Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.

Treatment: intraosseous basivertebral nerve ablation, code 64628.

The insurer denied coverage for intraosseous basivertebral nerve ablation, code 64628.

The denial is upheld.

This is an adult with a history of posterior tibial tendon dysfunction and lower back pain. The patient presented to the Pain Management physician's office for a follow up visit for lower back pain. The patient underwent medial branch blocks without improvement in pain. The physician recommended the Intracept procedure to treat lower back pain. 

There are several studies; however, no conclusions can be made. No definite statement nor guidelines showing definitive efficacy have been reported. Current Specialty Guidelines do not recommend this new procedure.

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 for over 10 years. There were several sites  of pathology. Injections and multiple conservative treatments have been completed. This person has been treated for facet disease, disc disease, stenosis, disc protrusion, sacroiliac dysfunction and hip labral disease. The records show axial and radicular pain patterns to extremities and sacrum. Physical findings were consistently reported to the posterior superior sacroiliac area. These sites of pain are not likely secondary vertebrogenic etiology. 

The likelihood of the basivertebral nerve causing the back pain is not credible. Utilization of a "new diagnostic parameter" (Modic changes) as causative would not be applicable for this clinical scenario.  (Multiple sites of pathology )

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

The adverse risks are increased over standard treatment/services. 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. 

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 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, labral tear, sacroiliac joint derangement 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  but does not report nor  discuss the probable etiology of pain. (Disc, facet, stenosis, SI joint, hip labrum). 

The likelihood of the basivertebral nerve being the pain generator is not credible. 

In summary, the denial of intraosseous basivertebral nerve ablation, code 64628 and coverage for the requested service/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.