Edwards Lifesciences (NYSE:EW) had words of praise and caution about a proposed reimbursement scheme for its Sapien transcatheter aortic valve implant unveiled by the Centers for Medicare & Medicaid Services last month.
Edwards, which boasts the only TAVI device cleared for the U.S. market, asked Medicare to reconsider limiting future clinical trials and asked the agency to re-think proposed rules for procedure credentialing focused on individual physicians.
CMS’s guidelines defined 5 requirements for coverage, including the types of facilities that may apply for reimbursement and enrollment in post-procedure registries to track patient outcomes.
Edwards lauded the agency’s flexible coverage for all FDA-cleared TAVI indications, its commitment to a registry for all TAVI patients and the recognition of the importance of a qualified heart team in TAVI treatment.
But the Irvine, Calif.-based med-tech titan warned that requiring individuals to obtain credentials to perform the surgery failed to follow through on that team-centric approach, according to a press release.
Instead, Edwards proposed that the agency credential facilities and heart teams for TAVI operations, rather than licensing individual physicians, and suggested setting criteria for maintaining and improving patient outcomes.
The company also offered amendments to CMS clinical trial proposals, which aim to limit future studies to "superiority trials," warning that such a move "undermines efforts to promote continued U.S.-based clinical research for Medicare patients."
"There are also important, yet relatively small, patient populations that would be well-served by further studies – and that may not get treatment if the proposed conditions are not revised," Edwards wrote.
CMS initiated a national coverage analysis for TAVI procedures last fall, before the Sapien device won FDA clearance. The uncertainty surrounding reimbursement slowed down Sapien’s sales, Edwards president Michael Mussallem said during the company’s recent Q4 earnings conference call.
EW shares lost nearly 7% on Sept. 29, 2011, the day CMS announced that it would review its TAVI coverage policy. The company’s response to the coverage proposal didn’t generate much love on Wall Street either, with shares trading down 2.5% at $69.05 as of about 12:45 p.m. today.
CMS is expected to issue its final TAVI coverage rule within 60 days.