Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain

Treatment: minimally invasive lumbar decompression (MILD)

The insurer denied coverage for minimally invasive lumbar decompression (MILD).

The denial is overturned.

This patient has chronic low back pain with neurogenic claudication. The patient is taking Gabapentin for pain. Magnetic resonance imaging (MRI) shows spinal stenosis at L (lumbar) 3-L4 and L4-L5 from hypertrophic ligamentum Flavum.  The request is for the Minimally Invasive Lumbar Decompression (MILD) procedure at L3-L4 and L4-L5.		

There are two prospective randomized controlled trials (1,2) that support this procedure.

Staats et al (1) conducted the Mild Decompression Alternative to Open Surgery (MiDAS) Encore study which was approved by the Centers for Medicare & Medicaid Services (CMS) as a Coverage with Evidence Development study for the purpose of providing level I evidence to support the safety and effectiveness of the MILD procedure. This randomized controlled trial assessed outcomes of the MILD procedure compared with epidural steroid injections (ESIs) in subjects with lumbar spinal stenosis (LSS) and neurogenic claudication symptoms, with verified Ligamentum Flavum Hypertrophy as a contributing factor. Study follow-up intervals occurred at 6 months and 1 year for the randomized phase of the study, and subjects in the MILD treatment group were followed at 2 years. Study design and 6-month and 1-year follow-up comparative results between MILD and ESI were previously reported. This is a report of 2-year clinical outcomes of patients treated with the MILD procedure in the MiDAS ENCORE study which were statistically significant improvement in pain and disability scores.

Deer et al. (2) also conducted a randomized controlled trial and reported the one-year results of this Level-1 study which demonstrated the superiority of MILD+ (plus) Conservative Medical Management (CMM) over CMM alone for patients with lumbar spinal stenosis who were suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum. Use of the validated Walking Tolerance Test to objectively measure increased ability to walk without severe symptoms provided evidence of statistically significantly better outcomes for MILD+CMM than for CMM alone. With no reported device or procedure-related adverse events, the long-standing safety profile of the MILD procedure was reaffirmed. MILD is a safe, durable, minimally invasive procedure that has been shown to be effective as an early interventional therapy for patients suffering from symptomatic lumbar spinal stenosis.

In a Cleveland Clinic study, a review of a case series found: "Seventy-five patients received MILD during the protocol-defined time period and were included in the study. Only 9 out of 75 patients required lumbar surgical decompression during the 5-year follow-up period. Subjects experienced statistically significant pain relief and reduction of opioid medications utilization at 3, 6, and 12 months compared to baseline.

Based on our analysis, the MILD procedure is durable over 5 years and may allow elderly patients with symptomatic lumbar spinal stenosis to avoid lumbar decompression surgery while providing significant symptomatic relief."

This procedure is more beneficial than the standard treatment for this patient. The procedure is reasonable and necessary.

In summary, the denial of minimally invasive lumbar decompression (MILD) procedure and coverage for the requested 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.