Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal. 
Treatment: Surgical Services. 

The insurer denied Intracept procedure. 
The denial is upheld. 

This is a female diagnosed with low back pain. Records indicate that the provider recommended the patient undergo the Intracept procedure, which was denied by the insurance carrier as experimental and investigational. The provider is appealing this determination, which is the subject of this review. 

Magnetic resonance imaging (MRI) of lumbar spine revealed disc bulging with left central disc herniation at lumbar (L) 3 - L4 contributing to moderate to severe spinal canal stenosis asymmetric to the left with complete effacement of the left lateral recess and mass effect upon the dissenting left L4 nerve roots. Disc bulging and facet hypertrophy with mild spinal canal stenosis L4-L5. Disc degeneration with disc bulging and left central disc herniation L5-sacral (S)1 effacing the descending left worse than right S1 nerve roots at the lateral recess. Mild narrowing of the spinal canal. The patient was noted to have Modic type I and play degenerative changes present about the L5-S1 intervertebral disc. 

The patient was seen for follow-up visit regarding chronic back pain rated at 5-10/10, alleviated with medications and heat. The patient has tried chiropractic treatment, medications, physical therapy. The patient reports since the last visit the right lower extremity pain has resolved but the patient continues with the same back pain. Physical examination revealed limited lumbar range of motion with complaints of pain. Negative straight leg raise bilaterally, normal motor strength, normal sensation. The patient was given medication refills and recommended to undergo the Intracept procedure at L5-S1 levels. 

The subject under review is whether the Intracept procedure is likely to be more beneficial for this patient than any standard treatment. 

The Intracept is not likely to be more beneficial for this patient. The patient is noted to have a history of chronic back pain that has not responded to conventional conservative treatment including activity modification, medications, epidural steroid injections, physical therapy, chiropractic treatment, trigger point injections and home exercises. The provider feels that the patient's pain is coming from Modic changes and was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). However, the patient is also noted to have multilevel disc herniations at L3-L4 and L5-S1 with nerve root compression as well as facet arthropathy and it is not clear that symptoms are primarily related to the Modic changes. 
This treatment is not currently considered standard of care in the general medical community. There is a lack of high-grade evidence and large, long-term studies found in the peer-reviewed medical literature demonstrating this treatment to be either safe or effective or resulting in superior benefits over that of other standard means of treatment. Additional studies are needed to evaluate long-term risks and benefits of this procedure. There is no evidence to suggest that this treatment would be likely to be more beneficial than other standard treatment options for this patient's condition.