Appeal type: Experimental/Investigational
Decision: Upheld


Diagnosis: Lower back pain

Treatment: Intracept procedure

The insurer denied coverage for Intracept procedure

The denial is upheld.

This is an adult with a history of arthritis, bipolar disease, deviated nasal septum, gastroesophageal reflux disease (GERD), hypertension, obesity, obstructive sleep apnea (OSA), and prostate enlargement. The patient presented to the Pain Management physician's office for a follow up for chronic lower back pain. The patient had temporary relief from medial branch blocks and epidural steroid injections. He also has multiple courses of physical therapy (PT) without relief. The treating physician recommended the Intracept procedure to treat back pain.

The 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.  

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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Basivertebral nerve ablation using the Intracept procedure is Food and Drug Administration (FDA) approved in a very select group of patients who have - A history of low back pain 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 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 - All other reasonable sources of pain have been ruled out.

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 not meeting one or more of the recommended requirements by Relievant, the Intracept Medical device manufacturer. 

Therefore, based on this evidence, this patient is not a good candidate for intraosseous basivertebral nerve ablation procedure with the Intracept device. This patient has two MRI findings that would have excluded him from the original Intracept studies, Modic changes at level other than L3-S1 and L5 pars interarticularis fractures.

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.

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.

The carrier's denial of Intracept procedure should be upheld.