Irvine-based Edwards Lifesciences Corp. (NYSE: EW) said that it’s encouraged by recent streamlining of rules by the Centers for Medicare and Medicaid Services for the life-changing transcatheter aortic valve replacement, or TAVR, procedure for aortic stenosis.
The streamlining has been a long time coming, and although the coverage is only indicated for patients who suffer positive symptoms related to severe aortic stenosis, those who are too high-risk for open heart surgery, this is a step in the right direction, according to Edwards.
“Often, the primary risk facing severe aortic stenosis patients is not treatment complications, but the risk of not receiving treatment at all,” the company said in a June 21 statement.
“Edwards emphasized that the priority must be ensuring timely patient access to high-quality care, so that clinicians can provide all people with heart valve disease with the therapy that is right for them.”
The price tag has often been the sticking point. Patient access to emerging technologies is often impeded by costs or coverage.
“The valve prices are anywhere from $30,000 to $35,000, which brings up a whole other healthcare economics discussion,” Dr. Anthony Caffarelli, the vice chair of cardiothoracic surgery at Hoag, told the Business Journal.
By contrast, Caffarelli estimates that open-heart surgery, which is much riskier, costs substantially less—$5,000 compared to the TAVR price tag, which can range up to $40,000.
About six years ago, the CMS began looking at whether Medicare patients should be eligible for the TAVR procedures instead of open-heart surgeries.
“We are encouraged that CMS is open to moving toward a quality measure focused on patient outcomes, not procedural volume,” Edwards said in a public statement in response to CMS announcing their coverage of the TAVR procedure for severe aortic stenosis patients.
Edwards continues to search for “the best way to ensure high quality and appropriate access for all Medicare beneficiaries in need of treatment for structural heart disease.”