Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

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

For individuals who have vertebrogenic low back pain who receive ablation of basivertebral nerves, the evidence includes two randomized controlled trials (RCTs) (SMART and INTRACEPT trials, both sponsored by device manufacturer Relievant Medsystems, Inc.). Relevant outcomes were symptoms, functional outcomes, quality of life and treatment-related morbidity. In one RCT, at 12 months, 73% (percent) of patients crossed over to the active treatment group and therefore long-term comparative data is not available. Limitations to the other RCT include lack of a sham control and short duration of follow-up. Furthermore, a systematic review (Conger et al.) concluded that further high-quality, large prospective studies, that are not industry funded, are needed to confirm these findings.

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 (Centers for Medicare and Medicaid Services) 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 radiculopathy. Furthermore, there is no evidence of Modic changes at any level in the MRI (magnetic resonance imaging) 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 2 vertebral bodies, lumbar or sacral and 64629; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral and coverage for the requested 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 risks are substantially increased over standard treatments.