Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

Diagnosis: Back pain

Treatment: Thermal destruction of intraosseous basivertebral nerves (procedure to destroy some of the nerves between the spinal bones of the lower back)

The insurer denied coverage for thermal destruction of intraosseous basivertebral nerves (procedure to destroy some of the nerves between the spinal bones of the lower back)

The denial is upheld

This is an adult patient who has had low back pain for 10 years. The patient has tried Chiropractic, Physical therapy and a Home exercise program. The patient has had Medial branch blocks and Radiofrquency Ablation (RFA), Sacroiliac Injections (SI) joint blocks as well as superior cluneal blocks. The patient has used Nonsteroidal anti-inflammatory Drugs (NSAIDs) and Tylenol for pain. The Magnetic Resonance Imaging (MRI) report shows Schnorls nodes at Lumbar (L) 4 and L5, L4-L5 disc herniation and L5-Sacral (S) 1 disc bulge. It also shows Modic changes at L4, L5 and S1. The request is for RFA of the basivertebral nerves at L4, L5 and S1.

In 2018, Fischgrund and colleagues (1) published a double-blind, sham-controlled Randomized Control Trial (RCT) evaluating the Intracept system and RFA of the Basivertebral nerve for the treatment of chronic low back pain. In the active treatment group, the Radiofrequency (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 Owestry disability index (ODI) of 30 points (on 100 point scale) and a minimum Visual Analogue 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. 

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. 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.
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."

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. Although thermal destruction of introsseus basivertebral nerves is Food and Drug Administration approved, this patient is not a good candidate at this time. This invasive procedure has risks of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments. 

In summary, the denial of thermal destruction of intraosseous basivertebral nerves (procedure to destroy some of the nerves between the spinal bones of the lower back) 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.