Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain

Treatment: Intraosseous basivertebral nerve ablation

The insurer denied coverage for intraosseous basivertebral nerve ablation

The denial is upheld 

Reviewer #1:

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.

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 magnetic resonance imaging (MRI) evidence of Modic changes at levels other than L (lumbar) 3-S (sacral) 1. An MRI states that there is evidence of Modic-type I endplate changes at L2-L3. MRI evidence of Modic at levels other than L3-S1 was 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; Spondylolisthesis > 2 mm at any level; Spondylolysis at any level; Facet arthrosis/effusion correlated with facet-mediated (low back pain) LBP; Beck Depression Inventory (BDI) > 24; 3 or > Waddell's signs; Compensated injury or litigation; Addiction behavior; or body mass index (BMI) > 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.

In summary, the supporting 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 for low back pain. Despite FDA approval, CMS guidelines limit the use of basivertebral nerve ablation to a very select group of patients who do not have evidence of other pain etiology such as disc herniation. Furthermore, there is no evidence of Modic changes at any level in the MRI report for this patient. 

In summary, the denial of 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first two vertebral bodies, lumbar or sacral (Intracept), 64629 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, each additional vertebral body, lumbar or sacral (list separately in addition to code for primary procedure (Intracept) 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.