Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intraosseous Nerve Ablation
The health plan denied the requested procedure as experimental/investigational. 
The health plan's determination is upheld.

This is a male patient. The patient is diagnosed with lumbar intervertebral disc degeneration. The provider submitted a request for the patient to undergo the Intracept procedure, which was denied by the insurance carrier as experimental and investigational. This determination is under appeal, which is the subject of this review.

A letter of appeal from the treating provider states that this procedure is an innovative procedure to address chronic low back pain identified by Modic changes and fulfills a treatment gap for patients with chronic back pain. The provider states that the patient has chronic low back pain due to degenerative disc disease that has resulted in development of vertebrogenic pain identified by degenerative endplate changes (Modic) on magnetic resonance imaging (MRI). The patient has had back pain for over one year and has tried multiple treatments including activity modification, medication management and radiofrequency ablations. Medications have included Cyclobenzaprine, Duloxetine, Gabapentin, Hydrocodone, Meloxicam, Naproxen, Prednisone and Tizanidine. Pain is impacting activities of daily living, and nothing has provided significant sustainable relief. Pain averages 7/10. The provider states the patient's MRI shows Modic type II changes at (lumbar) L4 - L5 and therefore his pain is coming from vertebrogenic changes at L4 - L5.

An MRI of the lumbar spine revealed no focal herniations, Modic type II and plate changes at L4 - L5 and areas of edema between the posterior facets.

The patient was seen via telemedicine appointment/telephone call noted to be status post left L4 - L5 radiofrequency ablation which provided about 10 to 20% (percent) pain relief for three weeks. The patient complains of ongoing axial low back pain and denies any radicular symptoms. The pain is rated at 7/10. Conservative measures have included time, rest, and medications. The plan was to proceed with the Intracept procedure at L4 - L5.

At issue is whether the proposed health service or treatment of Intraosseous Nerve Ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

I uphold, in whole, the health plan's determination regarding the proposed health service.

The patient is noted to have a history of chronic back pain that has not responded to conventional conservative treatment including activity modification, medication and facet radiofrequency ablation. However, there was no documentation that the patient has had any active conservative treatment such as physical therapy or chiropractic care. The provider feels that the patient's pain is coming from Modic changes and has recommended the patient to undergo the Intracept System (intra-osseous basivertebral nerve ablation). This 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.

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 that this treatment would be likely to be more beneficial than other standard treatment options for this patient's condition.