Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower back pain

Treatment: procedure code: 64628 (treatment for low back pain).

The insurer denied coverage for procedure code: 64628 (treatment for low back pain).

The denial is upheld.

In assessing whether intraosseous basivertebral nerve ablation (BVN) 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 for a select group of patients, there are many exclusion criteria.

Basivertebral nerve (BVN) ablation using the Intracept procedure is 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 - an magnetic resonance imaging (MRI) demonstrating Modic Type 1 or Type 2 changes at one or more vertebrae from lumbar (L)3 to sacral (S)1; and - activities of daily living that are limited by persistent low back pain; and finally, all other reasonable sources of pain have been ruled out.

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 the patient having a history of lumbar radiculopathy as well as MRI evidence of bilateral lumbar facet arthropathy and broad-based disc extrusion/herniation at L5-S1. Despite Modic Type 1 (endplate edema) changes at L5-S1, these additional exam and MRI findings were considered exclusion criteria for use of the Intracept procedure in the INTRACEPT study by Khalil et al. 

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. Furthermore, with a history of lumbar radiculopathy, bilateral lumbar facet arthropathy, and broad-based disc extrusion/herniation at L5-S1, this patient would have been excluded from the INTRACEPT trial and therefore the Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient.

In summary, the denial of  procedure code: 64628 (treatment for 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.