Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1 
 
A  52-year-old  female  enrollee  has  requested  authorization  and  coverage  for  the  Intracept 
procedure. The Health Insurer has denied this request and reported that the requested medication 
is investigational for the treatment of the enrollees low back pain. The Health Insurer indicated 
that the requested service is investigational for the treatment of the enrollees medical condition. 
Therefore, the Health Insurer has denied coverage for the requested service. The physician reviewer 
found that the patient is a 52-year-old female who presented with low back pain. In notes dated 
8/23/22, the patient rated her pain at a five to ten out of ten, describing it as sharp, dull, aching, 
and stabbing, with symptoms radiating to the right leg, hip, and buttock, along with associated 
numbness and tingling in the right leg. An examination revealed intact strength, sensation, and 
reflexes. A straight leg raise was negative, and Flexion Abduction External Rotation (FABER) and 
Flexion Abduction Internal Rotation (FADIR) were mildly positive bilaterally. Greater trochanters 
and sacroiliac joints are tender bilaterally. The U.S. Food and Drug Administration states, The 
Intracept  Intraosseous  Nerve  Ablation  System  is  intended  to  be  used  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 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). 
In this case, an MRI report dated 7/1/22 does not corroborate any Modic changes at the L3 level, 
as  mentioned  by  the  provider.  Conger  and  colleagues  report,  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. DeVivo and colleagues report,  Selection of 
patients is based on a multidisciplinary approach including both conventional diagnostic radiology 
and nuclear medicine imaging. In this case, the records did not include any nuclear medicine 
imaging to support diagnostic radiology. There are multiple plausible pathologic sources of 
significant pain generation. Tieppo Francio and colleagues note, 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. In this 
case, the patients noted back pain, pain-aggravating factors such as sitting, standing, bending, and 
twisting,  pain-relieving  factors  such  as  walking  and  laying  down,  and  intact  neurologic 
examination documented in notes dated 8/23/22 were non-specific to any pathologic entities. In 
the case of multiple plausible sites of symptomatic pathology, standard therapies may include 
repeat physical therapy, epidural steroid injections, and medications. Rivera notes, Lumbar 
epidural steroid injections under fluoroscopic guidance are used very commonly for the treatment 
of low back and lower extremity radicular pain. These procedures have been shown to be effective 
for pain relief in the short term and are relatively safe. Knezevic and colleagues report, Low 
back  pain  covers  a  spectrum  of  different  types  of  pain  (e.g.  nociceptive,  neuropathic  and 
nociplastic, or non-specific) that frequently overlap. The elements comprising the lumbar spine 
(e.g.  soft  tissue,  vertebrae,  zygapophyseal  and  sacroiliac  joints,  intervertebral  discs,  and 
neurovascular  structures)  are  prone  to  different  stressors,  and  each  of  these,  alone  or  in 
combination, can contribute to low back pain. The authors further note, To a large extent, therapy  depends  on  pain  classification,  and  usually  starts  with  self-care  and  pharmacotherapy  in 
combination with non-pharmacological methods, such as physical therapies and psychological 
treatments in appropriate patients. For refractory low back pain, a wide range of non-surgical (e.g. 
epidural steroid injections and spinal cord stimulation for neuropathic pain, and radiofrequency 
ablation and intra-articular steroid injections for mechanical pain) and surgical (e.g. decompression 
for neuropathic pain, disc replacement, and fusion for mechanical causes) treatment options are 
available in carefully selected patients. Therefore, the Intracept procedure is not likely to be more 
beneficial for treatment of the patients condition than any available standard therapy.