In July 2026, CMS released a proposed revision of its coverage policy for TAVR - Trans-vascular aortic valve replacement. The proposal and rational are at link.
See also this news story : https://www.scai.org/media-center/news-and-articles/proposed-tavr-ncd-released-key-changes-and-next-steps
Please review the history and rationales of CMS NCD coverage of TAVR discuss the proposal for a new coverage rules set, including more MAC discretion. summarize with a view of the process and what's likely to happen next. How could the proposed decision be improved in the final NCD in a few months? (Eg what would you comment to CMS?)
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CMS’s 2026 TAVR Proposal:
From National Managed Entry
to a Federal Floor
Bottom line
CMS’s proposed decision—posted June 15, 2026, with comments due July 15, 2026—would fundamentally recast the TAVR National Coverage Determination, or NCD. Symptomatic severe aortic stenosis would become ordinary nationally covered care under Social Security Act §1862(a)(1)(A), no longer Coverage with Evidence Development, or CED. Asymptomatic severe aortic stenosis would remain under a narrower, targeted CED pathway.
CMS would also eliminate mandatory hospital procedure-volume thresholds, mandatory TVT Registry participation, and the requirement that a surgeon and interventional cardiologist jointly perform every procedure. It would retain a heart-team structure, onsite cardiac surgery and intensive-care capabilities, and a minimum operator-level experience requirement. [1]
Conceptually, that is a defensible transition. TAVR has moved from a novel, high-risk technology needing nationally managed entry to a mature standard of care for symptomatic severe aortic stenosis. But CMS is simultaneously removing several mutually reinforcing quality controls. The proposal therefore needs stronger, more explicit outcome surveillance and considerably clearer limits on Medicare Administrative Contractor, or MAC, discretion.
How the NCD evolved
1. The 2012 NCD: controlled introduction
The original 2012 NCD followed the first FDA approval in November 2011. At that point, evidence came principally from the PARTNER program in inoperable and very-high-risk patients. CMS had to anticipate rapid diffusion of a technically demanding procedure with potentially catastrophic complications into hospitals with widely varying experience.
CMS therefore constructed what amounted to a national managed-entry system:
Coverage only through CED.
Independent face-to-face evaluations by a cardiac surgeon and interventional cardiologist.
A formal multidisciplinary heart team.
Joint performance of the procedure by the surgeon and interventional cardiologist.
Detailed institutional infrastructure and proxy-volume requirements involving open-heart surgery, aortic-valve surgery, and PCI.
Participation in a national, audited prospective registry—subsequently the STS/ACC TVT Registry.
Research pathways for uses outside the FDA-approved indication.
The requirements were not merely bureaucratic barriers. They created a national quality infrastructure while permitting Medicare beneficiaries to receive a new technology. CMS used coverage authority to generate the real-world evidence that did not yet exist. [2]
2. The 2019 revision: recalibration rather than deregulation
By 2019, TAVR had expanded through intermediate- and low-risk trials, devices had improved, and many centers had accumulated substantial direct experience. CMS relaxed and modernized the institutional thresholds, allowing established programs to qualify through actual TAVR and aortic-valve replacement volumes rather than relying entirely on proxy procedures.
But CMS retained:
CED and registry participation.
Independent surgeon and interventional-cardiologist assessments.
Joint intraoperative participation.
Explicit hospital-volume standards.
Continuing collection of mortality, stroke, pacemaker, durability, and patient-centered outcomes.
CMS acknowledged that risk-adjusted outcomes might ultimately be preferable to volume as a quality measure, but concluded that the necessary measures and reporting systems were not yet sufficiently mature. It also found a modest volume-outcome relationship, while recognizing that excessively high thresholds could close programs, concentrate care geographically, and delay treatment.
The 2019 policy was therefore a compromise between access and quality, not a determination that national controls had become unnecessary. [3]
3. The 2026 proposal: mature coverage plus targeted evidence development
CMS now notes that TAVR has been performed at more than 860 sites in over 450,000 patients, with at least 17 randomized trials involving more than 10,000 symptomatic patients. CMS reasonably concludes that symptomatic severe aortic stenosis no longer requires research-linked payment: TAVR is sufficiently established to be covered as reasonable and necessary care. [1]
The asymptomatic population is different. The April 2025 FDA expansion of Edwards’ SAPIEN indication was based largely on EARLY TAVR. In that trial, the composite outcome occurred in 26.8% of early-TAVR patients and 45.3% of surveillance patients. But there was no significant difference in death or stroke; much of the benefit came from cardiovascular hospitalizations, and approximately 87% of the surveillance group ultimately underwent valve replacement over five years.
CMS also lacks a direct randomized comparison of TAVR with surgical aortic-valve replacement in this population, while long-term durability matters particularly for younger, lower-risk patients. [1]
CMS therefore proposes:
Symptomatic severe aortic stenosis: national coverage under §1862(a)(1)(A), without CED.
Asymptomatic severe aortic stenosis: CED with an active contemporaneous comparator, addressing comparative management, long-term reintervention, or replacement of volume criteria with validated patient-centered outcomes.
Heart team: at least one cardiac surgeon and one interventional cardiologist, both privileged at the hospital. Initial review may be asynchronous.
Examination: at least one independent in-person examination by a heart-team clinician who is also a TAVR operator.
Operator experience: at least 20 transcatheter-valve procedures, including 15 TAVRs, in the preceding year; or 40 procedures, including 30 TAVRs, over two years.
Procedure staffing: one qualified operator may perform routine TAVR; two operators remain permissible when the heart team considers that appropriate.
Hospital requirements: onsite structural-heart interventional cardiology and cardiac surgery programs, an ICU, and continuous quality improvement—but no numerical hospital-volume threshold.
Registry: no express requirement for continued TVT Registry participation. [1]
The significance—and ambiguity—of MAC discretion
The proposed manual language says that, beyond the national coverage provisions, MACs may make reasonable-and-necessary determinations for “any other beneficiary seeking coverage for TAVR for AS.” Emergency scenarios are excluded from the NCD. There is no nationally noncovered category. [1]
That could permit local coverage for populations such as moderate aortic stenosis, unusual anatomic presentations, off-label uses involving aortic stenosis, or patients outside the precise national symptomatic and asymptomatic categories. It might also permit case-by-case coverage, an LCD, or article-based criteria.
The drafting problem is that CMS does not say:
Whether MAC discretion concerns only the clinical indication, or whether a MAC may also waive national heart-team, operator, and facility safeguards.
Whether locally covered treatment must be within an FDA-approved indication.
Whether registry or other longitudinal reporting applies.
Whether MACs should use case-by-case adjudication, an LCD, or another published policy.
How CMS will prevent materially different access among jurisdictions.
Whether and how emerging indications such as moderate aortic stenosis are expected to migrate from local decisions into national coverage.
The phrase applies expressly to TAVR “for AS.” It does not clearly delegate aortic-regurgitation indications. CMS should say that directly rather than leaving contractors and hospitals to infer the boundary.
The soundest interpretation would be: MACs may exercise discretion over additional aortic-stenosis indications, but may not waive nationally applicable program-safety conditions. CMS should put that interpretation into the final manual language.
What the proposal gets right
Ending CED for symptomatic severe aortic stenosis
This is overdue and well supported. Continued research-linked coverage for an established, FDA-approved treatment used in hundreds of thousands of patients would add little and would blur the distinction between evidence development and ordinary quality assurance.
Retaining CED for asymptomatic severe aortic stenosis
CMS is appropriately resisting the proposition that one positive trial automatically answers the entire Medicare question. EARLY TAVR establishes that waiting is not benign, but it does not fully resolve TAVR versus surgery, lifetime valve-management strategy, durability, younger beneficiaries, bicuspid valves, or the clinical meaning of a composite result heavily affected by hospitalization and crossover.
Eliminating facility proxy-volume requirements
The 2012 requirements depended partly on PCI and surgical volumes because direct TAVR experience was initially unavailable. Those proxies have become increasingly artificial. A strong operator and multidisciplinary program should not be barred merely because the hospital falls slightly below an unrelated procedural threshold.
Abandoning mandatory dual operators
A nationally mandated surgeon-plus-cardiologist operating pair is difficult to defend for every routine transfemoral procedure in 2026. The heart team should retain the ability to require two operators for difficult anatomy, alternative access, training, or anticipated rescue.
The proposal’s principal weakness: quality oversight
CMS proposes to remove mandatory registry reporting at the same time it removes hospital-volume thresholds, permits single-operator procedures, and potentially enables additional programs and indications through MAC discretion.
“Continuous quality improvement” is not an adequate substitute. The proposal does not specify:
Which outcomes must be measured.
How they will be risk-adjusted.
Whether data will be externally audited.
Whether outcomes will be benchmarked nationally.
Whether operators or hospitals will receive feedback.
What performance triggers remediation or suspension.
Whether patients or referring physicians will see meaningful results.
This is particularly incongruous because one of CMS’s own CED questions asks whether risk-standardized patient-centered outcomes can eventually replace operator-volume requirements. CMS cannot reliably develop and validate such measures while dismantling the national dataset that would support them.
The better solution is to end CED for symptomatic TAVR but retain registry reporting as a condition of coverage and quality assurance. Registry participation does not have to mean that every routine patient is enrolled in a clinical study or that payment remains research-dependent.
CMS could reduce the reporting burden while requiring a nationally qualified audited registry—or a functionally equivalent system—to collect, at minimum:
Risk-adjusted 30-day and one-year mortality.
Stroke.
Major bleeding and vascular complications.
Acute kidney injury.
Permanent pacemaker implantation.
Paravalvular regurgitation.
Functional status and Kansas City Cardiomyopathy Questionnaire scores.
Reintervention and valve replacement.
Longer-term durability, preferably through claims and mortality linkage.
Professional societies are divided over some details, but SCAI’s own member survey found substantial support for continued registry reporting, and SCAI has recommended that continuous quality improvement include registry participation. [4]
What I would ask CMS to change
1. Retain national registry reporting without retaining CED
Make qualified, audited registry participation a condition for all nationally and locally covered TAVR. Decouple it explicitly from CED and research consent. Permit a reduced core dataset for established symptomatic indications, with more extensive data collection for CED populations.
This is the highest-priority change.
2. Put guardrails around MAC discretion
CMS should distinguish three questions:
Clinical indication: MACs may consider additional aortic-stenosis populations.
Program safety: national operator, heart-team, hospital, and outcome-reporting standards continue to apply.
Evidence pathway: truly investigational or materially off-label uses should ordinarily proceed through an approved CED study, the Clinical Trial Policy, or an IDE trial rather than unstructured individual claims.
CMS should also require published MAC rationales and a national CMS review when multiple contractors begin covering the same emerging indication. Otherwise, the NCD could produce geographic variation precisely where CMS intended a coherent national policy.
3. Clarify the continuing heart-team obligation
Both the interventional cardiologist and cardiac surgeon should meaningfully participate in patient selection and lifetime-management planning, with their recommendations documented. Both should not necessarily be required to conduct in-person examinations.
A reasonable final formulation would require:
Documented review by both disciplines.
At least one in-person evaluation by a qualified TAVR operator.
Telehealth or asynchronous review by the second clinician when clinically appropriate.
Documentation of material disagreement rather than artificial unanimous “concurrence.”
This would preserve the substantive heart team without retaining ceremonial visits.
4. Define operator experience precisely
CMS needs to specify:
What constitutes a “transcatheter valve procedure.”
Whether a case counts for the primary operator, both co-operators, or all participants.
How multi-hospital practice is aggregated.
How proctored cases and training cases count.
How newly trained operators enter practice.
Whether an operator temporarily below the threshold can work under proctorship.
How extended medical leave is handled.
Otherwise, contractors and hospitals will adopt inconsistent counting rules.
CMS should create a provisional pathway for new operators and new programs involving formal training, proctoring, outcome review, and a defined ramp-up period.
5. Make quality improvement enforceable
The final NCD should define “continuous quality improvement” rather than leave it as an aspiration. At minimum, it should require:
Quarterly or semiannual review of standardized outcomes.
National risk-adjusted benchmarking.
A corrective-action process for outlier performance.
External data validation.
A method for identifying operator-level as well as site-level problems.
Reporting of access, transfer, and emergency-surgery outcomes.
6. Refine asymptomatic CED
CMS should retain the active-comparator principle but avoid making CED so rigid that only a conventional randomized trial can qualify. Properly designed registry-based comparative studies could be valuable, particularly when linked to Medicare claims.
The final NCD should also:
State how crossover from surveillance will be analyzed.
Require long-term reintervention and durability follow-up.
Prespecify analyses by age, life expectancy, sex, frailty, kidney disease, bicuspid anatomy, ejection fraction, and surgical risk.
Include meaningful patient-reported outcomes.
Grandfather appropriate ongoing FDA postapproval and professional-registry studies.
Establish an explicit reconsideration trigger or scheduled review rather than leaving asymptomatic CED indefinite.
7. Define the covered clinical categories
CMS should define or cross-reference accepted definitions of severe aortic stenosis, symptomatic disease, and asymptomatic disease. It should address exercise-provoked symptoms, reduced exercise capacity, discordant echocardiographic findings, and patients whose limited activity masks symptoms.
It should also distinguish emergency, urgent, and elective cases. Saying that the NCD does not apply in emergencies does not resolve urgent inpatient TAVR after decompensation.
8. Monitor the consequences of eliminating hospital volumes
Removing numerical facility thresholds may improve geographic access, but it may also encourage marginal low-volume programs whose creation fragments regional expertise without meaningfully reducing travel.
CMS should monitor:
Number and location of new programs.
Cases per site and operator.
Rural and urban travel time.
Race, socioeconomic status, and referral patterns.
Time from diagnosis to treatment.
Outcomes at newly established and very-low-volume centers.
What is likely to happen next
The second public-comment period closes July 15, 2026. CMS must ordinarily publish the final decision within 60 days, putting the expected statutory endpoint at approximately September 13, 2026. The final NCD is effective when CMS posts the final decision, although detailed claims-processing and manual instructions may follow. CMS must summarize and respond to substantive public comments in the final memorandum. [5]
The most likely outcome is that CMS preserves the proposal’s basic architecture:
Ordinary national coverage for symptomatic severe aortic stenosis.
CED for asymptomatic severe aortic stenosis.
Elimination of hospital-volume thresholds.
Operator rather than institution volume requirements.
One-operator flexibility.
CMS is less likely to restore mandatory dual operators or the old hospital-volume system because the proposed analysis explicitly explains why those requirements have outlived their original rationale.
The areas most likely to change are:
Registry reporting or a more concrete quality-improvement requirement.
The required role and documentation of the cardiac surgeon.
Telehealth flexibility.
Operator-volume counting and new-operator pathways.
Clarification of when two operators may be used and paid.
Boundaries on MAC discretion.
More precise CED study requirements.
Overall judgment
CMS has correctly identified the historical transition: symptomatic TAVR no longer needs research-linked national coverage, while asymptomatic TAVR still presents unanswered lifetime-management questions.
But the proposed decision goes one step too far in equating the end of CED with the end of nationally standardized data collection. The TVT infrastructure is one of the principal reasons CMS can now conclude that the technology has matured. It would be paradoxical to discard that infrastructure just as facility requirements are loosened and local discretion is expanded.
The strongest comment to CMS would therefore support the broad restructuring while asking for three major revisions:
Retain audited national registry reporting as quality assurance, not CED.
Specify that MAC discretion extends to additional indications, not to waiver of national safety requirements.
Replace vague “continuous quality improvement” language with measurable outcomes, benchmarking, and remediation requirements.
Those changes would preserve the proposal’s access gains without turning a carefully managed national program into a collection of locally variable, weakly observed programs.
References
Centers for Medicare & Medicaid Services. Proposed Decision Memo for Transcatheter Aortic Valve Replacement, NCA Tracking No. CAG-00430R2. June 15, 2026.
Centers for Medicare & Medicaid Services. Decision Memo for Transcatheter Aortic Valve Replacement, NCA Tracking No. CAG-00430N. May 1, 2012.
https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?ncaid=257&proposed=N
Centers for Medicare & Medicaid Services. Decision Memo for Transcatheter Aortic Valve Replacement, NCA Tracking No. CAG-00430R. June 21, 2019.
https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?ncaid=293&proposed=N
Society for Cardiovascular Angiography & Interventions. “Proposed TAVR NCD Released: Key Changes and Next Steps.” 2026.
Centers for Medicare & Medicaid Services. Public Comments: Transcatheter Aortic Valve Replacement, NCA Tracking No. CAG-00430R2.
