Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain. 
Treatment: Procedure codes 64628 and 64629. 

The insurer denied coverage for procedure codes 64628 and 64629. 

The denial is upheld. 

This case involves a patient with complaints of low back pain. Clinical notes reported the patient had complaints of axial low back pain that started years ago. Previous treatment included lumbar radiofrequency ablation (RFA), epidural steroid injection, sacroiliac joint injection, and medication management. Review of magnetic resonance imaging (MRI) noted degenerative disc disease with annular tear at lumbar (L) 2-3. Physical examination noted 50 degrees of lumbar flexion, 20 degrees of extension, symmetric deep tendon reflexes, intact sensation, and normal motor strength. The provider stated that there was endplate edema/inflammation at L4, L5, and sacral (S)1. The treatment plan was for Intracept procedure. Determination letter reported the procedure was denied as it was considered experimental/investigational. Appeal letter reported the procedure was Food and Drug Administration (FDA) approved and supported by current literature. 

Scientific literature supports RFA of the basivertebral nerve (BVN) for chronic low back pain exhibited sustained clinical benefits in Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) and maintained high responder rates at 2 years following treatment.  Per the International Society for the Advancement of Spine Surgery guideline, intraosseous ablation of the basivertebral nerve from the L3 through S1 vertebrae may be considered medically indicated for individuals with chronic low back pain of at least 6 months duration when there is failure to respond to at least 6 months of nonsurgical management, and MRI demonstrated Modic change 1 or Modic change 2 in at least 1 vertebral endplate at 1 or more levels from L3 to S1. 

The Intracept procedure does have final approval from the appropriate regulatory bodies for the diagnosis. The adverse risk is not increased over standard treatment/services. However, the patient would not be a good candidate for this procedure, and it would not be the best available treatment at this time. In this case, the patient is noted to have chronic back pain despite conservative measures. The provider reported there was endplate edema/inflammation on imaging. However, the summarization of the MRI did not note Modic type I or II changes. The independent MRI was not submitted for review. There is a lack of imaging evidence to support the proposed procedure at this time. Given the above, the requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient. As such, the request for 64628 and 64629 is not medically necessary. 

Peer reviewed literature does not support a result of improvement in health outcomes with the requested procedure. The requested procedure does have final regulatory approval from the appropriate regulatory bodies for this diagnosis. 

This patient is not a good candidate for the requested procedure.  It is not the best available treatment for this patient at this time. 

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments. 

The health plan's denial of the 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar and 64629 thermal destructions of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral should be upheld.