Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain

Treatment: Outpatient services, 64628 x 1

The insurer denied coverage for outpatient services, 64628 x 1

The denial is upheld 

Reviewer #2:

This patient has chronic low back pain.  The patient has had physical therapy and a home exercise program. The patient's medication trials have included Tylenol, Duloxetine, Gabapentin, Ibuprofen, Mobic, Oxycodone and Lidocaine patches.  The patient's magnetic resonance imaging (MRI) shows Modic changes at L (lumbar) 5 and S (sacral) 1.  The request is for radiofrequency ablation (RFA) of the Basivertebral nerve (BVN) at those levels.

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 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 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.

In sum, 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 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:

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

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 RF ablation in the management of chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

In summary, the denial of outpatient services, 64628 x 1 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.