Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower back pain
Treatment: Intracept procedure codes 64628 and 64629
The insurer denied coverage for Intracept procedure codes 64628 and 64629
The denial is upheld

This is a patient with a history of low back pain. A magnetic resonance imaging (MRI) was performed that showed degeneration of the lumbar (L) 4-L5 intervertebral disc with diffuse annular bulging. Stable prominent degeneration of the L5- sacral (S) 1 disc with diffuse annular bulging and moderate to severe bilateral foraminal stenoses. The patient had failed conservative pain care. The patient had a physician visit for chronic vertebrogenic low back pain, imaging stated Modic end plates changes at L4, L5 and S1. The physician recommended the basal vertebral nerve (BVN) ablation to treat lower back pain.

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.

No defined pain generator is present. The records show this person has chronic back pain. There are several sites of pathology. Surgery, injections, and multiple conservative treatments have been completed without benefit. There is presence of facet disease, disc disease, stenosis and herniation.  There is evidence of neural foraminal stenosis and previous lumbar surgery to L4 - L5. There are multilevel degenerative changes. The report of axial pain versus radicular pain is inconsistent. The likelihood of the basivertebral nerve causing the back pain is not credible, i.e. radicular pain pattern and several sites of other pathology. 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 neurosurgeon nor spine surgeon. There are no National Organizations which provide guideline nor indication. 

There were small numbers of people evaluated for a short duration. The procedure is not mainstay nor current accepted treatment by the practicing medical community. 

*The procedure is essentially a thermoablation performed within the vertebral body. 
There are several level 1 studies showing the benefit of this procedure up to 2 years after treatment compared to controls. However, all of these studies were either funded by the manufacturer and/or authored by consultants from the manufacturer. No high-quality study exists that does not have a significant conflict of interest with the manufacturer.

In summary, the denial of procedure codes 64628 and 64629 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 risk are substantially increased over standard treatments.