Transcatheter Aortic Valve Replacement (TAVR)

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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Memorandum

To: Centers for Medicare & Medicaid Services, Coverage and Analysis Group

Date: June 16, 2026

Submitted by:
Michael E. Bowdish, MD, MS
Division Director, Adult Cardiac Surgery
Vice Chair, Department of Cardiac Surgery
Smidt Heart Institute
Cedars-Sinai Medical Center

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

I write to comment on the Proposed Decision Memorandum for Transcatheter Aortic Valve Replacement (CAG-00430R2), published June 15, 2026. I write as a cardiac surgeon caring for patients with valvular heart disease. I have no financial relationship with any manufacturer of transcatheter or surgical valve devices. I support the determination that the evidence now supports coverage of symptomatic severe aortic stenosis without Coverage with Evidence Development, and I support the expansion of coverage to asymptomatic severe aortic stenosis under Coverage with Evidence Development. I recognize the careful deliberation CMS has brought to this complex determination.

My central concern is one element of the proposed revision: the effective elimination of participation in national clinical data registries as a condition of coverage for symptomatic TAVR. I address that concern in Part One. In Part Two, I offer several related recommendations regarding the asymptomatic study comparator, the operator-volume threshold, and retention of procedural safeguards.
Part One. Preserve National Registry Participation as a Condition of Coverage

I. The Proposed Decision Removes the Registry Mandate for Symptomatic TAVR
Under the current NCD (20.32), all TAVR procedures are furnished under Coverage with Evidence Development, which requires participation in the STS/ACC Transcatheter Valve Therapy (TVT) Registry. The proposed revision terminates CED for symptomatic severe AS, covering it under standard reasonable-and-necessary authority (§1862(a)(1)(A)). While the proposed Hospital Criteria (Section B3) require “a continuous quality improvement process that assesses procedural outcomes and makes necessary programmatic adjustments to assure patient safety,” this language does not specify participation in a national clinical data registry. An institutional quality improvement committee, an internal morbidity and mortality conference, or a local database would satisfy this criterion.
The practical consequence is that for the approximately 100,000 symptomatic TAVR procedures performed annually in the United States, there will no longer be a national coverage requirement mandating data capture in a standardized, auditable, multi-institutional registry. This represents a fundamental change in the infrastructure that has supported TAVR’s evidence base since its inception.

II. The TVT Registry Is the Foundation on Which TAVR Coverage Has Been Built
The STS/ACC TVT Registry is not merely a regulatory compliance tool. It is the single most important real-world evidence engine in structural heart disease. Since its inception, the TVT Registry has enrolled over 583,000 TAVR patients across 726 U.S. hospitals and has directly generated the evidence that CMS cites throughout the proposed decision memorandum to justify coverage expansion:

Volume-outcomes relationships: Vemulapalli et al. (NEJM 2019) used TVT Registry data to demonstrate a significant inverse association between hospital TAVR volume and risk-adjusted 30-day mortality. This analysis directly informed the volume requirements in the 2019 NCD and remains relevant to the operator volume thresholds proposed in the current revision.

Demographic shifts and indication patterns: Alabbadi et al. (JACC 2026) used TVT Registry data to document the shift from high-risk elderly patients to low-risk younger patients, with low-risk cases growing from 2.7% to 35.7% of all cases over the registry’s history. This analysis identified off-guideline use patterns that have raised concerns across the surgical community, medical societies, and CMS’s own evidence review.

Temporal trends and safety signals: The TVT Registry has enabled continuous monitoring of pacemaker implantation rates, paravalvular leak incidence, stroke rates, and reintervention trends across device generations and patient populations. These data have informed device iteration, guideline development, and post-market surveillance.

Health status outcomes: The STS/ACC TVT Registry health-status analyses cited in the proposed decision memorandum (Section II.D) used KCCQ data systematically collected through the registry to characterize real-world patient-reported outcomes.

None of these analyses would have been possible without a national coverage mandate requiring universal data capture. The TVT Registry’s near-complete capture of U.S. TAVR procedures is what distinguishes it from voluntary registries, which are subject to selection bias and incomplete enrollment.

III. Removing the Registry Mandate Undermines CMS’s Own Stated Evidence Needs
The proposed decision memorandum itself identifies critical unanswered questions that can only be addressed through continued comprehensive data collection. The three CED research questions mandated for asymptomatic coverage (Section B4) are illustrative:

CED Question 1: “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.”

CED Question 3: “Can longer term, risk-standardized, patient-centered health outcomes replace volume criteria for TAVR operators?”

Both of these questions require population-level, risk-adjusted outcomes data that can only be generated by a comprehensive national registry. Randomized controlled trials, however well-designed, enroll highly selected patients at experienced centers and cannot capture the heterogeneity of real-world practice. The paradox is that CMS is asking questions that require registry-level data while simultaneously removing the mechanism that generates that data for the majority of TAVR procedures.

The proposed decision memorandum also acknowledges throughout its evidence review that the durability question remains unresolved. The longest randomized follow-up available comes from the NOTION trial, which reports 10 years of follow-up, a small study of 280 elderly patients using first-generation devices. The pivotal low-risk trials (PARTNER 3 and Evolut Low Risk) will not have 10-year data until approximately 2029-2030. During this interval, continued comprehensive registry data collection is essential for detecting early signals of structural valve deterioration, characterizing reintervention patterns, and monitoring the expanding use of TAVR in populations not represented in the pivotal trials.

IV. Voluntary Registry Participation Declines Without Coverage Mandates
The history of medical device registries in the United States demonstrates that voluntary participation rates decline when coverage mandates are removed. Compliance-driven registries achieve near-universal capture precisely because participation is a condition of payment. When that linkage is severed, participation becomes discretionary, administrative burden calculations dominate, and data completeness erodes. The resulting selection bias undermines the registry’s value for the very analyses that CMS and the clinical community depend upon.

The TVT Registry’s current near-complete capture rate is a direct consequence of the CED mandate. It would be imprudent to assume that this capture rate would persist in its absence, particularly as TAVR expands to new, lower-volume centers where the administrative infrastructure for registry participation may be less robust.

V. A Registry Requirement Is Distinct from CED and Can Be Maintained Independently
CMS has historically linked registry participation to Coverage with Evidence Development. These are, however, conceptually and legally distinct mechanisms. CED is a framework for generating evidence to resolve specific coverage questions. Registry participation is a quality assurance and post-market surveillance mechanism that serves as an ongoing monitoring function independent of any specific evidence question.

CMS has the authority under §1862(a)(1)(A) to define conditions that are reasonable and necessary for the safe and effective furnishing of TAVR. Participation in a CMS-recognized national clinical data registry is a reasonable condition of coverage that serves patient safety, quality assurance, and population health surveillance. This is not a novel concept: Medicare conditions of participation for hospitals already include quality reporting requirements, and CMS has established quality measurement programs across numerous clinical domains.

I respectfully propose that CMS add the following language to the Hospital Criteria (Section B3):

“TAVR procedures must be reported to a CMS-recognized national clinical data registry that captures standardized demographic, procedural, and outcomes data, including but not limited to 30-day mortality, stroke, new permanent pacemaker implantation, paravalvular regurgitation, reintervention, and patient-reported health status outcomes.”

This language is device- and registry-agnostic (it does not mandate the TVT Registry specifically, though it is the only registry that currently meets these criteria) and is independent of CED. It preserves the quality assurance infrastructure that has served TAVR patients, clinicians, and CMS itself for over a decade.

VI. The Registry Is Especially Critical as TAVR Expands to New Populations and Settings
The proposed decision memorandum expands TAVR coverage in two dimensions simultaneously: to asymptomatic patients (under CED) and to potentially new institutional settings (through restructured volume requirements that shift from hospital-level to operator-level thresholds). Both expansions increase the urgency of comprehensive data collection:

New patient populations: Asymptomatic patients are, by definition, patients who feel well. The risk-benefit calculus for intervening in an asymptomatic patient is fundamentally different from that for treating a symptomatic patient, and the long-term consequences of that decision (valve durability, pacemaker dependence, coronary access, need for reintervention) require decades of follow-up to characterize. Registry data capture across the full spectrum of treated patients, not only those enrolled in CED-approved studies, is essential for detecting safety signals and characterizing real-world outcomes.

New institutional settings: The shift from hospital-level to operator-level volume requirements may facilitate TAVR at centers with less institutional experience. The volume-outcomes literature demonstrates that outcomes vary across institutions. Registry participation provides the monitoring infrastructure needed to ensure that quality standards are maintained as the procedure diffuses to new settings.

Off-guideline use: TVT Registry data show that TAVR is increasingly used in patients younger than guideline-recommended age thresholds, including, in some reports, nearly 50% of patients under 65 years in some U.S. states. Without registry-level data capture, there is no mechanism to monitor these trends, assess their outcomes, or inform future guideline and coverage revisions. Part Two. Related Recommendations

VII. The Asymptomatic CED Studies Should Require a Contemporaneous Surgical Comparator

I support covering asymptomatic severe aortic stenosis only under Coverage with Evidence Development, and I write to strengthen the comparator requirement. The expansion rests on a single contemporary randomized trial, EARLY TAVR (Genéreux et al., New England Journal of Medicine, 2025). Its statistically significant primary result, a composite of death, stroke, or unplanned cardiovascular hospitalization of 26.8% with early TAVR versus 45.3% with surveillance at a median of 3.8 years, is driven almost entirely by unplanned cardiovascular hospitalization (20.9% versus 41.7%). All-cause death (8.4% versus 9.2%) and stroke (4.2% versus 6.7%) did not differ significantly, and 87% of patients assigned to surveillance underwent valve replacement within five years. The trial therefore establishes that close surveillance with prompt intervention at symptom onset is safe; it does not establish that pre-emptive replacement improves survival or reduces stroke, and it never compared early TAVR with early surgical replacement. Because the durability and life-expectancy questions CMS itself raises in CED Question 1 cannot be answered without a surgical arm, I recommend that approved CED studies for asymptomatic disease include a contemporaneous surgical comparator wherever anatomy and risk permit, rather than relying on a surveillance comparator alone.

VIII. The Operator-Volume Threshold Should Be Reconciled with the Evidence CMS Cites
The proposal replaces hospital-level volume requirements with an individual operator threshold of fifteen TAVR procedures per year and removes the hospital open-heart surgical volume minimum. That operator threshold falls within the intermediate-volume band described in the analysis CMS cites (Kumbhani et al., 2026), which found a significant difference in outcomes between high- and low-volume operators but not between high- and intermediate-volume operators. The earlier volume-outcomes work from the TVT Registry (Vemulapalli et al., NEJM 2019) likewise demonstrated an inverse relationship between volume and risk-adjusted mortality. Permitting a single operator at intermediate volume, with no hospital volume floor, changes two variables at once. I recommend that CMS either retain a hospital-level volume or quality floor during a defined transition period, or, at a minimum, condition coverage at new and lower-volume programs on registry-based outcome reporting, so that the effect of this change can be monitored rather than assumed. This recommendation reinforces the central point of this letter: the registry is the instrument through which the safety of these structural changes can be verified.

IX. The Heart-Team and Procedural Safeguards Should Be Retained
I support retention of the multidisciplinary heart team, including a cardiac surgeon; the requirement for on-site cardiac surgery; and the requirement for at least one in-person evaluation by a heart-team operator that cannot be satisfied virtually. For asymptomatic and low-risk patients with long life expectancy, where five- to seven-year reintervention curves are still separating and bioprosthetic durability is not yet established relative to the long record of surgical valves, an independent surgical evaluation is the patient’s principal protection against a treatment decision made before the durability data mature. These safeguards should remain in place.

Conclusion and Specific Recommendations
The TVT Registry is not a burden to be retired; it is an asset to be preserved. It has been the single most productive source of real-world evidence in structural heart disease, directly enabling the coverage expansions that CMS now proposes. Removing the registry mandate at the very moment TAVR is expanding into new populations and new settings would deprive CMS, clinicians, patients, and the broader scientific community of the data infrastructure needed to ensure that this expansion occurs safely and with appropriate ongoing evaluation.

I respectfully recommend that CMS:

1. Add a national clinical data registry participation requirement to the Hospital Criteria (Section B3), independent of CED, applicable to all TAVR procedures covered under the NCD.
2. Specify that the registry capture standardized demographic, procedural, and outcomes data, including 30-day and 1-year mortality, stroke, new permanent pacemaker implantation, paravalvular regurgitation, reintervention, and patient-reported health status outcomes.
3. Require that registry data be made available for CMS-approved quality measurement, post-market surveillance, and research purposes, consistent with the data-sharing standards articulated in the CED Guidance Document.
4. Require that approved CED studies for asymptomatic disease include a contemporaneous surgical comparator wherever anatomy and risk permit.
5. Retain a hospital-level volume or quality floor, or condition coverage at new and lower-volume programs on registry-based outcome reporting, during any transition to operator-level volume criteria.
6. Retain the multidisciplinary heart team with a cardiac surgeon, on-site cardiac surgery, and the in-person operator evaluation that cannot be satisfied virtually.

Thank you for the opportunity to comment on this important determination. I am available to discuss these recommendations in further detail.

Respectfully submitted,

Michael E. Bowdish, MD, MS
Division Director, Adult Cardiac Surgery
Vice Chair, Department of Cardiac Surgery
Smidt Heart Institute
Cedars-Sinai Medical Center

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I write in strong support of the proposed NCD for Transcatheter Aortic Valve Replacement (TAVR).

The removal of the CED requirement for symptomatic severe aortic stenosis appropriately reflects the extensive randomized trial data now supporting TAVR across all surgical risk categories. Simultaneously, extending coverage to asymptomatic severe aortic stenosis under CED is well-justified by the EARLY TAVR trial, which demonstrated a 50% reduction in the composite of death, stroke, or unplanned cardiovascular hospitalization compared to surveillance.

The continued emphasis on the multidisciplinary heart team is essential. This collaborative model has been a cornerstone of TAVR's success, and its preservation ensures individualized, patient-centered care.

Finally, the decision to no longer mandate dual-operator participation in every case is a sensible acknowledgment of the decreasing procedural complexity of contemporary transfemoral TAVR. Preserving the heart team's authority to deploy additional operators when clinically warranted strikes the right balance between safety and access.

I urge CMS to finalize this proposal.

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I believe the proposed documentation would benefit from more explicit language regarding physician location and participation requirements during the procedure. Specifically, CMS should clearly define the expectations for both the primary procedural operator and the required surgical backup team.

The policy should unequivocally state that the procedure may be performed by a single qualified operator, including an appropriately credentialed interventional cardiologist, when all applicable training and competency requirements have been met. However, it should also provide detailed guidance regarding the required involvement of the on-site surgical team.

In particular, CMS should specify whether the surgical team must be physically present in the procedure room, immediately adjacent to the laboratory, elsewhere within the hospital, or simply available on standby. The policy should also clarify whether the surgeon is expected to be actively participating in the procedure, immediately available for emergency intervention, or merely on call within the facility.

Providing this level of specificity would promote consistent implementation across institutions, reduce variability in interpretation of the requirements, and ensure that all programs maintain an appropriate level of preparedness to respond to procedural complications. Most importantly, clearly defining these expectations would strengthen patient safety by establishing uniform operational standards for facilities performing these procedures.

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