Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.

Treatment: Nerve ablation (procedure code 64628).

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

The denial is upheld.

The 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. 

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% 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 (BVN) 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.

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 lumbar radiculopathy with pain radiating into the left buttock and down the left leg. Recent MRI showed evidence of diffuse disc bulging, facet arthropathy resulting in mild central canal stenosis and moderate foraminal narrowing, impinging the exiting L4 nerve roots. Diffuse disc bulging was also noted at L5-S1. Modic changes were only noted at a single level on this most recent MRI, at L3-4, and described as decreased from prior. Radicular pain with nerve compression seen on imaging was considered 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.

Despite limited 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 radicular pain with nerve compression seen on imaging, 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.

The denial of nerve ablation (procedure code 64628) 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 risk are substantially increased over standard treatments.