Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Chronic Low back Pain with Lumbar Radiculopathy.

Treatment: the Intracept Procedure (procedure codes 22899 and C9752).

The insurer denied coverage for the Intracept Procedure (procedure codes 22899 and C9752).

The denial is upheld.

This adult female patient has chronic low back pain with lumbar radiculopathy. She has tried physical therapy (PT), a home exercise program (HEP), acupuncture, and massage. Her current pain medications include Methocarbamol, Percocet, and Ibuprofen. She has had 2 epidural steroid injections with greater than 80% (percent) pain relief. Her magnetic resonance imaging (MRI) scan shows Modic Type II changes at the superior endplate of S (sacral) 1. It was also noted that there is disc bulge that contacts the S1 nerve root. The request is for the Intracept procedure. There has been no surgical consultation.

Fischgrund and colleagues (1) published a double-blind, sham-controlled randomized clinical trial (RCT) evaluating the Intracept system and radiofrequency (RF) 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 [natural 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 Oswestry disability index (ODI) of 30 points (on 100-point scale) and a minimum visual analog scale (VAS) 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%) 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 [irrational number]=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).

Additional data from the intervention group have been published. Data beyond one year 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.

In sum, this is still an experimental/ investigational procedure. UpToDate (3) considers this experimental/ investigational.  

The requested procedure is not likely to be more beneficial than any other existing standard health service for this patient.

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