Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbar back pain. 
Treatment: Intraosseous basivertebral nerve ablation (procedure code 64628). 

The insurer denied coverage for intraosseous basivertebral nerve ablation (procedure code 64628). 

The denial is upheld. 

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). 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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. 

Basivertebral nerve ablation using the Intracept procedure is Food and Drug Administration (FDA) approved in a very select group of patients who have - A history of chronic low back pain (CLBP) of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - magnetic resonance imaging (MRI) demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from lumbar (L) 3 to sacral (S)1; and - Activities of daily living that are limited by persistent low back pain; and - All other reasonable sources of pain have been ruled out. 

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 the patient having a history of recent lumbar discectomy surgery at L4-5. Previous lumbar spine surgery (discectomy/laminectomy only allowed if greater than (>) 6 months) was consider an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al. 

Therefore, based on this evidence, this patient is not a good candidate for intraosseous basivertebral nerve ablation procedure with the Intracept device. 

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 Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency. Despite limited Food and Drug Administration (FDA) approval, there is no current Centers for Medicare & Medicaid Services (CMS) approval for the use of the Intracept procedure, with a proposed local coverage determination (LCD) a work in progress. Furthermore, with a history of recent lumbar discectomy surgery at L4-5, this patient would have been excluded from the INTRACEPT trial and therefore the Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. 

In summary, the denial of  intraosseous basivertebral nerve ablation (procedure code 64628) and coverage for the requested procedure should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.