Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low back pain

Treatment: Intracept surgical procedure

The insurer denied coverage for Intracept surgical procedure. The denial upheld.

This patient is a female who reports low back pain for over 2 decades. She has failed multimodal conservative management including Physical Therapy (PT), Epidural Steroid Injections (ESI), and oral medications. She is significantly impaired for multiple Activities of Daily Living (ADL) because of this pain. She has a normal neurological exam. A recent Magnetic Resonance Imaging (MRI) is significant for mild uncovering of the intervertebral disc and a mild disc bulge. No significant central canal, subarticular zone, or foraminal narrowing noted. The provider, Ariel Sionov, cites Modic type 2 changes at L5-S1; However, there is no mention of such degenerative changes by the Radiologist. The physician is requesting an authorization for L5-S1 basivertebral nerve coagulation (Intracept).

According to Fischgrund, J.S., et al. (2018), "To evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP". They go on to conclude, "Patients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in 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. These slides can be retrieved under Electronic Supplementary Material". Khalil, J. G., et al. (2019) states, "Current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care"

Lastly, according to Rodriguez, T. (2016), "In July 2016, the US Food and Drug Administration (FDA) approved a radiofrequency ablation device* that targets the basivertebral nerve for the treatment of chronic low back pain.5 The INTRACEPT Intraosseous Nerve Ablation System from Relievant Medsystems, Inc. is intended for patients who have not responded to conservative treatment approaches for pain that has persisted for a minimum of 6 months. The FDA approval was based on results of Relievant's prospective, double-blind, randomized, sham-controlled clinical trial of 225 patients. The findings show that more than 75% of completers in the treatment arm demonstrated improvement of 10 points or more on the Oswestry Disability Index (ODI), and this group had a 48% reduction in scores from baseline to the 3-month follow-up assessment Though these initial findings seem promising, the utility of the device may be limited to a small number of patients, according to Steven P. Cohen, MD, director of the division of pain medicine and professor of anesthesiology and critical care medicine, physical medicine and rehabilitation, at the Johns Hopkins University School of Medicine. He is aware of the device but said that he attends all major pain conferences and has not seen any relevant data at those events or in major journals."      

The plan has acted reasonably and with sound medical judgment and in the best interest of the patient. In the Radiologist report for the MRI there is no mention of advanced degenerative changes of the L5-S1 disc space or end-pates. Therefore, the request for basivertebral nerve coagulation does not meet criteria and is not medically necessary in this case.
 
Based on the above, the medical necessity for the Intracept surgical procedure is not substantiated.   The insurer's denial is upheld.