Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain. 
Treatment: Surgical procedure to treat low back pain (procedure codes 64628 and 64629). 
The insurer denied coverage for surgical procedure to treat low back pain (procedure codes 64628 and 64629). 
The denial is upheld. 

This patient has had chronic low back pain for 10 years. The patient has tried acupuncture, Physical Therapy (PT) and lumbar bracing. The patient has had Facet blocks and then Radiofrequency Ablation (RFA), epidural steroid injections as well as sacroiliac (SI) joint injections. The patient's medication trials have included Tylenol, Gabapentin, Lyrica, Tramadol and nonsteroidal anti-inflammatory agents (NSAIDs).  The patient's magnetic resonance imaging (MRI) shows Modic changes at lumbar (L) 3, L4 and L5. The request is for RFA of Basivertebral nerves at L3, L4 and L5.

In 2018, Fischgrund and colleagues (1) published a double-blind, sham controlled randomized controlled trial (RCT) evaluating the Intracept system and RFA 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 radiofrequency (RF) probe was activated and the temperature at the tip was maintained at 85 degrees Celsius (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. 

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. 

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 a surgical procedure to treat low back pain (procedure codes 64628 and 64629) requested by Relievant Medsystems to be provided on a date yet to be determined and coverage for the requested service 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.