Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain (CLBP)
Treatment: procedure code 64628 (Intracept procedure; intraosseous basivertebral nerve ablation)
The insurer denied coverage for procedure code 64628 (Intracept procedure; intraosseous basivertebral nerve ablation)
The denial is upheld

This is the case of a patient with a history of lower back pain for greater than 6 months, lumbar spondylosis, and lumbar radiculopathy. The patient is noted to have tried physical therapy, chiropractic, and medications. Pain is noted to radiate. Magnetic resonance imaging (MRI) of the lumbar (L) spine showed a disc bulge and bilateral neural foraminal narrowing and bilateral facet joint arthrosis at L4-L5, and a disc bulge, bilateral neural foraminal narrowing and bilateral facet arthrosis at L5- sacral (S)1; the clinical impression was multilevel degenerative disc disease with neural foraminal narrowing. 

The scientific evidence in peer-reviewed literature is insufficient to determine if the technology supports a result of in an improvement in health outcomes.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 (RFA) for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve (BVN) 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 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. 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 low back pain of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - MRI demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to S1; and - Activities of daily living that are limited by persistent low back pain; and - All other reasonable sources of pain have been ruled out.

There are other evidence-based treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. 

The above-recommended requirements have not been met for basivertebral nerve ablation procedure with Intracept. Despite a history of chronic low back pain (CLBP) of more than six months, failed response to more than 6 months of non-surgical treatment, and ADLs (activities of daily living) that are limited by pain, the MRI report provided does not state any evidence of Modic changes at any level. In fact, the MRI report clearly states that the osseous structures were examined, where the vertebral bodies are normal height without fractures. The MRI report also states that the L5-S1 level demonstrates a 3-millimeter (mm) disc bulge, bilateral neural foraminal narrowing, no central canal stenosis, and bilateral facet joint arthrosis. There is no mention of Modic changes, endplate changes, or any bone marrow changes such as lesions, edema, or ischemia, that might suggest Modic changes of any kind in this MRI report.  Therefore, based on the lack of radiographic evidence of any Modic changes at any level, this patient is not a good candidate for intraosseous basivertebral nerve ablation procedure with the Intracept device.

In summary, the denial of procedure code 64628 (Intracept procedure; intraosseous basivertebral nerve ablation) 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 may be increased over standard treatments.