Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

Diagnosis: Low back pain.
Treatment:  Thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (code 64628).

The insurer denied coverage for thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (code 64628).  The denial is upheld.

The patient has been diagnosed with right-sided lower back pain. The patient has been treated with radiofrequency ablations (RFAs) that relieved left sided pain. The patient has severe stenosis and no clear picture of vertebrogenic low back pain. The request is for thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (code 64628), which is under review.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes.

The lack of unbiased randomized controlled trials (RCT) does not allow determination that peer-reviewed literature supports a result of improvement in health outcomes.      

Thermal destruction of intraosseous basivertebral nerve (BVN) first 2 vertebral bodies (code 64628) does not have final approval from the appropriate regulatory bodies for this diagnosis.

The Intracept procedure has 510(k) clearance as a radiofrequency device, but not specific approval for the performance of intraosseous basivertebral nerve ablation procedures.     

This patient is not a good candidate for thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (code 64628).

The patient's pain does not fit that of vertebrogenic pain. The patient's pain was relieved with facet blocks, which indicates the patient is not a good candidate for the proposed procedure.

Thermal destruction of Intraosseous basivertebral nerve first 2 vertebral bodies (code 64628) is not the best available treatment for this patient at this time.

The patient needs to have a determination of the actual site and source of the pain, of which treatment should be directed specifically to the etiology.     

The adverse risks are increased over standard treatment/services.

There is a risk of neural injury with this procedure as compared to standard treatment/services.     

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

As stated, the patient's pain does not fit that of vertebrogenic pain. The patient's pain was relieved with facet blocks. A determination and treatment directed at the source of pain is needed, which indicates the patient is not a good candidate for the proposed procedure and further indicates this requested service would not likely be more beneficial than any of the standard treatments/procedures.

While basivertebral nerve ablation has shown promise in the medical literature, the procedure has limited support overall. This service is not considered standard of practice for management of chronic back pain.

Based on these findings, basivertebral nerve ablation has not been proven safe, effective, or necessary. 

As such, the denial is upheld.

"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." (Conger, A. et al. 2021).                                                    

In summary, the denial of thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (code 64628) 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.