Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain

Treatment: outpatient minimally invasive lumbar decompression (MILD) procedure (back surgery) (code 0275T)

The insurer denied coverage for outpatient minimally invasive lumbar decompression (MILD) procedure (back surgery) (code 0275T)

The denial is overturned

This patient suffers from low back and left lower extremity pain that worsens when standing and on ambulation. The patient's pain has been refractory to an interlaminar epidural steroid injection, chronic non-steroidal anti-inflammatory drugs (NSAID) therapy, activity modification, and physical therapy performed continuously over the past year and a half. The patient does not want to pursue further injections and wants to avoid decompressive surgery. The minimally invasive lumbar decompression (MILD) procedure was recommended.

According to Mostoufi, S. Ali, and Cameron Mostoufi, to date, two randomized controlled trials, together with 11 other controlled clinical studies, have established the efficacy of the MILD procedure. MIDAS-I study, a multicenter, nonblinded, prospective clinical study evaluating Visual Analog Score (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12 Health Survey after performing the MILD procedure, showed statistically and clinically significant reduction in all metrics. There were no major MILD device or procedure-related complications reported in this patient cohort, with major complications defined as dural tears, nerve root injury, post-operative infection, and hemodynamic instability. For claudication symptoms, at 6 weeks, the mean patient satisfaction response was 2.02, on a scale of 1-4 (50%). With respect to disability index, this study showed a 17.9-point improvement in mean ODI from baseline to 6 weeks post procedure. The average baseline VAS was 7.3 (range 3/10-10/10), which improved to 3.7/10 in a 6-week follow-up [2].

The MIDAS ONCORE study examined the long-term durability of the MILD procedure in terms of functional improvement and pain reduction for patients with lumbar spinal stenosis and neurogenic claudication due to hypertrophic ligamentum flavum. This prospective, multicenter, randomized controlled clinical study compared outcomes for MILD procedure versus epidural steroid injections. Follow-up occurred at 6 months and at 1 year for the randomized phase and at 2 years for MILD subjects. Oswestry Disability Index (ODI), Numeric Pain Rating Scale (NPRS), and Zurich Claudication Questionnaire (ZCQ) were used to evaluate function and pain. Safety was evaluated by assessing incidence of device/procedure-related adverse events. At 2 years, ODI improved by 22.7 points, NPRS improved by 3.6 points, and ZCQ symptom severity and physical function domains improved by 1.0 and 0.8 points, respectively. During 2-year follow-up, 5.6% of patients required a subsequent surgical procedure (6-7.5% reoperation rate in traditional laminectomy). 

Deer et al (2) conducted a randomized trial comparing the MILD procedure with Conventional Medical management (CMM) to CMM alone. They concluded at one-year results of this Level-1 study demonstrated superiority of MILD+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. 

In summary, the denial of outpatient MILD procedure (back surgery) (code 0275T) 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.