Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower back pain
Treatment: Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (64628)
The insurer denied coverage for thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (64628)
The denial is upheld

According to the documentation submitted, this is a patient with a history of lower back pain. The patient had an epidural steroid injection, and there was not much relief. The magnetic resonance imaging (MRI) of the lumbar (L) spine showed degenerative disc disease throughout the lumbar spine and Modic change at L4-5 and L5- sacral (S) 1. The physician recommended the Intracept procedure to treat the patient's lower back pain.

The publications to date have been mostly company-sponsored, have had methodologic flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation (RFA) for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve (BVN) using radiofrequency (RF). 

For individuals who have vertebrogenic low back pain who receive ablation of basivertebral nerves, the evidence includes two randomized controlled trials (RCTs) (SMART and INTRACEPT trials). Relevant outcomes were symptoms, functional outcomes, quality of life and treatment-related morbidity. In one RCT, at 12 months, 73%(percent) of patients crossed over to the active treatment group and therefore long-term comparative data is not available. Limitations to the other RCT include lack of a sham control and short duration of follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Basivertebral nerve ablation using the Intracept procedure is Food and Drug Administration (FDA) approved in a very select group of patients who have - A history of low back pain of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - MRI demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to S1; and - Activities of daily living that are limited by persistent low back pain; and - All other reasonable sources of pain have been ruled out.

Despite a history of chronic low back pain of more than six months, failed response to more than 6 months of non-surgical treatment, and activities of daily living (ADLs) that are limited by pain, the MRI report provided does not state any evidence of Modic changes at any level. In fact, the MRI report clearly states that the vertebral bodies are normal in height without evidence of fracture or destructive osseous lesions or stress reaction.

Therefore, based on the lack of radiographic evidence of any Modic changes, this patient is not a good candidate for intraosseous basivertebral nerve ablation procedure with the Intracept device and the procedure is unlikely to be more beneficial than standard treatments/procedures for this patient.

There are other evidence-based medications and treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches.  

Any invasive procedure has risks of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

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.

The carrier's denial of thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (64628) should be upheld.