Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain

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

The insurer denied coverage for procedure to treat low back pain (procedure code 64628)

The denial is upheld

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 require their narcotics. For one level of disc disease each vertebral body requires precise targeting. The operation is not recognized by practicing neurosurgeons or spine surgeons. There are no National Organizations which provide guideline nor indication.

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. 

*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. As such, at this time the Intracept procedure is experimental/investigational and therefore not medically necessary.

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 contra indication is a treatable surgical lesion. The treating physician reports the Modic changes to several levels but does not report nor discuss the probable etiology of pain. (Disc, facet, stenosis, nerve compression). 
The likelihood of the basivertebral nerve being the pain generator is not credible. 

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.

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).

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 this procedure to treat low back pain (procedure code 64628) 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.