Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain

Treatment: Procedure to treat low back pain (procedure code 64628) Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral

The insurer denied coverage for procedure to treat low back pain (procedure code 64628) Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral. 

The denial is upheld.
 
This is a male status post Lumbar (L) 3-4 discectomy and presented with worsening back pain with residual left thigh pain. His magnetic resonance imaging (MRI) of the Lumbar spine revealed L2-L3 moderate spondylosis, moderate disc bulge, left foraminal disc protrusion, L3-L4 mild spondylosis, small disc bulge, L4-L5 moderate spondylosis, L5-Sacral (S)1 severe spondylosis, large broad based central disc protrusion. He had multiple treatments including injections, medication management, microdiscectomy, and physical therapy. The pain has affected his activities of daily living and quality of life. Since he has failed non operative treatment, the request was made for radiofrequency ablation (RFA) of the basivertebral nerve at L5 and S1.  

In 2018, Fischgrund and colleagues (1) published a double-blind, sham controlled randomized controlled trial (RCT) evaluating the Intracept system and RFA of the basivertebral nerve for the treatment of chronic low back pain. 

Additional data from the intervention group have been published, 24-month data in 2019 and five-year data in 2020. Data beyond 12 months on pain and function outcomes in the sham-treated group were not available as unblinding occurred at that time and most individuals crossed over to treatment with the Intracept system. Thus, long-term comparative outcomes are not known.

A second RCT evaluating the Intracept system, known as the INTRACEPT trial (2), was published by Khalil and colleagues in 2019. The trial was open label and compared intraosseous RF treatment to standard care in individuals with at least 6 months of chronic low back pain who had not responded to at least 6 months of conservative care. The primary study endpoint was different in the Oswestry Disability Index (ODI) at 3 months. The interim analysis found statistically significant differences between groups on all patient-reported outcome measures, favoring the Intracept group. As specified in the study protocol, the study was halted and individuals in the standard care group were allowed to cross over to treatment with the Intracept system. Limitations of this study include the lack of a sham control and limited duration of follow-up.

The publications to date have been company sponsored and had methodology flaws.  There is 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 carrier's denial of procedure to treat low back pain (procedure code 64628) Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral should be upheld.