Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Intracept Procedure (thermal destruction of intraosseous basivertebral nerve)
The insurer denied: Intracept Procedure (thermal destruction of intraosseous basivertebral nerve)
The denial is upheld.

The patient is an adult male patient. The patient is diagnosed with vertebrogenic low back pain. The patient was recommended to undergo the Intracept procedure, which has been denied as experimental and investigational and the provider has appealed multiple times. The provider disagrees that this treatment is experimental/investigational. The provider notes that the patient has a history of low back pain that began long ago and has had multiple treatments including injections, medication management and radiofrequency ablation. Medications have included acetaminophen, Ambien, duloxetine, hydrocodone, Norco, non-steroidal anti-inflammatory drugs (NSAIDs), and opiate analgesics and nothing has provided significant or sustained relief. 

It was noted the patient had a magnetic resonance image performed demonstrating Modic changes at disc spaces lumbar five (L5) and sacral one (S1) and therefore this is the source of the patient's chronic back pain. Physical examination revealed 5/5 strength in the bilateral lower extremities, sensation intact. Magnetic resonance image of the lumbar spine revealed moderate to severe discogenic degenerative disease at the lumbar five vertebrae (L5) / sacral one vertebrae (S1). There was a small left paracentral-extraforaminal protrusion at lumbar five vertebrae (L5) / sacral one vertebrae (S1) with probable minimal contact of the left descending nerve roots. There was osteophyte formation contributing to moderate left neural foraminal narrowing. There was mild bilateral neural foraminal narrowing at lumbar vertebrae four (L4) / lumbar vertebrae five (L5) related to a small circumferential disc bulge and facet arthropathy.

This treatment is considered experimental and investigational.

The requested health service or treatment has not been proven to be more beneficial than any standard treatment for the patient's condition or disease.

The patient is noted to have a history of chronic back pain that has not responded to conventional conservative treatment. There was no mention of degenerative endplate/Modic changes on the actual MRI (magnetic resonance imaging) report per radiologist read.

Per the Official Disability Guidelines (ODG) by Milliman Care Guidelines (MCG): "Not recommended. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required."

The International Society for the Advancement of Spine Surgery's guideline on "Intraosseous ablation of the basivertebral nerve for the relief of chronic low back pain" (Lorio et al, 2020) stated that intraosseous ablation of the basivertebral nerve is a new procedure; its limitations included industry funding as 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, and unknown effect on the primary degenerative process.

Per Becker et al: "Ablation of the BVN [basivertebral nerve] for the treatment of chronic lumbar back pain significantly improves patients' self-reported outcome early in the follow-up period; the improvement persisted throughout the 1-year study period." However, this is noted to be an industry-sponsored study and does not demonstrate long-term effects of the procedure beyond one year.

Per Fischgrund et al: "Patients treated with RF [radiofrequency] ablation of the BVN [basivertebral nerve] for CLBP [chronic low back pain] exhibited significantly greater improvement in ODI [Oswestry Disability Index] at 3 months and a higher responder rate than sham treated controls. BVN [basivertebral nerve] ablation represents a potential minimally invasive treatment for the relief of chronic low back pain." However, the study was fairly small (225 patients with chronic back pain) and there continues to be a lack of long-term studies evaluating long term risks/benefits when compared to other standard means of treatment and further large, high-quality studies are needed.