Updated 12:10 p.m. with comments from Edwards Lifesciences.
The Centers for Medicare & Medicaid Services released a proposal detailing guidelines for reimbursement of transcatheter aortic valve implantation procedures for treating severe symptomatic aortic stenosis.
The memo defines 5 requirements for coverage, including the types of facilities that may apply for reimbursement and enrollment in post-procedure registries to track patient outcomes.
That’s good news for Edwards Lifesciences (NYSE:EW) and its Sapien heart valve, which won FDA clearance in November 2011 and is still the only valve commercially available in the U.S.
The positive vote didn’t do much for Edwards on Wall Street, however, where shares are still down after the company forecast Q1 2012 earnings below analysts’ estimates.
CMS initiated a national coverage analysis for TAVI procedures last fall, before Sapien won FDA clearance, and the uncertainty surrounding reimbursement slowed down Sapien’s sales, Edwards president Michael Mussallem said during the company’s recent Q4 earnings conference call.
"This early NCD process has resulted in inconsistent interpretations among the regional Medicare contractors. The majority of these Medicare payers are reimbursing on a case-by-case basis, while policies of others are still evolving," Mussallem said. "We believe this reimbursement situation will improve as payors clarify their policies."
While Edwards is still reviewing the CMS memo in its entirely, things look good at first glance, an Edwards spokeswoman told MassDevice in an email.
"Based upon our initial review of the CMS proposed NCD, we are encouraged by the flexibility of the coverage," the company wrote. "The draft NCD extends coverage not only to existing indications, but also to future indications when they receive FDA approval."
The company plans to comb through the proposal in greater depth and put in its 2 cents on the parameters proposed by CMS.
"The company believes a well-written NCD that ensures adequate patient access to this rapidly evolving therapy will be positive for patients and physicians," Edwards told us. "We look forward to conducting a thorough analysis of the draft NCD and providing detailed comments to CMS."
The CMS proposal also supported coverage for patients in clinical trials if the trials meet certain conditions.
Fellow valve-maker and nearest rival Medtronic (NYSE:MDT) is about 2 years behind Sapien, expecting to gets its CoreValve device on the U.S. market in 2014.
The Fridley, Minn.-based device giant late last month closed enrollment in the “extreme risk” arm of patients in a pivotal trial of the CoreValve system in a bid for FDA clearance.
The CoreValve was the first TAVI system with regulatory approval and the only TAVI device on the market for about 6 months when it won CE Mark approval in the European Union in March 2007. Sapien won CE Mark approval in September 2007.
The Society of Thoracic Surgeons and the American College of Cardiology released a joint statement lauding CMS for its reimbursement proposal, which the agency generated as a response to a formal request from the groups.
"As surgeons, we support coverage efforts that seek to optimize patient safety and value physician collaboration," STS president Dr. Jeffrey Rich said in prepared remarks. "This coverage analysis achieves these goals through the use of specialized centers with multidisciplinary heart teams and registry enrollment."
STS and ACC together launched a TAVI registry last December, a first-of-its-kind benchmarking tool to track TAVI patient outcomes and a repository for all clinical data related to the procedure, according to a press release.
The CMS proposal is open for public comment until March 3, after which the agency will make a final decision on reimbursement.