Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Pain Management Service 01 Unit (Intracept)
The insurer denied coverage for Pain Management Service 01 Unit (Intracept)
The denial is upheld

The patient is a female with a history of low back pain. A lumbar magnetic resonance imaging (MRI) notes severe intervertebral disc space narrowing at L (lumbar)5-S (sacral) 1 with degenerative endplate marrow signal changes and mild degenerative endplate osteophytes. There is moderate intervertebral narrowing at L4-5 and mild at L3-4. At L5-S1 mild disc bulge with left facet hypertrophy that results in mild left neural foraminal narrowing. L4-5 mild disc bulge with superimposed mild right paracentral disc herniation with facet/flavum hypertrophy with mild central canal stenosis and mild right foraminal narrowing. She was evaluated for low back pain that radiated to the left lateral thigh, posterior thigh, medial thigh, anterior thigh, calf, shin, medial and lateral foot and toes with associated weakness. Her current pain score was 8/10 (on a pain scale of 1-10). It was exacerbated by standing and sitting. Current treatment included muscle relaxants and non-opioid analgesics. 

Although there has been benefit noted in two level 1 studies and is clinically supported by ISASS (international society for the advancement of spine surgery), there continues to be a question of limitations that they state, "Industry funding is a potential source of study bias for the available data reviewed; Limited number of studies; Short-term follow-up for the majority of studied patients; Unknown effect on the primary degenerative process" (2).

The Intracept Intraosseous Nerve Ablation System is Food and Drug Administration (FDA)-approved. 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 6 months duration that has not responded to at least six months of conservative care and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI (3).

Tieppo, et al. states, "Most importantly, the only commentary that can truly be pulled from this review is subject to the selection criteria from which the patients were selected in each study. While BVN (basivertebral nerve) RFA (radiofrequency ablation) may prove to be a successful treatment, we can only comment on its success as it relates to the rigid selection criteria upon which the foundational studies were completed. Any extrapolation of these findings to a differing patient population should be considered experimental and not supported by the data discussed in this review. Again, we must urge readers to be cognizant that while there has yet to be a study published to date on the amount of patients who may qualify for BVN RFA via the selection criteria described in the Fischgrund or Khalil studies in general practice, but there is an inherent understanding among spine providers that the percent of patients who meet such a rigid criteria for treatment is likely low in clinical practice." (1)

The patient has radicular pain as well as facet-related pain based on medical records. Imaging shows Modic changes to L5-S1 but also severe degenerative disc disease that is also a pain generator.  It is not clear that this procedure will improve the patient's pain as studies have excluded radiculopathy and she has multiple pain generators that could be causing her pain.

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of Pain Management Service 01 Unit (Intracept) is upheld.