Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low Back Pain. 
Treatment: Intracept Procedure. 

The insurer denied: Intracept Procedure. 
The denial is upheld. 

The patient is a female with a 12 year history of low back pain. A cervical/thoracic/lumbar x-ray was done for complaints of neck pain, torticollis, numbness of the lower/upper extremity and upper and lower extremity pins and needles. There is marked degenerative changes at the lumbar (L) 4-5 disc with vacuum disc phenomenon and endplate sclerosis with osteophytic ridging along the vertebral margins. There is facet arthrosis of the lower lumbar spine, mild. A lumbar magnetic resonance imaging (MRI) was done for low back pain, bilateral leg pain with numbness, weakness and difficulty walking. At L5-sacral (S)1 a disc herniation deforming the thecal sac and abutting the proximal S1 nerve roots bilaterally with bilateral proximal neural foraminal extension and bilateral facet hypertrophy. At L4-5 there is a disc herniation with grade 1 spondylolisthesis deforming the thecal sac and abutting the proximal L5 nerve roots bilaterally with bilateral proximal neural foraminal extension abutting the exiting L4 nerve roots. There is loss of disc space height and signal with associated disc degeneration with anterior hypertrophic change and anterior disc extension with Modic type 2 endplate signal changes. An older MRI was reviewed. There are two notes by the neurosurgeon with the same date. The one note states the patient is seen for intractable low back pain without significant radiation despite maximal medical therapy. Her exam notes moderate hyperreflexia at the knees bilaterally. The plan was for the Intracept procedure for Modic changes. The other note states she is seen for low back pain with radiation down the bilateral lower extremities with some numbness and tingling. At times she has numbness in the hands and lower cervical spine. Her exam is the same. Her diagnosis is cervical and lumbar radiculopathy. They would obtain a cervical MRI.
An appeal letter by the neurosurgeon was reviewed. It states that they feel the Intracept procedure is medically necessary as it is proven to be safe and effective to treat the patient's low back pain that has failed conservative treatment of medications of oxycodone, prednisone and tramadol. Her pain causes a significant impact on her activities of daily living. He states her lumbar MRI shows Modic type 2 changes at L4-5.
The subject under review is whether the Intracept procedure is medically necessary. 

The health plan's determination is upheld. 

The Intracept procedure is not medically necessary for this patient. She has multiple possible pain generators with back pain and lower extremity pain with numbness and tingling. Her MRI shows Modic changes, facet disease, disc disease, and disc herniation at both L4-5 and L5-S1 and a spondylolisthesis at L4-5 that may be contributing to her pain. The Intracept studies specifically excluded patients with her pathology. There is no indication that this procedure will relieve her pain over other treatments available. The Intracept procedure is not appropriate for this patient as it is not a generally accepted treatment for low back pain at this time. The procedure is currently undergoing a larger clinical trial. (1) Although there has been benefit noted in 2 level I studies and is clinically supported by International Society for the Advancement of Spine Surgery (ISASS), 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".(2)