Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Surgical procedure to treat low back pain (procedure code 64628 and 64629).

The insurer denied coverage for surgical procedure to treat low back pain (procedure code 64628 and 64629).

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.

For individuals who have vertebrogenic low back pain who receive ablation of basivertebral nerves, the evidence includes two randomized controlled trials (RCTs) (SMART and INTRACEPT trials, both sponsored by device manufacturer Relievant Medsystems, Inc.). Relevant outcomes were symptoms, functional outcomes, quality of life and treatment-related morbidity. In one RCT, at 12 months, 73% (percent)  of patients crossed over to the active treatment group and therefore long-term comparative data is not available. 

Centers for Medicare and Medicaid Services (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 reasonable for the treatment of cLBP (chronic low back pain) in patients who meet ALL the following criteria: chronic lumbar back pain of (greater than or equal to) >=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 I or Type II 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 I Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hypertensive signals (Type II Modic change), in one or more vertebrae from L3-S1.

This patient is not a good candidate for intraosseous basivertebral nerve ablation. The patient does not meet CMS criteria for use of the Intracept procedure due to insufficient evidence in the medical record of Modic endplate changes on MRI, as well as a body mass index (BMI) > (greater than) 40. The patient's MRI makes no mention of Modic changes, vertebral endplate changes, or bone marrow changes. In fact, the MRI report clearly states that the bone marrow signal is normal. A clinic note states that the patient's BMI is 42.13. Clinic notes also state that the patient reports onset of symptoms following previous "worker's compensation (WC) injury." 

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 denial of a surgical procedure to treat low back pain (procedure code 64628 and 64629) 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 risk are substantially increased over standard treatments.