Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: chronic low back pain (CLBP)

Treatment: Intracept procedure (CPT (current procedural terminology) codes 64628/64629)

The insurer denied coverage for Intracept procedure (CPT codes 64628/64629)

The denial is upheld.

This patient has had low back pain for greater than 6 months. The patient is taking Lodine and Norco for pain and is doing physical therapy. Magnetic resonance imaging (MRI) shows lumbar (L)2-L3 disc herniation, L3-L4 post-operative changes from a left hemilaminectomy and facet joint surgery as well as a disc herniation, and Modic type changes. There is no documentation of surgical consultation regarding the disc herniations. The request is for radiofrequency ablation (RFA) of the basivertebral nerves.

It is not clear if the scientific evidence in peer-reviewed literature support a result of improvement in health outcomes. 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 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 (radiofrequency) probe was activated and the temperature at the tip was maintained at 85 Celcius 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 Owestry disability index (ODI) of 30 points (on 100 point scale) and a minimum visual analog scale (VAS) of 4 cm (centimeters) on a 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.

Urits et al 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 sum, the publications to date have been company-sponsored and had methodology flaws. There is no published data on long-term complication rates.  

The Intracept procedure (CPT codes 64628/64629) does have final approval from the appropriate regulatory bodies for the patient's diagnosis.

It is uncertain if the patient is a good candidate for Intracept procedure (CPT codes 64628/64629). There are other evidence-based interventions available.

Intracept procedure (CPT codes 64628/64629) is not the best available treatment for this patient at this time. The long-term effects of the procedure are not known. 

In summary, the denial of Intracept procedure (CPT codes 64628/64629) 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 increased over standard treatments.