Appeal type: Experimental/Investigational
Decision: Upheld



Diagnosis: Chronic low back pain.

Treatment: current procedural terminology (CPT) code 64628, intraosseous basivertebral nerve ablation.

The insurer denied coverage for current procedural terminology (CPT) code 64628, intraosseous basivertebral nerve ablation.

The denial is upheld.

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. Furthermore, despite Food and Drug Administration (FDA) approval, 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 - 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.

This patient is not a good candidate for intraosseous basivertebral nerve ablation at L5-S1. 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 magnetic resonance imaging (MRI) evidence of other pain etiology at L5-S1. According to the MRI there is disc herniation extending for approximately 1 centimeter (cm) at L5-S1, with left lateral recess extension impinging the left S1 nerve root. Radiographic evidence of other pain etiology such as lumbar disc extrusion or protrusion; 5 millimeters (mm) was considered an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al (and others). 

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.

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. 

Furthermore, with MRI evidence of other pain etiology (lumbar disc extrusion/protrusion; 5 mm 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 current procedural terminology (CPT) code 64628, intraosseous basivertebral nerve ablation 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.