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 chronic low back pain.  She has tried medication management with Belbuca, Gabapentin, Hydrocodone/acetaminophen, hydromorphone and Meloxicam. She had Modic changes on Magnetic Resonance Imaging (MRI). 

In 2018, Fischgrund and colleagues (1) published a double-blind, sham-controlled RCT [randomized controlled trial] evaluating the Intracept system and RF [radiofrequency] ablation of the Basivertebral nerve for the treatment of chronic low back pain. A total of 225 participants with chronic isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham or treatment  intervention. In the active treatment group, the RF probe was activated and the temperature at the tip was maintained at 85 degrees Celsius for 15 minutes. The duration of the session in the sham group was the same but the RF treatment was only simulated. Study participants had a minimum Oswestry disability index (ODI) of 30 points (on 100 point scale) and a minimum VAS [visual analog scale] of 4 centimeters (cm) (10 cm scale). The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. Both intention-to-treat (ITT) and per protocol (PP) analysis were pre-planned. PP analyses of pain severity (assessed by VAS) found no significant difference between groups in VAS improvement at 3 months but significantly greater improvement in the treatment compared with the control group at 6 and 12 months. Eight procedure-related events (2.7%) were reported in 6 participants following the 225 procedures; 2 of these 6 participants were in the sham arm. The events included nerve root injury, lumbar radiculopathy, retroperitoneal hemorrhage, and transient motor or sensory deficits. 

Additional data from the intervention group have been published; 24-month data in 2019 and five-year data in 2020. Data beyond 12 months on pain and function outcomes in the sham-treated group were not available as unblinding occurred at that time and most individuals crossed over to treatment with the Intracept system. Thus long-term comparative outcomes are not known. 

A second RCT evaluating the Intracept system, known as the Intracept trial (2), was published by Khalil and colleagues in 2019. The trial was open label and compared intraosseous RF treatment to standard care in individuals with at least 6 months of chronic low back pain who had not responded to at least 6 months of conservative care. For the primary outcome, the mean change in the ODI at 3 months in the interim analysis was -25.3 points in the Intracept group and -4.4 points in the standard care group. Mean change in VAS was -3.46 points in the Intracept group and -0.01 in the standard care group. As specified in the study protocol, the study was halted and individuals in the standard care group were allowed to cross over to treatment with the Intracept system. Limitations of this study include the lack of a sham control and limited duration of follow-up. 

The ideal candidates have not been defined. The literature does not support that this procedure is likely to be more beneficial to this patient. Intracept is an invasive procedure thus the potential adverse risks are greater than standard conservative treatment. 

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