Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low back pain.
Treatment: Intracept procedure.
The insurer denied the Intracept procedure.
The determination is upheld.


This is a male patient 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. Letters of appeal indicate that the provider disagrees with the determination. The provider states that this procedure is a treatment for patients who do not receive adequate relief from traditional conservative methods and don't have instability to indicate fusion is the appropriate treatment. The provider states that the patient has a history of chronic back pain. The patient has tried medial branch block injections, radiofrequency ablation and sacroiliac joint injections. Medications have included Xanax. The pain is impacting activities of daily living such as hobbies and sleeping and nothing has provided sustained or significant relief. It was noted the patient had magnetic resonance imaging (MRI) performed and the provider states that their review demonstrated degenerative endplate changes at lumbar (L) 3, L4 and L5 vertebral bodies and feels that this is the primary cause of the patient's pain. The provider requests reconsideration for approval of the procedure.
Multiple copies of the first page of the MRI of the lumbar spine dated  were provided. There are multiple various findings shown on the page provided indicating retrolisthesis, nerve root compromise at multiple levels, as well as noting degenerative endplate changes at L3 - L4 and L4 - L5.
At issue is the medical necessity of the Intracept procedure.

The requested health service/treatment of Intracept procedure was not medically necessary for this patient.
The patient is noted to have a history of chronic back pain and the provider states that the patient has failed medial branch blocks, radiofrequency ablation and SI joint injections, though there was no documentation indicating the patient had maximized first-line traditional conservative treatments such as physical therapy, chiropractic treatment, or home exercise. The only medication noted to have been failed was Xanax, which is not a medication that would typically be indicated for chronic back pain. The patient does have MRI findings of degenerative endplate changes noted at L3 - L4 and L4 - L5, however, there are also multiple other findings that are likely pain generators. There is a lack of high quality studies evaluating the long-term risks and benefits of the requested 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 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 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 insufficient evidence in 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. The requested procedure is not medically necessary.