{"id":8033,"date":"2025-07-21T12:55:19","date_gmt":"2025-07-21T09:55:19","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=8033"},"modified":"2025-07-21T12:55:19","modified_gmt":"2025-07-21T09:55:19","slug":"cms-approves-coverage-of-tricuspid-teer-with-conditions","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/cms-approves-coverage-of-tricuspid-teer-with-conditions\/","title":{"rendered":"CMS Approves Coverage of Tricuspid TEER with Conditions"},"content":{"rendered":"<p><span>CMS Approves Coverage of Tricuspid TEER with Conditions<\/span><\/p>\n<p><span>Source: Brian Owens | July 18, 2025<\/span><br \/>\n<span>1. CMS Approval Overview<\/span><br \/>\n<span>\u2022 On July 2, 2025, the US Centers for Medicare &amp; Medicaid Services (CMS) approved coverage for Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER).<\/span><br \/>\n<span>\u2022 However, this approval is conditional under the Coverage with Evidence Development (CED) program, meaning procedures must be performed as part of CMS-approved clinical studies.<\/span><br \/>\n<span>2. Reason for Conditional Coverage<\/span><br \/>\n<span>\u2022 Concerns were raised about limited clinical benefit, particularly from the TRILUMINATE trial, which showed no significant reduction in mortality, surgery rates, or all-cause hospitalizations versus medical therapy.<\/span><br \/>\n<span>\u2022 CMS acknowledged evidence gaps but considered the data promising enough to support limited access under strict study conditions.<\/span><br \/>\n<span>3. Study Requirements<\/span><br \/>\n<span>\u2022 Clinical studies must measure:<\/span><br \/>\n<span>\u2022 All-cause mortality<\/span><br \/>\n<span>\u2022 Heart failure hospitalizations<\/span><br \/>\n<span>\u2022 With at least 24 months of follow-up<\/span><br \/>\n<span>\u2022 Patients must have symptomatic tricuspid regurgitation (TR) despite optimal medical therapy.<\/span><br \/>\n<span>\u2022 Care must be delivered by a multidisciplinary heart team, including:<\/span><br \/>\n<span>\u2022 A cardiac surgeon<\/span><br \/>\n<span>\u2022 An interventional cardiologist<\/span><br \/>\n<span>\u2022 A heart failure specialist<\/span><br \/>\n<span>\u2022 An interventional echocardiographer<\/span><br \/>\n<span>4. Expert Perspectives<\/span><br \/>\n<span>\u2022 Dr. Shamir Mehta (McMaster University, Canada), an investigator on TRILUMINATE, emphasized that:<\/span><br \/>\n<span>\u2022 The trial improved patients\u2019 quality of life, a key outcome for those with TR.<\/span><br \/>\n<span>\u2022 There was a reduction in HF hospitalizations at 2 years, which may correlate with decreased regurgitation over time.<\/span><br \/>\n<span>5. Limitations and Study Design Flaws<\/span><br \/>\n<span>\u2022 TRILUMINATE and TRISCEND II trials borrowed frameworks from left-sided heart failure trials.<\/span><br \/>\n<span>\u2022 This may have been inappropriate, as right heart failure (RHF) has different presentations and trajectories.<\/span><br \/>\n<span>\u2022 RHF patients typically develop peripheral fluid retention, often treated outpatient with diuretics, and are less likely to be hospitalized acutely like left HF patients.<\/span><br \/>\n<span>6. Implications for Future Research<\/span><br \/>\n<span>\u2022 Future studies under CED will aim to clarify which RHF patients benefit most from T-TEER.practice.<\/span><\/p>\n<p><span>Link:\u00a0<\/span><a href=\"http:\/\/www.cardiovascularbusiness.com\/news\/cms-coverage-tricuspid-teer\" target=\"_blank\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=http:\/\/www.cardiovascularbusiness.com\/news\/cms-coverage-tricuspid-teer&amp;source=gmail&amp;ust=1753173145318000&amp;usg=AOvVaw2Qx12UJIhKTMo40fY_7SpK\" rel=\"noopener\">http:\/\/www.<wbr \/>cardiovascularbusiness.com\/<wbr \/>news\/cms-coverage-tricuspid-<wbr \/>teer<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CMS Approves Coverage of Tricuspid TEER with Conditions Source: Brian Owens | July 18, 2025 1. CMS Approval Overview \u2022 On July 2, 2025, the US Centers for Medicare &amp; Medicaid Services (CMS) approved coverage for Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER). \u2022 However, this approval is conditional under the Coverage with Evidence Development (CED) program, [&hellip;]<\/p>\n","protected":false},"author":145,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-8033","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/8033","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/users\/145"}],"replies":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/comments?post=8033"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/8033\/revisions"}],"predecessor-version":[{"id":8034,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/8033\/revisions\/8034"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=8033"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=8033"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=8033"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}