Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Lower back pain.

Treatment: Intracept procedure.

The insurer denied coverage for Intracept procedure.

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. 

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 evidence in the medical record of radicular pain. Clinic notes provided state that the patient's low back pain radiates to the left buttock, lateral thigh, posterior thigh, calf, medial foot, lateral foot, toes, and is associated with weakness. Magnetic resonance imaging (MRI) states mild disc bulging at lumbar (L)2-sacral (S)1, with disc herniation at L3-S1, and left L5 nerve root impingement which was mildly worsened as compared to the prior MRI study. Radicular pain that correlates with nerve compression on imaging was considered an exclusion criterion in the INTRACEPT study by Kahlil et al. Full exclusion criteria in the INTRACEPT study were: MRI evidence of Modic at levels other than L3-S1; Radicular pain (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression in imaging); Previous lumbar spine surgery (discectomy/laminectomy allowed if > 6 months prior to baseline and radicular pain resolved); Symptomatic spinal stenosis (defined as the presence of neurogenic claudication confirmed by imaging); Metabolic bone disease, spine fragility fracture history, or trauma/compression fracture, or spinal cancer; Spine infection, active systemic infection, bleeding diathesis; Radiographic evidence of other pain etiology; Disc extrusion or protrusion > 5 mm; Spondylolisthesis > 2 mm at any level; Spondylolysis at any level; Facet arthrosis/effusion correlated with facet-mediated low back pain (LBP); Beck Depression Inventory (BDI) > 24; 3 or > Waddell's signs; Compensated injury or litigation; Addiction behavior; or Body Mass Index (BMI) > 40.

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.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Intracept procedure for intraosseous ablation of basivertebral nerve, codes 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral and 64629 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral is not substantiated.