Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal. 
Treatment: Surgical Services/ Intracept Procedure. 
The insurer denied Intracept Procedure. 
The denial is upheld. 

This is a female patient diagnosed with back pain. The patient was recommended to undergo the Intracept procedure, which was denied by her health plan as experimental and investigational. The provider is appealing this decision.
The patient's magnetic resonance imaging (MRI) of the lumbar spine revealed a left paracentral disc herniation at lumbar (L)1 - L2 and right paracentral disc herniation at L2-L3 causing mild decompression. At L3 - L4 there is an annular bulge flattening the thecal sac with mild bilateral foraminal narrowing. At L4 - L5 there is circumferential annular bulge flattening the thecal sac with foraminal narrowing right greater than left. At L5 - sacral (S)1 there is annular bulge eccentric to the right causing right lateral recess stenosis and moderate bilateral foraminal narrowing unchanged. There is also an addendum on this report that there are Modic type II endplate degenerative changes at L1 - L2, L4 - L5 and L5 - S1.
There is a visit note stating that the patient has low back pain present for at least six months that has not responded to at least six months of conservative treatment. The plan was for Intracept ablation procedure at L4 - S1.
At issue is the medical necessity of the Intracept Procedure.

The health plan's determination of medical necessity is upheld in whole.

The requested health service/treatment of Intracept Procedure is not medically necessary for this patient.
This 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). However, her MRI shows multiple other potential pain generators including multiple disc herniations and varying degrees of moderate to severe lateral recess and foraminal stenosis. This procedure remains experimental and investigational as 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 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 Occupational 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." There appears to be 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.
Therefore, the requested service of Intracept Procedure is not medically necessary.