Appeal type: Medical necessity
Decision: Upheld


 
Diagnosis: Low back pain

Treatment:  Intracept Procedure for intraosseous ablation of basivertebral nerve, code 64628.

The insurer denied coverage for Intracept Procedure for intraosseous ablation of basivertebral nerve, code 64628.

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 (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% 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.

CMS guidelines also state that BVN ablation will not be considered reasonable and necessary and cannot be covered by Medicare if any of the following findings or situations are present: skeletally immature patients (<=18 years old); severe cardiac or pulmonary compromise; active systemic infection or local infection at the intended treatment level; bleeding diathesis; pregnancy; active implantable pulse generators (e.g., pacemakers, defibrillators); radicular pain into the lower extremities (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging); previous lumbar/lumbosacral spine surgery at the intended treatment level (with the exception of discectomy/laminectomy if performed >6 months prior to BVN nerve ablation and radicular pain resolved); etc.

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. MRI report does not mention any evidence of Type I or Type II Modic changes. It does state evidence of Schmorl's node deformities at T11 through L5 that may indicate Type III Modic changes. Severe spinal stenosis with severe right foraminal stenosis noted at L4-L5 and left neural foraminal lesion at L5-S1 measuring 20 mm x 13 mm was also seen on MRI.

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, 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. The Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Intracept Procedure for intraosseous ablation of basivertebral nerve, code 64628 is not substantiated.