Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain
Treatment: procedure codes 64628 and 64629, intraosseous basivertebral nerve ablation
The insurer denied coverage for procedure codes 64628 and 64629, intraosseous basivertebral nerve ablation.
The denial is upheld.

The medical records indicate the patient has a history of low back pain with diagnoses of vertebrogenic low back pain and vertebral endplate pain.

Per an appeal letter, the patient's "primary problem is chronic low back pain (CLBP) due to degenerative disc disease that has resulted in the development of vertebrogenic pain identified by degenerative endplates changes (Modic) on their magnetic resonance imaging (MRI)." She has tried and failed treatment with non-operative measures that include activity modification, back brace, facet injections, heat/ice, home exercises, lumbar epidural steroid injections, medication management, physical therapy, and radiofrequency ablations (RFA). Medications have included: Aspirin; Duloxetine; Meloxicam; Robaxin." The patient's daily life has been impacted by their back pain and they complain of issues with sleeping, sitting, standing, walking and work. 

A Magnetic resonance imaging (MRI) showed Modic changes at lumbar three (L3), lumbar five (L5) and sacral one (S1) that is causing chronic low back pain. 

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

While results may appear promising, additional studies are necessary to determine efficacy as compared to other conventional therapies. 

"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 (basivertebral nerve). Non-industry funded high-quality, large prospective studies are needed to confirm these findings" (Conger, A., et al.).

"The basivertebral nerve (BVN) has been a recently discovered target as a potential source for vertebrogenic chronic low back pain (CLBP). Prior randomized controlled trials have demonstrated safety and efficacy of BVN ablation for vertebrogenic CLBP, but minimal data exists regarding BVN ablation's clinical effectiveness with broader application outside of strict trial inclusion criteria" (Macadaeg, K., et al.).

U.S. Food and Drug Administration (FDA) gave 510(k) clearance for the INTRACEPT Intraosseous Nerve Ablation System. However, at this time Intracept remains without established efficacy in this patient's diagnosis.     

This patient is not a good candidate for this procedure.

This treatment is not the best available treatment for this patient at this time.     

It is inconclusive if adverse risks are increased over standard treatment/services.     

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

In summary, the denial of procedure codes 64628 and 64629, intraosseous basivertebral nerve ablation and coverage for the requested service/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.