CMS grants Gore’s Excluder stent graft new tech status

W.L. Gore & Associates has won new technology status from the Centers for Medicare and Medicaid Services and the associated add-on reimbursement for its Excluder iliac branch endoprosthesis (IBE).

Beginning Oct. 1, medical facilities that use the device in conjunction with Gore’s Excluder AAA device for endovascular aneurysm repair, qualify for a new tech add-on payment of up to $5,250 per case. The payment is on top of the applicable base payment for the Medicare Severity Diagnosis-related group.

Additionally, the company said it was also successful in a separate petition to CMS for reclassification of EVAR to create two new DRGs with “increased hospital base reimbursement.”

“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,” Ryan Takeuchi, Gore’s aortic business unit leader, said in a statement. “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.”

The company said it received the European Union’s CE Mark in June 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.

Earlier in the year, Health Canada approved the Excluder with indications for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.

- here’s the release

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