Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: M48.062 - Spinal stenosis, lumbar region with neurogenic claudication Z00.6 - Encounter for examination for normal comparison and control in clinical research program
Treatment: Percutaneous Laminotomy/Laminectomy (MILD)
The insurer denied the Percutaneous Laminotomy/Laminectomy (MILD).
The denial is upheld.

The patient is a male. The request is for MILD procedure (minimally invasive lumbar decompression).

Per the letter of medical necessity by provider, the patient has tried epidural steroid injections, NSAIDs (nonsteroidal anti-inflammatory drugs) and PT (physical therapy). They note Level 1 evidence for MILD (minimally invasive lumbar decompression) procedure.

Per a note, the patient is a male who has history of lower back pain. Pain is relieved with sitting and nerve blocks, and it worsens on walking and standing too long. Pain score varies from 1-5/10. Patient is on Aleve. No history of anticoagulation or bleeding disorder. No history of drug use. Examination: Gait is normal. Diagnosis of neurogenic claudication due to spinal stenosis. Plan for MILD (minimally invasive lumbar decompression) procedure.

MRI (magnetic resonance imaging) revealed ligamentum hypertrophy at L3-4 (third lumbar spine vertebra - fourth lumbar spine vertebra), L4-5 (fourth lumbar spine vertebra - fifth lumbar spine vertebra) more than 3 mm (millimeters).

Per a note, the patient has history of chronic low back pain and leg pain. 3/10 pain. Tried PT (physical therapy), exercises, naproxen, cluneal nerve block, epidural steroid injections. He had lumbar RFA (radiofrequency ablation) bilateral. His functional status is limited. Examination: tenderness in the back. Intact motor strength and sensation. RFA (radiofrequency ablation) helped the back pain and now has leg pain. MRI (magnetic resonance imaging) lumbar spine ordered, last MRI (magnetic resonance imaging). Lumbar epidural steroid injection was suggested as it helped in past. Patient is full-time employed.

Toward the end of last year, the patient was status post LESI (lumbar epidural steroid injection) with 3-4 weeks of relief.

MRI (magnetic resonance imaging) Lumbar spine prior to injection revealed L3-4 mild disc bulge flattens, ventral thecal sac with ligamentum hypertrophy. Mild central canal stenosis with mild ascending L4 nerve root abutment and mild recess narrowing, mild right foraminal stenosis. L4-5 broad based left paracentral disc protrusion indents the ventral thecal sac, mild ligamentum thickening and bilateral facet arthropathy. Moderate central canal stenosis with moderate to severe right and severe left recess narrowing and mild dorsal displacement of descending L5 nerve root, tiny annular tear, mild left foraminal stenosis. L5-S1 (fifth lumbar spine vertebra - first sacral vertebra); moderate to severe disc height loss with grade 1 retrolisthesis L5 on S1. Mild dorsal disc bulge osteophyte complex abuts descending bilateral S1 nerve roots. Moderate left and mild right foraminal stenosis.

The health plan denied the minimally invasive lumbar decompression, as their policy considers minimally invasive lumbar decompression (MILD) procedure (back surgery) to be experimental/investigational in the treatment of spinal stenosis of the lumbar spine.

No, the health plan should not cover the requested health service.

The patient has history of lower back pain and has tried pain medications, chiropractic therapy, PT (physical therapy), home exercises, epidural steroid injections, and RFA (radiofrequency ablation). The patient has a diagnosis of neurogenic claudication due to spinal stenosis.

The appeal request contends that the MILD (minimally invasive lumbar decompression) procedure is supported by Level 1 clinical evidence that was most recently published as a result of Medicare approved MiDAS ENCORE study.

Although two-year results of MiDAS ENCORE study show MILD (minimally invasive lumbar decompression) showed excellent long-term durability with no evidence of spinal instability through two-year follow-up, other studies show that there is a lack of high-quality studies, and the long-term benefits of the procedure are currently unknown.

Minimally invasive lumbar decompression (MILD) has not been medically proven to be effective, and it is therefore considered to be experimental/investigational in this patient's clinical scenario.

No, the requested service is not more beneficial.