National coverage expanded for Abbott's tricuspid valve repair under Centers for Medicare and Medicaid Services (CMS)
In a significant development for heart patients, the Centers for Medicare & Medicaid Services (CMS) has issued a National Coverage Determination (NCD) that covers FDA-approved Transcatheter Edge-to-Edge Repair (T-TEER) for symptomatic tricuspid regurgitation (TR) under Coverage with Evidence Development (CED). This decision, effective from July 2, 2025, is expected to broaden access to minimally invasive treatment for those who are not good candidates for surgery.
The CMS decision comes following the approval of Abbott's TriClip device by the Food and Drug Administration (FDA) in April 2024. Abbott's device pulls together the leaflets of the tricuspid valve with a clip to help blood flow in the right direction and reduce leaking. The company's senior vice president, Sandra Lesenfants, stated that the decision helps open the door to treatment for more people with severe tricuspid regurgitation.
The coverage includes the use of Abbott's TriClip system. This development was anticipated after Susan Kelly, a healthcare journalist, reported in her article titled "CMS begins national coverage review for tricuspid repair" on Oct. 8, 2024.
Edwards Lifesciences, a competitor of Abbott, also manufactures a transcatheter tricuspid valve replacement device called Evoque to treat tricuspid regurgitation. However, the current focus is on T-TEER, which repairs the valve without replacing it.
The CMS decision is contingent upon procedures being performed in accordance with specific criteria outlined in the NCD and as part of CMS-approved studies. The evidence base for T-TEER is derived from several studies, including the TRILUMINATE single-arm trial, the TRILUMINATE Pivotal trial, and the Tri.Fr trial, which evaluated the TriClip device. While the evidence is considered insufficient for definitive conclusions, it is deemed sufficient to allow coverage under the CED framework.
There are concerns that the positive results may be driven more by improvements in quality of life rather than reductions in hard clinical outcomes like mortality. Despite this, the decision is expected to have a positive impact on patients with severe tricuspid regurgitation, reducing hospitalizations and improving their overall quality of life.
It's worth noting that private payers like UnitedHealthcare Community Plan still consider transcatheter tricuspid heart valve repair, including T-TEER, as unproven and not medically necessary due to insufficient evidence of efficacy. However, CMS coverage decisions often influence private payers, so this stance may change in the future.
In conclusion, the CMS's decision to cover T-TEER is a significant step towards providing minimally invasive treatment options for patients with severe tricuspid regurgitation. This decision is expected to improve patients' quality of life and reduce hospitalizations, paving the way for wider access to this life-changing treatment.
[1] Abbott. (2025). TRIClip CoverAge with Evidence Development (CED) Real-World Evidence (RWE) Study. Retrieved from https://www.abbott.com/-/media/global/investor-relations/pdfs/sec/2025q210q/2025q210q-exhibit999-1.pdf?la=en [2] Kelly, S. (2025). 3 takeaways from ACC 2025. Retrieved from https://www.medtechdive.com/news/3-takeaways-from-acc-2025/644954/ [3] Kelly, S. (2024, April 2). Abbott nets FDA approval for Triclip. Retrieved from https://www.medtechdive.com/news/abbott-nets-fda-approval-for-triclip/633630/ [4] UnitedHealthcare Community Plan. (2025, July 1). Coverage Policy: Transcatheter Tricuspid Heart Valve Repair. Retrieved from https://www.uhc.com/content/dam/uhc/en/provider-resources/coverage-policy/transcatheter-tricuspid-heart-valve-repair.pdf
- The Food and Drug Administration (FDA) approved Abbott's TriClip device in April 2024, marking a milestone in medtech AI advances for cardiovascular health.
- The Transcatheter Edge-to-Edge Repair (T-TEER) for symptomatic tricuspid regurgitation (TR), covered under the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD), is anticipated to boost the application of medtech devices in health-and-wellness and medical-conditions treatment.
- In analytics and news articles, it was reported that the CMS's decision follows Abbott's device approval and sets the stage for broader access to minimally invasive treatments for heart patients.
- The development opened a new chapter in science, as the coverage includes the use of Abbott's TriClip system, pioneering a less invasive approach for heart valve repair.
5.ially, the focus on T-TEER over transcatheter tricuspid valve replacement devices, like Edwards Lifesciences' Evoque, highlights the significance of these advancements in improving patient's quality of life and reducing hospitalizations.
- As private payers like UnitedHealthcare Community Plan continue to evaluate the evidence base for T-TEER, the CMS decision, coupled with ongoing research in medical-conditions and health-and-wellness, may influence the industry's stance on this life-changing technology.
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