Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Intracept procedure
The insurer denied coverage for the Intracept procedure.
The denial is upheld.

This is a patient with a history of low back pain, solitary sacroiliitis, lumbar radiculopathy, degeneration of lumbar intervertebral disc, and hypertension. The patient had a physician follow up visit for low back pain. As per the physician's note, the physician reviewed the magnetic resonance imaging (MRI) and stated the patient would be a candidate for the Intracept procedure due to the Modic changes. The patient had an MRI. The impression stated at lumbar (L) 4-L5, there was unchanged mild bilateral subarticular zone narrowing and moderate bilateral foraminal stenosis, at L5-sacral (S)1, there is unchanged moderate right and severe left foraminal stenosis with possible compression of the exiting left L5 nerve root.

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.

Food and Drug Administration (FDA) approval had been granted for pre-market approval. The FDA does not provide statements regarding benefit.

This patient is not a good candidate for intraosseous ablation (heat destruction) of the basivertebral nerve (BVN) (Intracept procedure).

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. There is evidence of nerve compression to several levels. There is pathology to the sacroiliac (SI) joint. There are several medical conditions which could be causative for his back pain. He is morbidly obese with a Body Mass Index (BMI) over 45 which can cause back pain. His pain patterns are global, axial and radicular. The reported MRI changes were not described by the radiologist. 

The likelihood of the BVN causing the back pain is not credible based upon clinical presentation and history. 

Intraosseous ablation (heat destruction) of the BVN (nerve branches that supply the lower vertebrae) (Intracept procedure) is not the best available treatment for this patient at this time.

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 BVN". 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 who no longer require their narcotics. For one level of disc disease each vertebral body requires precise targeting. The operation is not recognized by practicing neurosurgeons or spine surgeons. There are no National Organizations which provide guidelines or indications. 

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

In summary, the denial of intraosseous ablation (heat destruction) of the BVN (nerve branches that supply the lower vertebrae) (Intracept procedure) 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.