The International Society for the Advancement of Spine Surgery (ISASS) released a Policy Statement recommending coverage of decompression with interlaminar stabilization for select patients with lumbar spinal stenosis.
“This treatment has been utilized in Europe for many years before the U.S. IDE trial was begun,” explained Dr. Guyer, who is Co-Founder and Fellowship Director at the Texas Back Institute in Plano, and Associate Clinical Professor of Orthopaedics at the University of Texas Southwestern Medical School in Dallas. “It has become common practice for the major societies such as ISASS to produce position statements for various treatments, be they positive or negative. If positive, the statement allows the societies to advocate for treatments for our patients that as of yet are not universally accepted or approved by insurance companies despite having FDA approval.”
ISASS Indications for Decompression with Interlaminar Stabilization
Indications for decompression with interlaminar stabilization include the following:
Dr. Guyer noted that the coverage rationale only pertains to patients with moderate lumbar spinal stenosis at 1 or 2 contiguous levels who do not present with gross instability because interlaminar stabilization has only been used and tested in this patient group.
“It has been found to be equally effective as fusion,” in this patient subgroup, Dr. Guyer said. “However, it is not recommended for more severe levels of instability such as grade II or greater.”
“In select patients within the LSS [lumbar spinal stenosis] continuum, decompression with interlaminar stabilization has proven to provide equivalent outcomes with a reduced cost compared to decompression plus fusion,” the ISASS stated.
Currently, the coflex® Interlaminar Stabilization® device (Paradigm Spine) is the only product that is FDA-approved for surgical treatment of up to a Grade I spondylolisthesis.
The document includes a list of documentation requirements and states that only experienced surgeons who have undergone training on use of the device should perform the procedure.
Dr. Guyer hopes that the position statement will help educate surgeons “of an alternative treatment for spinal stenosis with or without low grade instability. And, if they choose to recommend this for their patients, the insurance companies will approve this minimally invasive procedure compared to other surgical alternatives, including fusion.”
New CPT Codes
The following new CPT codes are effective as of January 1, 2017, according to the ISASS.
Choll W. Kim, MD PhD
Associate Clinical Professor
University of California San Diego
San Diego, CA
ISASS has taken a leadership role in helping the spine community better understand and implement a growing number of new technologies. The position statement by Guyer et al represents one such important contribution. It is clear and compelling, and provides a framework for surgeons to better employ new technologies for the treatment of our patients with spinal conditions.
More importantly, it provides much needed, up-to-date information for policy makers whose coverage policy decisions can have a significant impact on our ability to provide the optimum, individualized treatment for our patients. I hope that these types of efforts will continue such that new technologies can find their rightful place in our treatment armamentarium.