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 female patient diagnosed with low back pain.  There were letters of appeal submitted from the provider stating that the provider disagrees that this procedure is experimental or investigational and 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 low back pain. The provider noted that the patient has a history of low back pain that began several years ago. She has tried multiple treatments including lumbar epidural steroid injections, medial branch block injections and sacroiliac joint injections. The pain is impacting activities of daily living and nothing has provided significant relief. The pain ranges from 7-8/10. The provider states the patient had a magnetic resonance imaging (MRI) scan performed demonstrating Modic type II changes at disc spaces lumbar (L) 5-sacral (S) 1 and the provider feels that this is where the patient's pain is coming from. The provider requests reconsideration for approving this procedure.
Per a progress note, the patient was seen for a follow-up visit reporting 50 percent (%) pain reduction after bilateral medial branch blocks but has residual pain at the lumbosacral junction right worse than left. This is chronic axial back pain of several years duration. Sacroiliac injections and epidurals have not been effective and a medial branch block only got rid of 50% of her pain. It was noted that physical therapy has not been helpful. She has not done chiropractic treatment. Current medication is piroxicam as needed. The physical examination revealed normal range of motion, normal motor strength, and normal sensation. Facet joint loading signs were positive. The patient was recommended to try chiropractic treatment and it was noted they "would like to get the ball rolling on Intracept." At issue is the medical necessity of the Intracept procedure.
The requested health service/treatment of Intracept procedure is not medically necessary for this patient. The patient was noted to have a history of chronic back pain and reportedly did not respond to physical therapy, though it was noted the patient had not tried chiropractic treatment and was recommended for a trial. The only medication noted to be tried includes piroxicam. The patient had 50 percent (%) improvement with medial branch blocks and there was no indication that the patient proceeded with radiofrequency ablation for further pain relief. There are a lack of high quality studies evaluating the long-term risks and benefits of the Intracept 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." 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.