Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: lower back pain
Treatment: Outpatient Intracept Procedure
The insurer has denied the Outpatient Intracept Procedure. 
The health plan's determination is upheld.

This is a female with a history of chronic low back pain. She has had physical therapy, injections, and medications without relief. The neurologic exam showed no motor, sensory, or reflex abnormalities. The lumbar magnetic resonance imaging (MRI) showed mild degenerative and endplate changes. The provider has recommended an Intracept procedure at lumbar (L)5- sacral (S)1.

At issue is whether outpatient 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.
I uphold, in whole, the health plan's determination.

The proposed health service or treatment, Outpatient Intracept procedure, is not likely to be more beneficial than any standard treatment or treatments for the insured'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 low back pain] CLBP 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 [low back pain] 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 (BVN), radiofrequency (RF) ablation of the BVN has emerged as a possible minimally invasive procedure to treat LBP. 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 CLBP. However, reproducible large randomized controlled trials (RCTs) 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 ablation in the management of CLBP and improve the quality of life of CLBP patients in the near future". [1]

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. Non-industry funded high-quality, large prospective studies are needed to confirm these findings". [2]

Michalik et al cite:

"BVN radiofrequency ablation appears to be an effective treatment for a subset of patients with CLBP and evidence of Modic change types 1 and 2 in the 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". [3]

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". [4]

I uphold, in whole, the health plan's determination.