Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain.
Treatment: Surgical procedure to treat low back pain (procedure code 64628).

The insurer denied coverage for surgical procedure to treat low back pain (procedure code 64628).  The denial is upheld.

Reviewer #1:

This patient has chronic low back pain (cLBP). The patient has had Physical Therapy (PT) and is doing a Home Exercise program. The patient has had prior back surgery, but level and location is not specified. The patient has had epidural steroid injections, medial branch blocks and trigger point injections. The patient's medication trials have included Methocarbamol, Naproxen and Oxycodone. The patient's magnetic resonance imaging (MRI) is noted to have Modic Type II changes at lumbar (L) 3-L4. The request is for radiofrequency ablation (RFA) of the L3-L4 levels.  There is no surgical consultation documented. 

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 (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 radiofrequency (RF) probe was activated and the temperature at the tip was maintained at 85Celcius (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. 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.

A second RCT evaluating the Intracept system, known as the INTRACEPT trial (2), was published by Khalil and colleagues in 2019. The trial was open label and compared intraosseous RF treatment to standard care in individuals with at least 6 months of chronic low back pain who had not responded to at least 6 months of conservative care. Intervention with the Intracept system consisted of treatment of up to 4 vertebrae in non-consecutive levels from L3 to S1. Individuals in the standard care continued treatment with conservative therapy. The primary study endpoint was difference in the ODI at 3 months. 

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 evidence-based interventions available to this patient.  This procedure is unlikely to be more beneficial than the standard approaches.

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 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 code 64628) on a date yet to be determined 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.