Appeal type: Experimental/Investigational
Decision: Upheld

An enrollee has requested authorization and coverage for the Intracept procedure  destruction of intraosseous basivertebral nerve including fluouroscopy.According to the FDA Indications for Use, the Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change) (FDA Indications for Use). Researchers, in their prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain (140 patients), concluded that minimally invasive radiofrequency ablation of the basivertebral nerve (BVN) led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related low back pain. Researchers, in their prospective randomized double-blind sham-controlled multi-center study (147 patients), concluded that patients treated with radiofrequency ablation of the BVN for chronic low back pain exhibited sustained clinical benefits in the Oswestry Disability Index and VAS pain scores, and maintained high responder rates at 2 years following treatment. A clinical trial of the Intracept procedure was initiated on 8/24/17 with no study results posted yet. Subjects in the radiofrequency ablation arm will be followed for 24 months following treatment. Radiofrequency ablation arm subjects will be approached to participate in a sub study of 3 additional years of follow-up at their 24-month visit. Control arm subjects will be offered optional crossover treatment after the 12-month follow-up visit and will be followed for an additional 6 months following crossover (ClinicalTrials.gov Identifier: NCT03246061).This patient presents with a long-history of chronic low back pain. He underwent L4/5 discectomy with persistent pain. Recent subjective complaints have included grade 8/10 axial low back pain and pain radiating down the left leg. Clinical exam findings have documented pain with bending forward, and normal lower extremity strength. There is imaging evidence of Modic type I and II changes at the L4/5 level, loss of intervertebral disc height, central disc extrusion with very mild thecal sac flattening, moderate right and moderately severe left neuroforaminal narrowing. The patient has reportedly failed to achieve sustained improvement with conservative treatment, including medications and physical therapy. He underwent a right radiofrequency ablation at the L3-L5 levels with 50% reduction in right-sided symptoms reported. He underwent a left L3-L5 medial branch block recently (with reduction in pain to grade 3/10) and follow-up is not documented in the available medical records. Under consideration is a request for the Intracept procedure at L4/5. There is a lack of large volume, long-term peer-reviewed outcome studies to support the use of these procedures for this patient as discussed above. A current clinical trial is underway with no results posted. Therefore, the requested Intracept procedure  destruction of intraosseous basivertebral nerve including fluoroscopy is not likely to be more beneficial than any other available standard treatment for the patients medical condition.