Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain.

Treatment: 64628 Thermal destruction of Intraosseous Basivertebral Nerve, including all Imaging Guidance, first 2 Vertebral bodies, Lumbar or Sacral and coverage for the requested treatment.

The insurer denied coverage for 64628 Thermal destruction of Intraosseous Basivertebral Nerve, including all Imaging Guidance, first 2 Vertebral bodies, Lumbar or Sacral and coverage for the requested treatment.  The denial is upheld.

Reviewer #1:

The patient has a history of low back pain beginning over 5 years ago. The patient has had multiple treatments including medication management and physical therapy. Medications have included Cyclobenzaprine, Naproxen, and Non-steroidal anti-inflammatory drugs (NSAIDs). The pain has had a significant impact upon activities of daily living (ADLs) such as: bending and standing. Nothing has provided significant sustainable relief. The severity of pain on visual analog scales (VAS) is an 8/10. The patient had a magnetic resonance imaging (MRI) performed, which demonstrated Modic type II changes. In addition, disc bulging was noted at L (lumbar) 3-4, and L2-3.  The MRI report concludes "There is multilevel multifactorial spondylosis, most significant at L4/L5 where there is moderate central canal stenosis and mild right neural foraminal stenosis. There is mild peri facet bone marrow edema and periarticular inflammatory changes at this level, felt likely related to spondylosis." Requesting authorization for Intracept procedure at L5,S (sacral) 1.

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

At this time Intracept remains a procedure without established efficacy. While results may appear, promising additional studies are necessary to determine efficacy as compared to other conventional therapies. Medicare does not have a National coverage determination (NCD) specifically for the use of the Intracept procedure in the treatment of chronic low back pain. 

"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 basivertebral nerve (BVN). Non-industry funded high-quality, large prospective studies are needed to confirm these findings" (Conger, A., et al. 2021).

64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral does not have final approval from the appropriate regulatory bodies for this diagnosis.     

This patient is not a good candidate for 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, Lumbar or sacral.     

64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral is not the best available treatment for this patient at this time as this procedure does not have established clinical efficacy.     
  
Intracept remains a procedure without established efficacy. 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 64628 Thermal destruction of Intraosseous Basivertebral Nerve, including all Imaging Guidance, first 2 Vertebral bodies, Lumbar or Sacral 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.