Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: intraosseous nerve ablation
The insurer denied intraosseous nerve ablation
The determination is upheld.

The patient has a history of low back pain. He has pain in his legs with any prolonged sitting and standing and gets relief with recumbency. His exam notes normal motor function, left straight leg raise produces buttock and leg pain and right straight leg produces buttock pain. He walks with a slightly left antalgic gait. He has completed physical therapy and injections with no sustainable relief. His pain has significant impact on activities of daily living. The plan by neurosurgery states that his pain is mostly vertebral genic given the severity of Modic changes at lumbar (L) 5- sacral (S) 1. He is not a candidate for fusion because of his smoking. He has buttock and leg pain status post L4-5 bilateral laminectomies with Coflex intralaminar spacer for spinal stenosis with neurogenic claudication. Radiographically, the stenosis is improved at L4-5. He has worsening foraminal stenosis from disc bulge and degeneration at L5-S1 on the left and some stenosis but not as severe on the right. His diagnoses are vertebrogenic low back pain, other spondylosis lumbar region, spinal stenosis lumbar region with neurogenic claudication with relief of claudication after decompression and nicotine dependence.
A lumbar magnetic resonance imaging (MRI) scan reports prominent type II endplate changes with increased signal on thoracic (T) 1 and T2 weighted images at L5-S1. L3-4 broad based disc herniation and moderate facet arthrosis and ligamentum flavum buckling resulting in mid central canal stenosis, disc bulge asymmetric to the right with right nerve root impingement suspected and stable. L4-5 broad based disc bulge, mild facet arthrosis with some fluid in the facet joints, moderate central canal stenosis, disc bulges in the neural foramina bilaterally without significant change in the right nerve root impingement. In the right spinae muscle, there is an area of intermediate signal on T1, increased signal T2 that measures about 1 times (x) 0.9 centimeters (cm). There is no enhancement after gadolinium administration. Small postoperative seroma may be present. Infection cannot be excluded by imaging alone. L5-S1 broad based disc herniation with mild central canal encroachment, bilateral neural foraminal encroachment with left nerve root impingement is noted without change. Stenosis appears slightly improved.
At issue is whether intraosseous nerve ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

No, the Intracept procedure is not likely to be more beneficial than any standard treatment for the patient's disabling condition. The patient has multilevel lumbar spine pathology per the MRI report that could be contributing to his pain. He has back and leg pain with a positive straight leg raise on the left for leg pain, as well as prior surgery at L4-5. It appears he is a fusion candidate, but he continues to smoke. His conditions are specifically excluded in the studies done for the Intracept procedure. Therefore, this requested procedure will not likely lessen his pain as it is not proven in patients with his multifactoral pathologies.
Study participants in the SMART [Sequential Multiple Randomization Trial for Low Back Pain] trial specifically excluded non-vertebrogenic pain etiologies such as spine instability, stenosis and nerve impingement as well as patients who have isolated lumbar back pain, do not have radicular pain, symptomatic spinal stenosis, previous lumbar spine surgery or disc protrusion greater than 5 mm. (1)
Study participants in the Intracept trial specifically excludes patients with radicular pain, symptomatic spinal stenosis, disc protrusion greater than (>) 5 mm, spondylolisthesis > 2 mm at any level, or Beck Depression Inventory of greater than 24. Also excluded were patients with facet arthrosis, body mass index (BMI) over 40 and prior lumbar surgery. (2)
Although there has been benefit noted in 2 level I studies and it is clinically supported by the ISASS (The International Society for the Advancement of Spine Surgery), there continues to be a question of limitations that they state, "Industry funding is a potential source of study bias for the available data reviewed; Limited number of studies; Short-term follow-up for the majority of studied patients; Unknown effect on the primary degenerative process". (3)