Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic Low Back Pain
Treatment: Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628
The insurer denied coverage for Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628
The denial is upheld.

This is an adult who is morbidly obese with body mass index (BMI) of 41 and has chronic low back pain. She tried Physical Therapy (PT), Home Exercise, Chiropractic, and ice/heat. Her medication trials have included Advil, Diazepam, Fioricet, Gabapentin, Naproxen, Prednisone dose pack and Morin. Her magnetic resonance imaging (MRI) shows Modic changes at L (lumbar) 3 and L4. The request is for radiofrequency ablation (RFA) of the basivertebral nerves (BVN) at L3 and L4.

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 BVN for the treatment of chronic low back pain. A total of 225 participants with chronic (>= (greater than or equal to) 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 [number]=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 85Celcius 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 analogue 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.

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 (5) 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 (basivertebral nerves) BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Similarly, a clinical practice guideline (6) 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, and unknown effect on the primary degenerative process.

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

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage of Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628 is upheld. Medical Necessity is not substantiated.