Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Vertebrogenic Pain. 

Treatment: 22899 Unlisted procedure, spine (Intracept Procedure); C9752 Destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/ sacrum; C9753 Destruction of intraosseous basivertebral nerve, each additional vertebral body, including guidance (e.g., fluoroscopy), lumbar/ sacrum. 

The insurer denied coverage for 22899 Unlisted procedure, spine (Intracept Procedure); C9752 Destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/ sacrum; C9753 Destruction of intraosseous basivertebral nerve, each additional vertebral body, including guidance (e.g., fluoroscopy), lumbar/ sacrum. 

The denial is upheld. 

This patient has had chronic low back pain for many years. She has had Epidural Steroid injections, Medial Branch blocks, and sacroiliac (SI) joint injections.  She has had Physical Therapy and is doing home exercises. A magnetic resonance imaging (MRI) shows Modic changes at L[lumbar]3-L4 and L4-L5.  The request is for radiofrquency ablation (RFA) of the basivertebral nerves. 

Fischgrund and colleagues (1) published a double-blind, sham controlled RCT [randomized controlled trial] evaluating the Intracept system and RF [radifrequency] ablation of the Basivertebral nerve 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 months of non-operative management were randomized to either a sham (n=78) or treatment (n=147) intervention. In the active treatment group, the RF probe was activated and the temperature at the tip was maintained at 85Celsius 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 Owestry disability index (ODI) of 30 points (on 100-point scale) and a minimum VAS [visual analog scale] of 4 cm (10 cm [centimeter] 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. A total of 19 of 147 (13% [percent]) participants in the treatment group were excluded from the PP analysis; 16 for a targeting failure, 1 for procedural failure and 2 for protocol non-compliance. One participant in the sham group was excluded from the PP analysis and this was for protocol non-compliance. 

The publications to date have been company sponsored and had methodology flaws.  There is no published data on complication rates.  UptoDate (3) has evaluated this procedure and concluded that it is still unproven.  There are other evidence - based interventions available to this patient.  This procedure is unlikely to be more beneficial than the standard approaches. 

Evaluate whether 22899 Unlisted procedure, spine (Intracept Procedure); C9752 Destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/ sacrum; C9753 Destruction of intraosseous basivertebral nerve, each additional vertebral body, including guidance (e.g., fluoroscopy), lumbar/ sacrum is considered more beneficial for this patient's diagnosis, addressing the following in your discussion: 

The complication rates have not been published, thus unclear if the risks are increase above standard therapies. 

The carrier's denial of 22899 Unlisted procedure, spine (Intracept Procedure); C9752 Destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/ sacrum; C9753 Destruction of intraosseous basivertebral nerve, each additional vertebral body, including guidance (e.g., fluoroscopy), lumbar/ sacrum should be upheld.