Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: 64628 Thermal destruction of intraosseous basivertebral nerve, including imaging guidance; first 2 vertebral bodies, lumbar or sacral. 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

The insurer denied coverage for 64628 Thermal destruction of intraosseous basivertebral nerve, including imaging guidance; first 2 vertebral bodies, lumbar or sacral. 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral.

The denial is upheld. 

Reviewer #2:

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. 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 lumbar spondylolysis. MRI report makes no mention of bone marrow changes, vertebral endplate changes, or Modic changes at any level. The MRI report does state that there is chronic bilateral L (lumbar) 5 spondylolysis and 5 millimeters (mm) anterolisthesis of L5-S (sacral) 1. Spondylolysis at any level from L3 to S1 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 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 lumbar spondylolysis. There is also insufficient evidence in the MRI report of Modic changes. 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 imaging guidance; first 2 vertebral bodies, lumbar or sacral. 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral and coverage for the treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition.