July 15, 2026
Centers for Medicare and Medicaid Services
Attn: Dr. Mehmet Oz, Administrator of the Centers for Medicare and Medicaid Services
Submitted on cms.gov
Re: Comments on Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2)
On behalf of National Taxpayers Union (NTU), the nation’s oldest taxpayer advocacy organization, we write with brief comments on the Centers for Medicare and Medicaid Services’ (CMS) proposed Decision Memo regarding the National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR). NTU was founded in 1969 to achieve favorable policy outcomes for taxpayers with Congress and the executive branch. Our experts and advocates engage policymakers on important matters affecting taxpayers in a variety of settings, including administrative actions that impact health care spending.
Taxpayers have a compelling interest in ensuring that Medicare’s coverage policies encourage the adoption of medical innovations that can meaningfully bend the long-term cost curve of federal health care programs. While new or recently introduced therapies often require high upfront costs, they can yield significant savings down the line by reducing the utilization of health care resources and shortening expensive hospital stays. This has proven especially true in the cardiac space. A growing body of evidence1 suggests the TAVR procedure, now in its 15th year of use as an alternative for patients who would otherwise be at risk with traditional open-heart surgery, can also provide significant value to Medicare by serving as a less invasive and cost effective alternative to surgical aortic valve replacement (SAVR) for patients suffering from aortic stenosis (AS).
As such, NTU commends CMS for proposing to expand access to TAVR for Medicare beneficiaries. Broadening eligibility to include asymptomatic patients with severe AS under Coverage with Evidence Development (CED), ending certain CED requirements for symptomatic patients, and streamlining burdensome operational requirements for providers, will allow more beneficiaries to receive timely treatment before disease progression requires more risky and resource-intensive care.
Any serious effort to shore up our nation’s finances must address the unsustainable growth of federal entitlement programs. Mandatory spending now accounts for roughly 60% of the federal budget2, and Medicare’s burden on taxpayers will only worsen as the U.S. population continues to age. Between 2024 and 2054, the share of federal noninterest outlays consumed by major health care programs is projected to rise from 28% to 39%.3 Against this bleak backdrop, CMS needs to be proactive about supporting technological innovations that lower costs, particularly in areas that account for a disproportionate share of overall health spending, such as inpatient hospital care.
Hospital systems are the single largest drivers of health care spending in recent years.4 Between 2022 and 2024, spending on hospital care represented 40% of the overall growth in national health expenditures.5 This surge outpaced every other source of medical spending, including physician services and prescription drugs. According to CMS, in 2024, hospital prices rose at their sharpest rate since 2007.6
It is not difficult to see why taxpayers have a stake in reducing extended hospital stays among Medicare beneficiaries, especially in matters related to cardiovascular health. Heart disease already imposes a significant burden on the U.S. health care system, with one in three adults receiving treatment for a cardiovascular condition or risk factor in 2020. Between 2020 and 2050, annual health care costs for cardiovascular conditions are projected to nearly quadruple, rising from $393 billion to $1.49 trillion.7 And yet, the fiscal burden of heart disease on Medicare is far from a long-term problem: the fund that pays for beneficiaries’ hospital stays is currently projected to run out of money by 20338 if no reforms are enacted.
Encouraging fiscal signs have appeared with previous medical breakthroughs in the cardiac space. For example, in our extensive 2023 paper, “How Much is Medicine Worth to the American Taxpayer?” we recounted research showing that a cluster of pharmaceutical interventions for hypertension, cholesterol, and diabetes slowed per-capita Medicare spending by $824 in the 2000s.9 More recently, a comprehensive Aon study of 139,000 employees taking GLP-1 medications between 2022 and 2024 found significant, rapid cost-growth reductions in treating health problems, led by reductions in heart attacks and strokes.10
While addressing the fiscal imbalances at the heart of Medicare requires a multitude of solutions, covering TAVR for asymptomatic patients under CED is a step in the right direction. Heart valve disease is currently undertreated in the U.S.11, and AS is one of the most common and dangerous forms of the disease. Data from the PARTNER 3 trial indicates that, in low-risk patients, TAVR fares better than SAVR at reducing death, stroke, or rehospitalization one year after the procedure.12 Yet, more importantly for taxpayers, the average length of hospitalization for a TAVR patient was three days, compared to one week for SAVR. This seemingly minor difference actually represents considerable budgetary savings.
In addition to extending coverage to asymptomatic patients, NTU also supports the proposal to phase out CED requirements for symptomatic AS patients being treated with TAVR. While a CED mandate is important for collecting safety data on novel medical treatments, it could, at the same time, be delaying the wider introduction of TAVR into the Medicare population if left in place too long. CMS first implemented a CED requirement for symptomatic patients in 2012, and since then, evidence supporting the procedure’s safety and cost effectiveness has continued to grow. At this point, keeping the CED stipulation for this particular population just creates more paperwork for providers and acts as a barrier to treatment for patients.
NTU has previously noted the need to carefully deploy CED in situations that demand a thoughtful balance between access and affordability for taxpayers. In June of 2025, our comments to CMS in Executive Order 14192 observed, “In theory, CED could help to expedite the introduction of lifesaving diagnostics and treatments, but in practice, it has sometimes functioned in a contrary manner by effectively stranding therapies in regulatory limbo.” We raised then, and reiterate now, the need for a methodical evaluation of CED’s mission and execution to improve transparency, impact, predictability for stakeholders, and cost-effectiveness for taxpayers.13
We are also encouraged by plans to simplify operational requirements for providers that perform TAVR procedures. In a similar vein to CED mandates, many of these rules were first implemented when the safety and efficacy profile of TAVR was still being evaluated. Failing to update these rules can limit the reach of this procedure. In particular, we applaud CMS for seeking to eliminate minimum procedural volume requirements for hospitals. While these requirements made sense when TAVR was still in its infancy, rigid volume thresholds unnecessarily restrict otherwise qualified providers from offering what is now known to be a safe and effective procedure.
To sum up, NTU supports efforts by CMS to expand the reach of TAVR to more Medicare beneficiaries. Deploying innovative treatments that reduce the long-term burden of cardiovascular disease on hospitals directly addresses one of the fastest growing sources of health care spending. At the same time, we urge CMS to exercise strong caution to ensure that loosened operational requirements for providers don’t result in the performance of unnecessary procedures. Other sensible guardrails will need to remain in place to protect patients and taxpayers from the overuse of TAVR.
Thank you for your consideration of these comments, and should you have any questions on this or any other fiscal or regulatory matter before CMS, we are at your service.
Sincerely and respectfully,
Alexander Ciccone
Policy and Government Affairs Manager
National Taxpayers Union
1 See, for example, https://pmc.ncbi.nlm.nih.gov/articles/PMC10625447/. The authors conclude that:
Overall, the price of TAVR is declining as advancements in medical technology bring more cost-efficient valves to the market. Although SAVR still holds a strong place in treating severe aortic stenosis, the associated costs of TAVR have demonstrated a notable and encouraging downward trajectory which allows more widespread use of the procedure.
Another excellent summary of research on the economic benefits of TAVR for patients in the category of severe symptomatic aortic stenosis (SSAS) appears in the comments of Professors David E. Bloom and Joseph S. Knee, of the Harvard T.H. Chan School of Public Health, filed 7/14/26 on CMS.gov. The comment authors note:
Rigorous and peer-reviewed research has also demonstrated that there is a strong economic case for using TAVR to treat SSAS patients. Relative to both CSMM [clinical surveillance and medical management] and SAVR, TAVR offers strong value-for-money for SSAS patients, with attractive incremental cost-effectiveness ratios, benefit-cost ratios, and rates of return.
In NTU’s opinion, the findings of this research are relevant to the fiscal condition of Medicare and other taxpayer-funded programs.
2 https://www.pgpf.org/federal-budget-guide/
3 https://www.ntu.org/publications/detail/ntu-comments-on-medicare-and-medicaid-coverage-of-anti-obesity-medications
4 https://www.realclearhealth.com/articles/2026/04/01/hospitals_perverse_incentives_are_inflating_healthcare_costs_1174043.html
5 https://www.kff.org/health-costs/hospital-spending-accounted-for-40-of-the-growth-in-national-health-spending-between-2022-and-2024/
6 https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2025.01683
7 Forecasting the Economic Burden of Cardiovascular Disease and Stroke in the United States Through 2050: A Presidential Advisory From the American Heart Association | Circulation
8 What’s in the 2026 Medicare Trustees Report? • Bipartisan Policy Center
9 How Much is Medicine Worth to the American Taxpayer? A Cost-Benefit Analysis - Publications - National Taxpayers Union
10 Referenced in Proposed Changes to Kentucky's Medicaid Outpatient Pharmacy Program can Help Taxpayers - Publications - National Taxpayers Union
11 About Heart Valve Disease | Heart Disease | CDC
12 Placement of Aortic Transcatheter Valves 3 - American College of Cardiology
13 NTU Comments to Centers for Medicare and Medicaid Services, “Unleashing Prosperity Through Deregulation of the Medicare Program (Executive Order 14192) - Request for Information,” June 10, 2025; summaries available at Medicare Regulatory Relief Request for Information | CMS