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 overturned. 

This is a male patient with a past medical history of chronic axial low back pain, lumbar facet arthropathy, and vertebrogenic pain. The patient noted his pain had been present for over a year. It was constant, aching, and sharp. The patient denied radicular symptoms, or bowel/bladder dysfunction. The pain continued to impede his daily life. It impeded his functional abilities. He had tried physical therapy with minimal effect. He had also been treated with multiple nonsteroidal anti-inflammatory drugs (NSAIDs) with minimal relief. The patient continued to stay active at home with stretching, walking, and swimming but often remained limited due to pain. He had seen a spine surgeon who recommended him to be treated with pain management and the Intracept procedure given the Modic changes on Magnetic Resonance Imaging (MRI). Physical examination revealed the straight leg raise was negative. The strength was full in the lower extremities. The request was received for the Intracept procedure. 

Per reference 1, in patients receiving the treatment, 60% of patients receiving the treatment decreased opiate usage. These patients also had improvements in both Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) measurements. 

Per reference 2, clinical improvements in the ODI, VAS, and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years. 

Per reference 3, comparing the radiofrequency (RF) ablation arm to the standard care arm, the mean changes in ODI at 3 months were -25.3 points versus -4.4 points, respectively, resulting in an adjusted difference of 20.9 points. Mean changes in VAS were -3.46 versus -1.02, respectively, an adjusted difference of 2.44 centimeters (cm). In the RF ablation arm, 74.5% of patients achieved a >=10-point improvement in ODI, compared with 32.7% in the standard care arm. 

The procedure received United States Food and Drug Administration (FDA) 510(k). This is based on improved ODI, VAS scores sustained at 24 months. 

The patient meets the criteria used for inclusion in the studies. He has chronic low back pain of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between lumbar vertebra (L)3 and sacral vertebra (S)1. His is at L4 and L5. 

The patient tried conservative measures and injections prior to this point. His options now include surgery or stronger medications and he and does not want to proceed to surgery or risk addiction with controlled substances. 

The patient fits the patient selection criteria used in the studies of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. He has axial low back pain and MRI findings consistent with the inclusion criteria. This is a reasonable therapy with studies that prove efficacy and is less invasive than the alternative, spinal fusion.

The safety profile of this procedure is comparable to kyphoplasty, minimally invasive lumbar decompression (MILD) procedure, and other minimally invasive spinal interventions. The adverse risks of this procedure are decreased compared to spinal fusion surgery. The requested procedure is likely to be more beneficial than any other existing standard health service. 

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 overturned.