Appeal type: Experimental/Investigational
Decision: Upheld



Diagnosis: Chronic low back pain.

Treatment: current procedural terminology (CPT) code 64628, intraosseous basivertebral nerve ablation.

The insurer denied coverage for current procedural terminology (CPT) code 64628, intraosseous basivertebral nerve ablation.

The denial is upheld.

This is an adult with a history of chronic lower back pain. The patient presented to the Pain Management physician's office for a follow up for lower back pain. The patient reported having some relief with a caudal epidural steroid injection, ambulation, and gabapentin. The physician recommended the Intracept procedure to treat lower back pain. 

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.

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.

It is important to define the pain generator and exclude other sites of pathology which could be causative. The records show degenerative disc disease (intervertebral disc and not the basivertebral nerve), facet pathology, nerve compression and stenosis. Any one of these or in combination could be responsible for symptoms. 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 likelihood of the basivertebral nerve being the pain generator is not credible. 

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 sties 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. 

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 scenrario. There were physical findings of + (positive) facet loading which has no correlation to vertebrogenic pain patterns. 

The procedure is invasive. There have been reported complications of infection, broken hardware and retroperitoneal hematoma.There also has been reported endplate fracture. 

The requested service is not likely to be more beneficial than any of the standard treatment/procedures. 

In summary, the denial of current procedural terminology (CPT) code 64628, intraosseous basivertebral nerve ablation 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.