Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Pain management services/ablation, 2 units
The insurer denied coverage for pain management services/ablation, 2 units.
The denial is upheld.

This is a patient with a history of hernia, low back and knee pain. The patient had a pain management consult for lower back pain and knee pain. The note stated that the current pain intensity is 10/10. The pain decreases with rest and increases with walking and bending. The patient previously saw a doctor who performed multiple interventional therapies with temporary relief. The patient has also trialed physical therapy with no relief, hot/cold packs, and multiple medications with minimal relief. A magnetic resonance imaging (MRI) showed Modic II degenerative endplate signal alterations were visualized at lumbar (L) 3-L4 and L4-L5.

The operation is not recognized by practicing neurosurgeons or spine surgeons. 

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.

A review of literature finds several studies; however, no conclusions can be made regarding the benefit of this procedure. 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 pain management services/ablation, 2 units.

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 disc protrusions. There were trigger point injections, which are used for myofascial disease. There is evidence of foraminal stenosis. Note, the physical examination was normal with the exception of facet disease. The records do not show limitation. The records show the patient is currently employed full time and takes Percocet. Several treatments were provided for facet pathology. It would be important to evaluate the previous response and confirm whether the facet was the pain producing site. There are reports of axial pain vs radicular pain. The likelihood of the basivertebral nerve causing the back pain is not credible. (i.e. [that is] several other sites of pathology which more than likely would be causative). Utilization of a "new diagnostic parameter" (plus modic) as causative would not be applicable for this clinical scenario. It is important to note he has end stage osteoarthritis to his knee which will cause a gait abnormality. This can also cause back pain. 

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 pain management services/ablation, 2 units 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.