Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal-Low back pain.
Treatment: Surgical Services (All)- Intracept Procedure.
The insurer denied the Intracept Procedure. 
The denial is upheld. 

This is a male patient. The patient is diagnosed with low back pain, lumbar intervertebral degeneration and vertebrogenic low back pain. Records provided indicate that a request for the Intracept procedure (intraosseous ablation of the basivertebral nerve) was denied by the health plan as experimental and investigational.
Letter of appeal from the provider stated that this procedure is an innovative procedure to address chronic low back pain identified by Modic changes and fulfills a treatment gap for patients with chronic back pain. The provider states that the patient has had a history of low back pain present for over six months and has tried multiple treatments including home exercises, medial branch block injections, medication management, physical therapy, and lumbar epidural steroid injection. The provider states that medications have included meloxicam and tramadol. His pain has a significant impact on activities of daily living such as sitting and standing, and nothing has provided sustained relief. The provider states the patient had a magnetic resonance imaging (MRI) showing degenerative endplate changes at lumbar (L)4 - L5 and L5 - sacral (S)1 and therefore the patient's chronic back pain is coming from vertebrogenic changes at L4, L5 and S1. 
He has tried gabapentin with no relief. Pain is rated at 4/10 at rest and 5/10 with activity. 
At issue is the medical necessity of the Intracept Procedure.

The health plan's determination of medical necessity is upheld in whole.

The requested health service/treatment of Intracept Procedure is not medically necessary for this patient.
The patient is noted to have complaints of chronic low back pain and the provider states that the patient has failed conservative treatment. There is no evidence to suggest that the patient's primary pain is coming from Modic changes.
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 (BVN) is a new procedure; its limitations included 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, and unknown effect on the primary degenerative process." Per Becker et al, "Ablation of the BVN 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 radiofrequency (RF) ablation of the BVN for chronic low back pain (CLBP) exhibited significantly greater improvement in Oswestry Disability Index (ODI) at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain." Again, there appears to positive initial results, 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. This treatment is not currently considered the standard of care in the general medical community.
Therefore, the requested health service/treatment of Intracept Procedure is not medically necessary.