Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: 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 was diagnosed with low back pain. The patient was recommended to undergo the Intracept procedure.

The letter of appeal from the treating provider notes that this is an innovative procedure to address chronic low back pain identified by Modic changes and fulfills a treatment gap for patients with chronic low back pain. The provider indicated that the patient has had low back pain for more than 22 years. The patient has tried multiple treatments including chiropractic care, heat, ice, injections, medication management, physical therapy, and radiofrequency ablations without sufficient or sustained relief. The patient's pain ranges from 6 to 7 out of 10. The provider stated that the patient had a magnetic resonance imaging (MRI) performed that demonstrated degenerative endplate changes at disc spaces lumbar (L) 4, L5, and sacral (S) 1 and therefore his chronic back pain is coming from vertebrogenic changes at L4, L5, and S1.

Another MRI of the patient's lumbar spine showed a slightly more conspicuous degenerative endplate edema signal at L5-S1. There is a mild edema signal about the facets at L4-L5. The L4-L5 disc bulge at the center contributes to mild spinal canal stenosis and moderate bilateral foraminal narrowing which was similar to his prior exam. 
It was noted that the patient did well with lumbar medial branch blocks and radiofrequency ablations. His most recent procedure was a lumbar radiofrequency ablation. During the last visit the patient's pain had returned and they decided to proceed with updated lumbar spine imaging. There are no medications documented for the patient. The patient's range of motion remained limited with a negative straight leg raise. There was a positive facet loading maneuver and negative provocative tests otherwise. There were no neurological deficits. 

 According to the 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. According to Becker, et al, "Ablation of the BVN for the treatment of chronic lumbar back pain significantly improves the 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. According to Fischgrund, et al, "Patients treated with radiofrequency (RF) ablation of the BVN for chronic low back pain (CLBP) exhibited significantly greater improvement in the Oswestry Disability Index (ODI) at 3 months and had a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain." Again, there appear to be positive initial results, however, the study was fairly small (225 patients with chronic back pain) and 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 the standard of care in the general medical community.