Appeal type: Experimental/Investigational
Decision: Upheld



Diagnosis: Low back pain

Treatment: Intracept procedure

The insurer denied coverage for Intracept procedure

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% 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.

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 clinical evidence of other pain etiology, such as radicular pain. Clinic notes state a diagnosis of lumbar radiculopathy with chronic low back pain that radiates to the left leg. Her pain responded well to lumbar (L)1-L3 medial branch nerve blocks. MRI shows evidence of disc bulge at L4-L5 with left neural foraminal narrowing. Evidence of other pain etiology such as radicular pain 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.

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. The Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. 

In summary, the denial of 64628 Thermal destruction of intraosseous basivertebral nerve, including all 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 requested service/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.