Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: low back pain

Treatment: procedure (intraosseous basivertebral nerve ablation) (procedure code 64628)

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

The denial is upheld

Reviewer #2:

This is a patient with a history chronic low back pain for many years.

In 2018, Fischgrund and colleagues (1) published a double-blind, sham controlled randomized controlled trials (RCT) evaluating the Intracept system and radiofrequency (RF) ablation of the Basivertebral nerve (BVN) 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 85 degrees 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 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. 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.

The publications to date have been company sponsored and had methodology flaws.  There is no published data on long-term complication rates.  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 I or II 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 basivertebral nerve (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 sum, this procedure is not likely to be more beneficial than the standard of care.

In summary, the denial of a procedure (intraosseous basivertebral nerve ablation) (procedure code 64628) on a date yet to be determined (TBD) 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 risk are substantially increased over standard treatments.