Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.

Treatment: a procedure to treat low back pain (intraosseous basivertebral nerve ablation).

The insurer denied coverage for a procedure to treat low back pain (intraosseous basivertebral nerve ablation).

 The denial is upheld.

This is a patient with a history of low back pain. The patient had a physician office follow up visit for back pain. The pain was currently at 7/10 and the patient had no pain relief with stretches, 6 weeks of physical therapy (PT) and 6 months of Flexeril and ibuprofen use. The patient's magnetic resonance imaging (MRI) showed Modic changes were present at lumbar (L) L2/L3, L3/L4, L4/L5, L5 / sacral (S) 1. 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 outcomes. There are several studies; however, no conclusions can be made. No definite statement or guidelines showing definitive efficacy have been reported. Intraosseous basivertebral nerve ablation (BVN) (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 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. The report of axial pain vs radicular pain is inconsistent. The likelihood of the basivertebral nerve causing the back pain is not credible. Each level of the spine reportedly has the radiographic abnormality (Modic changes).

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 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 who no longer require their narcotics. For one level of disc disease each vertebral body requires precise targeting. The operation is not recognized by practicing neurosurgeons or spine surgeons. There are no National Organizations which provide guidelines or indications. 

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 for a procedure to treat low back pain (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.