Lumbar (non-fusion) stabilization with FDA approved interlaminar or interspinous stabilization devices for treatment of spinal stenosis, following direct surgical decompression, may be considered medically necessary for one- or two-level use, when ALL of the following criteria are met:
- Lumbar stenosis from L1-L5 in skeletally mature individuals with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, who have significant risk for spinal instability with decompression alone; and
- Diagnosis of lumbar spinal stenosis with up to Grade I spondylolisthesis, confirmed by imaging and clinical exam; and
- Stenosis-related disability impacting activities of daily living, with or without mild-to-moderate back pain; and
- Completion and failure of at least 6 months of conservative treatment, such as (not an all-inclusive list):
- Anti-inflammatory medication; or
- Physical Therapy
The FDA approved interlaminar or interspinous stabilization devices is not to be used accompanying a fusion at the treatment level.
Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers) not meeting the criteria as indicated in this policy is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.