Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain. 

Treatment: Procedure code 22899 Unlisted procedure, spine (Intracept) and procedure code C9752 Destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum. 

The insurer denied coverage for procedure code 22899 and procedure code C9752. 

The denial is upheld. 

This is a male patient who has been recommended to undergo the Intracept procedure to treat chronic vertebrogenic pain. The documentation indicated the patient has a history of low back pain with a trial of prior multiple treatments that include physical therapy as well as home exercises, medial branch blocks and medication management. The documentation indicated the patient has utilized meloxicam and Tylenol. The patient has disabling pain affecting his quality of life. The physician indicated they have exhausted all traditional non-operative treatment. The documentation indicates the patient was seen for an initial examination where the patient had complaints of chronic axial low back pain. The documentation indicated he has had failed conservative care. The physical examination revealed decreased range of motion to the back with pain with extension and facet loading. The recommendation was made for the patient undergo bilateral lumbar vertebra (L)3, L4 and L5 medial branch blocks while awaiting approval for the requested procedure. Magnetic Resonance Imaging (MRI) findings demonstrated Modic changes. 

Intracept has been cleared by the Food and Drug Administration (FDA) for treatment of vertebrogenic low back pain with relevant imaging demonstrating Modic changes. Review of the literature reveals two randomized controlled trials (RCTs) (Smart and Intracept trials). In the Smart trial, participants randomized to the sham group were allowed to crossover at the 12 month mark. 73% of the sham group participants elected to cross over at the 12 month mark thus radiofrequency ablation (RFA) treatment participants acted as their own control group for the 24 month outcomes. Due to the high rate of crossover, long term comparative data is not available. The Intracept trial is limited by short term follow-up, lack of a sham group, and allowance of crossover at 3 months. Therefore, further high quality evidence of efficacy is needed prior to considering the Intracept procedure as being medically necessary. 

A clinic note indicated the patient was recommended to undergo bilateral L3, 4, 5 diagnostic medial branch blocks. The patient indicated in a letter that he received his first blocker shot and after a few weeks passed, he could already see this procedure was a very temporary fix. It is not clear based on the documentation provided, the percentage and duration of relief with the medical branch block procedure that was recommended, although the patient does indicate he has temporary relief. Therefore at this time, based on the documentation provided, the Intracept procedure is unlikely to be more beneficial than the standard approaches. 

The carrier's denial of coverage for procedure code 22899 Unlisted procedure, spine (Intracept) and procedure code C9752 Destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum should be upheld.