Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower back pain
Treatment: Intracept procedure codes 64628 and 64629
The insurer denied coverage for Intracept procedure codes 64628 and 64629
The denial is upheld

In assessing whether intraosseous basivertebral nerve ablation using the Intracept device - procedure codes 64628 and 64629 - 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. 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 (BVN), 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.

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.

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 MRI evidence of other pain etiology with lumbar compression deformities seen lumbar levels, most prominent at the L4 level, in addition to Modic changes. These compression deformities may represent severe osteoporosis (more common in elderly woman) or previous lumbar compression fractures given the patient's back injury history where "he has sustained injuries from multiple accidents" as documented in the provided chart notes. Regardless of the mechanism for the compression deformities, the Intracept procedure was not designed or approved to treat this type of pathology. 

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 denial of procedure codes 64628 and 64629 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.