VEO Ophthalmics announced that the Customflex ArtificialIris has been approved by the Center for Medicare and Medicaid Services (CMS) for transitional pass-through payment status, effective January 1, 2020. The HCPCS code for the Customflex ArtificialIris that is associated with pass-through payment is: C1839 Iris prosthesis.
The approval by CMS for transitional pass-through payment was under the new alternative pathway for breakthrough devices.
“Since receiving FDA approval, the Customflex ArtificialIris has helped many patients suffering from symptomatic aniridia,” Ron Gilliland, President and CEO of VEO Ophthalmics, said in a company news release. “The decision by CMS to grant pass-through payment status will now make this unique technology available to more patients in the U.S.”
The Customflex ArtificialIris is manufactured by HumanOptics. VEO Ophthalmics has an exclusive agreement for commercialization within the United States. The Customflex ArtificialIris, which received FDA approval on May 30, 2018, is the only iris prosthesis available in the United States for use in children and adults for the treatment of iris defects resulting from congenital aniridia, acquired defects, or other conditions associated with a completely or partially missing or damaged iris.
People may have a damaged or missing iris from birth or as a result of ocular injuries or other trauma, disease, or surgery. They struggle to cope with symptoms related to the eye’s inability to control the level of incoming light, including light sensitivity, glare, halos, reading difficulty, and problems with night driving. Many face above-average risk of glaucoma and cataract formation as well.