Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower back pain

Treatment: basivertebral nerve ablation, procedure code 64628

The insurer denied coverage for basivertebral nerve ablation, procedure code 64628

The denial is upheld 

The 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. 

For individuals who have vertebrogenic low back pain who receive ablation of basivertebral nerves (BVN), 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. Limitations to the other RCT include lack of a sham control and short duration of follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Basivertebral nerve 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 imaging demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L (lumbar) 3 to S (sacral)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.

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 due to lack of evidence of Modic changes on imaging. Clinic notes state the patient has Modic changes at lumbar (L)4, L5 and sacral (S)1, however, review of the imaging report finds no mention of Modic changes at any level. In fact, normal bone marrow signal was noted. In addition to lack of evidence for Modic changes, the imaging report also noted a 7 millimeter (mm) broad-based posterior disc herniation at L4-L5. Disc herniation greater than (>) 5 mm was consider an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al. 

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.

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. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency. 

In summary, the denial of  intraosseous basivertebral nerve ablation, procedure code 64628 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.