Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Back surgery (Intracept)

The insurer denied coverage for back surgery (Intracept).

The denial is upheld.

This patient has a history of lower back pain. The clinical impression of magnetic resonance imaging (MRI) lumbar spine non contrast performed was L (lumbar) 4-L5 diffuse disc bulge with broad-based central disc protrusion with mild central canal stenosis, and L5-S (sacral) 1 disc bulge with broad-based central disc protrusion with annular tear and mild bilateral facet arthropathy, resulting in mild left neural foraminal narrowing and mild central canal stenosis with disc abutting the exiting bilateral L5 and traversing bilateral S1 nerve roots.
 
Fischgrund and colleagues (1) published a double-blind, sham controlled RCT [Random Control Trial] evaluating the Intracept system and RF [Radio Frequency] ablation of the Basivertebral nerve for the treatment of chronic low back pain. A total of 225 participants with chronic (greater than or equal to 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=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 (centimeter) (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=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).

In sum, The Intracept procedure is an unproven procedure. 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 investigational. There are other evidence-based interventions available to this patient. This procedure is not medically necessary. The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient.

The insurer's denial of coverage for back surgery (Intracept) is upheld. Medical necessity is not substantiated.