Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: low back pain

Treatment: procedure (intraosseous basivertebral nerve ablation) (procedure code 64628)

The insurer denied coverage for procedure (intraosseous basivertebral nerve ablation) (procedure code 64628)

The denial is overturned

Reviewer #3:

This case involves a patient with a subject for review for the denial of coverage for a procedure (intraosseous basivertebral nerve ablation) (procedure code 64628).

The patient was seen for complaints of low back pain for many years. The patient has persistent axial low back pain. The patient has significant low back pain that radiates to bilateral buttocks. The patient reported that the pain is significant with prolonged standing and bending forward. 

The patient has a global reduction range of motion of lumbar spine and is very apprehensive about forward flexion as they reported it could elicit significant pain. 

The Food and Drug Administration (FDA) has offered section 510(k) approval for the Intracept intraosseous nerve ablation system. The system is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L (lumbar) 3 through S (sacral) 1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care and is also accompanied by either Type I or Type II Modic changes on magnetic resonance imaging. The cumulative data along with recent studies on basivertebral nerve (BVN) ablation have demonstrated consistent, reproducible, clinically meaningful, statistically significant improvement in reducing pain and improving functioning in patients with diagnostic evidence of vertebral pain. Given the clear findings of vertebrogenic pain, continued with Modic type changes at L5-S1, section 510(k) approval from the Food and Drug Administration, and failure of conservative treatment, the request is appropriate for the patient. In addition, the cumulative data among multiple studies on basivertebral nerve (BVN) ablation demonstrated consistent, reproducible, clinically meaningful, and statistically significant improvement in reducing pain and improving function in patients with diagnostic evidence of vertebral pain.

According to the referenced literature, documented improvements in pain reduction measured by the visual analog scale, functional disability measured by the Oswestry disability index (ODI), opioid utilization reduction, and improved quality of life measured by the short-form 36 have been reported. In fact, studies have pointed out that there is evidence that BVN ablation is more beneficial than the current standard of care for the treatment of low back pain from damaged vertebral endplates. 

In summary, the denial of a procedure (intraosseous basivertebral nerve ablation) (procedure code 64628) on a date yet to be determined (TBD) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are not substantially increased over standard treatments.