Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Chronic low back pain

Treatment: pain management; outpatient procedure (Intraosseous Nerve Ablation-Intracept procedure) 

The insurer denied coverage for pain management; outpatient procedure (Intraosseous Nerve Ablation-Intracept procedure)

The denial is overturned

This case involves a female diagnosed with vertebrogenic low back pain. The patient had magnetic resonance imaging (MRI) of the lumbar spine.  At L(lumbar)5-S(sacral)1, there was disc desiccation. There was disc space narrowing, subchondral sclerosis, and degenerative bone marrow edema. There was stable small broad-based disc herniation with right greater than left intraforaminal extension and facet arthropathy that caused thecal sac flattening and moderate bilateral L5 nerve root compression that was more right sided. There had been no significant change compared with the prior study. An addended note from the provider, reported Modic type I changes at the L5-S1 level. The patient was seen for an evaluation related to ongoing low back pain and lower extremity pain. The pain was described as chronic axial low back pain. There was 90% midline back pain with 10% radiation to both legs. The pain interrupted sleep and limited her activities of daily living. She had prior medial branch blocks and epidural steroid injections. She received only temporary relief from injections in the past. She had multiple courses of physical therapy. The exam findings of the patient noted limited active range of motion of the lumbar spine in all planes. There was 4 out of 5 strength with bilateral hip extension. The patient's sensation was intact in the bilateral lower extremities. The patient's reflexes were intact. There was diffuse tenderness over the lumbar paraspinals. The straight leg raise testing was negative. MRI revealed at L5-S1, disc desiccation. The provider recommended Intracept Intraosseous Nerve Ablation at L5-S1.

The Food and Drug Administration (FDA) 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. The findings should note either Type 1 or Type 2 Modic changes on MRI. Per the cited literature, studies have shown significant relief of pain that can be sustained at least 2 years with the requested procedure. 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 has symptoms consistent with axial low back pain and Modic changes on MRI L5-S1. The patient has received extensive treatment including epidural steroid injections, medial branch blocks, physical therapy, activity modification, medications, and rest. The provider recommended the Intracept procedure. Based on the FDA provided documentation and recent literature, there is support that the intervention is safe and effective for the patient's clinical presentation. The patient has exhausted standard treatment/services and is a good candidate for the procedure based on the image findings and exam findings. The scientific evidence supports results of improvement in health outcome. The risks of the procedure do not exceed standard treatments/services, and the patient has exhausted alternative treatments.  

The requested procedure (Intraosseous Nerve Ablation-Intracept procedure) is likely to be more beneficial than any other standard procedures.

The carrier's denial of pain management; outpatient procedure (Intraosseous Nerve Ablation-Intracept procedure) should be overturned.