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Interspinous process spacers have been developed and proposed as alternatives to conservative management or open lumbar spinal decompression surgery. These devices are intended to relieve symptoms of neurogenic intermittent claudication secondary to lumbar spinal stenosis by limiting extension of the spine in the affected area when the patient stands or walks.
Interspinous process spacers may be categorized as static or dynamic. Static devices are implanted between the vertebral spinous processes. After implantation, the device is opened or expanded to distract (open) the neural foramen and decompress the nerves. Dynamic spacers, or interlaminar devices, are implanted midline between adjacent lamina and spinous processes to provide dynamic stabilization following decompressive surgery.
The X-STOP® Interspinous Process Decompression (IPD®) System was approved by the U.S. Food and Drug Administration (FDA) for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. This device is no longer marketed.
The Superion® Interspinous Spacer (ISS; Veriflex) has been approved by the FDA and is indicated to treat skeletally mature patients suffering from neurogenic intermittent claudication secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without grade 1 spondylolisthesis, confirmed by x-ray, magnetic resonance imaging and/or computed tomography, evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing and who have undergone at least 6 months of non-operative treatment. The Superion® ISS may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated at no more than two levels, from the L1 to L5 vertebrae.
The coflex® Interlaminar Technology implant (Paradigm Spine) has been approved for use in 1- or 2-level lumbar stenosis from the L1 to L5 vertebrae in skeletally mature patients 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, and who have undergone at least six months of non-operative treatment.
For applicable clinical criteria, see the following eviCore clinical guideline(s):
No additional statements.
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies.
Medicaid products and some self-insured plans may have additional policies and prior authorization requirements. As applicable, review the provisions relating to a specific coverage determination, including exclusions and limitations. Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
For Medicare NCD and/or Medicare LCD, please consult CMS or National Government Services websites.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and /or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only, and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.