Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cervical spondylosis and lower back pain. 

Treatment: Intracept Procedure (procedure codes C9753, C9752 and 22899). 

The insurer denied coverage for the Intracept Procedure (procedure codes C9753, C9752 and 22899). 

The denial is upheld. 

This is a female patient with a history of cervical spondylosis. The patient has been followed by Pain Management for continued low back pain. The patient's Pain Management Specialist is requesting approval for the Intracept procedure for the patient.

This patient has been recommended to undergo the Intracept procedure. She has ongoing complaints of disabling pain despite a trial of failure conservative care. She has undergone multiple treatments that include epidural injections as well as medication management. The patient has also undergone Magnetic Resonance Imaging (MRI) revealing Modic type II changes at the L[lumbar]4-L5 and L5-S[sacral]1 disc space.  A chart note revealed the patient was seen for a follow-up.  She continues to have complaints of cervical spine pain.  The physical examination revealed grossly limited lumbar spine range of motion with pain.  There was positive facet loading bilaterally to the thoracolumbar spine.  The physician indicated the patient should undergo the Intracept interosseous nerve ablation procedure due to the continued low back pain affecting the patient's ability to function and perform activities of daily living. 

Evidence in peer-reviewed literature is insufficient to support a result of improvement in health outcome.  Intracept has been cleared by the Food and Drug Administration (FDA) for treatment of vertebrogenic low back pain with relevant imaging demonstrating Modic changes.  Review of the literature reveals two RCT [randomize controlled trial] (Smart and Intracept trials).  In the Smart trial, participants randomized to the sham group were allowed to crossover at the 12 month mark.  73% of the sham group participants elected to cross over at the 12 month mark thus RFA [radiofrequency ablation] treatment participants acted as their own control group for the 24 month outcomes.  Due to the high rate of crossover, long term comparative data is not available. The Intracept trial is limited by short term follow-up, lack of a sham group, and allowance of crossover at 3 months.  Therefore, further high quality evidence of efficacy is needed prior to considering the Intracept procedure as being medically necessary. 

The procedure does have FDA approval. The patient may be a good candidate for the procedure; however, there is a lack of high quality evidence demonstrating long term efficacy. Therefore further high quality evidence is needed prior to determining whether or not this would be an effective treatment. 

It is not clear that Intracept procedure is the best available treatment at this time due to the lack of high quality evidence demonstrating efficacy. The requested treatment is not likely to be more beneficial than standard treatments such as physical therapy.  It is noted in the documentation that the patient has failed conservative treatment including injections and physical therapy however it is not clear when the physical therapy was done, the frequency of visits, nor the duration. Intracept is an interventional procedure thus the potential adverse risks are greater than conservative treatment such as physical therapy. 

The carrier's denial of the Intracept Procedure (procedure codes C9753, C9752 and 22899) should be upheld.