Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain.
Treatment: Intracept procedure.
The insurer denied the Intracept procedure.
The determination is upheld.

This is a patient diagnosed with low back pain. The patient was recommended to undergo the Intracept procedure.
There is a letter of appeal from the provider stating that this is an innovative procedure to address chronic low back pain that fulfills a treatment gap for patients with low back pain. The provider states the patient has chronic low back pain due to degenerative disc disease that has resulted in the development of vertebrogenic pain identified by degenerative and plate changes (Modic) on magnetic resonance imaging (MRI). The provider states that the patient's back pain began over six months ago and she has had treatment including lumbar epidural steroid injections but nothing has provided significant sustainable relief. The provider states the patient had an MRI showing degenerative changes at disk space lumbar (L) 3 and therefore, her chronic back pain is coming from the vertebrogenic change at L3.
An MRI of the lumbar spine revealed chronic slight grade 1 anterolisthesis of L4 on L5 without spondylosis; L4- L5 unchanged minimal-mild spinal canal moderate right neural foraminal stenosis with impression upon the exiting right L4 nerve roots secondary to slight grade 1 anterolisthesis, tiny disc bulge and mild facet joint arthrosis with ligamentum flavum redundancy; L3-L4 unchanged mild-moderate left neural foraminal stenosis secondary to small left foraminal broad-based disc protrusion and facet joint hypertrophy; L2-L3 new tiny disc bulge and tiny central focal disc protrusion with associated annular fissure resulting in minimal flattening of the ventral thecal sac; chronic mild endplate spondylosis of the lower thoracic spine at thoracic (T) 12-L1 and L1-L2; chronic mild facet joint arthrosis L4-L5; new minimal inflammatory endplate degenerative changes L2; resolution of minimal inflammatory and plate degenerative changes L4; worsening mild degenerative disc disease L2-L3 and L4- L5; chronic diffuse disc desiccation.
Per a progress note , the patient was seen regarding chronic back pain stating over the past months she has had several episodes of severe pain in the right low back radiating down the right leg. It was noted she had an MRI done this past July showing degenerative changes. She had a third epidural injection and is feeling improvement but still has debilitating pain. The physical examination revealed tenderness at the lumbar region. The plan was for an L2, L3 Intracept procedure. At issue is whether the proposed 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

No, there is no evidence that the proposed health service or treatment 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. This patient is noted to have a history of chronic back pain and radiculopathy that has not responded to epidural injections. The provider feels that the patient's pain is coming from Modic changes and the patient was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation [BVN]). However, it is not clear that the patient has exhausted all other conservative means of treatment or other types of injections or that the patient has been ruled out for surgical treatment. Imaging studies show multiple likely causes for the patient's pain including nerve root impingement, facet arthropathy and varying degrees of stenosis. 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 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. If approved despite non-recommendation, there should be at least 6 months of chronic low back pain following a defined injury, refractory to conservative care, as well as Modic type I or II changes between L3 and S1 on magnetic resonance imaging." 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." Per Becker et al., " Ablation of the BVN for the treatment of chronic lumbar back pain significantly improves 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. Per Fischgrund et al., "Patients treated with radiofrequency (RF) ablation of the BVN for chronic low back pain (CLBP) exhibited significantly greater improvement in ODI(Oswestry Disability Index) 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." Again, there appears to 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 standard of care in the general medical community. There is a lack of high-grade evidence and large, long-term studies found in the peer-reviewed medical literature demonstrating this treatment to be either safe or effective or resulting in superior benefits over that of other standard means of treatment. Additional studies are needed to evaluate long-term risks and benefits of this procedure. There is no evidence to suggest that this procedure is likely to be more beneficial than standard treatment options.