Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

Diagnosis: Lower back pain.
Treatment: (procedure code 64628) to treat low back pain.

The insurer denied coverage for (procedure code 64628) to treat low back pain.  The denial is upheld.

This is a patient with a history of anxiety and low back pain. The patient had a physician visit for low back pain. The patient's imaging stated that the patient had an magnetic resonance imaging (MRI) that showed central disc herniation lumbar (L) 4-5 with diffuse disc bulging impression on the thecal sac as well as on the prevertebral soft tissues. Central disc herniation L5- sacral (S) 1 superimposed upon more diffuse disc bulging with impression on the thecal sac. Ventral disc herniation L3-L4 with impression on the prevertebral soft tissues and more diffuse disc bulging at this level.

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 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. There is evidence of Modic changes to multiple vertebrae.The report of axial pain vs (versus) radicular pain is inconsistent. The likelihood of the basivertebral nerve causing the back pain is not credible. 

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 treatments/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 guidelines nor indications.

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

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 (procedure code 64628) to treat low back pain 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.