Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain.
Treatment: Intracept Procedure (interosseous basivertebal nerve ablation).
The insurer denied the Intracept Procedure.
The determination is upheld.

The patient was diagnosed with lumbar spondylosis without myelopathy or radiculopathy. Records provided indicate the patient was recommended to undergo the Intracept procedure (interosseous basivertebal nerve ablation) which was denied by the health plan.
There is a letter of appeal from the treating provider stating that the intraosseous ablation of the basivertebral nerve 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 states that the patient has a history of low back pain beginning several years ago and has had multiple treatments including chiropractic care, facet injections, home exercises, medial branch blocks, medication management and trigger point injections. Medications have included Tylenol and nonsteroidal anti-inflammatory drugs (NSAIDs). The provider states that the patient's pain is having a significant impact on activities of daily living such as bending, lifting, home exercises and standing and nothing has provided significant sustainable relief. Pain is rated at 9/10. The provider states the patient underwent an magnetic resonance imaging (MRI) and the patient's back pain is coming from vertebrogenic changes at lumbar (L) 3, L4, L5. The provider is requesting reconsideration for approval of this procedure.
There is a letter of appeal from the patient. The patient reports the back pain is debilitating and he cannot carry on in his normal life. He states he is a general manager of a very busy car dealer in and is on his feet many hours of every day with a two hour commute each way and notes that the commute alone causes him to be combined to his office for several hours when arriving at the dealership and prohibits him from doing necessary duties throughout the day. He states he has gained more than 10 pounds of weight due to just sitting around without exercising and is getting very depressed as he was in amazing physical and mental shape for someone his age.
A progress report indicates the patient seen regarding chronic low back pain right greater than left it remains axial and denies any symptoms into the lower extremities. Reports pain is severe. He has tried and failed Tylenol and multiple NSAIDs without relief as well as has been going to a chiropractor with improvement throughout the years but not as of most recent time. Physical examination showed decreased lumbar range of motion, pain with extension and facet loading record and left, pain with flexion; negative straight leg raise; normal motor strength and sensation. The patient was recommended to undergo lumbar medial branch blocks at L2, L3, L4 and L5 on the right and it was noted they would obtain authorization for the Intracept procedure. The provider references an MRI  but this report was not submitted for review. 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 was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). The provider references an MRI of the lumbar spine that reportedly showed Modic changes, however, this MRI report was not submitted for review. 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 sacral (S) 1 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 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.