Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain

Treatment: Outpatient services, 64628 x 1

The insurer denied coverage for outpatient services, 64628 x 1

The denial is upheld 

Reviewer #1:

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% 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. Furthermore, a 2021 systematic review (Conger et al.) concluded that further high-quality, large prospective studies, that are not industry funded, are needed to confirm these findings.

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 patient does not meet Centers for Medicare and Medicaid Services (CMS) criteria for use of the Intracept device to treat the patient's pain based on magnetic resonance imaging (MRI) evidence of Modic changes at levels other than L (lumbar) 3-S (sacral) 1. MRI states that scattered degenerative marrow signal changes are present, most notably at the T (thoracic) 11-T12 and L5-S1 levels. MRI evidence of Modic changes at levels other than L3-S1 was considered an exclusion criteria for use of the Intracept procedure in the INTRACEPT study by Khalil et al. 

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 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, which includes those who do not have MRI evidence of Modic changes at levels other than L3-S1. The Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. The denial should be upheld.

In summary, the denial of outpatient services, 64628 x 1 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.