Appeal type: Experimental/Investigational
Decision: Upheld


Diagnosis: Lower back pain

Treatment: procedure code: 64628 (treatment for low back pain)

The insurer denied coverage for procedure code: 64628 (treatment for low back pain)

The denial is upheld.

This patient has chronic low back pain (CLBP). She has tried physical therapy, a home exercise program and a transforminal Epidural Steroid injection (ESI). She takes Cymbalta, Flexeril and Mobic for pain. Her magnetic resonance imaging (MRI) shows disc degeneration at lumbar (L)4-L5 (the physician believes that this level should be numbered L5-sacral (S)1. Also noted in the MRI but not discussed in the request is that there is disc extrusion/ herniation at L5-S1 with the disc exiting the foramen. There was no surgical consultation. The physician wants to perform radiofrequency (RF) ablation of the basivertebral nerves (BVN) at 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 this patient. This procedure is unlikely to be more beneficial than the standard approaches.

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."

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 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.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes, the studies presented have several flaws.

Procedure code: 64628 (treatment for low back pain) has final approval from the appropriate regulatory bodies for this diagnosis.

This patient is not a good candidate for procedure code: 64628 (treatment for low back pain). She has an extruded disc which should be evaluated by a surgeon.

Procedure code: 64628 (treatment for low back pain) is not the best available treatment for this patient at this time.

It is not known if the adverse risks are increased over standard treatment/services. 

In summary, the denial of procedure code: 64628 (treatment for low back pain) 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 substantially increased over standard treatments.