Last week, Mequon, WI-based Titan Spine made a pair of announcements related to its ongoing effort to commercialize a new line of surgical implants.
The first: that Southlake Equity Group, a private equity firm based in Southlake, TX, had made a “substantial” investment in Titan Spine.
The second: that the U.S. Centers for Medicare & Medicaid Services (CMS) had created a new medical billing code for “a nanotextured surface on an interbody fusion device.” Titan Spine co-founder and CEO Peter Ullrich says that the product line his company is preparing to roll out meets those criteria, and is the only set of devices that has been approved for use of the code.
Ullrich estimates that 85 percent of the market for spinal implants is controlled by six companies. They are all large and publicly traded: Medtronic (NYSE: [[ticker:MDT]]), Stryker (NYSE: [[ticker:SYK]]), Johnson & Johnson (NYSE: [[ticker:JNJ]]), NuVasive (NASDAQ: [[ticker:NUVA]]), Zimmer Biomet (NYSE: [[ticker:ZBH]]), and Globus Medical (NYSE: [[ticker:GMED]]).
“This is why the code is so immense for us,” Ullrich says. “Market access is difficult for small companies. If we have a different code than Medtronic and Stryker, [they] can’t say, ‘We already have one,’ because they don’t. It’s going to be a big selling point.”
Once it becomes available on Oct. 1, the code will be one of more than 70,000 that providers in the U.S. can choose from to document medical diagnosis and procedure information about patients. The list, known as ICD-10, is managed internationally by the World Health Organization and domestically by CMS and the National Center for Health Statistics; leaders at the latter two organizations make final decisions on adding new procedure codes to the list.
ICD-10 and other code sets, like Current Procedural Terminology, are used by groups such as researchers and the staff in a hospital’s billing office. Adhering to a uniform list of codes can help healthcare providers and insurers standardize costs and reimbursement levels across locations and state lines.
While some countries have been using ICD-10 codes to capture health data for more than a decade, the U.S. made the switch from ICD-9—which has one-fifth as many codes—last October.
Ullrich says that late last year, Titan Spine contacted CMS about creating a new code, which he calls a “very regimented process.” He and his colleagues attended and presented at several public forums, he says. Additionally, officials from the agency performed safety evaluations of the company’s technology and reviewed clinical assessments previously conducted by Titan Spine.
Successfully working with CMS to add a new billing code is somewhat similar to obtaining a patent in that it can grant businesses a measure of exclusivity over technologies they’ve developed. However, one key difference is that with code sets like ICD-10, other companies could develop similar technologies that could also meet the code’s criteria, even if they themselves didn’t help it get created.
“I think if somebody was able to get their device cleared through the FDA as a nanotextured surface, then they would have a good chance of being able to enter into this code,” Ullrich says.
