Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Pain Management Services/Radiofrequency Ablation 01 Unit

The insurer denied coverage for Pain Management Services/Radiofrequency Ablation 01 Unit

The denial is upheld 

Reviewer #1:

In assessing whether intraosseous basivertebral nerve ablation using the Intracept device is considered more beneficial for this patient than standard treatments or procedures, it is important to know that the publications in peer-reviewed literature to date have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation for low back pain. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

This patient is not a good candidate for intraosseous basivertebral nerve ablation. The basivertebral nerve ablation procedure with the Intracept device is not the best available treatment for this patient based on clinical evidence of other pain etiology, such as unresolved radicular pain and facet arthrosis, which would not be addressed by the Intracept procedure. Clinic notes state that the patient complains of pain and stiffness in the left lower back and left hip with pain radiating down the left leg to the bottom of the foot. The pain is associated with numbness/tingling on the bottom of the foot. The pain is throbbing and burning in nature. The pain is aggravated with activity such as sitting, standing, walking, and is alleviated by laying down. While the magnetic resonance imaging (MRI) does show evidence of Modic changes at (lumbar) L5-S (sacral) 1, there is also evidence of posterior facet arthropathy and diffuse disc bulge at L4-L5 and L5-S1, as well as Modic changes at S1/S2. The patient's prior MRI showed evidence of a broad-based central disc herniation at L5-S1 that contacted the descending left S1 nerve root. Evidence of other pain etiology such as radicular pain (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression in imaging), facet arthrosis, and Modic at levels other than L3-S1 were considered exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al. 

There are other medications and treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. Any invasive procedure has risk of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

In summary, the supporting publications to date have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation for low back pain. Despite FDA approval, Centers for Medicare and Medicaid Services (CMS) guidelines limit the use of basivertebral nerve ablation to a very select group of patients who do not have evidence of other pain etiology such as radiculopathy or facet arthrosis. It also excludes its use in patients who have MRI evidence of Modic changes at levels other than L3-S1. The Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient and would not address the patient's radicular pain or facet arthrosis. The denial should be upheld.

In summary, the denial of Pain Management Services/Radiofrequency Ablation 01 Unit and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.