Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain
Treatment: Procedure code 64628; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral and procedure code 64629; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral
The insurer denied coverage for procedure code 64628; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral and procedure code 64629; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral.
The denial is upheld.

This patient has low back pain. Pain was rated at a 7-9 out of 10. The patient has tried and failed physical therapy (PT), injections, lidocaine patches, prednisone, and naproxen without relief. Imaging revealed mildly progressed multilevel degenerative disc of the lumbar spine mildly increased paraspinal muscle atrophy. The physician recommended the Intracept procedure to treat back pain.		

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

Urits et al (6) also commented on the need for more research on this promising technique: "reproducible large RCTs (randomized control trials) 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 (radiofrequency) ablation in the management of chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. The requested procedure has approval from the appropriate regulatory bodies for this diagnosis. The patient is not a good candidate for the requested procedure. The procedure is not the best available treatment for this patient at this time. The long-term issues are not clear.

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition.

The insurer's denial of coverage for procedure code 64628; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral and procedure code 64629; thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral (list separately in addition to code for primary procedure) is upheld.