Shares of Edwards Lifesciences (NYSE:EW) jumped a few points as the Centers for Medicare & Medicaid affirmed coverage for the med-tech titan’s landmark Sapien transcatheter aortic valve implantation system.
EW shares jumped 2.2% to $84.78 in after hours trading as of about 6 p.m. today.
The latest CMS decision stuck to guidelines proposed in a February draft version of the coverage guidelines.
The new guidelines include minimum experience required by the heart team slated to perform the TAVI procedure and the types of facilities that may apply for reimbursement.
CMS also barred reimbursement for procedures in patients whose "existing co-morbidities would preclude the expected benefit," according to the agency’s decision memo.
Reimbursement relies on a number of factors, including a face-to-face patient evaluation prior to a TAVI recommendation by at least 2 cardiac surgeons who must document their reasoning.
A TAVI patient must also have access to a "heart team," defined as "a cohesive, multi-disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care."
The agency also outlined hospital program requirements, setting different bars for health providers with previous TAVI experience and those without.
Despite Edwards’ protests, the agency maintained credentialing for individual surgeons, rather than the team-centric approach the company recommended in its response to the draft guidelines released earlier this year.