Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbar back pain.
Treatment: Intracept procedure (Current Procedural Terminology (CPT) code 64628).
The insurer denied coverage for Intracept procedure (CPT code 64628).
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 (RF) ablation for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency. 

The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. 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 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. 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 radiographic evidence of other pain etiology. Despite evidence of mild degenerative endplate signal changes at L2-3, the MRI also showed evidence of diffuse disc bulging with a large broad-based posterior disc herniation at L2-3. Radiographic evidence of other pain etiology such as disc extrusion or protrusion was considered an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al.

Therefore, based on this evidence, this patient is not a good candidate for intraosseous basivertebral nerve 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. Despite treatment with lumbar epidural steroid injections, trigger point injections, and extensive chiropractic manipulation, there is no evidence provided of proven treatments with therapies such as physical therapy or cognitive behavioral therapy. There is also no evidence provided of additional pharmacologic treatment with proven second-line medications such as duloxetine or tricyclic antidepressants.

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. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency. 

In summary, the denial of the Intracept procedure (CPT code 64628). 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 risk are substantially increased over standard treatments.