Appeal type: Experimental/Investigational
Decision: Upheld


Diagnosis: Low back pain.

Treatment: procedure to treat low back pain (procedure codes 64628 &amp; 64629).

The insurer denied coverage for procedure to treat low back pain (procedure codes 64628 &amp;64629).

The denial is upheld.

This is a patient with a history of Lupus, and low back pain. The patient's magnetic resonance imaging (MRI) of the lumbar spine impression states that the right paracentral disc herniation lumbar (L) 4-5 level causing right lateral recess stenosis and posterior displacement of the right L5 nerve root. There is underlying spondylosis change with complete bone edema. Modic type I endplate degenerative changes. Since the previous examination disc herniation is smaller and slightly more lateralized to the right. Central disc herniation L5- sacral (S)1 level indenting the ventral epidural fat. No stenosis. Stable.

It is unclear if scientific, peer reviewed literature is supportive of this procedure. 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.

The medical records do not confirm the pain generator. The facts are her clinical presentation and diagnosis for vertebrogenic pathology are not confirmed. The subjective complaints noted radicular symptoms with axial back pain. The physical examination noted pains to the left sacro iliac joint with muscle spasm. The imaging cannot be discounted as there were herniations to several levels with specific nerve root compression. She had received multiple epidural steroid injections(ESI) but no documentation for reason nor effect. (ESI are used to treat radicular pain). She has underlying medical conditions which have been known to cause back pain. (Lupus and  an ependymoma). Utilization of a "new diagnostic parameter"  (+Modic )  as causative would not be applicable for this clinical scenario. Her neurosurgeon reported her back pain could be improved but unlikely to help her leg pain. No specific etiology was determined with additional diagnostic studies and consultations recommended. 

The procedure is invasive. There have been reported complications of infection, broken hardware, endplate fracture 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. 

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 to treat low back pain (procedure codes 64628 &amp;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 risks are substantially increased over standard treatments.