Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment the Intracept Procedure

The insurer denied coverage for the Intracept Procedure

The denial is upheld

This patient has chronic low back pain. She has tried physical therapy (PT), Chiropractic therapy, and acupuncture. She takes Percocet, Naproxen, and Gabapentin. She has had Medial branch blocks. Her magnetic resonance imaging (MRI) shows Modic type I changes at lumbar (L) 3.  It also shows a chronic compression fracture at L1 as well as Herniated discs at L2-L3 and L5-S (sacral) 1.  A surgical consultation is not documented.  The request is for the Intracept procedure at L3.

Fischgrund and colleagues (1) published a double-blind, sham-controlled RCT [randomized control 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 (>= 6 months) isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham (n [specific number]=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 85C [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 Owestry disability index (ODI) of 30 points (on 100 point scale) and a minimum VAS [visual analogue scale] of 4 cm [centimeters] (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. 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.

At 3 months, in the ITT analysis, there was no statistically significant difference between groups in the primary outcome, mean ODI. ODI improved a mean of 19.0 points in the treatment group and 15.4 points in the sham group, p [probability]=0.107. However, there was a difference between groups in the 3-month PP analysis: the mean ODI in the treatment arm improved 20.5 points and 15.2 points in the sham arm, p=0.019. In the 12-month PP analysis, the difference between the treatment and sham groups in mean ODI was no longer statistically significant (22.6 points versus 25.3 points, p=0.153). PP analyses of pain severity (assessed by VAS) found no significant difference between groups in VAS improvement at 3 months (p=0.083) 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 (n=1), lumbar radiculopathy (n=2), retroperitoneal hemorrhage (n=1), and transient motor or sensory deficits (n=4).

The peer reviewed data does not support the requested service in this clinical circumstance. The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for the Intracept Procedure is upheld. Medical Necessity is not substantiated.