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 procedures to treat low back pain (Procedure Code 64628).

The denial is upheld.


This is a patient with chronic low back pain (CLBP).  The patient has tried Acupuncture and Chiropractic therapy. The patient has had Physical therapy and is doing a Home Exercise program. The patient has also tried heat and Ice, Transcutaneous Electrical Nerve Stimulation (TENS), and Epidural steroid injections. The patient's pain medications have included Tylenol and non-steroidal anti-inflammatory drugs (NSAIDs). On magnetic resonance imaging (MRI), the patient has Modic changes at lumbar (L)4, L5, and S1. The request is for radiofrequency ablation (RFA) of the Basivertebral nerves at these levels.

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 (>= 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 85C 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 a 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.

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:

"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. The success of the procedure appears to be dependent on the effective targeting of the BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

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 shortly."

In sum, this procedure is NOT likely to be more beneficial than the standard of care.

In summary, the denial of surgical procedure to treat low back pain (Procedure Code 64628) is to be provided by the John T. Mather Hospital 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 risk are substantially increased over standard treatments.