Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.

Treatment: intraosseous basivertebral nerve ablation.

The insurer denied coverage for intraosseous basivertebral nerve ablation.

The denial is overturned.

This case involves an adult patient who is suffering from vertebrogenic pain and was being recommended for the Intracept interosseous nerve ablation procedure.  Magnetic resonance imaging (MRI) of the lumbar spine noted a loss of normal lumbar lordosis with hyperkyphosis and multilevel grade 1 subluxation.  She had broad-based disc extrusion at the lumbar (L)4-L5 level with 3 millimeter (mm) retrolisthesis and 6 mm caudad extension within the ventral epidural space.  This was indenting the thecal sac and there was degenerative endplate osteitis eccentric to the right compatible with Modic type I endplate degenerative changes.  There was mild bilateral neural foraminal stenosis and facet arthropathy.  At L2-L3, the patient had a focal hyperkyphotic angulation with disc base narrowing and disc osteophyte complex indenting the thecal sac.  There was superimposed left posterior lateral disc herniation abutting the exiting left L2 nerve root and mild left neural foraminal stenosis.  She had degenerative 3 mm retrolisthesis of L3 on L4 with disc base narrowing and a broad-based disc bulge, mild bilateral neural foraminal stenosis, and disc bulging with arthropathy at L1-L2 level with mild spinal stenosis.  

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes.

The procedure (intraosseous basivertebral nerve ablation) has final approval from the appropriate regulatory bodies for this diagnosis. 

This patient is a good candidate for procedure (intraosseous basivertebral nerve ablation).

The procedure (intraosseous basivertebral nerve ablation) 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 as beneficial or more beneficial than any of the standard treatments/procedures for this patient.

While reports claimed that clinical studies were funded by the developers of the Intracept procedure, it should be noted that it is common for a manufacturer to fund studies to help support a new/potential treatment.  Otherwise, new methods of treating patients would never come to fruition.  The Intracept was approved by the Food and Drug Administration in 2016.  Multiple studies have confirmed that several patients received pain relief for at least 1 to 2 years following this procedure, indicating that the treatment is beneficial on a long-term basis.  Prior studies have shown the safety and efficacy of Intracept and the patient in question previously treated her symptoms with multiple modalities of care with limited benefit. The documentation provided for the review noted that the patient satisfied the criteria for undergoing the Intracept procedure.  She had pain for greater than 6 months, failed treatment for greater than 6 months, and had confirmed evidence of Modic changes in the L3-S1 vertebral bodies on MRI.  Given this information, the prior determination should be overturned.  The interosseous basivertebral nerve ablation is medically necessary.  

In summary, the denial of procedure (intraosseous basivertebral nerve ablation) and coverage for the requested service/treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.