Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #1

Diagnosis: Low back pain

Treatment: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral, and 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

The insurer denied coverage for 64628 and 64629 

The denial is upheld

This patient has chronic low back pain. She also has new onset urinary incontinence and absent Achilles reflexes. She takes baclofen, gabapentin, and Oxycontin for pain. She has a functioning spinal cord stimulator (SCS). There is no documentation of how many reprogramming attempts have been made. Her magnetic resonance imaging (MRI) shows multi-level degenerative disc and facet disease as well as Modic changes at lumbar (L)3-L4, L4-L5 and L5-sacral (S)1. It also shows possible cauda equina compression. The progress notes state that she does not want spine surgery, but there is no consultation with neurology or neurosurgery documented. The request is for radiofrequency ablation (RFA) of the basivertebral nerves (BVN) at L3, L4, L5 and S1.

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 these patients.

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 randomized controlled trials (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 radiofrequency (RF) ablation in the management of chronic lower back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

Peer reviewed literature does not support a result of improvement in health outcomes with the requested procedure. The procedure does have final regulatory approval from the appropriate regulatory bodies for this diagnosis.

This patient is not a good candidate for the requested procedure. It is not the best available treatment for this patient at this time.

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.

The health plan's denial of the 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar and 64629 thermal destructions of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral should be upheld.