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 overturned

This case involves a female diagnosed with vertebrogenic low back pain who is being considered for 01 unit (Intracept). Magnetic Resonance Imaging (MRI) of the lumbar spine noted multilevel lumbar disc disease without significant change when compared to previous examination. There was severe vertebral disc space narrowing at L (lumbar) 5-S (sacral) 1 with associated degenerative endplate marrow signal changes and mild degenerative endplate osteophytes along with moderate intervertebral disc space narrowing at L4-L5 with mild intervertebral disc space narrowing at L3-L4 and disc desiccation at L3-L4, L4-L5, and L5-S1. The conus medullaris terminated at the level of L1-L2 and demonstrated normal signal characteristics.

The visit noted the patient had a dull stabbing pain rated 8/10 (on a pain scale of 1-10) affecting the neck with radiation into the bilateral shoulders. She also presented with low back pain and radiation to the left lateral thigh, posterior thigh, medial thigh, anterior thigh, calf, shin, medial foot, lateral foot as well as the toes. Associated symptoms included weakness with her pain level also 8/10 in this region. Prior relevant treatment included muscle relaxants, physical therapy, chiropractic therapy, home stretching, anti-inflammatories, and nonopioid analgesics. Her examination findings noted blood pressure of 166/199. She had a body mass index of 38.44. She had a slow and cautious gait with paraspinal muscle tenderness to palpation bilaterally. The treatment plan at that time was to proceed with a transforaminal epidural steroid injection at the bilateral L4-L5 and L5-S1. The patient received a notice of adverse determination regarding the pain management service 01 Unit (Intracept). It was determined that this procedure was considered experimental/investigational and not a covered benefit of the health spine. An appeal was submitted from the treating physician stating that the proposed treatment is safe, efficacious, durable, and reproducible for appropriately selected patients. The physician claimed that there are 15 peer-reviewed publications in 10 different scientific journals supporting the efficacy and safety of basivertebral nerve ablation with the Intracept procedure. This review pertains to the pain management service 01 Unit (Intracept).

Literature states that vertebral endplates, innervated by the basivertebral nerves, can be a source of vertebrogenic low back pain when damaged with inflammation, visible as types 1 or 2 Modic changes. Interosseous basivertebral nerve ablation demonstrates an excellent safety profile and significant improvements in pain, function, and quality of life that are sustained in patients with chronic vertebrogenic low back pain. While the diagnosis of vertebrogenic pain is a relatively new clinical concept, there is a substantial body of basic science evident supporting the vertebral endplates as a significant source of low back pain. Evidence has shown that the basivertebral nerve ablation is as beneficial, if not more beneficial than traditional ablation procedures given that the treatment is directed at areas of the spine that had previously been or identified as a contributor to ongoing low back pain. 

The scientific evidence and peer-reviewed literature supports a result of improvements in health outcome.

This treatment does not need to have final approval from the appropriate regulatory bodies for this diagnosis.

This patient is a good candidate for the Intracept unit.

The proposed treatment with the Intracept is the best available treatment for this patient at this time.

The adverse risks are not increased over standard treatment/services.

The requested service is 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 overturned.