Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain. 
Treatment: Intraosseous basivertebral nerve ablation. 
The health plan denied Intraosseous basivertebral nerve ablation. 
The determination is upheld. 

The patient is a male with a history of chronic low back pain (LBP). He has had physical therapy, injections, and medications without relief. The neurologic exam shows no motor, sensory, or reflex abnormalities. The lumbar magnetic resonance imaging (MRI) shows multilevel degenerative changes. The provider has recommended a Lumbar 5-Sacral 1 (L5-S1) intraosseous basivertebral nerve ablation (Intracept procedure). 
At issue is whether the proposed treatment is likely to be more beneficial than any standard treatment for the patient's condition. 
The health plan's determination regarding the proposed health service or treatment is upheld in whole. 
The procedure is not likely to be more beneficial than any standard treatment or treatments for the patient's life threatening or disabling condition or disease. While this is a promising technology, the literature describes further research needing to be performed, particularly from non-industry sources. Urits et al cite "Chronic LBP (low back pain) is a difficult yet common diagnosis that affects a significant portion of patients worldwide. In efforts to combat this debilitating disease, researchers have made great progress in understanding the pathophysiology of LBP in addition to unveiling the anatomy of the vertebrae in search of appropriate treatment options. As a result, with the growing evidence supporting the vertebrogenic model that involves the basivertebral nerve ablation (BVN), radio frequency (RF) ablation of the BVN has emerged as a possible minimally invasive procedure to treat LBP (low back pain). Several studies have supported the safety, durability, and efficacy of RF ablation of the BVN. There is also convincing evidence that BVN ablation is more beneficial than the current standard of care for the treatment of chronic LBP. However, reproducible large randomized controlled trials (RCT) are still needed for clinicians to gain full confidence in utilizing this treatment in practice. Additionally, further research is needed on the anatomy of the vertebrae to optimize the method of treatment. These studies can help to elucidate the role of RF (radio frequency) ablation in the management of CLBP (chronic low back pain) and improve the quality of life of CLBP patients in the near future." 
Conger et al cite "There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the BVN (basivertebral nerve ablation). Non-industry funded high-quality, large prospective studies are needed to confirm these findings." 
Michalik et al cite "BVN radiofrequency ablation appears to be an effective treatment for a subset of patients with chronic LBP (low back pain) and evidence of Modic change types 1 and 2 in the Lumbar 3 (L3) to S1 vertebral body endplates (VEPs) who have failed to respond to conservative treatment. However, all studies performed to date have been industry sponsored, and future non-industry-funded trials will be needed to confirm these results." 
In a recent review of the literature, Schnapp et al cite, "Current research has shown that basivertebral nerve ablation might be a promising treatment for chronic low back pain in patients exhibiting Modic type 1 or 2 endplate changes, while additional research on the association between Modic changes and low back pain is still needed to gain widespread use and acceptance of this new treatment modality. The introduction of new devices and a larger number of independent studies would greatly enhance the confidence in the outcomes reported with this treatment modality in order to ultimately benefit patients, clinicians, and society." 
Therefore, the proposed treatment is experimental/investigational.