Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging, first 2 vertebral bodies, lumbar or sacral

The insurer denied coverage for Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging, first 2 vertebral bodies, lumbar or sacral

The denial is upheld 

In assessing whether intraosseous basivertebral nerve ablation using the Intracept device is considered more beneficial for this patient than standard treatments or procedures, it is important to know that the publications in peer-reviewed literature 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 for low back pain. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

Basivertebral nerve (BVN) ablation using the Intracept procedure is FDA approved in a very select group of patients who have - A history of chronic low back pain (cLBP) of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - Magnetic Resonance Imaging (MRI) demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L (lumbar) 3 to S (sacral) 1; and - Activities of daily living that are limited by persistent low back pain; AND - All other reasonable sources of pain have been ruled out.

This patient is not a good candidate for intraosseous basivertebral nerve ablation. The basivertebral nerve ablation procedure with the Intracept device is not the best available treatment for this patient based on clinical evidence of other pain etiology, such as radicular pain. In clinic notes, the patient describes their pain as shocking sensation that feels like they are "being electrocuted" down the lower back into the lower extremities; that the patient describes pain that follows the L5/S1 dermatome pathway; physical exam reveals positive straight leg raising, slump, and quadrant testing; and that the patient has not trialed physical therapy (PT). In addition to minimal Modic type I endplate changes at L5-S1, the MRI also shows evidence of a 3 mm left subarticular disc extrusion at L5-S1 that contacts the descending left S1 nerve root, and a disc bulge at L4-5 that contacts the exiting bilateral L4 nerve roots. Evidence of other pain etiology such as radicular pain (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression in imaging) was considered an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al. 

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 risk of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

In summary, the denial of Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging, first 2 vertebral bodies, lumbar or sacral and coverage for the requested service/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 risk are substantially increased over standard treatments.