Appeal type: Experimental/Investigational
Decision: Upheld

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

This is patient diagnosed with low back pain. The patient was noted to have had chronic back pain and failed conservative treatment and the provider recommended that the patient undergo the Intracept procedure (Intraosseous ablation of the basivertebral nerve).
According to a letter of appeal from the treating provider, the provider states that Intraosseous ablation of the basivertebral nerve is an innovative procedure to address low back pain identified by Modic changes and fulfills a treatment gap for patients with chronic low back pain. The provider states that the patient has a history of low back pain beginning several years ago and has had multiple treatments including chiropractic care, home exercises, medication management and physical therapy. Medications have included nonsteroidal anti-inflammatory drugs (NSAIDs) and Tylenol. The provider states that nothing has provided significant sustainable relief and the patient has a pain level of 3/10. The provider is requesting reconsideration of approval for the Intracept procedure.
There is a magnetic resonance imaging (MRI) scan of the lumbar spine provided. It is somewhat difficult to read as it is enlarged and giant size and the reviewer is not able to view the sides of it. However, there is documentation of multilevel disc herniations/extrusions with nerve impingement at multiple levels, facet arthropathy, and varying degrees of canal and neural foraminal stenosis. This reviewer does not see any mentions of Modic changes in the portions of the report that are visible.
The patient was seen for a follow-up visit with complaints of chronic axial low back pain, worse with activities. It was noted the patient denies any leg pain, numbness or weakness. Tizanidine provides mild temporary relief and he reports the 12 weeks of physical therapy completed made no difference in pain. There was no physical examination performed. It was recommended that the patient undergo the Intracept procedure at L5 and S1 level. It was noted the patient would continue with ibuprofen and tizanidine.
At issue is whether the Intracept Procedure (Intraosseous Basivertebral Nerve Ablation) 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 (Intraosseous Basivertebral Nerve Ablation) 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 and has apparently failed physical therapy, chiropractic treatment, home exercises and medications including NSAIDs and Tylenol. The provider states that they believe the patient's Modic changes are responsible for symptoms. However, the portions of the MRI that are viewable show multilevel disc herniations with nerve root impingement and varying degrees of canal and foraminal stenosis as well as facet arthropathy. There appear to be multiple findings that are likely pain generators. It is not evident that the patient has exhausted other treatment options such as injections. The provider recommended that the patient 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 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 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 that the proposed health service or treatment Intracept Procedure (Intraosseous Basivertebral Nerve Ablation) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.