Titan Spine: New ICD-10 Code

Titan Spine, LLC is reporting 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. As indicated in the July 11, 2016 news release, 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.”

Peter Ullrich, M.D., Titan’s CEO, 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.”

Asked for details on the in vivo testing, Ullrich told OTW, “Titan was required to demonstrate biocompatibility in compliance with ISO 10993, which included in vivo testing, to secure the FDA clearance of our nanoLOCK technology. This testing involved inflammation and cellular reaction to our surface in vitro. In fact, our cell testing data demonstrating PEEK produces an inflammatory environment favoring cell death, whereas the proprietary micro topography of our titanium implants promotes osteoblastic differentiation and enhanced bone-forming environment, was published in Spine and granted the Whitecloud Award for Best Basic Science Research from the Scoliosis Research Society when initially presented at IMAST in 2014. Furthermore, it’s very common for CMS to look to FDA’s guidance or clearance of a technology prior to granting a coding model, and we are very pleased with both the approval and coding outcomes.”

Asked how he foresees the code being helpful to the company and to doctors, he added, “The new technology ICD-10 code for a nanotextured surface on an interbody fusion device is significant for us. We foresee that the new code will provide clarity to the science and discussion of nanotechnology in the spine industry because, since our nanoLOCK technology is the only approved product for the code’s use, it negates all other claims made in the industry regarding nanotechnology. For health care providers who work hard to understand which companies are innovating and which are not, a new technology designation helps administration penetrate through market noise and identify alternative, innovative technologies to improve the care of their patients.

“For physicians, the code is important because CMS will be able to accurately collect big data on surgery outcomes and identify which products resulted in better patient outcomes, allowing for transparent and publicized records that could affect reimbursement.”