Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Back Pain
Treatment: Basivertebral nerve ablation
The health plan denied the requested basivertebral nerve ablation as not medically necessary. 
The health plan's determination is upheld.

The patient is diagnosed with back pain. The patient was recommended to undergo the Intracept Procedure (intraosseous basivertebral nerve ablation).

The provider states that they disagree with the denial, and this is an innovative procedure to address chronic low back pain identified by Modic changes, which fulfills a treatment gap for patients with chronic back pain. The provider states that the patient has a history of low back pain that began over 4 years ago. The patient has had multiple treatments including activity modification, chiropractic care, home exercises, injections, lumbar epidural steroid injections, physical therapy and radiofrequency ablation. Medications have included Aspirin, Hydrocodone, non-steroidal anti-inflammatory drugs (NSAIDs), over-the-counter medications, Tizanidine, Trazodone and Tylenol. Pain is impacting activities of daily living and severity is rated at 8/10. The patient had a magnetic resonance imaging (MRI) performed showing mixed Modic type I and II changes at disc spaces L (lumbar) 3-L4 and L4-L5 and therefore the patient's pain is coming from vertebrogenic changes in L3, L4 and L5. The provider is requesting approval of this procedure.

A later MRI of lumbar spine showed cervical and lumbar degenerative changes. There were disc bulges at L3-L4 and L4-L5, mild flattening of the thecal sac/central canal narrowing L3-L4 and L4-L5, mild right foraminal narrowing L3-L4, and Schmorl's nodes superior to the endplate at L5. There was no mention of Modic changes.

According to a progress report, the patient was seen for a follow-up visit with a four-year history of low back pain has failed conservative treatment and injection.  It was noted the patient will be scheduled for basivertebral nerve ablation at L3, L4, L5.

At issue is the medical necessity for the requested basivertebral nerve ablation.

I uphold, in whole, the health plan's determination of medical necessity.

The requested health service/treatment of a basivertebral nerve ablation is not medically necessary for this patient.

The patient is noted to have a history of chronic back pain that has not responded to conventional conservative treatment and injections. 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, the MRI shows multiple findings, though no indication of Modic changes based on the radiologist read. The Intracept 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." 

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. The requested procedure is not medically necessary.