Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for an Intracept procedure (destruction of intraosseous basivertebral nerve including fluoroscopy). The U.S. Food and Drug Administration (FDA) notes that 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). Researchers report, There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the basivertebral nerve ablation. Non-industry funded high-quality, large prospective studies are needed to confirm these findings. Researchers report, Percutaneous computed tomography (CT) guided intra-osseous the basivertebral nerve ablation seems to be a safe, fast, and powerful technique for pain relief in patients with vertebrogenic chronic low back pain when the selection of patients is based on a multidisciplinary approach including both conventional Diagnostic Radiology and Nuclear Medicine imaging. In this case, visit notes reported diagnoses of lumbar spondylosis, lumbar intervertebral disc degeneration, and lower back pain. The patient presented with low back pain, sacroiliac joint pain, pain in the right hip, and inflammation of the left sacroiliac joint. An examination of the lumbar spine revealed tenderness at the midline axial area at the lower lumbar level, the bilateral paramidline axial area, the lower lumbar level and lumbosacral junction, the bilateral sacral sulcus, and the paraspinal region at the lower lumbar level bilaterally. There was pain with lumbar range of motion. Deep tendon reflexes were diminished at 1 in the bilateral ankle and knee, and sustained hip flexion of concentric/eccentric loading of the lumbar spine was positive for axial pain. In this case, there is plausible pain generation associated with sacroiliac pain radiation, diminished reflexes, and discal/thecal sac compression. In this clinical setting, there is a lack of support in current medical literature on the safety and efficacy of the requested service for the noted pathology. In this clinical setting, the guidelines for use of the Intracept procedure are not met, and the requested procedure has not been proven to be as effective as current treatments. Therefore, the Intracept procedure (destruction of intraosseous basivertebral nerve including fluoroscopy) is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested Intracept procedure (destruction of intraosseous basivertebral nerve including fluoroscopy) is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the service is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in orthopedic surgery and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.