Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #1:

Diagnosis: Lower back pain.
Treatment: (procedure code 64628) to treat low back pain.

The insurer denied coverage for (procedure code 64628) to treat low back pain.  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. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria, including lumbar disc herniation.

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% 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.

The medical record for this patient is incomplete. The official magnetic resonance imaging (MRI) report is missing. Without this MRI report it is difficult to accurately determine if this patient is a good candidate for intraosseous basivertebral nerve ablation. There are other evidence-based treatments available to this patient. Clinic notes provided state there is MRI evidence of diffuse disc bulging and disc herniation at multiple lumbar spine levels in addition to Modic changes. With possible multilevel lumbar disc herniations this procedure is unlikely to be more beneficial than the standard approaches. Without an official MRI report it is difficult to determine if these disc herniations may be the source of this patient's pain. 

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 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. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency. Despite limited FDA approval, there is no current CMS (Centers for Medicare & Medicaid Services) approval for the use of the Intracept procedure, with a proposed LCD (Local Coverage Determinations) a work in progress. Furthermore, without an official MRI report available to clearly asses this patient's lumbar disc herniations, it is difficult to determine if the Intracept procedure is likely to be more beneficial than standard treatments/procedures for this patient.

In summary, the denial of procedure (procedure code 64628) to treat low back pain 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.