Appeal type: Experimental/Investigational
Decision: Upheld


Diagnosis: Low back pain.

Treatment: intraosseous basivertebral nerve ablation, code 64628.

The insurer denied coverage for intraosseous basivertebral nerve ablation, code 64628.

The denial is upheld.

This adult has bilateral low back pain which radiates since several years ago. Her pain medications include Xanax and Percocet.  She has tried Physical therapy, Chiropractic and has had Medial branch blocks.  She has also had sacroiliac (SI) joint injection and Transforaminal Epidural steroid injection.  Her magnetic resonance imaging (MRI) shows Modic Type I and II at lumbar (L)5 and sacral (S)1. Also of note is an L5-S1 disc bulge and Left central disc protrusion. The request is for radiofrequency ablation (RFA) of the basivertebral nerves.

A randomized controlled trial (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. Intervention with the Intracept system consisted of treatment of up to 4 vertebrae in non-consecutive levels from L3 to S1. Individuals in the standard care continued treatment with conservative therapy. The primary study endpoint was difference in the ODI(Oswestry 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 Intracept group and n=53 in the standard care group). The interim analysis found statistically significant differences between groups on all patient-reported outcomes measures, favoring the Intracept group. For the primary outcome, the mean change in the ODI at 3 months in the interim analysis was -25.3 points in the Intracept group and -4.4 points in the standard care group, p&lt;0.001. Mean change in VAS(Visual analog scale) was -3.46 points in the Intracept group and -0.01 in the standard care group, p&lt;0.001. 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.

 In sum, the publications to date have been company sponsored and had methodology flaws.  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.

Conger et al (3) pointed out that all of the major studies while supportive, have been funded by the company.


Urits et al (5) also commented on the need for more research on this promising technique:  "reproducible large RCTs are still needed for clinicians to gain full confidence in utilizing this treatment in practice. Additionally, further research is needed on the anatomy of the vertebrae to optimize the method of treatment. These studies can help to elucidate the role of RFA in the management of chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

This procedure is NOT likely to be more beneficial than the standard of care.

In summary, the denial of intraosseous basivertebral nerve ablation, code 64628 and coverage for the requested service/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.