Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: intraosseous basivertebral nerve ablation
The insurer denied intraosseous basivertebral nerve ablation.
The determination is upheld.

This is a female patient who had lumbar magnetic resonance imaging (MRI) which states low thoracic (T) 1 and increased T2 fluid attenuated inversion recovery (FLAIR) is identified bordering the lumbar (L) 5- sacral (S) 1 disc space on the right, thought to be related to Modic type 1 degenerative endplate change. A similar finding was present. Increased intradiscal short T1 inversion recovery (STIR) signal is also again seen on the right at this level that may be degenerative in nature. Mild disc bulging at L2-3, L4-5 with a superimposed left foraminal disc protrusion that appears to contact the exiting left L4 nerve producing moderate left foraminal narrowing. Right foraminal disc protrusion at L3-4 that appears to be contacting the exiting right L3 nerve and produces mild right neural foraminal narrowing. Minimal retrolisthesis and mild disc bulging at L5-S1, mild disc bulging with bilateral foraminal disc protrusions that appear to contact the exiting bilateral L5 nerves, moderate right and mild left neural foraminal narrowing. Mild degeneration of the sacroiliac joints. A lumbar x-ray notes minimal lumbar dextroscoliosis. It also notes a history of low back surgery and right leg pain to the knee in the history.
It was noted that she has had chronic back pain for 10 years and is status post discectomy for leg pain and sciatica. It was noted that her leg pain resolved but she has severe incapacitating low back pain that failed conservative treatment. She takes hydrocodone. Her imaging was reviewed for absence of any significant disc, however there are Modic changes at L5-S1 that is more right sided. There is no exam. The plan was for the Intracept procedure. At issue is whether intraosseous basivertebral 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 patient has had a prior lumbar discectomy at an unknown level in 2019. It is not clear that her leg pain was resolved as the history on her lumbar x-ray notes right leg pain to the knee. There are no other supporting notes of her symptoms or exams. The Intracept procedure studies specifically exclude patients with prior surgeries. In this case, it is not clear that her only pain generator is related to her Modic type 1 changes. Therefore, it is unknown whether this procedure would be more beneficial than any standard treatment.
 
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)
Exclusions to studies include:
	MRI evidence of Modic at levels other than lumbar level 3 to sacral level 1 (L3-S1)
	Radicular pain (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression in imaging)
	Previous lumbar spine surgery (discectomy/laminectomy allowed if greater than (>) 6 months prior to baseline and radicular pain resolved)
	Symptomatic spinal stenosis (defined as the presence of neurogenic claudication and confirmed by imaging)
	Metabolic bone disease, spine fragility fracture history, or trauma/compression fracture, or spinal cancer
	Spine infection, active systemic infection, bleeding diathesis
	Radiographic evidence of other pain etiology
	Disc extrusion or protrusion >5 millimeters (mm)
	Spondylolisthesis >2 mm at any level
	Spondylolysis at any level
	Facet arthrosis/effusion correlated with clinically suspected facet-mediated low back pain (3)