Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain. 
Treatment: A procedure to treat low back pain, code 64628, 64629.

The insurer denied coverage for a procedure to treat low back pain, code 64628, 64629.   
The denial is upheld. 

This patient has chronic low back pain. The patient is status post laminectomy. Treatment includes Physical Therapy. The patient's magnetic resonance imaging (MRI) shows disc herniation at L (lumbar) 4-L5 and a disc bulge at L5-S (sacral) 1 along with facet arthropathy.  Radiofrequency ablation is requested (RFA). 

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 & 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 RCTs [randomized control trials] (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 sham control and short duration of follow-up. 

The INTRACEPT trial (sponsored by Relievant Medsystems, Inc.) was an open-label RCT conducted at 20 U.S. sites. (Khalil 2019) A total of 140 patients with lower back pain of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 were randomized to undergo radiofrequency ablation of the basivertebral nerve (BVN) or continue standard care. Patients with other pain etiology such as facet arthrosis were excluded from the trial. Treatment of up to 4 vertebrae in nonconsecutive levels from L3 to S1 was allowed. The primary study endpoint was change in ODI [Oswestry of disability index] at 3 months. A pre-planned interim analysis was undertaken when 60% of participants reached the 3-month follow-up (n=51 in the treatment group and n=53 in the standard care group) and reported statistically significant differences between groups on all patient-reported outcome measures, favoring the treatment group. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. 

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. 

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 meet very strict criteria, which excludes patients with MRI (magnetic resonance imaging) 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 is upheld. 

In summary, the denial of a procedure to treat low back pain, code 64628, 64629, should be upheld. This treatment is not likely to be more beneficial than any standard treatments.