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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the Intracept procedure. Findings:  The physician reviewer found that 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 magnetic resonance imaging (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). Conger and colleagues 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. De Vivo and colleagues 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. Fischgrund and colleagues report, Patients treated with radiofrequency ablation of the basivertebral nerve for chronic low back pain exhibited significantly greater improvement in Oswestry Disability Index (ODI) at three months and a higher responder rate than sham treated controls. Basivertebral nerve ablation represents a potential minimally invasive treatment for the relief of chronic low back pain. In this case, MRI of the lumbar spine reported multilevel mild-to-moderate severity degenerative disc disease, worse at L4-L5 and L5-S1. In visit notes, the provider reported that the MRI showed Modic end plate changes present at L4-L5 and L5-S1, however, this was not documented in the submitted MRI study. The patient reported low back pain for over ten years described as tense, tight, and worsening overall, that radiated bilaterally to the legs on occasion. He had episodes of pain that he rated as eight out of ten and rated his pain as two out ten otherwise. On examination, the patient had an antalgic gait, and his strength, sensation, and reflexes were noted as intact in the bilateral upper and lower extremities. Straight leg raises were negative bilaterally. In this clinical setting, there is a lack of published, large-scale, long-term, scientific, high-quality, and peer-reviewed literature showing the requested service to be an effective and/or safe treatment for the noted pathology. Therefore, an Intracept procedure (CPT 22899) with HCPCS (CPT C9752) 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 service 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 requested 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.