Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Pain management services/Ablation, 1 Unit
The insurer denied coverage for pain management services/ablation, 1 unit.
The denial is upheld. 

This is a patient with a history of lower back pain, back spasm, lower extremity numbness. A magnetic resonance imaging (MRI) was performed, Modic type II endplate changes adjacent to the lumbar (L) 5 - sacral (S) 1 disc space (a disc herniation with end plate osteophytes at L5-S1) were noted. The patient had a physician visit for low back pain follow up. The patient had failed more than 6 months of conservative pain care. The physician recommended the Intracept procedure to treat lower back pain.

It is unclear if the scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. There are several studies; however, no conclusions can be made. No definite statement nor guidelines showing definitive efficacy have been reported. 

Intraosseous basivertebral nerve (BVN) ablation (procedure code 64628) does not have final approval from the appropriate regulatory bodies for this diagnosis. 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 BVN 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. The reported Modic levels are at two levels. The report of axial pain vs radicular pain is inconsistent. The likelihood of the BVN causing the back pain is not credible. 

The intraosseous BVN 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 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 performed within the vertebral body. It has been proposed that pain relief is manifested by patients no longer requiring their narcotics. For one level of disc disease each vertebral body requires precise targeting. The operation is not recognized by practicing neurosurgeons nor spine surgeons. There are no National Organizations which provide guidelines or indications. 

A search was performed using PubMed. The key word was Intracept Lumbar. There were references. The articles submitted by appeal were also reviewed. There was a reported 65% (percent) success rate and further high-quality studies were recommended. The procedure is not mainstay nor current accepted treatment by the practicing medical community. 

The procedure is essentially a thermal ablation 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 for the pain management services/ablation, 1 unit 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.