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 who is diagnosed with low back pain. The records indicate that the patient was recommended to undergo the Intracept procedure, which was denied by the insurance carrier as experimental and investigational. 
Letters of appeal submitted indicate the provider disagrees that this procedure is experimental and investigational. The provider feels that the procedure may have been confused with intradiscal or annular ablations and states that this is a unique procedure that is done within that vertebral body to address vertebrogenic pain identified by Modic changes. The provider states that the patient has a history of chronic low back pain that began over 10 years ago the patient has tried chiropractic care, home exercise, medial branch block injections, physical therapy, radiofrequency ablations and lumbar epidural injections. Medications have included Celebrex, Etodolac, Gabapentin, Meloxicam, Oxycodone and Percocet. The pain is impacting activities of daily living and nothing has provided sustained relief. His pain is rated at 7 out of 10. The provider states the patient had a magnetic resonance imaging (MRI) demonstrated Mixed Modic type I and II changes in the lumbar vertebrae (L)4, L5, sacral vertebrae (S)1 vertebral bodies and the provider believes that this is the source of the patient's chronic back pain. The provider requests reconsideration for approval. 
The MRI of lumbar spine revealed multilevel degenerative disc disease with neural foraminal narrowing. It was noted that there was impingement on the right transiting S-1 nerve root from a disc bulge at L5 - S1. There was bilateral facet joint arthrosis at L4 - L5. There was mention of Modic type I changes at the superior end plate of L5.
The progress notes noted that the patient was seen regarding chronic low back pain present for many years and rated at 7 out of 10. The patient has tried conservative treatment and injections as well as multiple medications. Current medications include AcipHex and Lipitor. The physical examination revealed the patient's pain is minimal with extension and he has pain with forward flexion. He is neurologically intact. 

The patient is noted to have a history of chronic back pain that has not responded to conventional conservative treatment. 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). Although the provider states the patient had Modic type I and II changes at L4, L5, and S1 vertebral bodies, the radiologist only notes Modic type I changes at the superior end plate of L5. There was also noted to be nerve root impingement of the transiting S-1 nerve roots from disc bulge at L5 - S-1 as well as bilateral facet joint arthrosis at L4 - L5, both likely pain generators. 
This procedure remains experimental and investigational as 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 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."