Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain.

Treatment: 22899, unlisted procedure, spine (Intracept); C9752, destruction of intraosseous basivertebral nerve [BVN], first two vertebral bodies, including imaging guidance (e.g.) fluoroscopy, lumbar/sacral.

The insurer denied coverage for 22899, unlisted procedure, spine (Intracept); C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g.) fluoroscopy, lumbar/sacral.

The denial is upheld.

The patient has a history of asthma and a one-year history of lower back pain. Lumbar magnetic resonance imaging (MRI) revealed Modic type 2 end plate changes at lumbar (L)3 and L4, degenerative spondylolisthesis, moderate bilateral facet osteoarthritis, buckling of ligamentum flavum, mild central stenosis at L4-L5 and L5-sacral (S)1, degenerative spondylolisthesis grade 1, central left sided disc herniation with advanced bilateral facet osteoarthrosis, and no stenosis or nerve root compression. The request is for authorization for Intracept procedure.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. The available studies are limited by small sample size, lack of randomization and control, and short-term follow-up. Therefore, the scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.

An industry-sponsored study by Becker et al. (2017) assessed the efficacy of intraosseous BVN (basivertebral nerve) ablation, with the Intracept system, in 17 patients with chronic low back pain. Sixteen patients were treated successfully. Self-reported outcome measures were collected prospectively at each follow-up interval. There was a significant decrease in the average ODI [Oswestry disability index] at 3 months postoperatively, which was maintained at 12 months. Significant improvement in the VAS [visual analog scale] scores and quality of life were also reported at the 3-month follow-up.      

Medicare does not have a national coverage determination (NCD) specifically for the use of the Intracept procedure in the treatment of chronic low back pain. Local coverage determination (LCD) do not exist at this time.     

This patient is not a good candidate for 22899, unlisted procedure, spine (Intracept); C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g.) fluoroscopy, lumbar/sacral as Intracept remains an experimental/investigational procedure without established efficacy.     

Intracept is not the best available treatment for this patient at this time. The adverse risks are not increase over standard treatments. There is insufficient evidence to inform definitive conclusions about the clinical safety and efficacy of the Intracept procedure. The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.
                                            
The carrier's denial of 22899, unlisted procedure, spine (Intracept); C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g.) fluoroscopy, lumbar/sacral should be upheld.  It is not more beneficial than any other standard treatments.