Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain
Treatment: outpatient basivertebral nerve ablation procedure (The Intracept System) - Procedure code 64623
The insurer denied coverage for outpatient basivertebral nerve ablation procedure (The Intracept System) - Procedure code 64623
The denial is upheld

This is a patient with a history of low back pain. The patient had a physician follow up for low back pain. The clinical note stated the patient was still having significant pain that is affecting the patient's quality of life and activities. Currently, the pain is still mostly in the midline low back, flexion based, worse with activities in sitting or standing positions. Magnetic resonance imaging (MRI) study of the lumbar spine showed Modic changes affecting the posterior part of the lower lumbar (L) 3 subchondral area and the posterior part of the upper L4 subchondral area (L3-4 disc protrusion as well as annular fissure.)

The records show this patient has complex spinal pathology. His back pain goes back several years. There was documentation of a laser procedure. He had undergone a decompression and fusion to lumbar (L)4-L5. He reportedly did well but now has 3-4 years of ongoing back pain. It is important to note the pain generator is not clearly defined. He has at the very least adjacent segment disease. His imaging studies show disc disease to L3-4. The submitted images and report were reviewed. They were significant for a "black disc" to L3-4. There was facet arthrosis. There was a protrusion and reported nerve root compression. There was foraminal stenosis and simply stated progressive degenerative changes. The physician had discussed multiple treatment options including bone marrow aspirate, surgery for disc disease and the basivertebral nerve ablation. 

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. 

A relative contraindication is a treatable surgical lesion. The treating physician reports the Modic changes to several levels but does not report or discuss the probable etiology of pain. (Disc, facet, stenosis, nerve compression)

The operation is not recognized by practicing neurosurgeons or spine surgeons.

A search was performed using PubMed. The key word was Intracept Lumbar. There were several references. The articles submitted by appeal were also reviewed. There was a reported 65% success rate and further high quality studies were recommended.
 
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.

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 64623).

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. 

In summary, the denial of outpatient basivertebral nerve ablation procedure (The Intracept System) - Procedure code 64623 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.