Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.

Treatment: Nerve ablation (procedure code 64628).

The insurer denied coverage for nerve ablation (procedure code 64628).

The denial is upheld.

This is an adult with a history of lower back pain. The patient presented to the Pain Management physician's office for a follow up for back pain. The patient has tried and failed physical therapy (PT), heat, ice, pain medications, and transcutaneous electrical nerve stimulation (TENS). He had undergone epidural steroid injection (ESI). He has also undergone laminectomy. He had an magnetic resonance imaging (MRI) performed over 1 year ago showing Modic and disc space changes to lumbar (L) 3- sacral (S) 1. 

A recent MRI revealed multiple level degenerative changes, facet arthroses, status post laminectomy L5-S1 with granulation tissue impinging Right S1 nerve roots, narrowing and impingement to L4 nerve roots. Modic changes L3-4 decreased from prior. 
The physician recommended the Intracept procedure to treat lower back pain.
 
The literature is inconclusive. The procedure has not been recognized by the practicing orthopedic spine or neurosurgical community. There are no treatment guidelines nor recommendations made. 
 
Food and Drug Administration (FDA) approval had been granted. There are no recommendations provided for use or efficacy. 

No pain generator has been defined. The clinical presentation shows a generalized pain pattern. It varies between axial and radicular. There are several areas of pathology which more than likely could be causative for pain. The recent MRI notes facet disease, discogenic disease, stenosis and nerve root compression to at least 2 levels. The reported Modic changes had improved from the prior study. The reported vertebrogenic pathology has been reported to be present L3-S1. at multiple levels. It is not clear which level could even be the pain generator. 
 
The nerve ablation (procedure code 64628) is not the best available treatment for this patient at this time.  It is invasive. There have been reports of infection and instrumental breakage. 

The Intracept procedure is NOT likely to be more beneficial than any of the standard treatments for this patient.

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 were small numbers of people evaluated for a short duration. 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 nerve ablation (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 risk are substantially increased over standard treatments.