On 2 May 2012, Edwards Lifesciences announced that, effective immediately, the Centers for Medicare & Medicaid Services (CMS) will reimburse transcatheter aortic valve implantation (TAVI) procedures for US patients with symptomatic aortic stenosis under specified criteria.
The company commended CMS for issuing a flexible National Coverage Determination (NCD) that authorises coverage for current and future indications approved by the FDA. Edwards also noted that, under the NCD, coverage would extend to qualified non-inferiority or equivalence clinical studies. Additionally, important but small patient populations can be covered under a qualified study. The company continues to support the collection of TAVI outcomes data in a qualified national prospective registry.
“We endorse the NCD’s emphasis on the use of multidisciplinary heart teams in the treatment of TAVI patients,” said Michael A Mussallem, Edwards’ chairman and CEO. “While we are still analysing the policy and its lengthy supporting decision memorandum, we believe that this policy can provide appropriate and prompt access to treatment for these very sick patients.”