CMS proposes Medicare coverage for T-TEER
The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed providing Medicare coverage on a national level for the use of tricuspid transcatheter edge-to-edge repair (T-TEER) to treat symptomatic tricuspid regurgitation (TR). The update comes just weeks after the agency finalized its decision to cover transcatheter tricuspid valve replacement for TR.
The proposal would only cover patients who present with symptomatic TR despite optimal medical therapy. In addition, T-TEER has to be recommended by a heart team that includes, at a minimum, a cardiac surgeon, interventional cardiologist, heart failure cardiologist, electrophysiologist, multi-modality imaging specialists and an interventional echocardiographer.
At this time, the only medical device approved for T-TEER in patients with symptomatic TR is Abbott’s TriClip, which is delivered through a vein in the patient’s leg and repairs the tricuspid valve by clipping together flaps of tissue. TriClip uses the same technology found in Abbott’s MitraClip device designed to repair the mitral valve.
Back in October, CMS announced it was officially considering whether or not to cover T-TEER after receiving a formal request from Abbott.
“Abbott believes that a national coverage policy for T-TEER will ensure long-term, predictable, and consistent coverage for all Medicare beneficiaries,” Barbara J. Calvert, Abbott’s director of medical products reimbursement, said in the request.
Most public comments have been in favor of Medicare coverage for T-TEER
After CMS announced that it was considering Medicare coverage for T-TEER, the agency accepted public comments for a period of 30 days. During that time, the agency received a total of 64 comments.
“The majority of commenters spoke positively of the use T-TEER,” according to CMS. “A few commenters did not support coverage of T-TEER because of limited evidence … The majority of comments were anecdotes provided by physicians who utilized T-TEER among their patients.”
CMS raises questions—will two-year data help ease any concerns?
CMS officials reviewed data from the TRILUMINATE Pivotal trial when considering this decision. Initial results from that trial did find that treatment with the TriClip device was associated with improved outcomes, but the most significant benefits were related to patients' quality of life (QOL) and not specific clinical improvements.[1]
“In this context, it is impossible to assess true benefit against optimal medical therapy alone, and treatment benefit for hospitalization, total hospitalizations, and survival have not been shown,” according to CMS.
However, new two-year data just presented during ACC.25 in Chicago and published in Circulation showed that treatment with the TriClip device “significantly reduced TR severity and decreased rates of heart failure hospitalization compared with medical therapy alone.”[2]
“These new data reinforce the critical role TriClip plays in helping people with tricuspid regurgitation live the life they want while reducing the risk of hospitalization,” Sandra Lesenfants, senior vice president of Abbott's structural heart business, said in a company statement highlighting the data.
Only time will tell if these data help CMS regulators overcome any concerns and go through with this proposal to cover T-TEER for symptomatic TR. The agency is seeking public comments once again before making its final decision. The public comment period is scheduled to close May 3.
A final decision is expected by July 2.
Click here for additional details from CMS.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.