Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain

Treatment: Intraosseous basivertebral nerve ablation, procedure code 64628

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

The denial is upheld

This adult patient has chronic low back pain. His pain medications have included Diclofenac, Lido patch and Percocet. He has tried Physical Therapy and a Home Exercise Program. On magnetic resonance imaging (MRI) he has Modic Type I changes at lumbar (L)5 and sacral (S)1, also noted is L5-S1 disc extrusion, L4-L5 Annular Fissure and disc protrusion.  The request is for L5 and S1 Basivertebral nerve (BVN) radiofrequency ablation (RFA).

 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 (>(greater then) =(equal) 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 C (Celsius) for 15 minutes. The duration of the session in the sham group was the same but the radiofrequency (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 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 percent [%]) 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.

Additional data from the intervention group have been published; 24-month data in 2019 and five-year data in 2020. Data beyond 12 months on pain and function outcomes in the sham-treated group were not available as unblinding occurred at that time and most individuals crossed over to treatment with the Intracept system. Thus long-term comparative outcomes are not known.

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:

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."

This procedure is not likely to be more beneficial than the standard of care.

In summary, the denial of intraosseous basivertebral nerve ablation, procedure code 64628 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.