Paradigm Spine announces NASS coverage policy recommendation for coflex interlaminar stabilisation


The North American Spine Society (NASS) has issued a coverage policy recommendation for Lumbar Interlaminar Device without Fusion and with Decompression, which applies to Paradigm Spine’s coflex device. This recommendation is particularly significant for coflex because it provides the evidence private health insurance companies require to allow access for patients to benefit from this technology.

The policy recommendations cover the use of spinous interlaminar devices, in conjunction with a direct decompression procedure. However, the only FDA approved, on-label device that currently matches this product class is coflex. The coflex device, as described by Paradigm Spine, is the exclusive lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability for patients with moderate to severe lumbar spinal stenosis.

Health insurance companies and health care providers look to NASS for guidance when determining appropriate coverage decisions for state-of-the-art technologies, in this case the coflex device. NASS’ multi-disciplinary team of spine specialists systematically review available scientific literature. Searches include meta-analyses, clinical guidelines, and the highest level of clinical data with randomised controlled trials. There have been two separate, prospective, randomised controlled trials against two different control groups for coflex to date.

The recently issued NASS coverage policy recommends the use of coflex for the treatment of patients with lumbar spinal stenosis. The recommendations only apply to devices that are used in conjunction with a direct decompressive procedure, which for the foreseeable future is only coflex, and states, “More recently interspinous process devices have been used in conjunction with direct decompression via laminotomy. Some devices, such as coflex, according to its FDA labeling and available published data, are specifically approved for use in this manner.”

“It is gratifying to see the NASS Coverage Committee issue a coverage recommendation for coflex”, says Richard D Guyer (Texas Back Institute, Plano, USA), past-president of NASS. “I have been a member of NASS for over 20 years and trust in their process and recommendations for new technologies. I know the process is thorough and evidence-based, which gives me confidence in offering the latest and proven technologies to my patients. In particular with coflex, I think we as surgeons have the opportunity and responsibility to utilise the abundant clinical evidence and our experience to provide a superior alternative to decompression alone or spinal fusion for our patients with lumbar spinal stenosis.”

Commercial insurance carriers have started to write coverage policies supporting coflex, and Paradigm Spine is hopeful that this will expand, therefore allowing for improved patient access to the technology over the coming months.

“The NASS coverage policy recommendation for coflex is a major milestone for validating our technology and allows us to reach more private payors in the US market,” says Marc Viscogliosi, chair and CEO of Paradigm Spine. “Over the past decade, Paradigm Spine has worked diligently to build the clinical evidence in establishing coflex as the new standard of care for the treatment of moderate to severe lumbar spinal stenosis.”

Those pieces have been:

1) The FDA IDE [Investigational Device Exemption] clinical trial, which demonstrated positive, long-term Level I evidence of coflex compared to fusion
2) Establishment of CPT [Current Procedural Terminology] and site-of-service facility coding pathways
3) The recent publication of the landmark Level I ESCADA clinical trial, which demonstrated superiority of coflex compared to decompression alone
4) And now, the positive payer coverage recommendation from NASS with their coverage recommendation in support of coflex.

“As a company, we believe these achievements provide the evidence private payors require to create access to this important technology for patients suffering from lumbar spinal stenosis,” Viscogliosi continues.

Speaking to Spinal News International, Viscogliosi expresses his confidence that this policy recommendation will “position coflex as a treatment in the continuum of care”, and will mean “payors will embrace and recognise that the largest and most significant spine surgeon society in the world is saying there’s a place for this [coflex].”

The coflex interlaminar stabilisation device is currently used in over 60 countries worldwide, with more than 1,000 surgeons in the US regularly performing coflex procedures. As Viscogliosi says, “Their ability to provide coflex to their patients is limited, because of the insurance carriers. Our hope is that patient access will continue to expand with the NASS coverage policies, and with the recognition and quality of our two randomised, controlled clinical trials.”

Of coflex, Viscogliosi enthuses: “For patients with lumbar spinal stenosis, coflex is a true alternative to fusion, and we believe our data prove that coflex is superior to fusion including in procedure simplicity, postoperative recovery, speed of recovery, and long-term clinical outcomes. And we believe, for those patients that suffer with lumbar spinal stenosis, what they really care about is quality of life activity, and motion, and coflex is the only option that gives them that.”


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