Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic low back pain (CLBP)
Treatment: Intracept procedure for intraosseous ablation of basivertebral nerve, code 64628
The insurer denied coverage for Intracept procedure for intraosseous ablation of basivertebral nerve, code 64628
The denial is upheld.

This young adult has chronic low back pain. Her current medications are Mobic and Naproxen. She has done Physical Therapy and Chiropractic. She has had Trigger point injections and Transforaminal Epidural Steroid injections. Her Magnetic Resonance Imaging (MRI) shows Modic Type I (1) changes at L (lumbar) 4 and L5. It also shows paracentral disc herniation impingement on the Right L5 nerve root and at L5-S (sacral) 1 a posterolateral herniation also impinging on the L5 nerve root. No surgical consultation was documented.

A second RCT (randomized control trial) evaluating the Intracept system, known as the INTRACEPT trial, was published by Khalil and colleagues in 2019. The trial was open label and compared intraosseous RF (radiofrequency) 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 (Oswestry Disability Index) at 3 months. A pre-planned interim analysis was undertaken when 60% (percent) of participants reached the 3-month follow-up (n (number) =51 in the Intracept group and n=53 in the standard care group). The interim analysis found statistically significant differences between groups on all patient-reported outcomes measures, favoring the Intracept group. For the primary outcome, the mean change in the ODI at 3 months in the interim analysis was -25.3 points in the Intracept group and -4.4 points in the standard care group, p (probability) < (less than) 0.001. The mean change in VAS (visual analog scale) was -3.46 points in the Intracept group and -0.01 in the standard care group, p<0.001. As specified in the study protocol, the study was halted and individuals in the standard care group were allowed to cross over to treatment with the Intracept system. Limitations of this study include the lack of a sham control and limited duration of follow-up.

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.

Conger et al 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 (basivertebral nerve). Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Urits et al (and others) 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."

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Intracept procedure for intraosseous ablation of basivertebral nerve, code 64628 services is not substantiated.