Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Back Pain
Treatment: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance: first 2 vertebral bodies, lumbar or sacral (Intracept).
The insurer denied coverage for 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance: first 2 vertebral bodies, lumbar or sacral (Intracept).
The denial is upheld

The patient was seen by Pain Management for chronic back pain with radiation down the bilateral lower extremities. He underwent two epidural steroid injections with minimal relief, caudal epidural steroid injection with relief of radicular symptoms and radiofrequency ablation lumbar (L)3-sacral (S)1 of the facet joints with significant relief of symptoms for about 10 months. Currently he has 10/10 pain in the low back to the bilateral posterior thighs and numbness in both feet. He has undergone conservative treatments without improvement. A lumbar magnetic resonance imaging (MRI) shows compression deformities at L1, L2, L3 and L4. There is partial ankylosis of the L4 and L5 vertebrae and reciprocal type II Modic changes at L4-5. At L3-4 effacement of the right lateral recess abutting the descending right L4 nerve root and moderate right neural foraminal narrowing. L4-5-disc bulge with compression of the left L5 nerve root and moderate bilateral neural foraminal narrowing. L5-S1 moderate right foraminal narrowing. His exam notes bilateral weakness 4/5 hip flexion, adduction, extension and knee extension. He has positive facet loading bilaterally. Also noted that he has chronic back pain at this time without radiation at this time that appears facetogenic in nature. The plan was for the Intracept procedure for vertebrogenic low back pain L4, L5.

There is evidence in peer reviewed literature that supports improvement in health outcomes for patients with vertebrogenic pain for years. However, clinical trials are continuing for long term success. In this case, the Intracept procedure has not been studied in those with prior facet related pain, radiculopathy or compression fractures at the requested level.

The Intracept Intraosseous Nerve Ablation System is FDA (Food and Drug Administration) approved. The Intracept Intraosseous Nerve Ablation 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 6 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 a magnetic resonance imaging (MRI). The Intracept System technique uses RF ablation of the basivertebral nerve for relief of chronic low back pain and involves a two-step process.  First, utilizing the Instrument Set, a minimally invasive, "transpedicular approach" is used to allow the placement of a cannula into the vertebral body, and a path or channel is created to the terminus of the basivertebral foramen.  An RF Probe is then placed into this channel at the terminus of the basivertebral foramen, and controlled RF energy is delivered to destroy the basivertebral nerve where it enters the vertebral body.  This nerve has been identified as a proprioceptive sensory nerve with innervation of the vertebral endplates. (1)

The patient is not a good candidate for the Intracept procedure. His lumbar MRI shows compression deformities at L1, L2, L3 and L4. There is partial ankylosis of the L4 and L5 vertebrae and reciprocal type II Modic changes at L4-5, L3-4 effacement of the right lateral recess abutting the descending right L4 nerve root and moderate right neural foraminal narrowing, L4-5-disc bulge with compression of the left L5 nerve root and moderate bilateral neural foraminal narrowing. L5-S1 moderate right foraminal narrowing that could all be causing his symptoms. Furthermore, the Intracept procedure is not studied on patients with radiculopathy, facet related disease or compression fractures.

The Intracept procedure is not the best available treatment available given the fact that he has multiple pain generators, and it is not clear that this treatment will help his pain. 

The requested Intracept procedure is not likely to be more beneficial than any of the standard treatments/procedures for this patient. 

The carrier's denial of 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept) should be upheld.