Appeal type: Experimental/Investigational
Decision: Upheld

Orthopedic/Musculoskeletal
Surgical Services (All)

Diagnosis: Chronic Vetebrogenic Low Back Pain
Treatment: Intracept Procedure 
The insurer denied the Intracept Procedure.
The health plan's determination is upheld.

The patient is a male who is diagnosed with chronic vertebrogenic low back pain, Lumbar spondylosis, and lumbar radiculopathy. The patient was recommended to undergo interosseous basivertebral nerve ablation, which the insurance carrier denied as investigational. The provider is appealing that determination, which is the subject of this review.
The provider submitted letters of appeal indicating they disagree with the denial and do not believe that the Intracept procedure is experimental or investigational. The provider noted that the patient has a history of low back pain and has had treatment including education management and physical therapy. Medications have included Meloxicam and Tizanidine. The pain is impacting activities of daily living and rated at 9 out of 10. The provider states the patient had a magnetic resonance imaging (MRI) demonstrating Modic type I changes at disc spaces lumbar vertebrae (L)3 - L4, L4 - L5 and L5 - sacral vertebrae (S)1. The provider feels that this is the source of the patient's chronic back pain. The provider request reconsideration for approval of the Intracept procedure.
The MRI of lumbar spine revealed mild central canal stenosis L1 - L2 with mild left foraminal narrowing. Severe central canal stenosis at L2-L3 with compression of the descending right greater than left L3 nerve roots and moderate right foraminal narrowing. Severe central canal stenosis L3 - L4 with impingement of the descending bilateral L4 nerve roots and moderate bilateral foraminal narrowing. Mild central canal stenosis at L4 - L5 impingement of the descending L5 nerve roots and moderate foraminal narrowing. Degenerative changes at L5 - S1 impinges the left S1 nerve roots with moderate left foraminal narrowing. There was type I endplate Modic changes most pronounced at L2-L3.

There is no evidence that the proposed health service or treatment is likely to be more beneficial than standard treatment or treatments for the insured's life threatening or disabling condition or disease. The patient has complaints of chronic back pain with radiculopathy and while the MRI does show Modic changes, these were noted to be most severe at L2-L3 which is not a level being requested. The patient is noted to have severe central canal stenosis at multiple levels with nerve root impingement at multiple levels throughout the lumbar spine, likely the source of the patient's symptoms. It appears the only conservative treatment tried includes six weeks of physical therapy, Meloxicam and Tizanidine.
The requested Intracept procedure remains experimental and investigational as there is a lack of high quality studies evaluating the long-term risks and benefits of this procedure. Although some results have been promising, additional studies are needed to establish the safety and efficacy. 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.