Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Intracept procedure (intraosseous ablation of the basivertebral nerve)

The insurer denied coverage for Intracept procedure (intraosseous ablation of the basivertebral nerve.)

The denial is upheld.

Reviewer #1:

The patient is seeking coverage for Intracept procedure (intraosseous ablation of the basivertebral nerve).

Magnetic resonance imaging (MRI) of the patient's lumbar spine noted diffuse mixed Modic type I and II endplate changes.  There was chronic minimal height loss along the superior endplate of L (lumbar) 2.  There was mild L1-2 and moderate to severe L2-S (sacral) 1 disc space narrowing with diffuse disc desiccation.  There was moderate left L1-2, mild bilateral L2-3, mild bilateral L3-4, moderate to severe right, and moderate left L4-5, and moderate bilateral L5-S1 neuroforaminal narrowing.  There was moderate to severe spinal canal stenosis from L1-3, moderate canal stenosis at T (thoracic) 12-L1, mild canal stenosis at L3-4, and L5-S1, and severe canal stenosis at L4-5 secondary to combination of disc bulges, ligamentum flavum thickening, dorsal epidural fat, and moderate to severe bilateral facet arthropathy. At L4-5, there was superimposed right central disc extrusion that measured 12 millimeter (mm) in craniocaudal dimension and posteriorly displaces the descending right L5 nerve root.

The patient presented for an evaluation related to low back pain.  The physical exam findings noted intact thoracic spine range of motion with pain.  There was bilateral paraspinal musculature tenderness to palpation of the thoracic spine.  There was positive facet loading to the thoracolumbar spine bilaterally.  There was intact range of motion of the lumbar spine with pain.  There was bilateral paraspinal musculature tenderness to palpation of the lumbar spine.  The patient had 5 out of 5 strength in the bilateral lower extremities. There was decreased sensation in the bilateral lower extremities throughout dermatomes.

Per the cited references, the Food and Drug Administration has offered section 510(k) approval for the Intracept intraosseous nerve ablation system.  The system is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care and is also accompanied by either Type 1 or Type 2 Modic changes on magnetic resonance imaging.  Recent studies have shown significant relief of pain that can be sustained at least 2 years.  The cumulative data along with recent studies on basivertebral nerve ablation have demonstrated consistent, reproducible, clinically meaningful, statistically significant improvement in reducing pain and improving functioning in patients with diagnostic evidence of vertebral pain.  In this case, the patient had axial low back pain that had been refractory to conservative treatment.  There were Modic changes on magnetic resonance imaging.  The provider recommended Intracept procedure at L3-S1.  Based on the scientific evidence in peer-reviewed literature, there is improvement in health outcome with the requested treatment.  The treatment has final approval from appropriate regulatory bodies for the diagnosis of axial low back pain.  The adverse risks are not increased over standard treatments.  However, the patient is not a good candidate for the Intracept procedure, and the procedure is not the best available treatment for the patient.  

In summary, the denial of an Intracept procedure (intraosseous ablation of the basivertebral nerve) 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.