W.L. Gore & Assoc. said today that it won new technology status from the U.S. Centers for Medicare & Medicaid Services for its Gore Excluder iliac branch endoprosthesis.
Set to go into effect Oct. 1, the change will allow facilities that use the device, in conjunction with Gore’s Excluder AAA device for endovascular aneurysm repair, to be eligible for a new tech add-on payment of up to $5,250 per case. The payment will come in addition to the applicable base payment for the Medicare Severity Diagnosis-related group.
“Prior to the IBE, there were limited options for maintaining blood flow to the internal iliac arteries during endovascular aneurysm repair, which is a consideration in about 25% of AAA cases. The IBE provides physicians with an FDA-approved, off-the-shelf system to preserve blood flow to the internal iliac arteries and maintain patient quality of life,” Dr. Brian Peterson, of St. Anthony’s Medical Center in St. Louis, said in a press release.
Newark, Del.-based Gore said it was also successful in a separate petition to CMS for reclassification of EVAR to create 2 new DRGs with “increased hospital base reimbursement,” effective in fiscal 2016.
“Since receiving FDA approval, the IBE has experienced rapid adoption among physicians wanting to ensure their patients have access to the best therapies and treatment options available through technological innovation. The decision by CMS to support the new tech add-on payment is recognition of the significance of the IBE in providing a solution for a previously unmet need in endovascular aortic repair,” aortic business unit leader Ryan Takeuchi said in prepared remarks.
In June, Gore said it won CE Mark approval in the European Union for the Excluder device for treating abdominal aortic aneurysms in patients with challenging anatomies. The Excluder device won approval for patients with either proximal aortic neck angles of up to 90 degrees or a minimum aortic neck length of 10mm, the company said.
Two months earlier, Gore said it won Health Canada approval for its Excluder with indications for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.