Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain. 

Treatment: Procedure code 22899 Unlisted procedure, spine (Intracept) and procedure code C9752 Destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum. 

The insurer denied coverage for procedure code 22899 and procedure code C9752. 

The denial is upheld. 

This is a male patient who has chronic axial low back pain, lumbar facet arthropathy, and vertebrogenic pain. The chronic axial low back pain has been present for over a year. The pain was described as a constant aching and sharp pain. The patient has tried Physical Therapy (PT) for 6 weeks with minimal effect. He has also tried multiple non-steroidal anti-inflammatory drugs (NSAIDs) including Mobic as well as Tylenol with minimal relief. The visit notes state that the patient was seen by a spine surgeon who recommended him to pain management and the Intracept procedure given Modic changes seen on Magnetic Resonance Imaging (MRI). 

Fischgrund et al (1) published a double-blind, sham-controlled Randomized Controlled Trial evaluating the Intracept system and radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain. A total of 225 participants with chronic (>= 6 months) 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. Study participants had a minimum Oswestry Disability Index (ODI) of 30 points (on 100 point scale) and a minimum visual analog scale (VAS) 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. 

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 randomized controlled trial (RCT) evaluating the Intracept system, known as the Intracept trial, was published by Khalil et al (2) 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. Intervention with the Intracept system consisted of treatment of up to 4 vertebrae in non-consecutive levels from the third lumbar vertebrae (L3) to the first sacral vertebra (S1). Individuals in the standard care continued treatment with conservative therapy. Limitations of this study include the lack of a sham control and limited duration of follow-up. 

The Intracept procedure is an experimental/ investigational procedure. The publications to date have been company sponsored and had methodology flaws. UpToDate has evaluated this procedure and concluded that it is still investigational. This procedure is unlikely to be more beneficial than the standard approaches. The complication rates are unknown given the limited number of patients treated to date. 

The carrier's denial of coverage for procedure code 22899 Unlisted procedure, spine (Intracept) and procedure code C9752 Destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum should be upheld.