Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

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

The insurer denied coverage for 64628 Thermal destruction of intraosseous basivertebral nerve, including imaging guidance; first 2 vertebral bodies, lumbar or sacral. 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral.

The denial is upheld.

Reviewer #1:

This patient has chronic low back pain. The patient has tried chiropractic therapy, Physical Therapy (PT) and a transcutaneous electrical nerve stimulation (TENS) unit. The patient's medications for pain are Advil and Aleve. The patient has had Medial branch blocks, sacroiliac (SI) joint injections and Transforaminal Epidural Steroid injections. The patient's magnetic resonance imaging (MRI) shows Modic Changes at L (lumbar) 4-L5 and L5-S (sacral) 1.  It also shows a disc herniation into the left L4-L5 foramen.  No surgical consultation is documented.  The request is for radiofrequency ablation (RFA) of the basivertebral nerves (BVN) at L4, L5 and S1.

In sum, the publications to date have been company sponsored and had methodology flaws.  There is no published data on long-term complication rates.  A Hayes technology assessment (3) has evaluated this procedure and concluded that it is still investigational.  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 BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Similarly, a clinical practice guideline (5) 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 (6) 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 chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

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

In summary, the denial of 64628 Thermal destruction of intraosseous basivertebral nerve, including imaging guidance; first 2 vertebral bodies, lumbar or sacral. 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral 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.