Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Back pain.
Treatment:  Outpatient Intracept System (thermal heat destruction of a nerve in spine).

The insurer denied outpatient Intracept System (thermal heat destruction of a nerve in spine).  The denial is upheld.

This is an adult male patient. The patient is diagnosed with vertebrogenic low back pain. The provider states that the Intracept procedure received Food and Drug Administration 
(FDA) clearance and therefore believes that Food and Drug Administration clearance means that the procedure is safe and effective. The provider notes that the patient has a history of chronic low back pain that began after falling down a flight of stairs. The patient has tried chiropractic care, lumbar epidural steroid injections and physical therapy. Medications have included cyclobenzaprine, hydrocodone, hydromorphone, ketorolac, lidocaine patches, meloxicam, methocarbamol and methylprednisolone. The pain is impacting activities of daily living such as walking and nothing has provided significant sustained relief. The pain is rated at nine out of ten (9/10). The provider notes that the patient had a magnetic resonance image (MRI) performed demonstrating degenerative endplate changes in the L (lumbar) 5 vertebral bodies, and therefore the provider believes that this is the source of the patient's chronic back pain. Magnetic resonance image of lumbar spine revealed small disc bulge at L4-L5 with annular tear and superimposed right paracentral disc protrusion causing right lateral recess narrowing and mild right neural foraminal narrowing. The disk contacts the right L5 nerve root.  Disc bulge at L5-S1 with marginal osteophytes and superimposed central and left foraminal disc protrusions causing mild to moderate bilateral neural foraminal narrowing and impingement of the bilateral L5 nerve roots. There was noted to be degenerative endplate changes at L4-L5 and L5-S1.

The health plan should not cover the proposed treatment.

This treatment is considered experimental and investigational, which was noted as the reason for multiple previous denials.

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 degenerative endplate changes and was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). However, it should be noted that the lumbar spine magnetic resonance image shows multiple findings that are likely pain generators including an annular tear at L4-L5 as well as disc protrusions at L4-L5 and L5-S1 and impingement of the bilateral L5 nerve roots.

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." 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 experimental and investigational.