Business Wire07.12.16
Titan Spine reported that the U.S. Centers for Medicare & Medicaid Services (CMS) has announced the creation of a new technology ICD-10 code for a nanotextured surface on an interbody fusion device. Titan Spine’s nanoLOCK surface technology, which was the first FDA-cleared nanotechnology for interbody fusion devices, has been given access to use this code.
The “Interbody Fusion Device, Nanotextured Surface” code was approved as an XRG code by CMS and will be able to be used starting October 1, 2016. This code was approved based on information presented by Titan Spine on its nanoLOCK surface that demonstrated it as a unique and differentiated technology. Other technologies may be added to this code but must first either demonstrate equivalence to nanoLOCK, or demonstrate superiority to all other market alternatives through the CMS designated processes.
Several steps were required to procure the nanotextured code. Titan Spine has dedicated years researching and evaluating surface nanotechnology, including extensive scientific research, safety evaluations, and clinical retrospective assessments linking cellular response to clinical outcomes. All supporting studies were completed on Titan Spine’s proprietary surface topography. Next, Titan Spine gained a nanotechnology clearance from the FDA that required the establishment of nanoLOCK’s safety profile through extensive in-vivo testing. In late 2015, Titan Spine completed the CMS New Technology Procedural Coding System Application and ICD-10 Code Request, which was further supported in early 2016 through two CMS Public Forums: i) the CMS New Technology Add-On Payment Town Hall and ii) the CMS ICD-10 Coordination & Maintenance Committee. The culmination of these steps resulted in a Section X New Technology ICD-10 code, which aligns hospital coding to nanoLOCK’s product distinctiveness.
Peter Ullrich, M.D., Chief Executive Officer of Titan Spine, commented, “We are very pleased with the new nanotextured category designation that CMS has created. And I am extremely proud of the entire Titan team who worked tirelessly to create our nanoLOCK surface technology and to procure its code.”
The “Interbody Fusion Device, Nanotextured Surface” code was approved as an XRG code by CMS and will be able to be used starting October 1, 2016. This code was approved based on information presented by Titan Spine on its nanoLOCK surface that demonstrated it as a unique and differentiated technology. Other technologies may be added to this code but must first either demonstrate equivalence to nanoLOCK, or demonstrate superiority to all other market alternatives through the CMS designated processes.
Several steps were required to procure the nanotextured code. Titan Spine has dedicated years researching and evaluating surface nanotechnology, including extensive scientific research, safety evaluations, and clinical retrospective assessments linking cellular response to clinical outcomes. All supporting studies were completed on Titan Spine’s proprietary surface topography. Next, Titan Spine gained a nanotechnology clearance from the FDA that required the establishment of nanoLOCK’s safety profile through extensive in-vivo testing. In late 2015, Titan Spine completed the CMS New Technology Procedural Coding System Application and ICD-10 Code Request, which was further supported in early 2016 through two CMS Public Forums: i) the CMS New Technology Add-On Payment Town Hall and ii) the CMS ICD-10 Coordination & Maintenance Committee. The culmination of these steps resulted in a Section X New Technology ICD-10 code, which aligns hospital coding to nanoLOCK’s product distinctiveness.
Peter Ullrich, M.D., Chief Executive Officer of Titan Spine, commented, “We are very pleased with the new nanotextured category designation that CMS has created. And I am extremely proud of the entire Titan team who worked tirelessly to create our nanoLOCK surface technology and to procure its code.”