Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain

Treatment: Low back pain (procedure codes 64628 & 64629), DOS (date of service) TBD (to be determined)

The insurer denied coverage for low back pain (procedure codes 64628 & 64629), DOS (date of service) TBD (to be determined).

The denial is upheld.

In assessing whether intraosseous basivertebral nerve (BVN) 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 systematic review concluded that further high-quality, large prospective studies, that are not industry funded, are needed to confirm these findings.

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 insufficient evidence of Modic changes and insufficient evidence in the medical record of at least 6 months of failed non-surgical management. While the magnetic resonance imaging (MRI) report does mention fatty marrow endplate changes at L (lumbar) 3-L4, there is no mention of bone marrow changes, vertebral endplate changes, or Modic changes at any other levels. In fact, the MRI report specifically states, "no suspicious bone findings." The MRI findings would not support the recommended ablation of L3 through S (sacral) 1. In addition to lack of Modic findings on MRI, clinic notes mention 6 weeks and 12 weeks of failed non-surgical management of back pain; however, there is no clearly defined timeline in the medical record that indicates the Centers for Medicare and Medicaid Services (CMS) required 6 months or greater of failed non-surgical management. 

In summary, the supporting 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. Despite FDA approval, CMS guidelines limit the use of basivertebral nerve ablation to a very select group of patients who have MRI evidence of Modic changes at the levels of intended treatment and who have documented evidence of at least 6 months of failed non-surgical management. The Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. The denial is upheld.

In summary, the denial of low back pain (procedure codes 64628 & 64629) DOS (date of service) TBD (to be determined) 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 substantially increased over standard treatments.