Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain

Treatment: 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)

The insurer denied coverage for 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)

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 insufficient evidence of Modic changes. The magnetic resonance imaging (MRI) report makes no mention of bone marrow changes, no mention of vertebral endplate changes, and no mention of Modic changes. The MRI report does mention disc herniation at L (lumbar) 2-L3 and postoperative changes at L3-L4 and L4-L5 levels. 

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, Centers for Medicare and Medicaid Services (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. The Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. The denial is upheld.

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.