Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain. 
Treatment: Intraosseous basivertebral nerve ablation. 
The health plan denied Intraosseous basivertebral nerve ablation. 
The determination is upheld. 

The patient is a male with a history of low back pain for more than 10 years. His treatments have included chiropractic care, facet injections and ablations, home exercise, lumbar epidural steroid injections, massage therapy, physical therapy, spinal cord stimulation, meloxicam, and prednisone. His pain ranged from 6-10/10. He has difficulty with sleep, work, household chores, and leisure activities. 
He had a televisit, and his magnetic resonance imaging (MRI) was reviewed for no indication for structural surgery at this time. He had a successful spinal cord stimulator trial and wanted to proceed with permanent implantation. His diagnosis was lumbar back pain with radiculopathy affecting the lower extremity. He was seen by Neurosurgery for follow-up with back pain predominantly with a lesser radicular component. His MRI appeared to show Lumbar 5-Sacral 1 (L5-S1) Modic changes, but it was not read by Radiology. The plan was for a new MRI (magnetic resonance imaging). A new lumbar MRI was performed for lower back pain radiating into the bilateral legs, numbness, and difficulty walking for two years. At L5-S1 there were ventral marginal osteophytes, minimal disc narrowing, diffuse disc bulge that impinged upon the thecal sac and the L5 nerve roots within the neural foramina bilaterally, 3 millimeters (mm) of retrolisthesis of L5 on S1, and minimal bilateral facet hypertrophy. It also showed minimal scoliosis of the lumbar spine with convex to the right. Bone marrow signal was within normal limits. He was recommended for intraosseous basivertebral nerve ablation. 
At issue is whether the proposed health treatment is likely to be more beneficial than any standard treatment for the patient's condition. 
The health plan's determination regarding the proposed treatment is upheld in whole.
The treatment is not likely to be more beneficial than any standard treatment for the patient's condition. He has low back pain as well as radicular pain, and the most recent MRI showed nerve compression at L (lumbar) 5 bilaterally, spondylolisthesis 3-mm, and no mention of any Modic changes. Radicular pain and spondylolisthesis greater than 2-mm were specifically excluded in the studies for the Intracept procedure. Therefore, the treatment would be considered experimental/investigational. 
The INTRACEPT Trial was a prospective, randomized multicenter study at 20 United States sites. This randomized controlled trial (RCT) compared the effectiveness of intraosseous radio frequency (RF) ablation of the basivertebral nerve (BVN) to standard of care for the treatment of chronic lower back pain (cLBP) in a specific subgroup of patients suspected to have vertebrogenic symptoms. The trial involved 140 patients with cLBP of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between Lumbar 3 (L3) and S1, and who had not responded to at least 6 months of non-operative management.[2] 
Participants in all reviewed studies were adults with chronic lower back pain (LBP) for at least 6 months with Modic type 1 changes (MC1) and Modic type 2 changes (MC2) within at least one of the L (lumbar) 3-S (sacral) 1 vertebral bodies. In addition to MC1 and MC2 on MRI (magnetic resonance imaging), participants in the cohort study by De Vivo et al. underwent Single-photon emission computed tomography (SPECT)/computed tomography (CT) and CT-guided medial branch blocks to exclude lumbar facet joint pain[1]. Some studies specifically excluded individuals with disc protrusions >5mm, spondylolisthesis >2 mm (millimeter), and significant depression (Beck Depression Inventory >24). All studies excluded individuals with clinical evidence of symptomatic spinal stenosis or radicular pain.[3]