Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain. 
Treatment: Pain management (64628 x 1). 

The insurer denied coverage for pain management (64628 x 1). 

The denial is upheld. 

This is a patient with a history of back pain. The patient had microdiscectomy x 2 with resolution of radicular pain. The patient has been doing formal physical therapy (PT) and home exercises since two years ago. The patient takes gabapentin. The patient's pain is now midline and paramidline low back. Magnetic resonance imaging (MRI) demonstrates Modic changes at lumbar (L)5 through sacral (S)1. 

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. 

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. 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. 

While this patient does meet Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) criteria for use of the Intracept device, there is a lack of high-quality evidence demonstrating long term efficacy. Additional high-quality evidence is needed prior to determining whether this would be an effective treatment. It is not clear that Intracept procedure is the best available treatment currently due to the lack of high-quality evidence demonstrating efficacy. The requested treatment is not likely to be more beneficial than other evidence-based medications and treatments such as tricyclic antidepressants (TCAs). 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 evidence is insufficient to determine that the technology results in an improvement in the net health outcome. 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 pain management (64628 x 1) 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.