Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: procedure code 64628 (intraosseous basivertebral nerve ablation)

The insurer denied coverage for procedure code 64628 (intraosseous basivertebral nerve ablation)

The denial is upheld 


This patient has chronic low back pain.  The patient is taking Lyrica and Xtampza for pain. The patient's magnetic resonance imaging (MRI) shows an annular tear at L (lumbar) 4-L5 and Modic type II and III changes at L5 and S (sacral) 1.  The official MRI report also noted at L4-5 "diffuse disc bulge flattening the anterior thecal sac. There is stable mild bilateral foraminal narrowing due to facet arthropathy, slightly impinging  on the left greater than right exiting L4 nerve roots." The MRI report again noted disc bulge impinging on right greater than left L5 nerve roots. The MRI clinical history also noted the back pain occasionally radiates to bilateral lower extremities.  The request is for radiofrequency ablation (RFA) of the Basivertebral nerves (BVN) 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 radiofrequency (RF) 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 85Celsius (C) 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 Oswestry disability index (ODI) of 30 points (on 100-point scale) and a minimum visual analog scale (VAS) of 4 centimeters (cm) (10 cm scale). The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. 

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:

"There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Similarly, a clinical practice guideline (4) while favorable pointed out the limitations of the current literature:

.  Industry funding is a potential source of study bias for the available data reviewed.
.  Limited number of studies.
.  Short-term follow up for the majority of studied patients.
.  Unknown effect on the primary degenerative process

In summary, the denial of procedure code 64628 (intraosseous basivertebral nerve ablation), date of service to be determined, and coverage for the requested 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.