Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
A 43-year-old male enrollee has requested authorization and coverage for thermal destruction 
of intraosseous basivertebral nerve first two bodies, lumbar or sacral. The Health Insurer has 
denied  this  request  and  reported  that  the  requested  services  are  investigational  for  the 
treatment of the enrollees medical condition. The physician reviewer found that the U.S. Food 
and Drug Administration (FDA) approves the use of the Intracept Intraosseous Nerve Ablation 
System in conjunction with radiofrequency generators for the ablation of basivertebral nerves of 
the L3 through S1 vertebrae for the relief of chronic low back pain 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 magnetic resonance imaging (MRI), such as inflammation, edema, 
vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues 
within the adjacent marrow, hypointensive signals, and changes to the vertebral body marrow 
including replacement of normal bone marrow by fat, and hyperintensive signals. Conger and 
colleagues report, There is moderate-quality evidence that suggests this procedure is effective 
in reducing pain and disability in patients with chronic low back pain who are selected based on 
type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published 
literature to date. Success of the procedure appears to be dependent on effective targeting of 
the basivertebral nerve ablation. Non-industry funded high-quality, large prospective studies are 
needed to confirm these findings. DeVivo and colleagues conclude, Percutaneous computed 
tomography (CT)-guided intraosseous basivertebral nerve ablation seems to be a safe, fast, and 
powerful technique for pain relief in patients with vertebrogenic chronic lower back pain, when 
the selection of patients is based on a multidisciplinary approach including both conventional 
diagnostic radiology and nuclear medicine imaging. Fischgrund and colleagues noted, Patients 
treated with radiofrequency ablation of the basivertebral nerve ablation for chronic low back 
pain exhibited significantly greater improvement in Oswestry Disability Index at three months 
and a higher responder rate than sham treated controls. Basivertebral nerve ablation represents 
a potential minimally invasive treatment for the relief of chronic low back pain.  Michalik and 
colleagues report, Basivertebral nerve radiofrequency ablation appears to be an effective 
treatment for a subset of patients with chronic low back pain and evidence of Modic change 
types 1 and 2 in the L3 to S1 vertebral body endplates who have failed to respond to conservative 
treatment. However, all studies performed to date have been industry sponsored, and future 
non-industry-funded trials will be needed to confirm these results. Tieppo Francio and Sayed 
noted, Finding the source of chronic axial low back pain is clinically challenging, and often 80% 
of diagnoses are described as non-specific low back pain, and in only 20% of cases, an anatomical 
source  can  be  attributed.  Perhaps  it  is  due  to  this  variability  and  uncertainty  that  many 
interventions for the treatment of chronic axial low back pain directly targeting anatomical 
structures, such as intervertebral discs, muscles, facet joints, and ligaments, have limited success 
rates and variable outcomes in the general population. Several studies have reported a high 
incidence of vertebral endplate damage in up to 43% of subjects suffering from chronic axial low 
back pain symptoms. These tend to manifest differently than when the etiology is from other 
structures. Often, vertebral endplate pain patients tend to present with significant functional  impairment and debilitating pain while seated, standing, or during spinal flexion (in contrast to 
extension), with the pain reported as a burning, deep and achy, located in the midline region of 
the lumbar spine without radicular symptoms, and without motor weakness, numbness or 
tingling. In fact, vertebral pain from damaged endplates tends to present clinically different than 
non-specific etiologies with reported greater frequency and longer duration of painful episodes 
and  worse  outcomes  with  conservative  treatment  and  surgery.  In  this  case,  the  patient 
presented to his provider on 1/26/22 with low back pain for over five years that had been 
progressively worsening. The patient rated his pain at a current average of six out of ten, with 
daily pain flares up rated at ten out of ten, particularly when getting out of bed. Pain is entirely 
within his back without radiculopathy. The records noted that magnetic resonance imaging (MRI) 
on 4/19/21 showed marked L3-L4 disc degeneration and endplate edema, Modic type I change, 
and mild right L5 inferior endplate edema. However, the records did not include detailed 
documentation regarding any objective examination findings to corroborate the pathology. 
While the patient noted pain in the entirety of his back without radiculopathy, the absence of an 
objective examination does not corroborate this, and there are multiple plausible pathologic 
sources of significant pain generation. Overall, documentation is lacking regarding reasonably 
detailed  and/or  evidenced findings  supportive of the  spinal  vertebral bodies  as being  the 
overwhelming primary generators of this patients chronic persistent pain. Therefore, thermal 
destruction of intraosseous basivertebral nerve first two bodies, lumbar or sacral is not likely to 
be more beneficial for treatment of the patients condition than any available standard therapy.