Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low back pain
Treatment: Nerve treatment in the spine
The insurer has denied the appeal for the nerve treatment in the spine.
The determination is upheld.

The patient is a male who was diagnosed with low back pain. The patient was recommended to undergo the Intracept procedure, which was denied by the health plan. The determination was appealed and the denial was upheld. The provider is again appealing this determination.

An MRI of lumbar spine revealed broad-based central disc protrusion at (lumbar) L5 - (sacral) S1 resulting in severe right and moderate to severe left neural foraminal stenosis with impingement about the exiting right L5 and descending right S1 nerve roots. The MRI also shows moderate to severe bilateral neural foraminal stenosis at L4 - L5 due to diffuse disc bulge. There were degenerative endplate changes at L5 - S1.

There is a progress note that documents that the patient had complaints of low back pain status post lumbar medial branch blocks at bilateral L2, L3, L4 and reporting no improvement in pain. The patient's pain was rated at 6-7/10. He states he failed physical therapy in the past without benefit. He occasionally uses Norco and also uses Enbrel for psoriatic arthritis. The physical examination revealed limited lumbar range of motion. The patient had facet loading that caused central midback pain bilaterally. The patient's sensation was grossly intact, strength was 5/5 and his reflexes were normal.

The issue for review is the medical necessity for the Intracept 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." 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" 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 radio frequency (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.