On March 19, 2025, CMS issued an NCD that covers FDA approved Transcatheter Tricuspid Valve Replacement (TTVR) for the treatment of symptomatic tricuspid regurgitation (TR) under Coverage with Evidence Development (CED), when furnished in accordance with the coverage criteria specified in the NCD. The complete NCD decision memorandum is available on our website (see link below).
https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=314
Below is a list of studies that have been determined to meet the requirements for coverage under CED.
Study Title: Transcatheter Tricuspid Valve Replacement (TTVR) in Patients with Severe TR ONgoing Evidence Generation (STRONG) under Coverage with Evidence Development (CED)
Sponsor: Edwards Lifesciences
Clinicaltrials.gov number: NCT06833476
CMS Approval Date: 03/19/2025