Appeal type: Experimental/Investigational
Decision: Upheld

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

This is a patient who was diagnosed with low back pain. Records show that a request for lumbar Intracept procedure was denied by the health plan.
The provider states that this procedure fills a treatment gap for patients who do not receive adequate relief from traditional conservative measures and this patient has tried and failed conservative treatment without relief. The provider knows the patient has had acupuncture, caudal epidural injections, chiropractic treatment, medication management and trigger point injections. Medications tried include Advil and baclofen. The pain is impacting activities of daily living, home exercise, sleep and self-care. Nothing has provided sustained relief. The patient reports pain rated at 8/10. The provider indicates the patient had a magnetic resonance imaging (MRI) scan showing Modic type I changes at lumbar (L) 3, L4, L5 and sacral (S) 1 disc spaces and therefore, this is the source of the patient's pain. The provider is requesting reconsideration for approval.
There is a letter of appeal from the patient stating he has chronic back pain, has gone to a chiropractor for years, has undergone trigger point injections and massage as well as acupuncture without relief. The patient has difficulty performing activities and now going to the bathroom has become an issue as well. The patient is requesting approval for the procedure.
A progress note indicates the patient with complaints of chronic back pain with occasional radiation to the left buttock and both groin. The patient cannot put on shoes or socks. He has had conservative treatment. He tried Baclofen in the past with no relief and otherwise occasionally takes Advil. On examination there was decreased lumbar range of motion, negative straight leg raise, positive tenderness to palpation at the left greater trochanteric bursa. Motor strength was intact, reflexes and sensory exam were normal. The patient was given refills on medication and recommended to undergo the Intracept procedure at L3, L4, L5, S1.
MRI of the lumbar spine showed multilevel degenerative changes with mild spinal canal stenosis at multiple levels. There is an addendum to this note stating that there is mild bone marrow edema involving the inferior aspect of the L4 vertebral body, suggesting the presence of Modic type I changes. At issue is whether the nerve treatment in the spine is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The proposed health service or treatment nerve treatment in the spine is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The patient has complaints of chronic back pain with occasional radiation to left buttock and groin, although exam findings are essentially unremarkable other than decreased range of motion and tenderness at the left greater trochanteric bursa.The provider feels that the patient's pain is coming from Modic changes and he was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). Although it should be noted that the provider states that there are Modic changes at L3, L4, L5, and S1, while the radiology addendum only notes Modic changes at L4. 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." 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 to suggest this treatment would be more beneficial than standard treatment options for this patient's condition.