Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Intracept procedure, code 64628 and code 64629

The insurer denied coverage for Intracept procedure, code 64628 and code 64629

The denial is upheld 

This patient has chronic low back pain (CLBP). The patient has had Physical Therapy and is doing a Home exercise program. The patient's medication trials have included Diclofenac, Mobic, Tizanidine, a steroid dose pak and Tramadol. The patient's magnetic resonance imaging (MRI) shows multi-level disc bulges and facet arthrosis without central or neuroforaminal stenosis.  The physician notes that there are Modic changes at lumbar (L)4, L5 and sacral (S)1 but these are not noted in the Radiology report. The request is for radiofrequency ablation (RFA) of the Basivertebral nerves (BVN) at L4, L5 and S1. 

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 85Celsius 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. 

 In sum, 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:

"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. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Similarly, a clinical practice guideline (4) 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.
Unknown effect on the primary degenerative process

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."

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 Intercept procedure, code 64628 and code 64629 is not substantiated.