Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbar back pain. 
Treatment: Intraosseous basivertebral nerve ablation (procedure code 64628). 

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

The denial is upheld. 

This is an adult with a history of lumbar spondylosis and lumbar radiculopathy. The patient presented to the Pain Management physician's office for a follow up for lower back pain. Imaging revealed Modic changes at the lumbar (L) 4 and L5 levels. The patient has tried and failed over 6 months of physical therapy (PT), injection therapy, and pain medications. The physician requested coverage for the Intracept procedure. 

He had undergone microdiscectomy which reportedly resolved his radicular pain. He still reported axial back pain. The magnetic resonance imaging (MRI) showed herniations at two levels, degenerative discs, foraminal stenosis and nerve root compression. 

It is unclear whether intraosseous basivertebral nerve ablation (procedure code 64628) is considered more beneficial for this patient's diagnosis. 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  but 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 sites of pathology. Surgery 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 report of axial pain vs radicular pain is inconsistent. The likelihood of the basivertebral nerve causing the back pain is not credible. 

Intraosseous basivertebral nerve ablation (procedure code 64628) is not the best available treatment for this patient at this time. 

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

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

There were small numbers of people evaluated for a short duration. The procedure is not the 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  intraosseous basivertebral nerve ablation (procedure code 64628) and coverage for the requested procedure 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.