Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Low back pain.
Treatment:  Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level; Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level; Interspinous process distraction device (implantable)(Superion Procedure).

The insurer denied Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level; insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level; interspinous process distraction device (implantable)(Superion Procedure).  The determination is upheld.

The patient has a history of obesity, lumbago and neurogenic claudication symptoms.  She had a prior lumbar microdiscectomy; however, there is magnetic resonance imaging (MRI) evidence of moderate spinal stenosis persisting at the lumbar (L) 4-L5 level.  The treatment history includes physical therapy/home exercise (effective), pharmacotherapy with nonsteroidal anti-inflammatory drugs (NSAIDs) (Mobic), Skelaxin, Amitriptyline (helped with nocturnal pain), and Hydrocodone (effective); diagnostic facet nerve blocks; and radiofrequency ablation with initial transient pain relief.

The MRI of the lumbosacral spine revealed moderate facet degenerative changes that resulted in mild right neural foraminal narrowing.  There was a mildly increased disc bulge and facet degenerative changes at L3-L4 resulting in new mild spinal canal stenosis.  Mild bilateral neural foraminal narrowing, right greater than left.

The patient received right lumbar medial branch nerve blocks at L2-L3, L3-L4, and L4-L5 level with 80% pain relief for one to five days.  

She did not respond to the right-sided radiofrequency ablation.  She reported increased lumbar pain for three weeks.  

She was noted to have increased low back pain radiating to her right buttock.  The patient rated her pain as 5-8/10 in intensity.

The progress note by her provider indicated that she reported 4-8/10 low back pain.  Palliation was achieved somewhat with rest and sitting.  Provocative factors of pain included standing and ambulating.  The patient's active problems included a bulging lumbar disc, long-term (current) use of opiate analgesic, lumbosacral stenosis with neurogenic claudication, mid-back pain, intractable migraine without aura, lumbar postlaminectomy syndrome, and spondylosis of the lumbar region without myelopathy or radiculopathy.  The physical exam was unremarkable.  The patient's gait was noted to be normal.  The diagnoses were low back pain, lumbar postlaminectomy syndrome, and lumbar stenosis with neurogenic claudication.  Hydrocodone/acetaminophen 7.5/325 milligrams (mg) was renewed.  Flexion and extension radiographs were ordered to rule out/in instability of the lumbar spine.  It was noted that the patient was interested in pursuing the interspinous spacer implant across the L4-L5 level.  At issue is whether this is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.  

The proposed treatment:  insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level; insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level; interspinous process distraction device (implantable)(Superion Procedure) is not likely to be more beneficial than any standard treatment or treatments for the insured's disabling condition.

The patient was diagnosed with low back pain, lumbar postlaminectomy syndrome, and lumbar stenosis with neurogenic claudication.  She had a lumbar microdiscectomy, however, there is MRI evidence of mild spinal canal stenosis persisting at the L3-L4 level.  Her treatment history includes physical therapy/home exercise (effective), pharmacotherapy with NSAIDs (Mobic), Skelaxin, Amitriptyline (helped with nocturnal pain), and Hydrocodone (effective); diagnostic facet nerve blocks; and radiofrequency ablation with initial transient pain relief.

She reported 4-8/10 low back pain.  Palliation was achieved somewhat with rest and sitting.  Provocative factors of pain included standing and ambulating.  The physical exam was unremarkable.  The patient's gait was noted to be normal.  Flexion and extension radiographs were ordered to rule out/in instability of the lumbar spine.  It was noted that the patient was interested in pursuing the interspinous spacer implant across the L4-L5 level.

Although the development and use of interspinous spacers has become more common in the treatment of lumbar spinal stenosis, the data supporting the use of these devices in place of decompressive surgery is largely inconclusive.

The treatment options of lumbar spine stenosis vary widely in clinical practice and may include medication, bracing, exercise and physical therapy, transcutaneous electrical nerve stimulation (TENS), epidural steroid injections (ESIs), or surgical decompression.  The choice of therapy is usually made by combining clinical evidence of recommendation with individual patient characteristics and patient preference.  Surgical decompression is generally reserved for patients with moderate to severe symptoms that have had a chronically worsening course or failed an initial line of conservative measures.

Based on the documentation reviewed, and peer-reviewed literature, the requested treatment: insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level; insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level; interspinous process distraction device (implantable)(Superion Procedure) is not likely to be more beneficial than standard treatment.

The determination is upheld.