Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain
Treatment: Intraosseous basivertebral nerve ablation (procedure code 64628)
The insurer denied coverage for intraosseous basivertebral nerve ablation (procedure code 64628)
The denial is upheld.

This is a patient with a history of chronic axial low back pain. The patient was evaluated for an Intracept consult. The patient reported 80 to 90% bilateral back pain and 10 to 20% bilateral leg pain radiating down the posterior aspects of the thighs and calves. The patient's pain is exacerbated with forward flexion/bending with and without lifting, prolonged sitting, and affects of daily living activities. The patient's Oswestry Disability Index score is 32. The patient has completed extensive treatments, such as interventional spine injections, pain relief medications, and adjunctive therapies with short-term relief but not significant or sustained relief. The patient showed a positive thigh thrust, Yeoman's, and sacroiliac (SI) joint compression upon assessment. The patient's diagnostic imaging revealed scattered mild facet arthropathy throughout the lumbar spine and Modic type II changes at the inferior endplate of L5 (lumbar) and superior endplate S1 (sacral). The Intracept procedure was presented to the patient as a treatment plan.

It is unclear if the scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes. There are several studies; however, no conclusions can be made. No definite statement nor guidelines showing definitive efficacy have been reported.

This patient is not a good candidate for intraosseous basivertebral nerve ablation (procedure code 64628). No defined pain generator is present. The records show chronic back pain with several sites of pathology. Injections and multiple conservative treatments have been completed for facet disease, disc disease, stenosis and herniations. He has received epidural steroids, facet injections and radiofrequency ablation (RFA). He has imaging studies showing nerve compression with a disc extrusion. The report of axial pain vs (versus) radicular pain is inconsistent. The likelihood of the basivertebral nerve causing the back pain is not credible. Utilization of a "new diagnostic parameter" as causative would not be applicable for this clinical scenario.

Intraosseous basivertebral nerve ablation (procedure code 64628) is not the best available treatment for this patient at this time.

The adverse risks are increased over standard treatment/services. The procedure is invasive. There have been reported complications of infection, broken hardware and retroperitoneal hematoma.

The requested service is not likely to be more beneficial than any of the standard treatment/procedures.

The Intracept procedure is "intraosseous ablation of the basivertebral nerve". It has been proposed to address low back pain identified by Modic changes. The procedure is performed within the vertebral body. It has been proposed that pain relief is manifested by patients no longer requiring their narcotics. For one level of disc disease each vertebral body requires precise targeting. The operation is not recognized by practicing neurosurgeons nor spine surgeons. There are no National Organizations which provide guidelines nor indications.

The procedure is not mainstay nor current accepted treatment by the practicing medical community.

In summary, the denial of intraosseous basivertebral nerve ablation (procedure code 64628) and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.