Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain.
Treatment: Surgical procedure to treat low back pain (procedure code 64628).

The insurer denied coverage for surgical procedure to treat low back pain (procedure code 64628).  The denial is upheld.

Reviewer #3:

Per appeal information the patient has a history of low back pain for 2 years. Prior treatment includes surgery to the low back, home exercises, epidural steroid injections, medial branch block injections, medication, physical therapy and trigger point injections. A magnetic resonance imaging (MRI) performed showed Modic Type 2 changes in the lumbar (L)3 and L4 vertebral bodies.  A request for the Intracept procedure has previously been denied and is being appealed.

On encounter claimant presents with lower back pain. The pain is described as sharp and shooting. The pain is aggravated while standing, going from a sitting to a standing position, bending, lifting, kneeling, and working. On back exam there is decreased range of motion and pain with extension. Musculoskeletal exam shows strength full in all extremities. Neuro exam shows reflexes 2+ in all extremities and sensory is normal and intact.

Although the publications included for review indicate Intracept is an effective treatment for chronic axial low back pain refractory to conservative treatment, when associated with Modic type I or type II changes on lumbar spine MRI, the mentioned clinical trials state exclusion criteria include radicular low back pain or lumbar radiculopathy. Currently, the procedure requires further investigation to firmly establish the short-term and long-term efficacy of this treatment as it pertains to back pain as well as several other patient presentations. Therefore, there is an absence in the scientific evidence and peer review literature to support a result of improvement in the health outcomes after this procedure.

Khalil, J.G., et al. (2019), "Eligibility was adjudicated by an independent medical monitor based on each patient's medical, clinical, and radiographic presentation. The primary inclusion criteria included skeletally mature patients with >=6 months of chronic low back pain (cLBP) who had not responded to at least 6 months of conservative care and had Type 1 or Type 2 Modic changes on an MRI at one or more vertebral bodies from L3 through S1. Primary exclusion criteria included radicular pain, symptomatic spinal stenosis, disc protrusion >5 millimeters (mm), spondylolisthesis >2 mm at any level, or Beck Depression Inventory of greater than 24. See Table 1 for a complete listing of inclusion and exclusion criteria for this study." 

Urits, I., Noor, N., Johal, A. S., Leider, J., Brinkman, J., Fackler, N., Vij, N., An, D., Cornett, E. M., Kaye, A. D., & Viswanath, O. (2021), "Studies postulate that the pathophysiology of low back pain (LBP) may be vertebrogenic rather than only discogenic in origin. Several studies have supported the safety, durability, and efficacy of radiofrequency ablation of the basivertebral nerve (BVN). There is also convincing evidence that BVN ablation is more beneficial than current standard of care for the treatment of chronic LBP. Further reproducible large clinical studies are needed to study BVN ablation before clinicians can confidently apply this treatment in their practice."      

The 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 a surgical procedure to treat low back pain (procedure code 64628) on a date yet to be determined 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.