Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain. 
Treatment: pain management services/ablation, 3 units. 
The insurer denied coverage for pain management services/ablation, 3 units. 
The denial is upheld. 

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. 

Basivertebral nerve (BVN) ablation using the Intracept procedure is FDA approved in a very select group of patients who have - A history of chronic low back pain (cLBP) of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - MRI demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from lumbar (L)3 to sacral (S)1; and - Activities of daily living that are limited by persistent low back pain; and - All other reasonable sources of pain have been ruled out. 

Centers for Medicare and Medicaid (CMS) guidelines (DL39420/L39420 - Thermal Destruction of the Intraosseous Basivertebral Nerve for Vertebrogenic Lower Back Pain) indicate that thermal destruction of the intraosseous BVN will be considered medically reasonable and necessary for the treatment of cLBP in patients who meet ALL the following criteria: chronic lumbar back pain of >=6 months duration that causes functional deficit measured on a pain or disability scale; and documented failure to respond to >=6 months of non-surgical management; and absence of untreated radiculopathy or neurogenic claudication; and absence of non-vertebrogenic pathology per clinical assessment or radiology studies that could explain the source of the patient's pain, including but not limited to fracture, tumor, infection, or significant deformity; and evidence of Type 1 or Type 2 Modic changes on magnetic resonance imaging (MRI), such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypotensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hypertensive signals (Type 2 Modic change), in one or more vertebrae from L3-S1. 

This patient is not a good candidate for intraosseous basivertebral nerve ablation. There are other evidence-based treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. 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, facet arthrosis. MRI showed evidence of facet arthropathy at L3-4, L4-5, and L5-S1. 

There are other evidence-based 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 denial of pain management services/ablation, 3 units requested, 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.