by
Loren Bonner, DOTmed News Online Editor | March 28, 2013
With the exception of a single manufacturer's one trans-catheter aortic implant, which is FDA approved, all other percutaneous heart valves — aortic as well as mitral — are currently in clinical trials.
Financial impact for hospitals
TAVR, or transcatheter aortic valve replacement, involves transporting a prosthetic valve through a catheter in the leg to the heart in patients with aortic stenosis. Edwards Lifesciences received FDA approval for TAVR in November 2011, and several U.S. hospitals were part of testing the procedure in clinical trials over the past five years. Today, TAVR is performed in roughly 200 hospitals nationwide.
However, because of lag time in reimbursement from CMS, the vast majority of the hospitals performing TAVR have had negative bottom lines due to the very high cost of the actual procedure, said Richman.
Although hospitals want to adopt these more advanced technologies and surgical methods, in general, new technologies or treatment modalities are often introduced before the reimbursement models for these procedures have been determined. In addition, many of the technologies do not have available data based on long-term clinical studies to support their improvement effectiveness at the point of their introduction, said Richman.
Besides renal denervation and TAVR, drug-eluting balloon catheters, drug-eluting peripheral stents and bioabsorbable coronary scaffolding are emerging technologies hospitals should be keeping an eye on as well.
"To our understanding, it was only after the release of the Cypher Sirolimus-eluting coronary stent that CMS approved a unique reimbursement code for Johnson & Johnson. We understand that Abbott Laboratories is attempting to work with CMS to get reimbursement for their new Absorb Everolimus-eluting coronary scaffold," said Richman.
In particular, he said Abbott Laboratories Absorb Everolimus-eluting coronary scaffold has promising long-term clinical data. "The outstanding question is the ultimate price and reimbursement in the United States," he said.
Ultimately, it is too early to speculate on the ability of these technologies to improve outcomes while lowering costs — something hospitals will be more concerned about than ever in this era of health care reform. But stakeholders will certainly be monitoring those outcomes closely.
Back to HCB News
