Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: intraosseous basivertebral nerve ablation, procedure codes 64628 and 64629

The insurer denied coverage for intraosseous basivertebral nerve ablation, procedure codes 64628 and 64629.

The denial is upheld. 

In assessing whether intraosseous basivertebral nerve ablation using the Intracept device 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. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

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. Furthermore, a 2021 systematic review (Conger et al.) concluded that further high-quality, large prospective studies, that are not industry funded, are needed to confirm these findings.

The INTRACEPT trial (sponsored by Relievant Medsystems, Inc.) was an open-label RCT conducted at 20 U.S. sites (Khalil 2019). A total of 140 patients with lower back pain of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L (lumbar) 3 and S (sacral) 1 were randomized to undergo radiofrequency ablation of the basivertebral nerve (BVN) or continue standard care. Treatment of up to 4 vertebrae in nonconsecutive levels from L3 to S1 was allowed. The primary study endpoint was change in Oswestry Disability Index (ODI) at 3 months. A pre-planned interim analysis was undertaken when 60% (percent) of participants reached the 3-month follow-up (n=51 in the treatment group and n=53 in the standard care group) and reported statistically significant differences between groups on all patient-reported outcome measures, favoring the treatment group. The study was halted, and the individuals were allowed to cross over to the treatment arm. Study limitations include short term follow-up, lack of a sham group and allowance of crossover at 3 months. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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.

In summary, the denial of intraosseous basivertebral nerve ablation, 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 risks are not substantially increased over standard treatments.