1.      Percutaneous Image-Guided Lumbar Decompression for Spinal Stenosis (NCD 150.13)

General documentation requirements for PILD for LSS through CMS’ CED7 are as follows:

1.      Enrollment in an active CMS-approved trial associated with this NCD/CED

2.      Documentation of:

2.1 Neurogenic claudication symptoms defined generally as leg/buttock/groin pain and/or paresthesias that are exacerbated with standing and walking and relieved by flexion and/or sitting/laying down

2.2 VAS leg symptom severity greater than 50 (in either leg) during episodes of neurogenic claudication

2.3 Persistence of symptoms for at least 3 months

2.4 Treatments tried and failed including but not limited to:

2.4.1       Medications

2.4.2       Physical therapy

2.4.3       Home exercise program

2.4.4       Injections

3.      Diagnosis of central canal spinal stenosis, with or without mild to moderate lateral recess stenosis, from hypertrophic ligamentum flavum, at one or two levels from L1-L5 with radiologic evidence performed within the last 12 months of baseline visit

4.      Assessment and documentation of none of the following:

4.1 Significant back, buttock or leg pain from causes other than lumbar central canal stenosis, e.g., acute compression fracture, metabolic neuropathy, vascular claudication symptoms

4.2 Axial back pain only

4.3 Severe foraminal stenosis at index level(s) and/or symptomatic foraminal stenosis at any lumbar level

4.4 Severe lateral recesses

4.5 Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention

4.6 Prior PILD or decompressive or fusion surgery at index level(s)

4.7 Epidural steroid or nerve block steroid injection at index level(s) within 8 weeks of baseline assessments

4.8 Spondylolisthesis (anterolisthesis or retrolisthesis) of any Grade

4.9 Spondylolysis (pars fracture)

4.10 Acute traumatic spinal fractures within the last 3 months with related pain       symptoms

4.11 Degenerative lumbar scoliosis with Cobb angle greater than or equal to 30 degrees including index level(s)

4.12 Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician)