Appeal type: Medical necessity
Decision: Upheld

Diagnosis: chronic low back pain.

Treatment is Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral.

The insurer denied coverage for Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral.
 
The denial is upheld.

This patient has chronic low back pain. He has had multiple treatments including acupuncture, chiropractic care, medical branch block injections, medication management, physical therapy, and radiofrequency ablations. Medications have included: Advil, Aleve, Cymbalta, Flexeril, Gabapentin, Mobic, NSAIDs (non steroidal anti-inflammatory drugs), and Vicodin. His MRI (magnetic resonance imaging) shows degenerative changes at the end-plates of L (lumbar) 4 and L5.  The request is for RFA (Radiofrequency ablation) of the basivertebral nerves of L4 and L5.

In 2018, Fischgrund and colleagues (1) published a double-blind, sham-controlled RCT (randomized controlled trial) evaluating the Intracept system and RF (radiofrequency) ablation of the Basivertebral nerve for the treatment of chronic low back pain. A total of 225 participants with chronic (>= 6 months) isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham (n (number)=78) or treatment (n=147) intervention. In the active treatment group, the RF probe was activated and the temperature at the tip was maintained at 85C (Celsius) for 15 minutes. The duration of the session in the sham group was the same but the RF treatment was only simulated. Study participants had a minimum Owestry disability index (ODI) of 30 points (on 100 point scale) and a minimum VAS (Visual Analogue Scale) of 4 cm (centimeters) (10 cm scale). The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. Both intention-to-treat (ITT) and per protocol (PP) analysis were pre-planned. A total of 19 of 147 (13%) participants in the treatment group were excluded from the PP analysis; 16 for a targeting failure, 1 for procedural failure and 2 for protocol non-compliance. One participant in the sham group was excluded from the PP analysis and this was for protocol non-compliance.

In sum, the publications to date have been company sponsored and had methodology flaws. Up to Date summarized the issue of radiofrequency for low back pain "We suggest not using radiofrequency denervation for the management of chronic low back pain. The available data are inconsistent and suggest that, compared with placebo, radiofrequency denervation may modestly reduce pain in the short-term; however, there does not appear to be clear long-term benefit. When added to a treatment regimen that includes a regular exercise program and psychologic support, radiofrequency denervation provides little additional benefit." There are no published data on long term complication rates.  There are other evidence-based interventions available to this patient. This procedure is unlikely to be more beneficial than the standard approaches.

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for the Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral is upheld. Medical Necessity is not substantiated.