Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: On campus-outpatient hospital/surgical care Intracept Procedure
The insurer denied coverage for on campus-outpatient hospital/surgical care Intracept Procedure.
The denial is overturned.

This case involves an adult patient diagnosed with low back pain who was being recommended for the Intracept procedure to treat chronic vertebrogenic pain. Magnetic resonance imaging (MRI) of the lumbar spine showed minimal Modic type II endplate degenerative changes at the lumbar (L) 4-L5 level and minimal Modic type II endplate degenerative changes at L2-L3 level. The patient was seen regarding chronic low back pain. The patient presented with non-radicular low back pain described as axial in nature that had occurred for more than 24 months' duration. The physician stated the patient had been refractory to conservative treatment consisting of but not limited to physical therapy, home exercises, nonsteroidal anti-inflammatory drugs (NSAIDs), opiate analgesics, and spinal injections. The patient's activities of daily living are affected by the persistent low back pain with the inability to sit or stand for prolonged periods of time. The patient's pain was rated up to 10/10 at worst with all other reasonable sources of pain ruled out. The physician recommended the Intracept procedure at L5- sacral (S)1 due to the patient's clinical findings and failure of nonoperative measures. The patient received a notice of adverse determination stating that the requested service was experimental/investigational. The physician responded stating that this treatment was founded on 30 years of basic science research linking Modic to chronic low back pain and is an objective biomarker for indicated patients, and paralleled the level 1 clinical evidence, that demonstrates sustained clinical improvement in function and pain with longitudinal follow-up. The physician also stated that the procedure had an excellent safety profile; stating that the treatment has no demonstrated effectiveness, safety, and efficacy is not appropriate. This review pertains to the denial of coverage for on campus-outpatient hospital/surgical care Intracept procedure to treat chronic vertebral genic pain.

Current medical literature has determined that that intraosseous radiofrequency (RF) ablation of the basivertebral nerve is an effective and durable therapy for low back pain and can be offered to patients who have chronic low back pain of greater than 6 months of duration, failure to respond to noninvasive therapies for 6 months, with either Modic Type I or Type II changes at L3-S1. To date, only basivertebral nerve ablation has demonstrated consistent clinical efficacy in the treatment of vertebrogenic low back pain with intraosseous RF ablation being studied in Level I randomized controlled trials (RCTs). 

The most widely used and studied technique (The Intracept Procedure, Relievant Medsystems Inc.) has demonstrated consistent, statistically significant, clinically meaningful, and durable improvements in pain and function, as well as an excellent safety profile. The information provided for the review confirmed that the patient had Modic type II changes within the L3-S1 dermatomal region, failure of the 6 months of conservative measures, and complaints of chronic low back pain. Based upon this
information, it was determined that the proposed treatment with the Intracept surgery would be a reasonable course of care for this individual.  Evidence has proven that the Intracept procedure was FDA (food and drug administration) approved in 2016 and is safe and effective for treating chronic vertebral genic pain. The prior determination is overturned.

In summary, the denial of on campus-outpatient hospital/surgical care Intracept Procedure to treat chronic vertebrogenic pain and coverage for the requested treatment should be overturned.