Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.
Treatment: Pain Management-Intracept procedure.
The health plan denied the Intracept procedure as experimental/investigational. 
The reviewer has upheld in whole the health plans determination.

This is an adult female who is diagnosed with back pain. The patient was recommended to undergo the Intracept procedure.
There is a progress note indicating the patient to have complaints of low back, neck and left rib pain reporting no relief from intercostal nerve blocks. She reports her pain is worsening. She cannot drive more than 10 to 20 minutes without severe pain in the low back. She states the current medication regimen keeps her functional. Pain is rated at 9/10. The patient was to continue with medications, the patient is pending authorization for the Sprint peripheral nerve stimulator (PNS) stimulator and is pending authorization for the Intracept procedure at Lumbar (L)2, L3 and L4 levels.
MRI of lumbar spine revealed multilevel degenerative disc disease without significant spinal canal or neural foraminal narrowing. Interbody spinal fusion with posterior decompression from L1 - sacral (S)-1. There was no mention of Modic changes on the initial impressions, however there is an addendum that states there are Modic type II changes at the superior endplate of thoracic (T)12, superior endplate of L2, inferior endplate of L3 and superior endplate of L4. There are no Modic type I, or type III changes identified in the lumbar spine.
There is no evidence to suggest that the health service or treatment Intracept procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The patient was noted to have a history of chronic back pain and has reportedly failed treatments including intrathecal pain pump, physical therapy, sacroiliac (SI) joint injections and trigger point injections as well as opioids. The provider feels that the patient's pain is coming from Modic changes and was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). 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. Per 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 (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." 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 standard of care in the general medical community. There is a lack of high-grade evidence and large, long-term studies found in the peer-reviewed medical literature demonstrating this treatment to be either safe or effective or resulting in superior benefits over that of other standard means of treatment. Additional studies are needed to evaluate long-term risks and benefits of this procedure.