Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Lower Back Pain. 
Treatment: Procedure codes 22899, unlisted procedure, spine 64628- thermal destruction of intraosseous basiverterbral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral, and 64629- thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 

The insurer denied coverage for procedure codes 22899, unlisted procedure, spine 64628- thermal destruction of intraosseous basiverterbral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral, and 64629- thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 

The denial is upheld. 

This patient has chronic low back pain.  She has tried Physical therapy. She takes Mobic, Flector patches, Lidocaine patches, Vicodin, and Hydrocodone-Acetaminophen for pain. She has had Medial Branch blocks and subsequent radiofrequency ablation (RFA) of her facet joints.  Her MRI  (magnetic resonance image) shows disc herniations at lumbar (L)4-L5 and at L5-S (sacral)1. As well as Modic Type II changes at L5-S1.  No surgical consultation is documented.  Rather, the request is for the Intracept procedure at L5 and S1. 

Fischgrund and colleagues (1) published a double-blind, sham controlled randomized controlled trial (RCT) evaluating the Intracept system and RF (radio frequency) 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=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 visual analog score (VAS) of 4 cm (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.  There is no published data on long term complication rates.  UpToDate (3) has evaluated this procedure and concluded that it is still unproven.  There is other evidence- based interventions available to this patient.  This procedure is unlikely to be more beneficial than the standard approaches. The risks are not increased. 

The carrier's denial of procedure codes 22899, unlisted procedure, spine 64628- thermal destruction of intraosseous basiverterbral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral, and 64629- thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral should be upheld.