Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2:

Diagnosis: Back pain

Treatment: Thermal destruction of intraosseous basivertebral nerves (procedure to destroy some of the nerves between the spinal bones of the lower back)

The insurer denied coverage for thermal destruction of intraosseous basivertebral nerves (procedure to destroy some of the nerves between the spinal bones of the lower back)

The denial is upheld

Basivertebral nerve (BVN) ablation using the Intracept procedure is Food and Drug Administration (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 - Magnetic Resonance Imaging (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 Services (CMS) coverage guidance is currently not available for thermal destruction of the intraosseous BVN for vertebrogenic lower back pain. A proposed Local Coverage Determination (LCD) is currently in progress (DL39420). The CMS proposed LCD indicates 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; and evidence of Type 1 or Type 2 Modic changes on 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 BVN ablation. The BVN ablation procedure with the Intracept device is not the best available treatment for this patient based on lack of evidence in the medical record of Modic changes. There is no mention in the MRI report, of any Modic changes. In fact, the MRI report specifically states: "The bone marrow signal intensity within normal limits."

There are other evidence-based medications and treatments available to this patient. Any invasive procedure has risk of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

The supporting publications to date have been mostly company sponsored, have had methodological flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency. Despite limited FDA approval in a very select group of patients, there is no current CMS approval for the use of the Intracept procedure, with a proposed LCD a work in progress. Furthermore, without MRI evidence of Modic changes at any level, the Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient.

In summary, the denial of thermal destruction of intraosseous basivertebral nerves (procedure to destroy some of the nerves between the spinal bones of the lower back) 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.