Vertera Spine said today that the Centers for Medicare & Medicaid Services issued a new ICD-10 code for its radiolucent porous spinal fusion device.
The company’s Cohere cervical interbody fusion device is the 1st and only clinically-available porous fusion device made out of Vertera Spine’s radiolucent PEEK biomaterial. It is also the only device approved for use under the new code.
Conventionally, spinal interbody fusion devices have been classified by the implant material – either synthetic or tissue-derived alternative.
But Vertera said using a single coding identifier for all synthetic devices may not be appropriate for accurately describing fusion procedures, since companies have developed more advanced orthopedic biomaterials.
The unique properties of porous PEEK likely prompted the new ICD-10 code, which will go into effect October 1st, according to Vertera.
“The issuance of this new code signifies the unique performance of porous PEEK devices compared with other fusion devices and the importance of monitoring how this technology impacts healthcare,” Dr. Richard Guyer, from the Texas Back Institute, said in prepared remarks. “As a clinician, I am always looking for innovative technologies, such as Vertera Spine’s porous PEEK Cohere device, that have the potential to improve patient outcomes.”
“The development of porous PEEK has allowed for the combination of radiolucency and porosity in an interbody implant that is completely plastic. In vivo studies have demonstrated that bone will grow into porous implants, improving their osseointegration,” Dr. Kevin Foley, from the Semmes-Murphey Neurologic and Spine Institute, said. “Until now, the only porous implants clinically available were made of metal or had a metallic coating, which can limit the surgeon’s ability to assess fusion on imaging. This new code gives us the potential to better correlate bony tissue ingrowth into Vertera Spine’s porous PEEK Cohere device with clinical outcomes.”
“I began to see my 1 year follow-up Cohere device patients in May of this year and the results have shown a clear and consistent trend of rapid and readily visible progression to robust osseous union,” Dr. Erik Westerlund, from the St. Francis Spine Center, added. “Not only is there characteristic radiographically visible osseous incorporation at the interconnected porous margin of the Cohere PEEK spacers, there is also a notable continuity of bridging bone across the entire interspace. The grant of a new specific ICD-10 code for porous PEEK will provide myself and other spine surgeons greatly refined capacity to track clinical outcomes and cost savings with this genuinely transformational class of porous PEEK interbody spacers like Vertera Spine’s Cohere.”
“We are excited that CMS has adopted a new code for radiolucent porous devices and are pleased that Cohere will fall under this designation,” Vertera Spine founder & CEO Chris Lee said. “The availability of a radiolucent porous fusion device means that for the 1st time, bone tissue ingrowth can potentially be assessed into the device. This will allow us to further understand the role of implant integration with clinical outcomes.”