Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Low back pain. 
Treatment: 22899 - Intracept procedure. 
The insurer denied the 22899 - Intracept procedure. 
The denial is upheld. 

The patient is a female with history of chronic axial low back pain due to Modic type-1 changes leading to vertebrogenic pain. The patient has tried physical therapy (PT), massages, heat , ice, lumbar epidural steroid injections and medial branch blocks, home exercises, medications with tizanidine Duexis, and non-steroidal anti-inflammatory drugs (NSAIDs). The pain affects activities of daily living (ADLs). Magnetic resonance image (MRI) of the lumbar spine shows Modic changes at L5,S1. Recommended for Intracept intraosseous destruction of the basivertebral nerve. The patient was scheduled for lumbar radiofrequency ablation (RFA). 

No, the health plan should not cover the Intracept procedure. 

The patient has a history of chronic axial lower back pain thought to be related to vertebrogenic pain. The patient has failed conservative therapy for more than six months with medications, PT, exercises and injections. This is a request for RFA of basivertebral nerve at L5, S1 related to Modic changes seen on magnetic resonance image (MRI) of the lumbar spine. Modic changes and associated endplate damage strongly correlate with chronic low back pain. 

Research shows chronic low back pain may be caused by lumbar vertebral endplate changes involving the basivertebral nerve (BVN) and there is evidence showing radiofrequency (RF) ablation of the BVN can lead to short term improvement of pain and function in patients with chronic vertebrogenic related LBP. 

A new MRI may be necessary to ensure persistence of Modic changes as one of the pain generators as a cause of the vertebral body pain. Therefore, the health plan should not cover the proposed treatment, requested Intracept procedure for radiofrequency ablation of the basivertebral nerves. 

Per reference #1: FDA indications 
Indications for Use (Describe) 
The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type-1 or Type-2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type-1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type-2 Modic change). The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type-1 or Type-2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type-1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type-2 Modic change). 

Per reference #2: 
Abstract 
Background: The purpose of the present study is to report the two-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported one-year follow up. 
Methods: A total of 147 patients were treated with RF ablation of the BVN in a randomized controlled trial designed to demonstrate safety and efficacy as part of a Food and Drug Administration-Investigational Device Exemption trial. Evaluations, including patient self-assessments, physical and neurological examinations, and safety assessments, were performed at two and six weeks, and 3 three six, 12, 18, and 24 months postoperatively. Participants randomized to the sham control arm were allowed to cross to RF ablation at 12 months. Due to a high rate of crossover, RF ablation treated participants acted as their own control in a comparison to baseline for the 24-month outcomes. 
Results: Clinical improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through two years. The mean percent improvements in ODI and VAS compared to baseline at two years were 53.7 and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through two years with patients showing clinically meaningful improvements in both: ODI >= 10-point improvement in 76.4% of patients and ODI >= 20-point improvement in 57.5%; VAS >= 1.5 cm improvement in 70.2% of patients. 
Conclusions: Patients treated with RF ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at two years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP. 

Per reference #3: 
Abstract 
BACKGROUND CONTEXT 
Current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care. Prior two-year data from the treatment arm of a sham-controlled randomized controlled trial (RCT) showed maintenance of clinical improvements at two years following radiofrequency (RF) ablation of the basivertebral nerve (BVN). 
PURPOSE 
The purpose of this randomized clinical trial (RCT) was to compare the effectiveness of intraosseous RF ablation of the BVN to standard care for the treatment of chronic LBP in a specific subgroup of patients suspected to have vertebrogenic related symptomatology.
STUDY DESIGN/SETTING 
A prospective, parallel, open label RCT was conducted at 20 U.S. sites. 
PATIENT SAMPLE 
A total of 140 patients with chronic LBP of at least six months duration, with Modic Type-1 or -2 vertebral endplate changes between L3 and S1, were randomized 1:1 to undergo either RF ablation of the BVN or continue standard care. 
OUTCOME MEASURES 
Oswestry Disability Index (ODI) was collected at baseline, three, six, nine, and 12-months postprocedure. Secondary outcome measures included a ten-point Visual Analog Scale (VAS) for LBP, ODI and VAS responder rates, SF-36, and EQ-5D-5L. The primary endpoint was a between-arm comparison of the mean change in ODI from baseline to three months post-treatment. 
METHODS 
Patients were randomized 1:1 to receive RF ablation or to continue standard care. Self-reported patient outcomes were collected using validated questionnaires at each study visit. An interim analysis to assess for superiority was prespecified and overseen by an independent data management committee when a minimum of 60% of patients had completed their three-month primary endpoint visit. 
RESULTS 
The interim analysis showed clear statistical superiority (p<.001) for all primary and secondary patient-reported outcome measures in the RF ablation arm compared with the standard care arm. This resulted in a data management committee recommendation to halt enrollment in the study and offer early cross-over to the control arm. These results are comprised of the outcomes of the 104 patients included in the intent-to-treat analysis of the three-month primary endpoint, which included 51 patients in the RF ablation arm and 53 patients in the standard care arm. Baseline ODI was 46.1, VAS was 6.67, and mean age was 50 years. The percentage of patients with LBP symptoms more than or equal to (>=) five years was 67.3%. Comparing the RF ablation arm to the standard care arm, the mean changes in ODI at three months were -25.3 points versus -4.4 points, respectively, resulting in an adjusted difference of 20.9 points (p<.001). Mean changes in VAS were -3.46 versus -1.02, respectively, an adjusted difference of 2.44 cm (p<.001). In the RF ablation arm, 74.5% of patients achieved a >= ten-point improvement in ODI, compared with 32.7% in the standard care arm (p<0.001). 
CONCLUSIONS 
Minimally invasive RF ablation of the BVN led to significant improvement of pain and function at three-months in patients with chronic vertebrogenic related LBP.