Premia Spine Announces New Technology Add-On Payment for TOPS System

Premia Spine has initiated a Centers for Medicare & Medicaid Services (CMS) New Technology Add-on Payment (NTAP) Program for the TOPS System. The payment—up to an additional $11,375 beyond the standard DRG procedure payment—is available to facilities that provide inpatient spinal stenosis and spondylolisthesis care. This is only the third time that CMS has granted an incentive payment to facilities for the use of any spinal implant.

“We are honored by the recognition of CMS. TOPS has proven its ability to provide both clinical excellence and healthcare economic advantage to patients, providers, and payers,” Premia Spine CEO Ron Sacher said. “The NTAP program is an example of forward-thinking policy that aligns incentives so that patients receive the best short-term and long-term care.”
 
The U.S. Food and Drug Administration (FDA) designated the TOPS System as a breakthrough technology in 2020 and granted it PMA approval in June 2023 with a “superior-to-fusion” claim, underscoring its safety and efficacy. The TOPS System provides patients with spinal stenosis and spondylolisthesis advantages over lumbar fusion, including enhanced mobility, decreased post-operative neuro deficit, and more rapid and sustained return to normal activity.
 
In the TOPS U.S. clinical trial, the mean age of patients was 64 years, thus indicating a sizable addressable market for the NTAP program. 
 
A study published in the Journal of Health Economics and Outcomes Research confirmed the cost-effectiveness and economic benefit of the TOPS System versus TLIF fusion for patients suffering from spondylolisthesis and spinal stenosis. Data from the prospective randomized study show that, despite being $4,000 more expensive than a TLIF implant, TOPS still achieves cost-effectiveness at a willingness-to-pay threshold of $100,000 within a year after surgery. Furthermore, TOPS becomes the dominant strategy when data is examined at two years and beyond. From the societal perspective, TOPS is even more highly cost-effective at one year and dominant at two years and beyond.
 
“TOPS appears to be a highly cost-effective surgical modality compared with TLIF as a motion-preserving, non-fusion alternative for the treatment of grade 1 spondylolisthesis with lumbar spinal stenosis. Since the TOPS System yields greater QOL [quality of life] at a lower total cost over time, it deserves serious attention,” stated study author Jared Ament, M.D., a neurosurgeon at the Neurosurgery & Spine Group in Los Angeles.
 
Premia Spine is committed to enhancing the quality of life for patients suffering from chronic leg and back pain. Its products are designed to offer durability, stability, and increased mobility to those struggling with lumbar spinal stenosis, degenerative spondylolisthesis, and related spinal conditions. The TOPS System, Premia Spine’s flagship product, has received the CE mark and has now obtained approval for distribution within the United States.