Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.

Treatment: intraosseous basivertebral nerve ablation.

The insurer denied coverage for intraosseous basivertebral nerve ablation.

The denial is upheld.

This is a patient with a history of hypertension, obesity and back pain. The patient had physician visit follow up due to back pain. The note stated that the patient presented with axial low back pain with no radicular pain of more than 18 months of duration that has been refractory to conservative approaches including but not limited to physical therapy, home exercises, opiate analgesics, spinal injections among others with very mild response and continued chronic pain that has been attempted for at least 12 months. And Modic changes were noted on the magnetic resonance imaging (MRI). The patient's activities of daily living are limited by persistent low back pain. The physician recommended lntracept procedure at lumbar (L) 3-4-5- sacral (S) 1 for therapeutic purposes.

The scientific evidence in peer reviewed literature is unclear in supporting improved health outcomes. There are several studies however no conclusions can be made. No definite statement nor guidelines showing definitive efficacy have been reported. 

The 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 sites 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. There is evidence of instability. There is deformity causing severe disc disease. It is important to note physical findings were positive for facet loading. Facet loading indicate facet disease where the treatments are medial branch block (MBB) and radiofrequency ablation (RFA). The physician reports he will continue MBB, epidural steroid injections (ESI) and RFA. It is unclear how treatment to the basivertebral nerve will relieve her pain (i.e. different location of pathology). 

The report of axial pain vs radicular pain is inconsistent. 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. 

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, endplate fracture and retroperitoneal hematoma.

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

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 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. 

In summary, the denial of procedure (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.