertise.

Cardiac surgeons receive extensive training in operative cardiovascular anatomy, vascular exposure, arterial reconstruction, management of catastrophic complications, and complex open cardiac surgery.

My own background includes comprehensive vascular and endovascular training. That experience provides a detailed understanding of vascular anatomy, large-bore arterial access, peripheral vascular disease, arterial reconstruction, and management of vascular complications—skills that remain directly relevant to TAVR despite advances in delivery systems.

As TAVR has become more routine, there is a risk that the complexity of vascular anatomy and vascular complications is underestimated. Careful assessment of iliofemoral anatomy, aortic pathology, and alternative access strategies remains critical to procedural success. The expertise developed through vascular surgical training continues to provide an important perspective in patient selection and procedural planning.

These are complementary—not interchangeable—skill sets.

The Cardiac Surgeon Should Not Be Reduced to a Rescue Consultant

Throughout my career I have unfortunately witnessed catastrophic complications of structural heart procedures and catheter-based cardiovascular interventions that ultimately required emergency surgical rescue.

Too often, surgeons are asked to intervene only after the patient has suffered profound physiologic deterioration.

We become the final option.

This is not the model upon which the Heart Team was founded.

The purpose of having a cardiac surgeon involved is not simply to perform emergency surgery after catastrophe occurs.

Our role is to prevent catastrophe through appropriate patient selection, procedural planning, recognition of anatomic limitations, and balanced decision-making.

When catastrophic complications occur—including annular rupture, ventricular perforation, coronary obstruction, valve embolization, aortic injury, or major vascular injury—minutes determine survival.

A surgeon who is immediately involved in the procedure is fundamentally different from a surgeon who must be called after the complication has already occurred.

It is neither appropriate nor fair to expect surgeons to rescue patients after irreversible deterioration has occurred and then judge outcomes without acknowledging the delayed timing of surgical involvement.

The Heart Team exists to prevent disasters—not simply respond to them.

The Need for Oversight Has Increased—Not Decreased

Perhaps the most concerning aspect of the proposal is the reduction of national oversight and outcome reporting.

The STS Adult Cardiac Surgery Database fundamentally transformed cardiac surgery in the United States.

Surgeons understood that every major operation would be risk-adjusted, benchmarked, and compared nationally.

Poor outcomes were identified.

Programs improved.

Best practices evolved.

Accountability became part of the culture.

The result has been one of the most successful quality improvement initiatives in modern healthcare.

Likewise, the STS/ACC TVT Registry has become the international standard for measuring TAVR outcomes.

These registries accomplish far more than data collection.

They identify outlier programs.

They improve patient selection.

They improve procedural performance.

They identify complications.

They facilitate research.

Most importantly, they create accountability.

Physicians naturally strive for excellence, but transparent measurement and national benchmarking encourage continual improvement and responsible adoption of new technologies.

Reducing registry participation or weakening quality oversight removes one of the most effective mechanisms available to CMS to ensure appropriate patient selection, procedural quality, and responsible use of healthcare resources.

Healthcare should move toward greater transparency—not less.

Excellent Outcomes Are the Result of Oversight

The outstanding outcomes achieved with TAVR should not be interpreted as evidence that oversight is no longer necessary.

Rather, they demonstrate that the current system works.

CMS required:

• Multidisciplinary Heart Teams
• Independent surgical participation
• Institutional quality standards
• National registry participation
• Continuous outcome reporting
• Transparent accountability

These policies helped create the exceptional outcomes now enjoyed by patients throughout the United States.

Removing these safeguards because outcomes are excellent ignores the very reasons those outcomes became excellent.

Recommendations

I respectfully urge CMS to:

Maintain mandatory, meaningful participation of cardiac surgeons within every TAVR Heart Team.
Preserve independent multidisciplinary evaluation for every patient being considered for TAVR.
Continue comprehensive participation in the STS/ACC TVT Registry and maintain robust national outcome reporting.
Preserve institutional quality standards and accountability for all TAVR programs.
Recognize that as TAVR expands into younger and lower-risk patients, the need for multidisciplinary expertise has increased—not decreased.
Continue policies that ensure treatment decisions are based upon the patient’s long-term interests and lifetime management strategy rather than procedural convenience.
Conclusion

I have dedicated 27 years of my career to caring for patients with complex cardiovascular disease and have had the privilege of participating in the development and clinical evaluation of TAVR technology from its early years.

I firmly believe that the Heart Team model has been one of the greatest successes in modern cardiovascular medicine.

It protects patients through independent evaluation.

It promotes balanced clinical judgment.

It recognizes the complementary expertise of cardiac surgeons and interventional cardiologists.

It provides immediate surgical capability when catastrophic complications occur.

It has contributed directly to the outstanding outcomes achieved in the United States.

CMS should preserve—not weaken—the multidisciplinary framework that has made TAVR a global success.

Patient safety, accountability, transparency, and thoughtful lifetime management of aortic valve disease should remain the guiding principles of national policy.

Yours sincerely
Sirish Parvathaneni MD

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I am disappointed at the NCD changes that are being recommended by CMS. Patient satisfaction and outcomes are better with a healthy heart team approach involving both cardiac surgeons and cardiologists throughout the entire care continuum including preoperative, intraprocedural (IC and CS working together) and followup decision making. There is really only one knock or downside to true "team based care"......and that maybe efficiency. However, in my opinion, the trade offs for superior decision making and technical outcomes far outweigh the perceived challenges of inefficiency that some physicians associate with team based care. In addition, registries like the STS and TVT data bases are critical to maintain and optimize clinical outcomes. In my opinion, removing and limiting these requirements risks patient care and outcomes in the future.

I recommend that patients with aortic valve disease be evaluated by a heart team including a cardiac surgeon in person, maintaining 2 operators for TAVR (maintaining a interventional cardiologist and cardiac surgeon) and continuing participation in the TVT registry by all centers.

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I support the proposed CMS changes to the TAVR National Coverage Determination.
Overall, the proposed revisions appropriately modernize the coverage framework, better reflect contemporary clinical practice, and have the potential to improve timely access to high-quality care while preserving appropriate oversight and shared decision-making.

Regarding operator requirements, I support the move toward greater flexibility, including the ability for appropriately qualified operators to perform TAVR without a mandatory two-operator requirement in every case. In many mature programs, this reflects current practice and accumulated experience. Updating the NCD to align with contemporary care delivery may reduce unnecessary scheduling constraints, improve procedural efficiency, and enhance patient access without compromising quality when programs maintain appropriate infrastructure, team-based evaluation, and outcomes monitoring.

With respect to Coverage with Evidence Development and registry-based oversight, I agree that continued data collection can be valuable, particularly for evolving indications. However, registry reporting must be transparent, consistent, and meaningful. The TVT Registry has been an important quality tool, but its value depends on complete participation, accurate reporting, and public accountability. CMS should ensure that reported registry outcomes are aligned with contemporaneous institutional publications and other publicly disseminated data. Institutions should not be able to report favorable registry performance while publishing materially different outcomes from the same time period without clear explanation. Public reporting should be mandatory for all participating institutions, including outcomes, follow-up rates, and measures of data completeness. If patient-reported outcome measures such as KCCQ follow-up are incomplete, those limitations should be reported transparently alongside clinical outcomes rather than used as a reason to withhold public reporting.

Regarding asymptomatic severe aortic stenosis, I support coverage when the decision is made through a documented shared decision-making process that includes a balanced discussion of the risks and benefits of TAVR, SAVR, and continued clinical surveillance or medical management. Regardless of differing interpretations of the emerging evidence, clinical practice is moving toward individualized consideration of earlier intervention in selected patients. In that context, coverage is appropriate when patients are fully informed and the decision is supported by the Heart Team. CED for this population is reasonable, but the resulting data should be publicly reported and participation requirements should be applied consistently and transparently.

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I am supportive of the proposed changes that promote high-quality, patient-centered cardiovascular care, support appropriate access to TAVR, and reinforce strong program integrity and oversight. I believe quantity of procedures should be tracked by provider not facility. I support:

1. On-site structural heart interventional cardiology and cardiac surgery
2. Intensive care capabilities appropriate for managing patients undergoing surgical aortic valve replacement
3. Continuous quality improvement processes that assess procedural outcomes and support patient safety
4. Removal of Coverage with Evidence Development (CED) requirements for symptomatic severe aortic stenosis
5. Coverage of TAVR for asymptomatic severe aortic stenosis under CED requirements
6. Revised operator competency requirements
7. Removal of hospital procedural volume requirements

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As an interventional cardiologist actively performing structural heart procedures, I am writing to strongly support the proposed revision allowing a single qualified operator (either an interventional cardiologist or a cardiac surgeon) to perform TAVR.

The original two-operator mandate was a product of its time. When TAVR was introduced, the technology was primitive, the learning curve was steep, and we had zero national experience. Today, the landscape is entirely different. A decade of dramatic device iterations, advanced multimodality pre-planning, and standardized training pathways have turned what was once a high-risk novelty into a highly reproducible, remarkably safe procedure.

At this stage, operator competency is defined by training, volume, and clinical outcomes and not a specialty board. Many structural heart physicians are fully capable of independently managing routine transfemoral TAVR from access to closure. Forcing a second operator into the room based on specialty rather than clinical necessity adds no proven safety margin.

Furthermore, the current rule creates a severe logistical barrier for patients. Coordinating the schedules of both an interventional cardiologist and a cardiac surgeon for every single case causes unnecessary procedural delays. This is especially true in community hospitals where surgical availability is tightly stretched. It is an administrative hurdle that is not backed by clinical data.

This change does not diminish the Heart Team concept which I strongly support. Cardiac surgeons remain vital to the program for patient selection, anatomical planning, complex anatomies, and managing the very rare complication requiring open conversion. The collaborative model should remain the standard for treatment decisions, but that collaboration does not require a surgeon's physical presence during every routine case.

Finally, I support the flexibility to utilize two operators when clinically indicated, without a rigid specialty mandate. Complex cases often benefit from a second set of hands, and teams should have the autonomy to choose the best co-operator based on the patient's specific anatomy.

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Syed A. Mehmood, MD
Cardiothoracic Surgeon | Director of Structural Heart
Willis-Knighton Health, Shreveport, Louisiana
Adjunct Clinical Professor, Arkansas College of Osteopathic Medicine

July 1 2026

Centers for Medicare & Medicaid Services
Re: National Coverage Analysis for Transcatheter Aortic Valve Replacement (TAVR), CAG-00430N — Comment on Proposed Decision Memo (June 15, 2026)

To the Coverage and Analysis Group:

I am writing as a practicing cardiothoracic surgeon and Director of Structural Heart at a high-volume regional health system, with direct clinical experience across the full spectrum of aortic valve disease management, including primary SAVR, primary TAVR, and reoperative surgery in patients with failed transcatheter valves. I am submitting this comment in the strongest terms to oppose three specific elements of the June 15, 2026 Proposed Decision Memo for the TAVR National Coverage Determination: (1) the removal of the requirement for joint intra-operative participation by a cardiac surgeon, (2) the elimination of mandatory registry participation as an explicit condition of coverage, and (3) the scope and design of proposed coverage for asymptomatic severe aortic stenosis, particularly in younger patients.

1. Removing Mandatory Surgeon Participation Will Degrade Outcomes — Especially When Patients Later Require Explant

The proposed decision would permit TAVR to be performed by a single operator without a cardiac surgeon jointly participating in the intra-operative technical aspects of the case. This change is being framed as a modernization that reflects TAVR's procedural maturity. It does not adequately account for what happens downstream when a transcatheter valve fails, and the downstream risk is precisely where surgeon involvement matters most.

The peer-reviewed literature on surgical explant of failed TAVR valves should give CMS serious pause about further separating surgeons from TAVR programs:
- A national STS Adult Cardiac Surgery Database analysis found that TAVR explant carries an operative mortality of 15.8%, with a stroke incidence of 4.5%, and that TAVR explant and SAVR is now the most rapidly growing cardiac reoperation in the United States¹. A separate STS database analysis of 782 TAVR explants reported an overall 30-day mortality of 19.4%². Both figures represent a multi-fold increase over the mortality of a first-time, native SAVR.
- Even patients who were low-risk at the time of their original TAVR do not remain low-risk if the valve fails. A 2025 single-center series stratified by original risk profile found that operative mortality in originally low-risk patients was statistically comparable to that of higher-risk groups, with a significantly elevated observed-to-expected mortality ratio (2.8 vs. 1.0 vs. 0.8) in the low-risk cohort specifically³.
- A substantial proportion of TAVR explants require concomitant aortic root or ascending aortic repair, mitral valve intervention, or CABG. In the international EXPLANT-TAVR registry, a quarter of patients required two or more additional procedures, and mortality was worse among patients requiring concomitant aortic repair⁴; the EXPLANTORREDO-TAVR registry corroborates high concomitant-procedure rates and mortality in this population⁵. This is not a routine reoperation — it is frequently a complex aortic and structural case.
- Even redo-TAVR — the less invasive reintervention pathway when anatomy allows it — carries a 1-year mortality of 17.5% in the largest published registry series⁶, underscoring that reintervention risk after TAVR failure is elevated regardless of which reintervention strategy is used.
- Structural valve deterioration is expected to increase as TAVR is used more heavily in younger patients with longer life expectancy, and the reintervention burden this creates falls substantially on cardiac surgeons⁷. Encouragingly, outcomes for isolated SAVR after TAVR have improved with surgeon experience and refined risk modeling⁸ — which is itself an argument for keeping surgeons structurally embedded in TAVR programs rather than making their participation optional.

The clinical logic that got a patient safely through an index TAVR does not automatically extend to a subsequent surgical explant. A cardiac surgeon's intra-operative involvement in the index procedure is not merely procedural experience — it is direct familiarity with that patient's anatomy, valve positioning, and any technical compromises made at implant, all of which materially affect the difficulty and risk of a future explant. Removing the surgeon from routine participation does not just risk the index procedure; it removes continuity of surgical judgment for a population that we already know will need surgical rescue at meaningfully higher rates than the TAVR success narrative suggests. I urge CMS to retain a requirement for surgeon participation in the heart team's intra-operative decision-making, not merely pre-procedural consultation.

2. Registry Participation Should Remain an Explicit Condition of Coverage

The proposed decision memo does not explicitly require registry participation, instead characterizing registries as one possible mechanism within CED-supported studies. I strongly disagree with removing this as a hard requirement.

We do not yet have 15-year valve durability data for transcatheter aortic valves. The longest published follow-up available today extends to roughly 8-10 years for the earliest treated cohorts, and that data comes disproportionately from older, higher-risk patients who were never expected to live long enough to test the outer limits of valve durability. We have essentially no reliable long-term data on structural valve deterioration, leaflet thrombosis, coronary obstruction risk at reintervention, or explant outcomes in patients treated at 55, 60, or 65 years of age with 20-30+ years of remaining life expectancy. The STS/ACC Transcatheter Valve Therapy (TVT) Registry is the single mechanism that has allowed the field, and CMS, to track exactly the outcomes cited above — explant mortality, concomitant procedure risk, and reintervention trends^1,2,3. Making registry participation optional, at the exact moment CMS is proposing to expand TAVR into younger and asymptomatic populations for whom long-term data does not yet exist, is not deregulation — it is removing the instrument we need to know whether this expansion is safe five, ten, and fifteen years from now.

I request that CMS retain mandatory, audited registry participation (TVT Registry or successor) as an explicit condition of coverage for all TAVR procedures, with specific mandatory long-term follow-up fields for age at implant, valve type, structural valve deterioration, reintervention (redo-TAVR and explant), and mortality, tracked to a minimum of 10 years with a stated goal of extending to 15-year follow-up as the cohort matures.

3. Asymptomatic Severe AS Coverage Requires a More Conservative, Age-Stratified Approach — Particularly Under Age 70

I recognize that expanding coverage to asymptomatic severe AS follows the FDA's 2025 expanded indication and is grounded in emerging trial evidence. I also recognize CMS's own characterization of that evidence as "promising but incomplete," and the acknowledgment that the evidence base may be stronger in patients with reduced versus preserved LVEF. I agree with that assessment, and I do not believe the current evidence justifies broad, age-blind coverage of TAVR in asymptomatic patients.

My specific concerns and recommendations: - Asymptomatic severe AS patients, by definition, have a choice about timing and modality of intervention that symptomatic patients do not. This is precisely the population where getting the long-term durability question right matters most, because these patients have the most years of life ahead of them during which a failed valve, and a high-risk explant, would occur.
- I recommend that CMS require Coverage with Evidence Development specifically structured as an age-stratified comparative study for asymptomatic patients under age 70, comparing TAVR against surgical AVR, with mandatory long-term follow-up. I recognize a full 15-year randomized outcome cannot be a precondition for any coverage decision — no coverage policy realistically waits over a decade to act. What I am requesting is that CMS require this comparative, age-stratified data collection as a continuing condition of coverage for the under-70 asymptomatic population, with defined interim follow-up checkpoints (5, 10, and 15 years) built into the CED structure, rather than allowing this population to move to unrestricted coverage before that data exists.
- Until that data matures, TAVR in asymptomatic patients under 70 should not be treated as equivalent in evidentiary footing to symptomatic TAVR, and coverage policy should reflect that distinction rather than folding both populations into the same relaxed framework.

The core clinical reality CMS should weigh is this: TAVR is, in most cases, technically the easier procedure to perform the first time. It is not the easier procedure the second time. A young, asymptomatic patient who receives a transcatheter valve today and requires explant in 10 or 15 years because of structural valve deterioration is not facing a routine reoperation — they are facing a complex aortic surgery with a reported mortality several-fold higher than the first-time SAVR they could have had at the outset^1,2,4, frequently complicated by root or annular involvement from the retained transcatheter device. Trading a lower-risk index procedure for a much higher-risk explant procedure, in a population with decades of life expectancy remaining, is not a neutral trade-off. It should not be made without long-term, age-stratified evidence, and it should not be made in a coverage environment that simultaneously removes the surgeon from routine participation and makes registry tracking optional.

Summary of Requested Changes

- Retain a requirement for cardiac surgeon participation in the intra-operative technical aspects of TAVR, not merely pre-procedural heart team consultation.
- Retain mandatory, audited national registry participation (TVT Registry or successor) as an explicit condition of coverage for all TAVR procedures, with mandatory structured long-term follow-up fields extending toward 15 years.
- Structure asymptomatic severe AS coverage under age 70 as CED with a comparative TAVR-versus-SAVR framework and defined long-term follow-up checkpoints, rather than unrestricted coverage, until durability data matures.

A Note on the Origin of This Reconsideration

I would also note for the record that this reconsideration originated from a formal request by Edwards Lifesciences, and that industry financial analysts have publicly characterized the proposed changes as commercially favorable to TAVR device manufacturers, including Edwards, Medtronic, and Abbott. I raise this not to suggest impropriety on CMS's part, but because it underscores why independent, mandatory, long-term registry data — not industry-sponsored trial data alone — should remain the backbone of ongoing evidence collection for this technology as it expands into younger and asymptomatic populations.

I appreciate CMS's willingness to reconsider this policy and its stated goal of expanding access to a therapy that has genuinely transformed care for many patients. My concern is not with TAVR itself, but with the pace and structure of this specific expansion relative to the durability evidence we currently have. I would welcome the opportunity to provide additional data or clinical perspective as CMS finalizes this determination.

Respectfully submitted,

Syed A. Mehmood, MD
Cardiothoracic Surgeon, Director of Structural Heart
Adjunct Clinical Professor, Arkansas College of Osteopathic Medicine
Willis-Knighton Health

References
1. Bowdish ME, Habib RH, Kaneko T, et al. Cardiac Surgery After Transcatheter Aortic Valve Replacement: Trends and Outcomes. Ann Thorac Surg. 2024;118(1):155-162.
2. Fukuhara S, Brescia AA, Deeb GM. Surgical Explantation of Transcatheter Aortic Bioprostheses: An Analysis From the Society of Thoracic Surgeons Database. Circulation. 2020;142(23):2285-2287.
3. Fukuhara S, Suzuki T, Deeb GM, Ailawadi G, Patel HJ, Yang B. Clinical outcomes of TAVR explant stratified by original risk profile: insights from 110 TAVR explants. Ann Cardiothorac Surg. 2025;14(2):122-130.
4. Bapat VN, Zaid S, Fukuhara S, et al. Surgical Explantation After TAVR Failure: Mid-Term Outcomes From the EXPLANT-TAVR International Registry. JACC Cardiovasc Interv. 2021;14(18):1978-1991.
5. Tang GHL, Zaid S, Kleiman NS, et al. Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry. JACC Cardiovasc Interv. 2023;16(8):927-941.
6. Makkar RR, Kapadia S, Chakravarty T, et al. Outcomes of repeat transcatheter aortic valve replacement with balloon-expandable valves: a registry study. Lancet. 2023;402(10412):1529-1540.
7. Braasch MC, Rahimi M, He J, et al. Volume-outcome relationship of mortality following surgical explant of transcatheter aortic valve replacements. J Thorac Cardiovasc Surg. 2025 Sep 30. Epub ahead of print. doi:10.1016/j.jtcvs.2025.09.053.
8. Hawkins RB, Hamilton BCS, Sukul D, Deeb GM, Ailawadi G, Fukuhara S. Increased risk of surgical aortic valve replacement after prior transcatheter versus surgical aortic valve replacement with concomitant valve disease. Ann Thorac Surg. 2025;120(4):722-728.
9. Centers for Medicare & Medicaid Services. Transcatheter Aortic Valve Replacement (TAVR) — Proposed Decision Memo (CAG-00430N). Published June 15, 2026. Available at: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=257

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I would caution approving TAVR for asymptomatic patients with severe AS. TAVR durability is still not yet established; TAVR procedures are not risk free so why put asymptomatic patient at earlier risk; more over, TAVR carries pacemaker risk, bioprosthetic valve thrombosis risk and TAVR endocarditis can potentially create higher complexity for surgery rather than native valve endocarditis. Performing TAVR in asymptomatic patients did not cause improvement in mortality; the health benefit is simply related to reduction in unplanned hospitalization. Thus weighing risk vs benefit, TAVR should not be offered in truly asymptomatic patients since the risk outweigh the true benefit.

Also, I like the current model of necessitating both surgeon and interventional cardiology to see the patient as it reflects the true heart team multidisciplinary model to determine the best management approach for the patient. It keeps both CV surgeon and interventional cardiology "honest/in check" rather than favoring one particular pathway.

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To the Centers for Medicare & Medicaid Services:

Thank you for the opportunity to comment on the proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR). I am writing as a cardiovascular specialist involved in the care of patients with severe aortic stenosis and structural heart disease. I strongly support CMS’s effort to modernize the TAVR coverage framework in a way that reflects contemporary clinical practice, preserves patient safety, supports evidence-based care, and improves timely access for Medicare beneficiaries.

TAVR has evolved from a therapy reserved for inoperable or prohibitive-risk patients into a mature, guideline-supported, evidence-based treatment option across a broad spectrum of patients with severe aortic stenosis. Over the past decade, interventional cardiologists, cardiac surgeons, imaging specialists, anesthesiologists, advanced practice clinicians, nurses, and structural heart teams have developed robust systems for patient selection, procedural planning, intraprocedural safety, and longitudinal follow-up. The national experience with TAVR has demonstrated that carefully selected patients can experience meaningful improvements in survival, symptoms, functional status, and quality of life. CMS policy should now reflect this maturation by removing outdated barriers that no longer improve quality but may delay care, limit access, and impose unnecessary administrative burden.

I support CMS’s proposal to remove the Coverage with Evidence Development requirement for Medicare beneficiaries with symptomatic severe aortic stenosis when TAVR is performed using an FDA-approved valve system for an FDA-approved indication. Symptomatic severe aortic stenosis is a progressive and life-threatening disease. Once symptoms occur, delay in valve replacement can expose patients to avoidable heart failure, syncope, hospitalization, functional decline, and death. In many communities, the continued CED requirement has become less useful as a mechanism of evidence generation and more burdensome as an administrative requirement. The existing evidence base and real-world experience are sufficient to support national coverage of TAVR for symptomatic severe aortic stenosis without CED. Removing this requirement would appropriately recognize TAVR as established therapy rather than investigational care.

I also support CMS’s continued emphasis on the Heart Team model, but I strongly encourage CMS to preserve flexibility in how the Heart Team functions. The Heart Team should remain central to patient-centered valve care because treatment decisions require individualized assessment of anatomy, surgical risk, frailty, comorbidities, patient preference, life expectancy, vascular access, coronary anatomy, valve durability, future coronary access, and lifetime valve strategy. However, CMS should avoid overly prescriptive requirements that create delays without improving decision-making. The most important requirement should be that the patient receives a thoughtful, documented evaluation by appropriately qualified clinicians. Requiring every patient to undergo multiple separate in-person visits before TAVR can be burdensome for elderly patients, rural patients, frail patients, patients dependent on family transportation, and patients with limited access to specialty care.

I therefore support CMS’s proposal to allow an initial Heart Team evaluation to be performed through review of medical records and clinical data, with an in-person evaluation by a TAVR operator. This approach preserves the core value of multidisciplinary care while reducing duplicative visits and improving efficiency. CMS should explicitly recognize that modern Heart Team review may occur through structured conferences, electronic health record review, telehealth discussion, imaging review, and asynchronous multidisciplinary communication. These approaches can be rigorous, patient-centered, and safe when appropriately documented. They also reflect how high-quality structural heart programs actually operate in contemporary practice.

I strongly support CMS’s proposal that joint participation of two TAVR operators should not be required for every TAVR procedure. Many TAVR procedures are now standardized, transfemoral, percutaneous procedures performed safely by experienced operators. Mandatory two-operator requirements may consume physician resources, reduce scheduling flexibility, delay treatment, and increase operational complexity without necessarily improving outcomes in routine cases. The decision to use one operator or two operators should be made by the Heart Team and the treating physicians based on patient complexity, vascular access, annular anatomy, coronary risk, need for alternative access, anticipated bailout risk, trainee involvement, and local program structure. CMS should allow clinically appropriate single-operator TAVR while preserving coverage when two operators are needed for complex cases. This approach respects physician judgment and supports efficient use of highly trained interventional cardiology and cardiac surgery resources.

CMS should also ensure that operator requirements recognize the actual expertise needed to deliver TAVR safely. Interventional cardiologists with structural heart training and experience have developed specialized skills in vascular access, large-bore closure, catheter manipulation, hemodynamic management, coronary protection, valve deployment, bailout strategies, and management of complications. Coverage policy should not undervalue this expertise or impose requirements that unnecessarily restrict experienced interventional cardiologists from providing care. Operator competency should be assessed through a combination of training, privileges, outcomes, continuing experience, and participation in quality improvement—not simply through rigid historical volume thresholds that may not account for case complexity, program maturity, or individual outcomes.

I support CMS’s proposed movement away from fixed hospital procedural volume requirements and toward a focus on infrastructure, quality processes, and outcomes. Rigid volume thresholds can unintentionally restrict access, particularly in regions where patients must travel long distances to reach a high-volume center. For elderly Medicare beneficiaries with severe aortic stenosis, travel burden is not a minor issue; it can delay treatment, worsen frailty, increase family burden, and reduce access for underserved communities. High-quality care should be measured by appropriate program infrastructure, multidisciplinary evaluation, complication management capability, imaging expertise, procedural outcomes, and continuous quality improvement. Volume may be one useful marker, but it should not be the sole determinant of coverage.

At the same time, I agree that TAVR should be performed only in hospitals with appropriate infrastructure. Programs should have structural heart expertise, cardiac surgery availability, intensive care capability, advanced imaging support, vascular and surgical bailout pathways, multidisciplinary case review, and formal quality improvement processes. CMS should maintain these requirements because TAVR is a complex therapy requiring institutional readiness. However, CMS should avoid requirements that are so restrictive that they prevent responsible programs from serving their communities. A balanced policy should encourage access while requiring programs to demonstrate safety, readiness, and accountability.

I strongly encourage CMS to support continued national quality measurement and registry-based outcomes tracking, even if registry participation is no longer tied to CED for symptomatic severe aortic stenosis. Registry data have been essential in monitoring procedural outcomes, mortality, stroke, vascular complications, pacemaker rates, valve performance, readmissions, and long-term trends. Ongoing quality tracking protects patients, allows benchmarking, identifies outlier performance, and supports continuous improvement. However, registry requirements should be streamlined and should not create excessive documentation burden that diverts physicians and staff from patient care. CMS should work with professional societies to preserve meaningful data collection while reducing duplication and administrative complexity.

Regarding asymptomatic severe aortic stenosis, I support a more cautious evidence-development approach. Asymptomatic patients differ from symptomatic patients because the risk-benefit balance may depend heavily on age, surgical risk, valve durability, life expectancy, left ventricular function, biomarkers, exercise testing, anatomic risk, and likelihood of progression. Coverage with Evidence Development for asymptomatic severe aortic stenosis is reasonable if it is designed to answer clinically meaningful questions without limiting enrollment to only large academic centers. CED studies should include community-based structural heart programs when appropriate, so that evidence reflects real-world Medicare beneficiaries and does not exclude patients based on geography. CMS should ensure that CED requirements for asymptomatic patients are practical, inclusive, and focused on outcomes that matter to patients: survival, stroke, heart failure hospitalization, functional capacity, quality of life, valve durability, need for reintervention, and ability to preserve future treatment options.

I also encourage CMS to explicitly recognize the importance of lifetime management in TAVR decision-making. In contemporary practice, the choice between TAVR, SAVR, surveillance, and palliative care is not simply a question of immediate procedural risk. It requires consideration of future coronary access, redo TAVR feasibility, valve-in-valve strategy, surgical bailout options, bicuspid anatomy, annular and root dimensions, durability, anticoagulation needs, frailty, and patient goals. Interventional cardiologists play a central role in this analysis because they understand the procedural, anatomic, imaging, hemodynamic, and coronary implications of TAVR. CMS policy should support—not restrict—the ability of the Heart Team and TAVR operator to tailor treatment recommendations to each patient.

The updated NCD should also reduce unnecessary delays in care. Many patients referred for TAVR are elderly, symptomatic, and already experiencing reduced functional capacity. Administrative barriers, duplicative consultations, rigid procedural rules, and outdated coverage requirements can prolong the time from diagnosis to treatment. Delays may lead to decompensated heart failure, emergency hospitalization, loss of independence, and worse outcomes. CMS should adopt a coverage framework that allows efficient evaluation and timely treatment while maintaining appropriate safeguards. A streamlined, flexible Heart Team process with clear documentation is preferable to a rigid checklist that does not necessarily improve care.

I ask CMS to protect access for rural and underserved patients. Structural heart disease care should not be available only to patients living near major academic centers. Many Medicare beneficiaries live in communities where travel to distant centers is difficult. Eliminating rigid hospital volume requirements, allowing flexible Heart Team evaluation, and recognizing qualified structural heart programs can improve access while preserving safety. CMS should evaluate programs based on infrastructure, outcomes, and quality improvement rather than geography or legacy volume criteria alone.

I also encourage CMS to ensure that the final policy does not create unintended disadvantages for interventional cardiologists or structural heart programs that provide high-quality care in non-academic or community settings. Interventional cardiologists are essential to TAVR delivery. They evaluate patients, interpret CT and echocardiographic findings, plan vascular access, perform the procedure, manage complications, coordinate post-procedure care, and follow patients longitudinally. CMS should preserve the ability of appropriately trained and privileged interventional cardiologists to serve as TAVR operators and to lead structural heart programs in collaboration with cardiac surgery and the broader Heart Team.

In summary, I respectfully recommend that CMS finalize a TAVR NCD that:

Removes CED requirements for symptomatic severe aortic stenosis treated with FDA-approved TAVR systems for FDA-approved indications.
Preserves the Heart Team model while allowing flexible, efficient, and well-documented evaluation pathways.
Allows single-operator TAVR when clinically appropriate, with two operators covered when patient complexity or Heart Team judgment supports it.
Avoids rigid hospital volume thresholds and instead emphasizes infrastructure, outcomes, patient safety, and continuous quality improvement.
Maintains meaningful national quality tracking and outcomes monitoring while reducing unnecessary administrative burden.
Supports CED for asymptomatic severe aortic stenosis in a practical, inclusive, real-world manner focused on patient-centered outcomes.
Protects access for rural, underserved, elderly, and frail Medicare beneficiaries.
Recognizes the central role of interventional cardiologists and structural heart teams in delivering safe, timely, high-quality TAVR care.

CMS has an important opportunity to modernize Medicare coverage for TAVR in a way that reflects current evidence, supports clinical judgment, improves access, and maintains strong safeguards for patient safety. The final NCD should allow experienced Heart Teams and interventional cardiologists to provide individualized, timely, evidence-based care to Medicare beneficiaries with severe aortic stenosis. I appreciate CMS’s thoughtful review of this important issue and urge CMS to finalize a policy that balances access, innovation, quality, and accountability.

Respectfully submitted,
Abhishek C. Sawant, M.D.,M.P.H.,F.A.C.C.
Structural Heart and Interventional Cardiology
Assistant Clinical Professor
University of Arizona School of Medicine
Creighton University School of Medicine

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I appreciate CMS’s continued commitment to expanding access to transcatheter aortic valve replacement while simplifying unnecessary administrative requirements. However, I have significant concerns regarding the proposed changes to the Heart Team evaluation process and the removal of the expectation for direct cardiac surgeon participation in patient evaluation and procedural care.

The Heart Team model has been one of the defining strengths of TAVR since its inception. It was developed not merely as an administrative requirement, but because treatment decisions for severe aortic stenosis are inherently multidisciplinary. Appropriate management often requires balancing transcatheter therapy, surgical aortic valve replacement, medical management, future lifetime valve strategies, coronary disease, aortopathy, and patient-specific anatomical considerations.

The proposal permits the initial Heart Team evaluation to occur asynchronously through review of the medical record and requires only an in-person evaluation by a qualified TAVR operator, who may be either an interventional cardiologist or cardiac surgeon. While this approach may improve efficiency, it risks reducing the Heart Team from a collaborative clinical process to a documentation exercise.

I respectfully recommend that CMS preserve two essential principles:

1. Every patient should undergo an independent in-person evaluation by both an interventional cardiologist and a cardiac surgeon before elective TAVR whenever clinically feasible.

The cardiac surgeon provides expertise that complements, rather than duplicates, the evaluation of the interventional cardiologist. Surgical consultation informs patients regarding:

* The comparative risks and benefits of SAVR versus TAVR.
* Lifetime valve management strategies, particularly in younger or lower-risk patients.
* Management of concomitant coronary artery disease, ascending aortic pathology, multivalve disease, or other conditions that may favor surgery.
* Operative risk that may not be fully appreciated through imaging or registry-based risk scores alone.

This independent evaluation ensures patients receive balanced counseling regarding all appropriate treatment options and supports truly informed consent.

2. A cardiac surgeon should remain immediately available and actively involved in every TAVR procedure.

Although procedural safety has improved substantially, catastrophic complications remain uncommon but life-threatening. These include annular rupture, ventricular perforation, coronary obstruction, aortic dissection, valve embolization, ventricular injury, and major vascular complications requiring emergency surgical intervention.

Successful rescue in these situations depends not only upon the availability of a cardiac surgeon but upon a surgeon who has participated in the patient’s evaluation, understands the anatomy, has reviewed the imaging, and is integrated into procedural planning.

The presence of an experienced cardiac surgeon also promotes optimal intraoperative decision-making when conversion to surgery or alternative management becomes necessary.

The Heart Team concept has been instrumental in achieving the excellent outcomes observed in TAVR programs throughout the United States. Weakening the requirement for direct surgeon involvement may unintentionally shift care toward a single-specialty model and diminish the multidisciplinary decision-making that has consistently benefited patients.

Efficiency should not come at the expense of comprehensive evaluation or patient-centered care. While asynchronous record review may be appropriate for preliminary screening, it should not replace direct evaluation by both physician specialties responsible for treating severe aortic valve disease.

I respectfully urge CMS to revise the proposed National Coverage Determination to require:

* Independent in-person evaluations by both an interventional cardiologist and a cardiac surgeon before elective TAVR whenever clinically feasible.
* Continued active participation of both specialties within the procedural Heart Team.
* Maintenance of the multidisciplinary Heart Team model that has contributed substantially to the safety, quality, and success of TAVR in the United States.

These recommendations preserve patient-centered decision-making while maintaining the collaborative framework that has become the standard of care for structural heart disease

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I think the proposed TAVR NCD update allowing transition to a single operator provides needed institutional flexibility. As TAVR outcomes/techniques have improved, this is a pragmatic evolution that alleviates scheduling bottlenecks. We have a high volume program with a robust, collaborative surgical presence so these regulatory changes will likely not alter our successful co-management formula, however it will likely improve patient access in community and rural programs. Eliminating the dual-operator mandate should be paired with an absolute requirement for an on-site, standby perfusion team. ECMO/CPB can generally effectively bridge catastrophic complications such as annular rupture or ventricular perforation until a cardiothoracic surgeon arrives. Compensation for a cardiothoracic surgeon who is “on call” for TAVR procedures may help maintain collaboration of the heart team.

Agree with maintaining a rigorous multidisciplinary Heart Team. TAVR is an exceptional technology for most patients with severe AS, but SAVR remains the superior strategy for younger populations and complex anatomies. Preserving the mandatory, comprehensive Heart Team review ensures that clinical decisions prioritize the optimal therapeutic pathway for a patient’s entire lifespan, rather than simply favoring the least invasive procedure for today

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I write to commend the Centers for Medicare & Medicaid Services (CMS) for its efforts to modernize the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR). The proposed revisions appropriately reflect the maturation of transcatheter valve therapy and represent a meaningful step toward improving timely patient access to a proven, life-saving intervention.

The proposed modifications introduce greater flexibility for hospitals and multidisciplinary heart teams to tailor patient management in accordance with local resources, institutional expertise, and individual clinical presentations. These provisions have the potential to meaningfully reduce structural barriers to care, streamline treatment pathways, and ensure that patients with severe aortic stenosis receive appropriate therapy without undue delay.

I must, however, respectfully urge CMS to reconsider one significant aspect of this proposal. While reducing administrative burden is a laudable objective, the simultaneous removal of both TVT Registry participation requirements and minimum procedural volume standards eliminates critical mechanisms for quality oversight. Without these safeguards, there are insufficient checks and balances to reliably ensure that participating programs maintain the clinical experience, institutional infrastructure, and quality improvement processes necessary to consistently achieve optimal patient outcomes.

It is my strong belief that sound health policy must pursue the dual imperatives of expanding access and preserving quality. CMS has an opportunity to advance both goals by broadening patient access to this life-saving therapy while retaining evidence-based standards that protect patient safety and uphold the high level of care this population deserves. I respectfully urge CMS to adopt a balanced approach that achieves meaningful access expansion without compromising the accountability frameworks essential to program quality.

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Heart team approach is the core of the strength, safety and success of current TAVR programs.

Any attempt to weaken this structure would jeopardize the entire cardiac care structure.
In addition to providing timely support for the procedure itself, the heart team approach provided absolutely necessary checks and balances of appropriate use of this expensive technology.

Composition of the TAVR team with mandatory combination of Surgeons and cardiologist is vital for continued safety, effectiveness and appropriate use of TAVR.

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I agree this proposed NCD is a very positive and practical step forward for TAVR programs and, more importantly, for patients. TAVR has matured substantially, and in the vast majority of cases the decision-making and procedural execution are now straightforward and appropriately handled by an experienced heart team without unnecessary mandated barriers.

I strongly support removing the blanket requirement for two operators and a mandatory surgical consultation in every case. These requirements can create delays, increase cost, complicate scheduling, and add little value for most patients. Of course, surgical input and additional consultation remain essential when the anatomy, clinical scenario, or patient preference makes the decision more nuanced.

Clarification around reimbursement for a second scrubbed operator would be very helpful, particularly for programs where surgeons remain actively involved and highly invested in TAVR. I would support flexibility rather than a mandate — allowing centers to structure their programs based on local expertise, patient needs, and procedural complexity. In addition, CPT codes for centers structured around a single operator would also be helpful whether it is a surgeon or interventionist.

I completely support of the proposed changes and would encourage others to do the same.

Steve Jenkins

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The proposed CMS change of allowing TAVR to be performed by a single physician represents a significant departure from the principles that have underpinned the success of TAVR in the US. While expanding access to care is an important goal, CMS should carefully consider whether these changes may unintentionally compromise patient safety, and ultimately, procedural outcomes.

The exceptional clinical results achieved with TAVR over the past decade were not the result of a single operator or discipline. Rather, they were attained by the unique collaboration of cardiologists and surgeons within the Heart Team Framework. This model ensures a comprehensive patient evaluation, balanced assessment of surgical vs transcatheter options, real time management of complications, and shared accountability of outcomes. Eliminating the requirement for dual physician participation risks reducing TAVR from a multidisciplinary therapy to a procedure-driven intervention, thereby, undermining the patient-centered decision-making that CMS originally endorsed. All of this at a time when the mid-term results of the low risk TAVR trials are calling into question the long -term durability of TAVR.

As it pertains to hospital and physician volume prerequisites, a substantial body of literature already exists demonstrating the relationship between institutional volume and perioperative outcomes. Volume requirements are not arbitrary barriers, rather, they are quality safeguards designed to uphold specific standards of care. Removing these standards while simultaneously eliminating registry reporting mandates, leaves this life saving procedure to a "free-for-all" intervention with no oversight.

CMS may argue that relinquishing the above TAVR requirements will improve access in underserved regions, however, it will likely result in lesser outcomes. Access and quality should not be competing priorities.

As TAVR is moving into younger patients, lifetime management for these patients, is of utmost important. Optimal management and the future of these patients relies on both surgical and transcatheter expertise.

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1. I was a participant in Partner I and all subsequent Partner Trials and a reviewer of the original TAVR NCD for the ACC. The Heart Team Concept was devised to allow collaboration rather than competition between cardiology and cardiothoracic surgery with this new technology. This concept gave birth to a new field of Structural Heart Disease which has grown into the amazing partnership we see nationally.
2. Fifteen years later, its time to modernize this model.
3. I agree with all of the proposed changes to the NCD in this document.
4. We value our Heart Team and will continue to use two operators on most TAVR cases but the mandate to do so should stop. There are times and places when it isn't feasible to have both a surgeon and a cardiologist in a case. One operator and an experienced team is enough.
5. While 90% of patients have a straightforward pathway to treatment, 10% still need thoughtful collaboration and this will still exist without being mandated by CMS.
6. Treating asymptomatic patients should also be allowed based on numerous trials.

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I support the proposed updates to the TAVR coverage rules. After more than 14 years, TAVR is a mature therapy with strong evidence showing it reduces risk compared to open surgery—lower complications, shorter hospital stays, and faster recovery for patients with severe aortic stenosis. It’s time to update the rules to match that reality. The current requirements are too restrictive and get in the way of patients getting timely care. I work in a cath lab and structural heart program, and I see how volume thresholds, rigid evaluation rules, and other barriers delay treatment—especially for older, frailer patients who don’t have time to wait or travel far. I particularly like these changes in the proposal:

National coverage for symptomatic severe AS without CED — this removes unnecessary hurdles for patients who clearly need the procedure.

Removing hospital volume requirements to start or keep a TAVR program — this will help more community hospitals offer TAVR and improve access in areas that currently don’t have it.

Updating operator rules so it’s an interventional cardiologist or cardiac surgeon (not both required every time) and focusing volume requirements on actual TAVR/transcatheter experience — this reflects how programs actually work now.

Allowing more flexibility in the heart team evaluation process (including async/chart review for the initial review) while still keeping one in-person operator evaluation — this cuts down on delays without cutting corners.

The proposal keeps the important safeguards: heart team involvement, on-site cardiac surgery and interventional programs, ICU capability, and a focus on ongoing quality monitoring. That balance makes sense.

These changes will expand access without lowering standards. TAVR has proven itself. Patients—especially in smaller communities—will benefit.

I urge you to finalize these updates.

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CMS's proposed NCD supports continued coverage of TAVR for symptomatic severe aortic stenosis, but without the requirement to collect registry data on all patients through CED. For patients who have not yet developed symptoms, Medicare proposes to cover these patient under CED. On many key points, the proposed decision aligns well with the analysis and recommendations in our recently posted Health Affairs Forefront article: https://www.healthaffairs.org/content/forefront/lessons-tavr-medicare-s-coverage-evidence-development-program

Areas of agreement include:
- Ending CED for symptomatic patients, on the grounds that the original questions had been adequately addressed.
- Requiring CED studies for asymptomatic patients. CMS notes that studies could be designed using a wide range of data sources, including “a registry, clinical EHRs, claims data, the social security death index, and patient data from any type of study…”

In the 2012 and 2019 TAVR coverage decisions, CMS required that “the heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TAVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year…”

An important emphasis of our Forefront article was that the 14-year duration of the CMS registry data collection mandate for TAVR significantly exceeded the time needed to address the CED questions cited in the decisions. We argued that by limiting federal data collection mandates to a shorter period of time, it would create stronger incentives for the TVT and other CED-related registries to adopt efficiencies that reduce the data collection burden and operating costs, possibly enabling more community hospitals to participate.

We also noted that high quality registries like the TVT registry would be likely to be financially sustainable after a start-up period without a federal data collection mandates by supporting investigational device trials sponsored by device companies, post-approval studies required by the FDA, hospital quality reporting and benchmarking, and other multi-stakeholder research collaborations.

Modest refinements to the CED approach, including time-limited studies and reliance on a wider range of data sources, will further improve this policy tool.

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1. Reimbursement is sub-par for the amount of time and complexity for the treatment of valvular disease. The reimbursement should be at least above $1000 professional fee.
2. Single operator is adequate for TAVR.
3. Minimum SAVR requirement for the center to maintain a TAVR program should be at least 10 annually for the institution to be a TAVR center.
4. TAVR surgeons involved in structural team should have at least 10 SAVRs a year experience to perform SAVR.
5. TAVR operator should perform 18-24 TAVRs a year to maintain quality - some formula needs to be in place to be sure quality metrics are achieved.
6. If two operators scrub for procedure, both should be compensated.

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The proposed changes by CMS are entirely reasonable and supported by evidence. The reality is that TAVR has evolved tremendously since it was first approved, and much of the current regulation is antiquated and purely historical at this point.

1) TAVR procedures can be done safely by a single operator (either an appropriately trained interventional cardiologist or cardiothoracic surgeon). All other structural heart procedures being done are single operator, and the vast majority of those are far more complex and higher risk than TAVR. There is nothing "special" about the aortic valve that should mandate 2 operators or necessarily mandate the presence of a cardiac surgeon. Requiring 2 operators only makes scheduling much more challenging and delays treatment for a 0.2% chance that urgent surgery will be required (which is lower than PCI procedures that don't have such requirements). This makes no sense in contemporary TAVR.

2) The heart team concept has generally worked well, but it no longer makes sense for every single patient to be evaluated by both a cardiac surgeon AND an interventional cardiologist- this adds substantial delay to treatment and is unnecessary for the vast majority of straightforward cases in contemporary practice. Patients who are more complex or pose specific challenges will certainly benefit from the "heart team" approach and should be evaluated by both a cardiothoracic surgeon and an interventional cardiologist- but that should be left up to physician discretion and not mandated. The current system is not academically consistent: if a patient is sent to a CT surgeon for SAVR there is no such obligation that they must also be evaluated by an interventional cardiologist to discuss TAVR prior to proceeding with SAVR, but if that same patient is sent to an interventional cardiologist first they must be seen by a CT surgeon first if the plan is to do TAVR. This no longer makes sense in contemporary practice and this inconsistency should not be mandated.

3) TAVR should definitely be covered for asymptomatic patients- this is clearly supported by robust data

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1) Obviously, decades of experience has taught us that TAVR is a single operator procedure. Two operators are not mandated for transcatheter mitral valve or tricuspid repair of replacement.
The only plausible argument for two operators would be for surgical availability in case of emergency surgery. But the need for emergency open chest surgery during TAVR has been documented at 0.25%. This is less than the need for emergency surgery during PCI.
Requiring two operators is not practical and can significantly delay the procedure, and very significantly increases the length of stay for inpatients and, of course, increases costs

2) Requiring a surgical consultation causes delays, is often difficult to arrange for elderly patients, increases costs and often confuses the patient. The “heart team” approach was very valuable early in the life of TAVR, but now the decisions are straightforward in >90% of patients. Like everything else in cardiology, when a patient falls into a grey area its up to physicians to get additional opinions. It is not mandated for an interventional cardiologist to consult on every patient who receives SAVR, why should a surgeon need to comment on every patient receiving TAVR? Mandating a separate surgical opinion in every patient is a significant waste of resources.

3) TAVR for asymptomatic patients is supported by EARLY TAVR and other trials.

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I am writing as a practicing cardiac surgeon in New York State with over two decades of experience in structural and minimally invasive cardiac surgery, including the first use of robotic cardiac surgery in my region in 2004. I support several aspects of this proposal, particularly the continued requirement that the heart team include both a cardiac surgeon and an interventional cardiologist, and the requirement that hospitals maintain on-site cardiac surgery programs. These reflect the reality that structural heart disease was a surgical discipline long before "structural heart" became its own subspecialty — cardiac surgeons were doing this work, managing these patients, and owning these outcomes before the term existed.
I am concerned, however, about the proposed weakening of outcome reporting requirements for symptomatic TAVR once the CED requirement is removed. As proposed, hospital-level accountability would rest on an undefined "continuous quality improvement process," with no specified registry, no specified metrics, and no external audit. This stands in sharp contrast to the rigor CMS itself imposes on the asymptomatic CED population in the same proposal, where milestone reporting, ClinicalTrials.gov registration, and 12-month public reporting are mandatory.
The current TAVR ecosystem already has the infrastructure to do better than a vague QI standard. My colleagues and I report every case to the STS database, and in New York State we are additionally subject to mandatory state-level cardiac surgery outcomes reporting — a system with real statutory teeth that produces actual risk-adjusted, publicly available mortality data. There is no principled reason for CMS to retreat from registry-based reporting for TAVR at the exact moment it is loosening operator and hospital volume thresholds and removing barriers to new program entry. Volume thresholds and an unaudited internal QI process are not a substitute for risk-adjusted outcomes data submitted to a national registry.
I respectfully urge CMS to retain mandatory participation in a national, audited TAVR-specific registry (e.g., the STS/ACC TVT Registry or successor) as a hospital-level coverage criterion for symptomatic TAVR, not only for the CED-supported asymptomatic population. As CMS itself notes in this proposal, one of the open CED research questions is whether risk-standardized, patient-centered outcomes could eventually replace volume criteria altogether. That question can only be answered if outcomes continue to be captured systematically and audited externally — which requires mandatory registry participation, not a voluntary or undefined QI process.
Thank you for the opportunity to comment.
Respectfully,

Charles J. Lutz, M.D.

Cardiac Surgery Associates of CNY, P.C.

Syracuse, NY

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While I support CMS efforts to modernize TAVR coverage and reduce unnecessary administrative burden, I have significant concerns regarding several elements of the proposed revision.

First, I strongly oppose elimination of hospital and operator volume thresholds. TAVR is a technically complex structural heart procedure with potentially catastrophic complications, including annular rupture, coronary obstruction, stroke, major vascular injury, valve embolization, paravalvular leak, and emergent need for surgical bailout. Procedural experience matters. As proven in other interventional procedures, minimum hospital and operator volume standards help ensure that programs maintain the technical skill, multidisciplinary infrastructure, and complication-management readiness necessary to deliver high-quality care. Removing these thresholds risks allowing low-volume programs or inexperienced operators to perform TAVR without sufficient procedural repetition to maintain excellence. This could dilute quality, increase variability in outcomes, and expose Medicare beneficiaries to avoidable risk.

Second, I believe CMS should continue to require both an interventional cardiologist and a cardiac surgeon to be meaningfully involved in the implanting team. TAVR is not simply a catheter-based procedure; it is a valve-replacement procedure performed in patients who may still require surgical judgment, surgical rescue, or alternative surgical therapy. The collaborative heart-team model has been central to the success of TAVR. A cardiac surgeon brings critical expertise in operative risk assessment, anatomy, bailout feasibility, and comparison of TAVR versus SAVR. An interventional cardiologist brings expertise in catheter-based valve delivery, vascular access, and intraprocedural imaging and hemodynamics. Weakening this dual-specialty model would undermine the very structure that has helped make TAVR safe and successful.

Third, I am concerned about expanding TAVR to asymptomatic patients based on an echocardiographic report alone. Severe aortic stenosis on echo does not automatically equal a need for valve replacement, particularly in patients who deny symptoms. Echo findings must be interpreted in clinical context, including symptom assessment, functional status, frailty, comorbidities, valve anatomy, gradient-flow relationships, LV function, exercise testing when appropriate, CT anatomy, and shared decision-making. In asymptomatic severe AS, the risk-benefit threshold is fundamentally different because the patient is not yet clinically limited by the disease. Proceeding to TAVR based only on an echo report risks overtreatment, exposes patients to procedural complications, and may lead to premature bioprosthetic valve implantation in patients who could have been safely monitored.

For these reasons, I would urge CMS to retain meaningful hospital and operator volume standards, preserve the requirement for both cardiac surgery and interventional cardiology participation in the implanting team, and avoid coverage of TAVR in asymptomatic severe AS unless there is comprehensive heart-team evaluation beyond the echocardiographic report alone.

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1. Mandatory Cardiac Surgeon Involvement Is No Longer Clinically Justified
The proposed NCD requires that the heart team include at least one cardiac surgeon for every TAVR procedure. While this requirement may have been appropriate when TAVR was in its early stages, the extensive clinical evidence reviewed in this memo — including pivotal RCTs such as PARTNER 3, Evolut Low Risk, NOTION, DEDICATE-DZHK6, SURTAVI, and others — now firmly establishes TAVR as a safe and effective percutaneous procedure with outcomes comparable or superior to surgical aortic valve replacement (SAVR) across all surgical risk strata.
TAVR is a catheter-based, percutaneous procedure that falls squarely within the scope of interventional cardiology. It does not require surgical exposure, cardiopulmonary bypass, or open-chest techniques. Mandating the physical involvement of a cardiac surgeon in every TAVR procedure does not align with the technical realities of the intervention and creates an artificial structural barrier that is not evidence-based. CMS should recognize that TAVR’s proven safety profile makes blanket surgical co-management at the procedural level unnecessary.

2. The Current Reimbursement Model Is Inequitable and Inconsistent
There is a fundamental inconsistency in how CMS structures reimbursement across the two procedures for aortic stenosis:

• When a cardiac surgeon performs a SAVR, interventional cardiologists are not required to be co-operators and do not receive a share of the surgical reimbursement.
• Yet under the current framework, a cardiac surgeon who participates in a TAVR procedure — a procedure that does not require surgical skill or technique — receives co-operator reimbursement equivalent to the interventional cardiologist performing the procedure.

3. Patient Autonomy Should Govern the Choice Between TAVR and SAVR
The proposed NCD mandates that all TAVR patients undergo evaluation for SAVR suitability as part of the heart team assessment. While multidisciplinary input is valuable, CMS should recognize that SAVR and TAVR now represent clinically equivalent treatment options across most risk categories based on the evidence CMS itself has reviewed. Requiring a mandatory SAVR discussion for every TAVR patient — without a parallel requirement for TAVR consultation in every SAVR case — reflects an asymmetry that does not serve patient-centered care.
Patients who have been evaluated by an interventional cardiologist, have been determined to be appropriate candidates for TAVR, and are satisfied with the risks and benefits of the percutaneous approach should not be required to undergo a formal surgical consultation if they do not wish to pursue SAVR. Autonomy-preserving informed consent — led by the treating TAVR operator — should be sufficient, with surgical consultation available at the patient’s request or when the clinical situation genuinely warrants it.
Just as not every SAVR patient is required to consult with an interventional cardiologist before surgery, not every TAVR patient should be required to obtain a formal cardiac surgery evaluation. This parallel structure is the more equitable and patient-centered approach.

Recommendations to CMS:

1. Revise the Heart Team requirement to mandate cardiac surgery availability at the hospital level — rather than mandatory individual surgeon participation in each TAVR case — recognizing TAVR as an interventional cardiology procedure with established safety.
2. Align TAVR co-operator reimbursement policy with that of SAVR: a solo TAVR operator (interventional cardiologist) should receive full procedural reimbursement, consistent with how cardiac surgeons are reimbursed for SAVR performed without mandatory IC co-operators.
3. Allow patient autonomy in the decision to seek a surgical second opinion, rather than requiring a mandatory SAVR evaluation as a condition of TAVR coverage. Surgical consultation should be offered and encouraged, but not mandated as a prerequisite.

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On behalf of millions of taxpayers and consumers across the country, the Taxpayers Protection Alliance (TPA) applauds the Centers for Medicare & Medicaid Services (CMS) for proposing to cover Transcatheter Aortic Valve Replacement (TAVR) for symptomatic severe aortic valve stenosis—or aortic stenosis (AS)—without a coverage with evidence development (CED) requirement. Additionally, CMS laudably proposes to expand coverage of TAVR to asymptomatic severe AS with CED, and update coverage criteria for related assessments and requirements.

Using TAVR to treat patients with AS is significantly more affordable for taxpayers and patients than traditional alternatives and expanding treatment to asymptomatic patients will save lives and reduce Medicare spending. TPA urges CMS to adopt commonsense reimbursement policies in line with comprehensive clinical evidence guidelines and sound fiscal stewardship.

TAVR is an innovative approach to treating AS, a life-threatening narrowing of the heart’s aortic valve that disproportionately affects older Americans. Unlike traditional Surgical Aortic Valve Replacement (SAVR), which requires open-heart surgery and cardiopulmonary bypass, TAVR allows physicians to replace the valve through a catheter inserted into a blood vessel, typically in the groin. This approach avoids major surgery, reduces physiological stress on patients, and has expanded treatment options for elderly and higher-risk populations whose treatments account for most of Medicare’s $1 trillion budget.

Clinically, TAVR has demonstrated outcomes that are often superior to open surgery. Large, randomized trials and real-world registry data show similar survival rates, faster symptom relief, and more rapid improvements in quality of life, particularly for older patients and those at intermediate or high surgical risk. Patients undergoing TAVR generally experience fewer complications related to surgical trauma, such as major bleeding or prolonged ventilator use, which are common drivers of extended hospital stays and downstream costs. A 2024 review of the evidence published in the medical research journal Cureus concludes, “TAVR is preferred over SAVR in terms of cost-effectiveness across a variety of patients with other coexisting medical conditions, including cancer, advanced kidney disease, cirrhosis, diabetes mellitus, and bundle branch block. TAVR also appears to be superior to SAVR with fewer post-operative complications.”

Unsurprisingly, the reduced length of stay and diminished likelihood of complications translate to significant savings for taxpayers and patients. According to a 2019 analysis published in Circulation—an American Heart Association journal—“Over a lifetime horizon, TAVR was projected to lower total costs by $8000 to $10 000 and to increase quality-adjusted survival by 0.15 to 0.27 years.” These findings are consistent with Edwards Lifesciences’ 2024 Early TAVR study, which focused on asymptomatic patients in particular and found improved outcomes following early intervention with TAVR. When the abundance of evidence all points in one direction, it is critical that CMS listens and updates its reimbursement policies accordingly—as it wisely proposes doing.

TPA further encourages CMS to remove its CED determination for TAVR (including for asymptomatic severe AS) and scale back CEDs as part of a wider reform effort. When first put into place via 2005 and 2006 CMS guidance, CED was designed to allow Medicare to verify the effectiveness of new treatments covered by the insurance program. CMS ordinarily employs the “reasonable and necessary” standard for covering treatments, but this standard may not be met by premarket trial data alone. CED data collection ideally serves as a way of closing the evidentiary gap, particularly when the treatment is off label (i.e., not approved by the Food and Drug Administration (FDA) for a particular use).

Unfortunately, CED policy has not lived up to its promise, even blocking treatments approved by the FDA with a wealth of clinical trial data. As healthcare policy advisor and researcher Joe Grogan noted in 2023, “with the advent of a new class of Alzheimer’s treatments, CMS has now for the first time applied this policy to therapies when used on-label, effectively inserting itself as a ‘check’ on the [FDA].” TAVR is just another proven treatment in a long line of medical breakthroughs shackled by this unnecessary and outdated process.

CMS should reform the CED program to only encompass therapies not approved by the FDA for relevant uses being considered by Medicare. This change would ensure that CED is not a costly regulatory add-on to already-onerous FDA rules. By reforming CED determinations and shifting course on TAVR reimbursements, CMS could save patient lives and help stabilize Medicare’s finances. Thank you for your time and consideration of these important issues.

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I think there needs to be a legislative inclusion of a cardiothoracic surgeon in the heart team to decide on TAVR and surgical AVR treatment and then be physically present and reimbursed for being there.

If there is no CT surgeon, then the decisions will be made by cardiologists only who have all the incentives to use TAVR as that is their only tool whereas a surgeon can do TAVR or SAVR and can be the balancing influence about doing what is best for the patient and not leaving the patient to be sold only TAVR unless the cardiologist goes out of their way to suggest SAVR. I am not saying that all cardiologists act in a financially/RVU/use your only tool sort of way, but when dealing with thousands of patients over the entire country every year, this is where the bias will lie.

Also, there is currently a big debate about using TAVR in younger patients and cardiologists are more likely to do that when the evidence is nowhere near sufficient to say that it is safe over the long life of young patients to do that. More evidence is coming out that shows there may be greater harm in using these valves in younger patients (choosing a tissue TAVR valve over a mechanical valve and justifying that by saying the patient requests it - which all depends on how the evidence is presented).

I think excluding CT surgeons from a mandatory role on the TAVR Heart Team and RVU-generating participation in TAVR is a huge disservice and potentially dangerous to patients.

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- Dats regarding the benefit of TAVR in asymptomatic severe AS is compelling and change to reflect that is needed.

- Heart team should always be involved in AS management discussions, however for practicality reasons I agree that only one TAVR operator (either cardiologist or surgeon) to in person meet with the patient is adequate.

- Years of physicians performing TAVR have proved to us that TAVR proceudre can be proficiently performed by one qualified TAVR operator. I support the change to permit performing the TAVR proceudre by one operator only.

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To the Coverage and Analysis Group:

I have read the proposed decision memorandum and appreciate the opportunity to comment. As a structural interventional cardiologist who performs TAVR, I am broadly supportive of the direction CMS has taken, and I want to offer focused comments on the following points.

1. I support extending coverage to asymptomatic severe aortic stenosis, consistent with the EARLY TAVR data and the recent FDA label expansion.
2. I agree that continued submission of all TAVR procedures to a national registry should be retained.
3. I strongly support preserving the cardiac surgeon's role in the multidisciplinary heart-team evaluation. Independent surgical assessment of SAVR versus TAVR candidacy adds value to lifetime-management decisions.
4. I support the simplified pre-procedural evaluation pathway to reduce delays for a baseline high risk AS population.
5. Maintaining operator flexibility is critical. I strongly urge CMS to preserve, and to state clearly in the final NCD, that the intraoperative technical aspects of TAVR may be performed by two appropriately qualified and experienced interventional cardiologists, without a regulatory mandate that a cardiac surgeon serve as one of the two operators. The relevant patient safeguard is institutional. On-site cardiac surgery and interventional cardiology capability, which the NCD already requires, is absolutely critical. However, a surgeon scrubbed into every routine case is not. TAVR has matured into a procedure with low complication rates, and the majority of intraprocedural complications can be stabilized percutaneously while on-site surgical support is mobilized when needed. The multi-society systems-of-care framework already defines operator competency by procedural volume and experience rather than by specialty. A flat intraoperative co-operator requirement does not improve outcomes at experienced centers, and it functions as an access barrier in precisely the underserved areas the proposal seeks to help, where a second surgeon-operator may not be reliably available. To be clear, this comment concerns the performance of the procedure itself and is fully separable from the heart-team evaluation, which I support retaining.
6. I strongly support establishing a payment mechanism for surgical standby during TAVR procedures in which the surgeon is not an operator. I share the concern that relaxing the intraoperative requirement could inadvertently disincentivize active surgical engagement, and I believe a surgical-standby payment is the right policy lever to address it. It keeps surgeons meaningfully involved in the program and in balanced SAVR-versus-TAVR counseling, and it ensures immediate surgical availability for the rare catastrophic complication without converting that engagement into a coverage mandate that a surgeon co-operate in every case. This approach preserves surgical participation while removing an unnecessary access barrier, and I would encourage CMS to advance it in coordination with the relevant payment rulemaking.
7. Finally, there should be a mechanism for coverage to update automatically as additional FDA indications for aortic stenosis are approved, so that new indications can be covered without reopening the NCD.

Thank you for your consideration of these comments.

Sincerely,

Jay Khambhati, MD
Interventional & Structural Cardiology
University of Chicago Medicine

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The proposed framework eliminates joint operator requirement. I respectfully asked that the NCD should explicitly note that dual specialty operators—consisting of both a cardiac surgeon and an interventional cardiologist— are optimal for patient care. This balanced co-participation ensures that the distinct, complementary skill sets of both specialties are immediately available at the bedside to optimize outcomes and manage complex anatomy or sudden complications.

I asked that for the first year of operation, any new TAVR site must be required to utilize a dual-specialty operator composition consisting of both a cardiac surgeon and an interventional cardiologist. This requirement is especially critical in low-volume settings, where institutional infrastructure and heart team partnerships may still be developing and where close, formal collaboration provides an essential safety net for optimal patient care.

I asked that TAVR be covered under CED for the following indications or conditions:

Asymptomatic aortic stenosis, bicuspid aortic valve anatomy, moderate aortic stenosis, valve-in-valve TAVR, aortic insufficiency, and low risk aortic stenosis patients.
New TAVR programs for hospitals without TAVR experience for all indications.
Newly FDA approved TAVR valves.

I asked that for the above CED indications and conditions, the heart team and hospital must participate in a prospective, national, audited registry that consecutively enrolls TAVR patients, follows them for at least one year, and reports on the relevant clinical outcomes.

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Dear CMS Administrator,

As the Chief of Cardiac Surgery at St. Bernards Medical Center (Jonesboro, AR) and a practicing cardiac surgeon caring for patients throughout Northeast Arkansas and Southern Missouri, I am deeply concerned by the proposed removal of the requirement for a two-operator TAVR team consisting of both a cardiac surgeon and an interventional cardiologist.

The success of TAVR in the United States has been built upon the “heart team model”, which ensures multidisciplinary expertise in patient selection, procedural planning and execution, intraoperative decision-making, and management of complications. The requirement for participation by both a cardiac surgeon and an interventional cardiologist has been a cornerstone of the outstanding safety and quality outcomes achieved nationwide in this field.

Importantly, every pivotal clinical trial that led to FDA approval and expansion of TAVR across extreme-risk, high-risk, intermediate-risk, and low-risk patient populations was conducted within the framework of a multidisciplinary heart team and a two-operator model involving both a cardiac surgeon and an interventional cardiologist at the table. The safety and efficacy data upon which FDA approvals and Medicare coverage decisions were based were generated exclusively using this care model. There is currently no comparable body of evidence (written or otherwise) demonstrating equivalent outcomes with a single-operator or single specialty approach. While there are many other good reasons, for this reason alone CMS should reject any proposal attempting to modify or abandon this foundational requirement that was integral to the evidence supporting TAVR safety and leading to its wide spread adoption in the United States.

TAVR is not simply a catheter-based procedure. It is the treatment of a complex structural heart disease in a patient population that often carries significant comorbidities and may require immediate surgical intervention when life-threatening complications occur. The presence and active involvement of a cardiac surgeon during the procedure provides critical expertise that cannot be replicated through consultation alone. Neither interventional cardiologists nor cardiac surgeons, in isolation, can provide the depth of care achieved when both specialties are immediately available to the patient. Simple examples such as the need to deploy a coronary stent for an acutely occluded coronary artery or the need to perform an emergency sternotomy to manage a ruptured aorta illustrate situations in which either operator may encounter a life-threatening complication that requires the expertise of the other. Much like a contractor attempting to build a house with two plumbers or two electricians instead of one of each, performing TAVR with two surgeons or two interventional cardiologists would undermine the complementary skill set that has been central to the procedure’s massive and unfettered success.

Removing the requirement for a surgeon-cardiologist operator team risks eroding the collaborative framework that has made TAVR successful and may create incentives that prioritize procedural efficiency over comprehensive patient care. Importantly, there is no compelling clinical evidence demonstrating that eliminating this requirement improves outcomes, efficiency, access, or patient safety. In contrast, the existing evidence base supporting TAVR was developed entirely under the heart team and dual-operator (cardiac surgeon and interventional cardiologist) paradigm.

CMS has appropriately emphasized evidence-based policy in its coverage decisions. Maintaining the surgeon-cardiologist two-operator requirement is consistent with that principle. Until prospective evidence demonstrates that a single-operator or single specialty model achieves equivalent outcomes across the full spectrum of TAVR patients, the standard that produced the current evidence base should remain in place.

As indications continue to expand into younger, lower-risk, and more anatomically complex patient populations, preserving—not weakening—the heart team model (both in evaluation as well as procedural treatment of patient) is absolutely essential.

I respectfully urge CMS to retain the requirement for active participation by both a cardiac surgeon and an interventional cardiologist during TAVR procedures to protect patient safety, preserve evidence-based care, and uphold the multidisciplinary approach that has been fundamental to the success of TAVR in the United States.

Respectfully,

Jay K. Bhama, MD
Chief, Cardiac Surgery
Medical Director, Advanced Heart Surgery Program
Medical Director, MCS (LVAD/ECMO) Program
Medical Director, Cardiovascular Intensive Care Unit (CVICU)

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Thank you for the opportunity to comment on the proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR).

As cardiac surgeons practicing within a large, integrated academic cardiovascular system, we appreciate CMS's thoughtful review of this important policy and recognize several positive aspects of the proposed determination. We are particularly encouraged by CMS's decision to preserve the Heart Team model, maintain the requirement for participation of a cardiac surgeon in patient evaluation, and continue to require on-site cardiac surgical programs. These elements have been foundational to the outstanding clinical outcomes achieved in the United States since the introduction of TAVR and remain critical safeguards for patient safety and quality.

We also acknowledge CMS's efforts to expand patient access to TAVR and to modernize the coverage framework in response to the maturation of the technology and the growing body of clinical evidence.

At the same time, we respectfully request reconsideration of several aspects of the proposed determination.

First, we remain concerned by language that permits TAVR to be performed as a single-operator procedure, especially as it is agnostic to patient anatomy or procedural risk. While we recognize that not every case requires active participation by two operators, the ability of the Heart Team to determine when dual-operator participation is appropriate should be preserved and encouraged. The success of TAVR in the United States has been built upon a collaborative model involving both interventional cardiologists and cardiac surgeons. This partnership enhances procedural planning, patient selection, management of complications, and overall quality of care.

Importantly, catastrophic complications requiring immediate surgical intervention, although uncommon, continue to occur. In these situations, the immediate availability and active participation of an experienced cardiac surgeon can be lifesaving. We believe CMS should preserve language that recognizes the value of dual-operator participation in appropriate cases and avoids creating incentives that may unintentionally diminish multidisciplinary collaboration.

Second, we encourage CMS to reconsider the removal of Coverage with Evidence Development (CED) requirements for evolving clinical indications, including moderate aortic stenosis, bicuspid aortic valve disease, pure aortic regurgitation, valve-in-valve procedures, and low-surgical-risk patients. These patient populations continue to represent areas of active investigation where important questions remain regarding long-term durability, optimal patient selection, lifetime management strategies, and comparative effectiveness. Continued evidence generation through registries and structured data collection will help ensure that future expansion of TAVR indications remains grounded in high-quality clinical science.

Third, we encourage CMS to continue supporting robust operator competency standards. As TAVR expands into increasingly complex patient populations, operator experience, procedural volume, and multidisciplinary expertise remain essential determinants of quality and patient outcomes. Any future coverage framework should continue to emphasize training, competency, and ongoing outcomes assessment for all operators regardless of specialty.

The Heart Team model has transformed the care of patients with aortic valve disease. Its success stems not from the interests of any individual specialty, but from the shared commitment of cardiologists, cardiac surgeons, imaging specialists, anesthesiologists, nurses, and allied professionals working together to provide the safest and most effective care possible.

We respectfully urge CMS to preserve and strengthen those collaborative principles in the final National Coverage Determination. Doing so will continue to promote patient safety, evidence-based innovation, and optimal long-term outcomes for Medicare beneficiaries.

Thank you for your consideration.

Raymond L. Singer, MD, MMM, FACS, FACC, FCCP, FCOPP

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A cardiologist (or two cardiologists) should not be able to perform TAVR without an involved surgeon as they cannot perform necessary life-saving procedures in the event of a complication. Only surgeons should be able to perform this procedure as a single operator as that is the only type of training that allows for comprehesive management of TAVR complications.

Needs to include continue Coverage with Evidence Development (CED) for the areas where clinical science is lacking to include asymptomatic aortic stenosis (AS), moderate AS, bicuspid AS, pure aortic regurgitation (AR), valve-in-valve repeat interventions, and low surgical risk.

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I write to express strong support for the proposed revisions to TAVR NCD 20.32. CMS should be commended for undertaking this thoughtful reconsideration. The proposed changes reflect the substantial maturation of TAVR over the past decade and will meaningfully improve access to this lifesaving therapy for Medicare beneficiaries. As a structural heart specialist who performs these procedures and cares for patients with aortic stenosis, I am encouraged that the proposed NCD addresses several critical barriers that have limited timely patient access.

The most impactful proposed change is clarifying that joint participation of two TAVR operators is not required. This revision will have immediate, tangible benefits for patient access and program capacity. In my experience, the prior requirement for both a cardiac surgeon and interventional cardiologist to be present created scheduling bottlenecks that delayed procedures, particularly at centers with limited staffing or in rural and suburban settings where TAVR-trained physicians may cover multiple hospitals. Contemporary TAVR has an excellent safety profile, with conversion to open surgery occurring in fewer than 0.5% of cases, which is comparable to PCI, which has never required dual-operator presence. The COVID-19 pandemic demonstrated that excellent outcomes could be achieved without the strict two-operator requirement. By allowing experienced operators to perform TAVR independently while still permitting centers to maintain two-operator systems if they choose, this proposal strikes the right balance between safety and access. I anticipate this change alone will reduce patient wait times, improve procedural throughput, and help centers meet the ACC/AHA quality target of treatment within 90 days of diagnosis.

I strongly support removing CED requirements for symptomatic severe AS. The evidence base for TAVR in this population is now definitive, with long-term durability demonstrated through 10 years, real-world outcomes from the TVT Registry matching pivotal trial results, and a validated 30-day composite quality metric endorsed by the National Quality Forum. The original CED questions have been thoroughly answered. Sunsetting CED for symptomatic AS appropriately recognizes TAVR as an established, evidence-based therapy and will reduce administrative burden on programs while maintaining quality through direct outcome measurement.

I also support expanding coverage to asymptomatic severe AS. The EARLY TAVR trial, published in the New England Journal of Medicine, demonstrated significant reductions in death, stroke, and cardiovascular hospitalization with early intervention compared to watchful waiting. These findings are consistent with earlier randomized trials, including RECOVERY and AVATAR. Clinically, disease progression in AS is unpredictable, where patients can convert rapidly from asymptomatic to acutely decompensated, carrying higher procedural risk. While I understand the rationale for CED in this newer indication, I would note that the existing randomized trial evidence is robust and may already satisfy many of the proposed CED questions. I encourage CMS to establish a clear pathway for transitioning asymptomatic coverage from CED to standard coverage as additional data accrue, and to ensure CED requirements do not create undue barriers to enrollment or delays in treatment for appropriate patients.

The revised volume requirements allowing operators to count all transcatheter valve procedures toward their threshold is reasonable and reflects the reality that skills developed across structural heart interventions are transferable. The continued emphasis on heart team evaluation and hospital infrastructure requirements appropriately maintains quality standards while removing outdated process barriers. In summary, I urge CMS to finalize this proposed NCD. These changes will improve patient access, reduce delays in care, address geographic disparities, and better align coverage policy with the current evidence and safety profile of TAVR while maintaining appropriate quality oversight through outcome-based measurement

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It would be a serious mistake to remove the requirement for cardiac surgeon participation during TAVR procedures. While TAVR has become a mature and highly successful therapy, catastrophic complications—including annular rupture, coronary obstruction, aortic dissection, ventricular perforation, and valve embolization—remain possible and can require immediate surgical intervention.

The Heart Team model has been a cornerstone of the excellent outcomes achieved with TAVR in the United States. Requiring the presence and participation of a cardiac surgeon ensures that patients have access to the full spectrum of expertise and treatment options, including emergent conversion to open surgery when necessary.

The argument that complications are infrequent is not a justification for eliminating surgical involvement. The rarity of these events does not diminish their severity. Medicare beneficiaries deserve the highest standard of care, and that includes maintaining a multidisciplinary approach with active cardiac surgeon participation during TAVR deployment.

CMS should preserve the current requirement for cardiac surgeon involvement in TAVR procedures and continue to support the Heart Team model that has contributed substantially to patient safety and procedural success.

The consequence of not having a surgeon immediately available is not a minor inconvenience—it is potentially a preventable death.

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I disagree with the plan to change coverage decision for TAVR. Specifically, the complication rate for bicuspid Aortic valves should make the procedure limited to very high risk patients. The data on intermediate and longterm survival of TAVR vs SAVR in young patients should prohibit these young low risk patients from having TAVR. These survival curves diverge at about 3 years. I also believe that having a cardiac surgeon and interventional cardiololgist on these cases has resulted in great outcomes

Modifying the coverage decision will dilute the commitment to the heart team

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It is of utmost and critical importance for patient safety, optimal patient outcomes and lifetime patient disease management that cardiac valvular disease be treated with a heart team approach, irrespective of whether it involves the aortic, mitral, tricuspid or pulmonic valve.

Moreover, it is important that continuing evidence development be an important and integral part of future national coverage decisions as therapies continue to develop and emerge for valvular heart disease.

White the composition of the heart team may vary, surgical input should remain a necessary and key part of therapy development for this patient subset.

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Public Comment Regarding the Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement

I appreciate the opportunity to comment on the proposed National Coverage Determination for transcatheter aortic valve replacement (TAVR).

Over the past decade, TAVR has transformed the treatment of aortic valve disease and has become one of the great successes of contemporary cardiovascular medicine. That success did not occur by chance. It was built upon rigorous clinical investigation, careful patient selection, transparent outcomes reporting, and the collaborative heart team model that brought together interventional cardiologists, cardiac surgeons, imaging specialists, anesthesiologists, and multidisciplinary support teams. These principles have contributed to excellent patient outcomes and should remain foundational as indications continue to evolve.

I support several aspects of the proposed determination, including preservation of the surgeon’s role in patient evaluation and the requirement for onsite cardiac surgical capability. These provisions recognize that aortic valve disease management is not simply a procedure, but rather a comprehensive process of patient-centered decision-making and lifelong valve management.

However, I am concerned that the proposed determination retreats from the principle of Coverage with Evidence Development (CED) in several important areas where the science remains incomplete. Expanding routine coverage for asymptomatic severe aortic stenosis, moderate aortic stenosis, bicuspid valve disease, pure aortic regurgitation, valve-in-valve interventions, and low surgical risk populations without continued evidence generation risks outpacing the clinical data necessary to guide optimal patient care.

Innovation and evidence generation are not competing goals. Continued CED provides an important mechanism to ensure that expansion of indications is accompanied by robust collection of outcomes data, allowing clinicians and patients to understand durability, reintervention rates, and long-term consequences of therapy. This is particularly important given the younger age and longer life expectancy of many patients now being considered for transcatheter therapies.

I am also concerned by language permitting single-operator procedures. While local heart teams should retain flexibility, the success of TAVR in the United States has been inseparable from the collaborative heart team model. The involvement of multiple disciplines has enhanced patient selection, procedural safety, and management of complications. Policies should reinforce—not inadvertently weaken—the culture of collaboration that has distinguished structural heart care.

As indications broaden and technologies evolve, it is essential that national coverage policy maintain the appropriate balance between expanding access, encouraging innovation, and preserving evidence-based safeguards. The quality standards incorporated into prior coverage determinations have served patients well and should not be abandoned without compelling evidence that doing so will improve outcomes.

The history of TAVR demonstrates that disciplined adoption and rigorous evidence have accelerated, rather than impeded, innovation. We should be cautious about abandoning the very principles that made this success possible.

The remarkable progress achieved in structural heart disease has been a triumph of multidisciplinary care and scientific rigor. Future policy should preserve both.

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I submit these comments as a board-certified cardiothoracic surgeon and former leader of multidisciplinary structural heart programs with extensive experience in both surgical and transcatheter therapies. My practice has included minimally invasive valve surgery, complex mitral valve repair, surgical aortic valve replacement, aortic root enlargement procedures, coronary artery bypass grafting, and the treatment of complex aortic pathology. I have also been actively involved in the development and performance of structural heart interventions, including transcatheter aortic valve replacement (TAVR), transcatheter edge-to-edge repair (TEER), and other transcatheter valve therapies. Having participated in the evaluation and treatment of a large number of patients with valvular heart disease, I have witnessed firsthand how the Heart Team model improves patient selection, promotes balanced counseling regarding available treatment options, and enhances procedural safety and outcomes. The concerns expressed in this comment arise not from opposition to TAVR, but from a commitment to preserving the patient-centered principles that have contributed substantially to the success of TAVR in the United States.

I am writing to express my concerns regarding the proposed modifications to the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR), specifically those changes that may diminish the role of the multidisciplinary Heart Team and reduce the involvement of cardiac surgeons in the evaluation and management of these patients.

The extraordinary success of TAVR over the past decade has not been attributable solely to technological advances. Rather, it has been the direct result of the Heart Team approach, which brought together interventional cardiologists, cardiac surgeons, cardiac imaging specialists, anesthesiologists, advanced practice providers, and nursing teams to provide comprehensive evaluation and individualized treatment recommendations. This collaborative model has improved patient selection, procedural planning, complication management, and overall outcomes. It has become one of the defining strengths of structural heart programs in the United States.

The Heart Team was established because patients with severe aortic stenosis often have multiple treatment options, each with distinct short- and long-term implications. A balanced evaluation is critical to ensure that patients receive the therapy most appropriate for their anatomy, age, comorbidities, life expectancy, and personal goals. Without meaningful surgeon involvement, there is concern that some patients who may derive greater long-term benefit from surgical intervention could instead be directed toward transcatheter therapies without a comprehensive discussion of all available options.

Examples include younger patients who may be better served with surgical aortic valve replacement, patients who may benefit from mechanical prostheses because of durability considerations, individuals requiring aortic root enlargement to prevent prosthesis-patient mismatch, patients with bicuspid aortic valve anatomy, and those with concomitant cardiac conditions such as coronary artery disease or ascending aortic pathology that can be addressed at the time of surgery. While transcatheter approaches have transformed the treatment of aortic stenosis, they are not universally the optimal strategy for every patient.

There is also increasing recognition that TAVR explantation represents a complex and high-risk operation associated with substantial morbidity and mortality. As TAVR expands into younger populations with longer life expectancy, the downstream implications of lifetime valve management become increasingly important. Decisions made today may significantly affect the safety and feasibility of future interventions. Therefore, careful patient selection remains essential. Consideration should be given to establishing guardrails regarding age, anticipated life expectancy, valve durability, anatomic suitability, and conditions such as small annular dimensions relative to body size, bicuspid valve anatomy, and the presence of other surgical indications.

The concern is not primarily with experienced, high-volume centers where multidisciplinary evaluation is deeply embedded in clinical practice and adherence to guidelines is routine. Rather, the concern is that removing the requirement for Heart Team participation may inadvertently weaken these safeguards in smaller or less experienced programs. In such settings, the absence of structured multidisciplinary review could increase the risk of inappropriate utilization, incomplete counseling regarding treatment alternatives, and variability in patient selection.

Maintaining the Heart Team should not be viewed as an administrative requirement but rather as an essential patient safety measure. Patients deserve an unbiased evaluation that incorporates the expertise of both interventional cardiologists and cardiac surgeons. Shared decision-making is strongest when all reasonable therapeutic options are presented transparently and without specialty-specific bias.

In addition, the presence and active involvement of cardiac surgeons during TAVR procedures continues to provide an important safety net. Although procedural complications have become less frequent, they can still occur unexpectedly and may require immediate surgical judgment or intervention. The collaborative procedural environment has contributed significantly to the excellent outcomes observed in contemporary TAVR practice.

As CMS considers modifications to the NCD, I strongly encourage the preservation of the multidisciplinary Heart Team framework and meaningful cardiac surgeon participation in both the evaluation and management of patients undergoing TAVR. The success of TAVR in the United States has been built upon collaboration rather than convenience. Any changes to coverage policy should reinforce, rather than weaken, the safeguards that have contributed to improved outcomes, enhanced patient safety, and more appropriate use of these transformative technologies.

Respectfully submitted,

Roberto Rodriguez, MD, MS, FACC, FACS

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