Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Neck and Low Back Pain. 

Treatment: 64628 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; Intracept) and 64629 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral [list separately in addition to code for primary procedure]). 

The insurer denied coverage for 64628 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; Intracept) and 64629 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral [list separately in addition to code for primary procedure]). 

The denial is upheld. 

The patient has a history of lower back pain. The patient had a follow up with a physician for chronic neck and low back pain, status post bilateral lumbar (L) 4-L5, L5 - sacral (S) 1 facet joint radiofrequency ablation (RFA). The patient reported 50% (percent) relief but continued to have axial lower back pain with flexion and prolonged activities. The patient had a magnetic resonance imaging (MRI) of the lumbar spine performed; the findings showed multilevel degenerative disc disease, spinal canal stenosis, and neural foraminal narrowing. Reciprocal type I Modic change at L3/4. The physician recommended the Intracept procedure for Modic changes noted at L3, L4, L5 for vertebrogenic pain. 

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. 

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% 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. 

This patient is not a good candidate for the Intracept procedure. There are other evidence-based treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. 

In addition to the MRI findings, the history of presenting illness (HPI) and physical exam from follow up visit demonstrate radiating pain towards the left hip and bilateral feet. This patient's MRI report and physical exam findings also suggests evidence of other pain etiology such as facet joint arthritis. Facet arthritis would correlate with this patient's complaint of pain radiating to the hip. 

Based on this evidence, this patient is not a good candidate for intraosseous basivertebral nerve ablation procedure with the Intracept device. Any invasive procedure has risks of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments. 

In summary, the denial of 64628 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; Intracept) and 64629 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral [list separately in addition to code for primary procedure]) and coverage for the requested 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.