Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower 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 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 denial is upheld.

This adult patient has ankylosing spondylitis. She has chronic low back pain. She has tried transcutaneous electrical nerve stimulation (TENS), Chiropractic care, Heat/Ice, Physical Therapy, Medial branch blocks, Epidural Steroid injection and sacroiliac (SI) joint block injection. She has taken Advil and Aleve for pain. Her magnetic resonance imaging (MRI) shows Modic changes at lumbar (L) 4, L5 and sacral (S) 1. It also shows anterolisthesis at L4-L5 causing foraminal stenosis, disc bulges at L4-L5 and L2-L3 as well as disc herniation at L3-L4.  The patient has not had a surgical consultation.

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 basivertebral nerve (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:

1)  Industry funding is a potential source of study bias for the available data reviewed.
2)  Limited number of studies.
3)  Short-term follow up for the majority of studied patients.
4)  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."

It is not certain that the scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes.

It is not certain that this patient is a good candidate for procedure codes 64628 and 64629.

The requested procedure is not the best available treatment for this patient at this time.  

Long term complications are unknown when evaluating adverse risks compared to standard treatment.

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 carrier's denial of 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 should be upheld.