Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain. 
Treatment: Procedure codes 64628 and 64629. 

The insurer denied coverage for procedure codes 64628 and 64629. 

The denial is upheld. 

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 (BVN) using radiofrequency (RFA). 

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 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. The BVN 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 following recommended requirements by the Intracept Medical device manufacturer. 

Despite a history of chronic low back pain of more than six months, failed response to more than 6 months of non-surgical treatment, endplate reactive signal changes (Modic) at L3-4 and L5-S1, and activities of daily living (ADLs) that are limited by pain, this patient's MRI report also shows evidence of other pain etiology such as facet joint arthritis at L4-5, as well as hemangiomata in the L3 and L4 vertebral bodies. This patient also unfortunately suffers from addiction behavior with a history of polysubstance abuse and alcoholism. Radiographic evidence of other pain etiology and addiction behavior were considered exclusion criteria in the INTRACEPT study by Khalil et al. 

Therefore, based on this evidence, this patient is not a good candidate for intraosseous BVN ablation procedure with the Intracept device. 

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. 

With radiographic evidence of other pain etiology such as facet joint arthritis and vertebral body hemangiomas, as well as addiction behavior, this patient would have also been excluded from the INTRACEPT trial. Based on these findings the Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. 

Peer reviewed literature does not support a result of improvement in health outcomes with the requested procedure. The requested procedure does have final regulatory approval from the appropriate regulatory bodies for this diagnosis. 

This patient is not a good candidate for the requested procedure.  It is not the best available treatment for this patient at this time. 

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 health plan's denial of the 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar and 64629 thermal destructions of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral should be upheld.