The Centers for Medicare & Medicaid Services (CMS) has initiated a national coverage analysis (NCA) to determine whether to establish national Medicare reimbursement for tricuspid valve transcatheter edge-to-edge repair (T-TEER). This decision follows a formal request from Abbott, the manufacturer of the TriClip device, which is used in T-TEER procedures.
Abbott's request is being reviewed under the CMS’ Transitional Coverage of Emerging Technologies (TCET) pathway, designed to expedite Medicare coverage for breakthrough devices. The TriClip system gained FDA approval in April and is intended for patients with tricuspid regurgitation (TR).
Understanding Tricuspid Regurgitation and the TriClip Solution
Tricuspid regurgitation occurs when the tricuspid valve, located between the heart's right atrium and right ventricle, does not close properly, causing blood to flow backward. This condition can lead to heart failure, irregular heartbeats, and blood clots. The TriClip device addresses this issue by clipping together the leaflets of the tricuspid valve, reducing leakage and improving blood flow in the correct direction.
CMS Review Focus
The CMS review will focus on several key areas:
- Clinical indications for T-TEER in treating tricuspid regurgitation.
- Evidence regarding patient characteristics that may influence the benefits of the device.
- Specific treatment conditions necessary to achieve outcomes observed in clinical studies.
CMS is soliciting public comments on the request for the next 30 days, with a particular interest in scientific evidence and considerations related to health disparities and equity.
Timeline and Potential Impact
A proposed decision memo is expected by April 3, 2025, and the complete analysis is anticipated by July 2, 2025. According to BTIG analysts, Abbott's request to CMS referenced previous national coverage determinations (NCDs) for mitral TEER coverage and transcatheter aortic valve replacement (TAVR), suggesting that CMS might consider a therapy-focused NCD organization that includes TEER for both mitral and tricuspid valves.
Market Context and Expert Opinions
The TriClip's U.S. launch follows the FDA approval of Edwards Lifesciences' Evoque valve replacement device for tricuspid regurgitation. "We see this as a positive development for both Abbott’s TriClip and Edwards’ Pascal that should further bolster the momentum that we’ve seen in tricuspid repair thus far," noted J.P. Morgan analyst Robbie Marcus.
Andrew Rassi, MD, a cardiologist with Kaiser Permanente, highlighted the unmet clinical need in tricuspid valve treatment, noting that the number of devices being studied speaks to the need that will only be partially answered with the two FDA-approved devices.
Abbott's Perspective
An Abbott spokesperson stated, "The TriClip device represents an important intervention for patients suffering from TR, offering a safe and effective treatment that can greatly improve quality of life. We are encouraged by CMS's recognition of the importance of addressing TR and its impact on heart failure, and we look forward to contributing our insights during the comment period to support broader patient access to this vital therapy."
