Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain

Treatment: intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629)

The insurer denied coverage for intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629)

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(RF) ablation for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

Basivertebral nerve (BVN) ablation using the Intracept procedure is Food and Drug Administration (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 an MRI (magnetic resonance imaging) demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from lumbar (L)3 to sacral (S)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. There are other evidence-based treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. The basivertebral nerve ablation procedure with the Intracept device is not the best available treatment for this patient based on the patient having Modic changes at levels other than L3-S1. Modic changes were seen at thoracic (T)11-T12 on the magnetic resonance imaging (MRI). Modic changes at levels other than L3-S1 were considered an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al. Full exclusion criteria in the INTRACEPT study were: MRI evidence of Modic at levels other than L3-S1; Radicular pain (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression in imaging); Previous lumbar spine surgery (discectomy/laminectomy allowed if > 6 months prior to baseline and radicular pain resolved); Symptomatic spinal stenosis (defined as the presence of neurogenic claudication confirmed by imaging); Metabolic bone disease, spine fragility fracture history, or trauma/compression fracture, or spinal cancer; Spine infection, active systemic infection, bleeding diathesis; Radiographic evidence of other pain etiology; Disc extrusion or protrusion > 5 mm (millimeters); Spondylolisthesis > 2 mm at any level; Spondylolysis at any level; Facet arthrosis/effusion correlated with facet-mediated lower back pain (LBP); Beck Depression Inventory (BDI) > 24; 3 or > Waddell's signs; Compensated injury or litigation; Addiction behavior; or BMI (body mass index) > 40.

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.

The denial of  intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629) and coverage for the requested service 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.