Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Intracept/radiofrequency ablation, 2 units

The insurer denied coverage for Intracept/radiofrequency ablation, 2 units.

The denial is upheld.

Reviewer #2:

This is a patient with a chief complaint of chronic axial back pain which they have had for over 3 years. The patient has had epidural injections, medial branch blocks, and radiofrequency ablation without much relief. Clinic notes state that the patient has participated in physical therapy (unknown duration) and taken oral analgesics without relief. The patient's pain is now affecting their activities of daily living (ADLs). A magnetic resonance imaging (MRI) demonstrates Modic changes at L (lumbar) 5-S (sacral) 1. Physical exam reveals positive facet load test bilaterally. The patient's provider recommends treatment with basivertebral nerve (BVN) ablation with the Intracept device.

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 (RFA) 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.

Basivertebral nerve (BVN) ablation using the Intracept procedure is Food and Drug Administration (FDA) approved in a very select group of patients who have - A history of chronic low back pain (cLBP) of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - magnetic resonance imaging (MRI) demonstrated Modic Type I or Type II changes at one or more vertebrae from L3 to S1; and - Activities of daily living that are limited by persistent low back pain; and - All other reasonable sources of pain have been ruled out.

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 Intracept/radiofrequency ablation, 2 units 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.