ARTICLE SUMMARY:
After being the first to achieve regulatory approval of a transcatheter tricuspid valve, Edwards is following that technology innovation with regulatory advances by getting CMS authorization for the EVOQUE valve under the recently-announced TCET pilot program, addressing an important unmet need for patients who previously lacked device options.
When Edwards Lifesciences pioneered the introduction of the transcatheter tricuspid valve replacement (TTVR) EVOQUE valve by receiving FDA Breakthrough approval in February 2023, the company knew that this regulatory success was only half the battle. The next hurdle was reimbursement.
Edwards took a big step towards that goal in December when CMS issued a proposed national coverage analysis (NCA) decision addressing Medicare beneficiaries with severe symptomatic tricuspid regurgitation (TR). Under this determination, Medicare coverage will be provided for procedures conducted under CMS-approved clinical trials, using a Coverage with Evidence Development (CED) approach to promote the safe and effective collection of data in these new treatments. (In specific cases, Medicare patients could be covered for TTVR under the program’s clinical trial policy or under FDA’s IDE (investigational device exemption) program.)
