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Modernizing Medicare coverage for TAVR

TAVR NCD

Ensuring patients with aortic stenosis can access timely, lifesaving, evidence-based care.

CMS is currently reconsidering the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).

Regulatory requirements in the TAVR NCD may increase access challenges for patients

The current TAVR NCD sets Medicare coverage conditions nationwide and includes more complex coverage criteria than many other Medicare coverage policies. These coverage conditions were appropriate for early adoption but may now introduce avoidable barriers to timely care for eligible Medicare beneficiaries, given that TAVR is now a mature and well-studied therapy.1, 2, 3, 4, 5, 6, 7, 8

The Centers for Medicare & Medicaid Services (CMS) is now evaluating the TAVR NCD for potential updates.

What is aortic stenosis and how is it treated?

  • Aortic stenosis (AS) is a progressive, life-threatening heart valve disease affecting more than 1.5 million seniors in the U.S. today, projected to double in the coming decades9
  • Without treatment, 1 in 10 patients experiencing symptoms of severe AS may die within 5 weeks10   
  • Fewer than half of indicated patients receive treatment†11  
  • AS is the most common form of valvular heart disease and a leading cause of cardiovascular death when untreated12  
  • Patients with AS are recommended to be evaluated by a Heart Team13  
  • Severe symptomatic AS typically requires aortic valve replacement  — either with open-heart surgery, which is not governed by an NCD, or TAVR, which has had an NCD in place since 20121, 13
† Severe symptomatic AS patients within 1 year of diagnosis


What is TAVR and why is it relevant for Medicare policy?

Transcatheter Aortic Valve Replacement (TAVR) is a mature, minimally invasive therapy supported by one of the largest evidence bases in cardiovascular medicine. Over the past 15 years, TAVR has transformed care for more than one million severe symptomatic AS patients.

TAVR:

  • Improves recovery times and the patient care experience‡, 14, 15, 16
  • Reduces hospital stays and complications‡ 16, 17
  • Creates long-term savings for Medicare§‡, 16

Delayed treatment harms outcomes and increases costs

  • Patients wait approximately two months longer, on average, for TAVR than open-heart surgery** 6
  • Delayed TAVR is associated with:††, 18
    • 50% higher mortality risk
    • 59% higher heart failure hospitalization risk
    • Over $36,000 higher health care costs over three years
  • Patients receiving TAVR before symptom progression had better outcomes and lower rehospitalization risk‡‡ 19
‡ TAVR compared with open-heart surgery
§ Demonstrated lower total cost of care for Medicare beneficiaries undergoing TAVR vs open-heart surgery
** Time-to-treatment in a real-world analysis of clinically significant AS patients undergoing TAVR or open heart-surgery
†† A real‑world analysis comparing TAVR delay >90 days verses ≤90 days was associated with higher 3‑year mortality (HR 1.50), higher heart failure hospitalization (HR 1.59), and higher cumulative health care costs at 3 years ($36,740).
‡‡ Improved composite of death, stroke or unplanned hospitalization in Early TAVR (asymptomatic severe AS) vs clinical surveillance


Patient access is a challenge

Disparities in access to AS treatment are well-documented. Some regions of the U.S. have limited or no access to TAVR, leading to longer travel distances, untreated disease and higher mortality — despite urgent clinical need.11, 20, 21, 22, 23

Evidence supports change

  • TAVR demonstrates excellent long-term outcomes§§ 24, 25
  • FDA-approved indications for asymptomatic AS patients are not addressed by the TAVR NCD1
  • TAVR has more trials and registries than other therapies under Coverage with Evidence Development (CED)5
  • Published performance measures are available to directly assess quality of care26
§§ 7-year clinical outcomes and valve-performance for TAVR vs open-heart surgery in severe AS patients; 10-year reintervention risk in real-world Medicare claims


Edwards Lifesciences’ priorities align with patient needs

Edwards Lifesciences supports policies that improve patient outcomes, improve access and reduce long-term Medicare costs.

Policy considerations:

  • Aligning TAVR coverage with approved FDA indications, including asymptomatic AS
  • Recognizing that TAVR is a reasonable and necessary procedure for AS that has satisfied its CED requirements, while continuing to support contemporary engagement with national registries as an ongoing cornerstone of quality and transparency
  • Preserving and supporting the critical importance of the multidisciplinary Heart Team (including an interventional cardiologist and cardiac surgeon), while permitting flexibility to address evolving models of treatment for AS patients.

Engage in the TAVR NCD reconsideration

CMS is reconsidering the NCD for TAVR. Stakeholder input during this process helps ensure coverage policies reflect current evidence and patient needs. Engage CMS today about updating the TAVR NCD to improve patient access to this mature and lifesaving technology.


Learn more

References

  1. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (20.32). Medicare Coverage Database
  2. Centers for Medicare & Medicaid Services. National Coverage Analysis (NCA) – Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R) – Decision Memo. Medicare Coverage Database.
  3. Centers for Medicare & Medicaid Services. Transcatheter Aortic Valve Replacement (TAVR) – Coverage with Evidence Development (CED).
  4. Centers for Medicare & Medicaid Services (CMS). Medicare Coverage Database (MCD).
  5. Zeitler EP, Gilstrap LG, Coylewright M, et al. Coverage with evidence development: where are we now? The American Journal of Managed Care. 2022;28(8):382-389.
  6. Stinis C, Tunis S, Lauck S, et al. Impact of pre-procedural requirements on time to aortic valve replacement: Transcatheter AVR vs surgical AVR. American Heart Journal Plus: Cardiology Research and Practice. 2025;61:100698.
  7. Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT Registry of Transcatheter aortic valve replacement. Journal of the American College of Cardiology. 2020;76(21):2492-2516
  8. Nathan AS, et al. Socioeconomic and Geographic Characteristics of Hospitals Establishing Transcatheter Aortic Valve Replacement Programs, 2012–2018. Circulation: Cardiovascular Quality and Outcomes. 2021;14(11):e008260.
  9. Owens DS, Bartz TM, Buzkova P, et al. Cumulative burden of clinically significant aortic stenosis in community-dwelling older adults. Heart. 2021;107(18):1493-1502
  10. Malaisrie SC, McDonald E, Kruse J, et al. Mortality while waiting for aortic valve replacement. Ann Thorac Surg. 2014;98(5):1564-1571
  11. Brennan JM, Leon MB, Sheridan P, et al. Racial Differences in the Use of Aortic Valve Replacement for Treatment of Symptomatic Severe Aortic Valve Stenosis in the Transcatheter Aortic Valve Replacement Era. Journal of the American Heart Association. 2020;9(16):e015879
  12. Centers for Disease Control and Prevention. Heart Valve Disease Toolkits (Aortic stenosis—the most common form of heart valve disease).
  13. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143(5):e72-e227.
  14. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695-1705.
  15. Marsh K, Hawken N, Brookes E, et al. Patient-centered benefit-risk analysis of transcatheter aortic valve replacement. F1000Research. 2021;8:394
  16. Baron SJ, et al. Contemporary Costs Associated With Transcatheter Versus Surgical Aortic Valve Replacement in Medicare Beneficiaries. Circulation: Cardiovascular Interventions. 2022;15(3):e011295.
  17. Harvey JE III, Kapadia SR, Cohen et al. Trends in Complications Among Patients Undergoing Aortic Valve Replacement in the United States. Journal of the American Heart Association. 2024;13(17):e031461.
  18. Vemulapalli S, Russo M, Murphy S, et al. The Clinical and Economic Consequences of Delayed Transcatheter Aortic Valve Replacement. Structural Heart. 2025.
  19. Généreux P, Schwartz A, Oldemeyer JB, et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med. 2025;392(3):217-227
  20. Lowenstern A, Sheridan P, Wang TY, et al. Sex disparities in patients with symptomatic severe aortic stenosis. American Heart Journal. 2021;237:116-126.
  21. Kapadia S, Shen M, Hanna J, et al. Evaluating the Accessibility of Transcatheter and Surgical Aortic Valve Replacement Across the US Via Driving-Times. American Journal of Cardiology. 2026;262:61-67.
  22. David G, Epstein AJ, Giri J, et al. No-Transcatheter Aortic Valve Replacement (TAVR) Zones and Their Effect on Access to Care for Medicare Beneficiaries with Aortic Stenosis. Advances in Therapy. 2025;42(4):1716-1728
  23. David G, Strom JB, Epstein AJ, Gunnarsson C, Chikermane SG, Clancy S, Russo MJ. Determinants of Unmet Demand for Surgery: the Case of Transcatheter Aortic Valve Replacement. Value in Health. 2026.
  24. Leon MB, Mack MJ, Pibarot P, et al. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. New England Journal of Medicine. 2025.
  25. Baron SJ, Ryan MP, Chikermane SG, Thompson C, Clancy S, Gunnarsson CL. Long-term risk of reintervention after transcatheter aortic valve replacement. American Heart Journal. 2024;267:44-51.
  26. Desai ND, O’Brien SM, Cohen DJ, et al. Composite Metric for Benchmarking Site Performance in Transcatheter Aortic Valve Replacement: Results From the STS/ACC TVT Registry. Circulation. 2021;144(3):186-194.
Important safety information

Important safety information

Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System

Indications: The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated to reduce the risks associated with progression from asymptomatic to symptomatic severe native calcific aortic stenosis in patients who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical or transcatheter bioprosthetic aortic valve, or a native mitral valve with an annuloplasty ring who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 4% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications: The valves and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections, or who have significant annuloplasty ring dehiscence.

Warnings: Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation. There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic valvuloplasty or other standard treatments in high or greater risk patients. The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Incorrect sizing of the valve may lead to paravalvular leak, migration, embolization, residual gradient (patient-prosthesis mismatch), and/or annular rupture. Accelerated deterioration of the valve due to calcific degeneration may occur in children, adolescents, or young adults and in patients with an altered calcium metabolism. Prior to delivery, the valve must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. Valve leaflets mishandled or damaged during any part of the procedure will require replacement of the valve. Caution should be exercised in implanting a valve in patients with clinically significant coronary artery disease. Patients with pre-existing prostheses should be carefully assessed prior to implantation of the valve to ensure proper valve positioning and deployment. Do not use the valve if the tamper-evident seal is broken or the storage solution does not completely cover the valve (SAPIEN 3 and SAPIEN 3 Ultra only), the temperature indicator has been activated, the valve is damaged, or the expiration date has elapsed. Do not mishandle the delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g., kinked or stretched), or if the expiration date has elapsed. Use of excessive contrast media may lead to renal failure. Measure the patient’s creatinine level prior to the procedure. Contrast media usage should be monitored. Patient injury could occur if the delivery system is not un-flexed prior to removal. Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials. The procedure should be conducted under fluoroscopic guidance. Some fluoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disfiguring, and long-lasting. Valve recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician. This device has not been tested for use without anticoagulation. Do not add or apply antibiotics to the storage solution (SAPIEN 3 and SAPIEN 3 Ultra only), rinse solution, or to the valve. Balloon valvuloplasty should be avoided in the treatment of failing bioprostheses as this may result in embolization of bioprosthesis material and mechanical disruption of the valve leaflets. Do not perform stand-alone balloon aortic valvuloplasty procedures in the INSPIRIS RESILIA aortic valve for the sizes 19-25 mm. This may expand the valve causing aortic incompetence, coronary embolism or annular rupture. Transcatheter valve replacement in mitral annuloplasty rings is not recommended in cases of partial annuloplasty ring dehiscence due to high risk of PVL. Transcatheter valve replacement in mitral annuloplasty rings is not recommended in cases of partial (incomplete) annuloplasty rings in the absence of annular calcium due to increased risk of valve embolization. Transcatheter valve replacement in mitral annuloplasty rings is not recommended in cases of rigid annuloplasty rings due to increased risk of PVL or THV deformation.

Precautions: Long-term durability has not been established for the valve. Regular medical follow-up is advised to evaluate valve performance. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established. Data on TAVR in patients with asymptomatic severe aortic stenosis are based on study of predominantly low surgical risk patients. Limited clinical data to inform benefit-risk considerations are available for TAVR in patients with asymptomatic severe aortic stenosis who are deemed to be at intermediate or greater surgical risk. Glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to, or breathing of, the solution. Use only with adequate ventilation. If skin contact occurs, immediately flush the affected area with water; in the event of contact with eyes, seek immediate medical attention. For more information about glutaraldehyde exposure, refer to the Safety Data Sheet available from Edwards Lifesciences. If a significant increase in resistance occurs when advancing the catheter through the vasculature, stop advancement and investigate the cause of resistance before proceeding. Do not force passage, as this could increase the risk of vascular complications. As compared to SAPIEN 3, system advancement force may be higher with the use of SAPIEN 3 Ultra/SAPIEN 3 Ultra RESILIA THV in tortuous/challenging vessel anatomies. To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and endocarditis. Additional precautions for transseptal replacement of a failed mitral valve bioprosthesis include, the presence of devices or thrombus or other abnormalities in the caval vein precluding safe transvenous femoral access for transseptal approach; and the presence of an Atrial Septal Occluder Device or calcium preventing safe transseptal access. Special care must be exercised in mitral valve replacement to avoid entrapment of the subvalvular apparatus. Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: non-calcified aortic annulus; severe ventricular dysfunction with ejection fraction < 20%; congenital unicuspid aortic valve; pre-existing prosthetic ring in the tricuspid position; severe mitral annular calcification (MAC); severe (> 3+) mitral insufficiency, or Gorlin syndrome; blood dyscrasias defined as leukopenia (WBC < 3000 cells/mL), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mL), or history of bleeding diathesis or coagulopathy; hypertrophic cardiomyopathy with or without obstruction (HOCM); echocardiographic evidence of intracardiac mass, thrombus, or vegetation; a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated; significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater, marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding, or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta; access characteristics that would preclude safe placement of the Edwards sheath, such as severe obstructive calcification or severe tortuosity; bulky calcified aortic valve leaflets in close proximity to coronary ostia; a concomitant paravalvular leak where the failing prosthesis is not securely fixed in the native annulus or is not structurally intact (e.g., wireform frame fracture, annuloplasty ring dehiscence); or a partially detached leaflet of the failing bioprosthesis that in the aortic position may obstruct a coronary ostium. For Left axillary approach, a left subclavian takeoff angle ~ ≥ 90° from the aortic arch causes sharp angles, which may be responsible for potential sheath kinking, subclavian/axillary dissection and aortic arch damage. For left/right axillary approach, ensure there is flow in Left Internal Mammary Artery (LIMA)/Right Internal Mammary Artery (RIMA) during procedure and monitor pressure in homolateral radial artery. Residual mean gradient may be higher in a “THV-in-failing prosthesis” configuration than that observed following implantation of the valve inside a native aortic annulus using the same size device. Patients with elevated mean gradient post procedure should be carefully followed. It is important that the manufacturer, model and size of the preexisting prosthesis be determined, so that the appropriate valve can be implanted and a prosthesis-patient mismatch be avoided. Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the inner diameter as possible.

Potential Adverse Events: Potential risks associated with the overall procedure, including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; stroke/transient ischemic attack, clusters, or neurological deficit; paralysis; permanent disability; respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, atrium, septum, myocardium, or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; thoracic bleeding; embolization including air, calcific valve material, or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; arteriovenous (AV) fistula or pseudoaneurysm; reoperation; ischemia or nerve injury or brachial plexus injury; restenosis; pulmonary edema; pleural effusion; bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes (e.g., wound infection, hematoma, and other wound care complications) at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; and fever. Additional potential risks associated with the use of the valve, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; left ventricular outflow tract obstruction; valve deployment in unintended location; valve stenosis; structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis); device degeneration; paravalvular or transvalvular leak; valve regurgitation; hemolysis; device explants; nonstructural dysfunction; mechanical failure of delivery system and/or accessories; and non-emergent reoperation.

Edwards Crimper

Indications: The Edwards crimper is indicated for use in preparing the Edwards SAPIEN 3 transcatheter heart valve, Edwards SAPIEN 3 Ultra transcatheter heart valve, and the Edwards SAPIEN 3 Ultra RESILIA transcatheter heart valve for implantation.

Contraindications: There are no known contraindications.

Warnings: The device is designed, intended, and distributed for single use only. Do not resterilize or reuse the device. There are no data to support the sterility, nonpyrogenicity, and functionality of the device after reprocessing. Do not mishandle the device. Do not use the device if the packaging or any components are not sterile, have been opened or are damaged, or the expiration date has elapsed.

Precautions: For special considerations associated with the use of the Edwards crimper prior to THV implantation, refer to the THV Instructions for Use.

Potential Adverse Events: There are no known potential adverse events associated with the Edwards crimper.

CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.