Dive Brief:
- The Centers for Medicare and Medicaid Services is considering whether to establish national Medicare reimbursement for a transcatheter repair procedure to treat tricuspid valve regurgitation after receiving a formal request from Abbott.
- Abbott requested a national coverage analysis for the procedure, called tricuspid valve transcatheter edge-to-edge repair (T-TEER), according to its letter to the CMS. The company in April said it won Food and Drug Administration approval for its Triclip heart valve repair device, which is used in T-TEER procedures.
- The request is a pilot of the CMS’ Transitional Coverage of Emerging Technologies pathway, intended to expedite Medicare coverage of certain breakthrough devices.
Dive Insight:
Triclip is similar to Abbott’s Mitraclip for mitral valve regurgitation, but the device is designed for the tricuspid valve’s anatomy.
Regurgitation occurs when the valve does not function properly as it opens and closes, which can cause blood to flow backward into the heart. The condition can increase the risk of heart failure, irregular heartbeat and blood clots.
Abbott’s repair device pulls together the leaflets of the valve with a clip to help blood flow in the right direction and reduce leaking.
The CMS said its national coverage review for T-TEER will focus on clinical indications for use in tricuspid regurgitation, evidence for characteristics that make patients more or less likely to benefit from the device, and whether specific treatment conditions are necessary to achieve outcomes shown in clinical studies.
The agency, which is seeking public comment on the request for 30 days, said it is particularly interested in comments that include scientific evidence and that address health disparities and equity aspects that should be considered in the review.
A proposed decision memo is due by April 3, 2025, and the analysis is expected to be completed by July 2, 2025, the CMS said.
Abbott’s Triclip U.S. launch followed shortly after Edwards Lifesciences gained FDA approval for its valve replacement device, called Evoque, to treat tricuspid regurgitation.
Edwards also sells the Pascal device in the U.S. and Europe for repair of the mitral valve. In Europe, Pascal is also approved for tricuspid patients.
“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,” J.P. Morgan analyst Robbie Marcus wrote in a note to clients Thursday.