Appeal type: Experimental/Investigational
Decision: Upheld

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

The patient is diagnosed with low back pain. The patient is noted to have failed conservative treatment and the provider recommended that the patient undergo the Intracept procedure. In a letter of appeal, the provider states that their patient's primary pain is chronic low back pain due to degenerative disc disease that resulted in the development of vertebrogenic pain identified by degenerative endplate changes (Modic) on their magnetic resonance imaging (MRI). The provider states the pain began more than six months ago. She has had multiple treatments including home exercises, medial branch block injections, medication management, microdiscectomy, physical therapy, radiofrequency ablation, sacroiliac joint injections, transforaminal epidural steroid injections and trigger point injections. The patient has tried medications including Ambien, Aspirin, celecoxib, gabapentin, and nonsteroidal anti-inflammatory drugs (NSAIDs) but continues with the pain level of 7/10. The provider states her MRI shows degenerative endplate changes at lumbar (L) 4, L5, sacral (S) 1 disc spaces and therefore, her chronic back pain is coming from vertebrogenic changes at these levels. The provider is requesting reconsideration of the Intracept procedure.
MRI of lumbar spine dated 12/6/19 revealed postsurgical changes at L4 - L5. Minimal bulging annuli at L3 - L4 and L4 - L5. It was noted to be loss of disc height and Modic type II endplate signal changes at L4 - L5 where there was also evidence of a prior left laminotomy with excision of a large disc herniation that was noted on prior study.
According to the progress note, the patient had complaints of chronic low back pain greater than six weeks rated at 7/10 that recently worsened about three weeks ago. Pain was described as located in the low back and radiating down the left leg into the ankle described as shooting and dull when radiating and associated with numbness and tingling. It was noted the patient had tried and failed multiple conservative treatments. Physical examination revealed no midline tenderness, no sciatic notch tenderness. There was paraspinal muscle tenderness bilaterally and mild restriction with lumbar extension. Lower extremity motor strength and sensation was normal. There was pain with facet loading bilaterally and pain with palpation at the SI joints bilaterally. The patient was recommended to undergo lumbar trigger point injections on this visit, continued chiropractic treatment and it was noted they would schedule the patient for Intracept procedure (intraosseous nerve ablation) at the L4, L5, S1 levels.
At issue is whether the 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.
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.
Records provided indicate the patient has a history of chronic back pain with radiculopathy as well as sacroiliac (SI) joint pain. The patient was noted to have failed conservative treatment including multiple injections and medications. It is noted on MRI that the patient had Modic type II endplate changes and the provider states that they believe the patient's pain is coming from vertebrogenic changes. The patient was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). There are 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 (BVN) 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 Oswestry Disability Index (ODI) 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 this treatment would be more beneficial than that of other standard treatments for this patient's condition.