Transcatheter Aortic Valve Replacement (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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