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 who was diagnosed with low back pain. Records indicate that the patient was recommended to undergo the Intracept Procedure (intraosseous basivertebral nerve ablation), which was denied by the health plan. 

There is a letter of appeal from the provider stating that they disagree with the denial of the Intracept Procedure as this is an innovative procedure to address chronic low back pain identified by Modic changes and fulfills a treatment gap for patients with chronic back pain. The provider notes that the patient has a history of low back pain that began over a year ago and has tried multiple treatments including lumbar epidural injections and physical therapy. Medications have included Tylenol. Pain is impacting activities of daily living and ranges from 4-9/10. Nothing has provided significant sustainable relief. The provider stated that she had a magnetic resonance imaging (MRI) scan performed  demonstrating Modic changes at lumbar (L) 4-L5 and L5-sacral (S) 1 disc spaces and therefore this is the source of her chronic back pain. The provider is requesting reconsideration for approval.

There is a progress note indicating the patient had complaints of back pain rated at 2-9/10, 70% (percent) in the low back and 30% in the left leg. The patient has tried physical therapy and epidural injections as well as medications. The current medication was Tylenol. On examination, there was limited lumbar range of motion in all planes, decreased motor strength at 4/5 with bilateral hip extension and hip abduction. There was diffuse tenderness over the lumbar paraspinals. Negative straight leg raise bilaterally, positive Kemp's and pain with flexion. The patient was recommended to undergo lumbar medial branch blocks at bilateral L4-L5 and L5-S1 facet joints with plans for radiofrequency ablation after a diagnostic medial branch block and it was also noted the patient was recommended to undergo the Intracept Procedure but will proceed with palliative steroid injections while they await insurance approval.

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.

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.

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 the patient was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). However, there is no official MRI report provided for review and the patient is also noted to have exam findings suggestive of radiculopathy as well as possible facet joints as a primary pain generator with no evidence to suggest Modic changes given no MRI report was provided. 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." 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." 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 that this procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.