Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic vertebrogenic pain.
Treatment: Procedure codes 64628 & 64629 to treat low back pain.

The insurer denied coverage for procedure codes 64628 & 64629 to treat low back pain.  The denial is upheld.

This is a male with history of low back pain for eight years that has not been responsive to acupuncture, chiropractor care, injections, radiofrequency ablation (RFA), trigger point injections and medications of meloxicam and Percocet. His pain is rated an 8/10. He had a positive response to trigger point injections, epidural steroid injections and lumbar RFA. His exam notes pain with transitioning from sit to stand. He has diagnoses of lumbar degenerative disc disease, vertebrogenic back pain and myofascial pain. An actual MRI (magnetic resonance imaging) of the lumbar spine notes a grade 1 retrolisthesis of L2 on L3, Modic Type 1 changes L3-4 and L4-5, loss of thoracic (T) 2 signal of multiple intervertebral discs and loss of intervertebral disc height at L3-4 and L4-5. At L3-4-disc bulge with a superimposed right foraminal disc herniation moderately narrowing the adjacent foramen and abutting the exiting L3 nerve root, mild left sided foraminal and central canal stenosis. L4-5 diffuse disc bulge with superimposed left foraminal disc herniation severely narrowing the adjacent foramen impinging the exiting L4 nerve root. It was recommended that he undergo the Intracept procedure.

There is evidence in peer reviewed literature that supports improvement in health outcomes for patients with vertebrogenic pain over 5 years. However, clinical trials are continuing for long term success.

The Intracept Intraosseous Nerve Ablation System is Food and Drug Administration (FDA) approved. The procedure is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through sacral (S)1 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 an MRI. (1)

The patient is not a good candidate for the procedure. He has multiple pathologies in the lumbar spine at L3-4 and L4-5 to include herniated discs with foraminal stenosis as well as a retrolisthesis at L2-3 as well has having positive responses to trigger point injections, epidural steroid injections and RFA which make it unclear if his back pain is coming from the basivertebral nerve.

He has responded well to other treatments, and it is not clear if this procedure will improve his back pain given multiple pain generators.

Long term adverse risks with this procedure are unknown at this time as further clinical studies (2) are being conducted over standard treatment/services.

It is unknown if there are long-terms adverse risks with the requested surgery over standard services or treatment. The SMART study states, "Preclinical studies showed no evidence of negative effect on tissues outside the ablation zone. Histologic data demonstrated that existing boney trabecular structure is not damaged with the procedure and that at 3 months new bone formation and thickening trabeculae are widespread. Over the long term (6 months and 1 year), there are a fatty replacement of bone marrow, a thickening of remaining trabecular bone elements, and concurrent regeneration of blood vascular network. There have been 378 human clinical trial participants treated with bivertebral nerve (BVN) ablation to date with controlled collection of adverse events." (3)

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

The carrier's denial of procedure codes 64628 & 64629 to treat low back pain should be upheld.