Coverage Policy Manual
Policy #: 2010021
Category: Surgery
Initiated: April 2010
Last Review: May 2018
  Minimally Invasive Image-Guided Lumbar Decompression for Spinal Stenosis

Image-guided minimally invasive lumbar decompression (mild®) describes a novel percutaneous procedure for decompression of the central spinal canal in patients with lumbar spinal stenosis. In this procedure, a specialized cannula and surgical tools are used under fluoroscopic guidance for bone and tissue sculpting near the spinal canal.
In lumbar spinal stenosis (LSS), the space around the spinal cord narrows, compressing the spinal cord and the nerve roots. The most common symptom of LSS is back pain with neurogenic claudication, i.e., pain, numbness, or weakness in the legs that worsens with standing or walking and is alleviated with sitting or leaning forward. Compression of neural elements generally occurs from a combination of degenerative changes including ligamentum flavum hypertrophy, bulging of the intervertebral disc, and facet thickening with arthropathy. Spinal stenosis is often linked to age-related changes in disc height and arthritis of the facet joints. LSS is one of the most common reasons for back surgery and the most common reason for lumbar spine surgery in adults over 65 years of age. The goal of surgical treatment is to “decompress” the spinal cord and/or nerve roots. Although treatment of disc herniation may be required as a component of lumbar decompression, the present policy addresses posterior decompression of central LSS with a percutaneous treatment that is performed under fluoroscopic guidance.
Image-guided percutaneous minimally invasive lumbar decompression (IG-MILD) has been proposed as an ultra-minimally invasive treatment of central LSS. In the mild® procedure, the epidural space is filled with contrast medium under fluoroscopic guidance. Using a 6-gauge cannula that is clamped in place with a back plate, single use tools (portal cannula, surgical guide, bone rongeur, tissue sculpter, trocar) are used to resect thickened ligamentum flavum and small pieces of lamina. The tissue and bone sculpting is conducted entirely under fluoroscopic guidance, with additional contrast media added throughout the procedure to aid visualization of the decompression. The process is repeated on the opposite side for bilateral decompression of the central canal. The devices are not intended to be used near the lateral neural elements and are contraindicated for disc procedures.
Alternative posterior decompressive surgical procedures include:
    • Decompressive laminectomy, the classic treatment for LSS, which unroofs the spinal canal by extensive resection of posterior spinal elements, including the lamina, spinous processes, portions of the facet joints, ligamentum flavum, and the interspinous ligaments. Wide muscular dissection and retraction is needed to achieve adequate surgical visualization. The extensive resection and injury to the posterior spine and supporting muscles can lead to instability with significant morbidity, both post-operatively and longer-term. Spinal fusion, performed at the same time as laminectomy or after symptoms have developed, may be required to reduce the resultant instability. Laminectomy may be used for extensive multi-level decompression.
    • Hemilaminotomy and laminotomy, sometimes termed laminoforaminotomy, are less invasive than laminectomy. These procedures focus on the interlaminar space, where most of the pathologic changes are concentrated, minimizing resection of the stabilizing posterior spine. A laminotomy typically removes the inferior aspect of the cranial lamina, superior aspect of the subjacent lamina, ligamentum flavum and the medial aspect of the facet joint. In contrast to laminectomy, laminotomy does not disrupt the facet joints, supra- and interspinous ligaments, a major portion of the lamina or the muscular attachments. Muscular dissection and retraction are required to achieve adequate surgical visualization.
    • Microendoscopic decompressive laminotomy (MEDL) is similar to laminotomy, but utilizes endoscopic visualization. The position of the tubular working channel is confirmed by fluoroscopic guidance, and serial dilators (METRx™ lumbar endoscopic system, Medtronic) are used to dilate the musculature and expand the fascia. For MEDL, an endoscopic curette, rongeur, and drill are used for the laminotomy, facetectomy, and foraminotomy. The working channel may be repositioned from a single incision for multilevel and bilateral dissections.
Regulatory Status
The mild® tool kit (Vertos Medical) initially received 510(k) marketing clearance as the X-Sten MILD Tool Kit (X-Sten Corp.) from the U.S. Food and Drug Administration (FDA) in 2006, with intended use as a set of specialized surgical instruments to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
Vertos mild® instructions for use state that the devices are not intended for disc procedures but rather for tissue resection at the perilaminar space, within the interlaminar space and at the ventral aspect of the lamina. These devices are not intended for use near the lateral neural elements and remain dorsal to the dura using image guidance and anatomical landmarks.
Note: The abbreviation MILD has also been used for microscopic muscle-preserving interlaminar decompression, which involves a small skin incision at the interspinous level and partial drilling of the spinous process, with decompression performed under microscopic visualization.
Effective July 1, 2011, there is a CPT category III code that is applicable to this procedure:
0275T: Percutaneous laminotomy/laminectomy (intralaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy) any method under indirect image guidance (e.g., fluoroscopic, [computed tomography] CT), with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; lumbar
The procedure uses an epidurogram, so CPT code 72275 (epidurography, radiological supervision and interpretation) would probably also be reported.
Effective January 1, 2015 (and retroactive for Medicare claims to January 9, 2014, the effective date of the Medicare National Coverage Determination), there is a HCPCS “G” code specific to percutaneous image-guided lumbar decompression:
G0276 Blinded procedure for lumbar stenosis, percutaneous image-guided lumbar decompression (PILD) or placebo-control, performed in an approved coverage with evidence development (CED) clinical trial

Image-guided minimally invasive lumbar decompression for the treatment of spinal stenosis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.  This procedure is currently being studied in clinical trials.
For contracts without primary coverage criteria, image-guided minimally invasive lumbar decompression for the treatment of spinal stenosis is considered investigational.  Investigational services are contract exclusions in most member benefit certificates of coverage.

Posterior Decompressive Surgery
A 2009 systematic review of surgery for back pain, commissioned by the American Pain Society (APS), was conducted by the Oregon Health Sciences University Evidence-Based Practice Center (Chou, 2009). Four higher quality randomized trials were reviewed that compared surgery to nonsurgical therapy for spinal stenosis, including 2 studies from the multicenter Spine Patient Outcomes Research Trial (SPORT) evaluating laminectomy for spinal stenosis (specifically with or without degenerative spondylolisthesis) (Weinstein, 2007) (Weinstein, 2008).  Baseline pain scores averaged 31 to 32 on the SF-36 bodily pain score or 7 on a 0 to 10 pain scale. Two trials permitted enrollment of patients with >12 weeks of symptoms, however, symptoms were present for more than 6 months in the majority of patients in all trials. All 4 trials found that initial decompressive surgery (laminectomy) was slightly to moderately superior to initial nonsurgical therapy (e.g., average 8 to 18 point difference on the SF-36 and Oswestry Disability Index). Although differences were decreased at longer follow-up, interpretation of results was complicated by the large proportion of patients in the nonsurgical therapy group who crossed over to surgery before the final follow-up. Dural tears were the most common complication of laminectomy, occurring in 7% to 11% of patients. There was insufficient evidence to determine the optimal adjunctive surgical methods for laminectomy (i.e., with or without fusion, and instrumented vs. non-instrumented fusion) in patients with or without degenerative spondylolisthesis.
Laminotomy versus Laminectomy
A 2005 study randomized 120 patients with lumbar stenosis to bilateral laminotomy, unilateral laminotomy or laminectomy (Thome, 2005).  Patients were refractory to at least 3 months of conservative therapy, with neurogenic claudication or radiculopathy, imaging evidence of degenerative lumbar stenosis, and absence of herniation or instability. Three patients were excluded due to discectomies during surgery; follow-up of at least 1 year was obtained in 110 patients (94% of the cohort of 117 and 97% of surviving patients). The average visual analog score (VAS) for overall pain at baseline was 7.5, improving to 2.3 for bilateral laminotomy, 3.6 for unilateral laminotomy, and 4 for laminectomy. Neurogenic claudication improved in 92% of patients with bilateral laminotomy, compared with 74% treated with unilateral laminotomy and 68% of patients who had laminectomy. Similar improvements were obtained for the SF-36 (post-op bodily pain scores of 61, 47, 45, respectively), Roland-Morris scale (8, 8.5, and 11 post-operatively), and patient satisfaction scores (97%, 74%, and 74% satisfied). The perioperative morbidity rate was lower with bilateral laminotomy (5%) than unilateral laminotomy (17.5%) or laminectomy (22.5%), due primarily to the incidence of dural tears with the 3 procedures. Blinding of patients to the procedure to which they were randomized was not described; the potential for bias is unknown.
A 2008 quasi-randomized study from Asia compared laminoforaminotomy with laminectomy in 152 consecutive patients (Fu, 2008). Inclusion criteria required that each patient have 1) neurogenic claudication as defined by leg pain limiting standing, ambulation, or both; 2) a history of exercise intolerance; 3) magnetic resonance imaging (MRI), myelogram, or computed tomography (CT) confirmation of compressive central stenosis (central sagittal diameter less than 10 mm) with or without lateral recess stenosis (lateral recess diameter less than 3 mm); and 4) failure of conservative therapy after an adequate trial (not defined). Patients were excluded from the study if they had 1) previous surgery at the same level, 2) isthmic spondylolisthesis, 3) congenital spinal stenosis less than 8 mm caused by short pedicles, 4) dynamic instability, 5) cauda equine syndrome, 6) worker’s compensation claim or other litigation, 7) dying of other disease or otherwise lost to follow-up. At an average 40 months after surgery, the Oswestry Disability Index and VAS for back and leg pain and were low (e.g., < 1 on VAS) for both groups, and significantly lower for laminotomy. The proportion of patients with good to excellent results (absent or occasional mild back and leg pain and the ability to ambulate more than 1 mile or 20 minutes) was 89% for patients treated with laminotomy and 63% for patients treated with laminectomy. Seven percent of patients treated with laminectomy had poor results at the final interview (range of 27-58 months), compared with none in the laminotomy group. The study is limited by the lack of information about the number of patients lost to follow-up and the lack of blinding.
Microendoscopic Decompressive Laminotomy
No comparative trials with MEDL were identified. In 2009, Castro-Menendez et al. reported 4-year outcomes (from a prospectively maintained institutional database) of 50 patients with LSS who were treated by single level microendoscopic decompression. Twenty of the patients received microendoscopic discectomy at the same time, which may be considered a part of the endoscopic procedure that can be performed when needed (Castro-Menendez, 2009). Inclusion criteria for the study were 1) low back pain and/or radicular pain (70%), 2) neurogenic claudication (58%), 3) personal history of exercise intolerance, 4) radiological/neuroimaging evidence of degenerative lumbar stenosis, 5) clinical-radiological concordance, 6) failure of conservative management after at least 6 months of therapy. Excluded from the study were patients with 1) nonclinical-nonradiological correlation, 2) congenital stenosis, 3) previous lumbar spinal surgery, 4) higher than grade I degenerative spondylolisthesis, 5) spondylolisthesis with spondylolysis, 6) preoperative instability, 7) more than 1 level clinically affected, 8) associated degenerative scoliosis of more than 20 degrees, and 9) the presence of an associated pathology such as acute inflammation, tumor, or cauda equine syndrome. The mean postoperative hospital stay was 3.2 days. The Oswestry Disability Index decreased by 30 (65.2 preoperatively), leg pain VAS by 6.02 (8.3 preoperatively) and lumbar pain VAS by 0.84 (5.3 preoperatively) at an average 4 year follow-up (range 24-72 months). Of the 29 patients (58%) with neurogenic claudication, 21 (72%) reported improvement in the ability to walk (> 1 mile) at the end of the study. Dural tears occurred in 5 patients (10%), all in the first 25 interventions. One patient (2%) had epidural hematoma causing cauda equine syndrome. Although the study may be relatively representative of outcomes during the learning curve for this highly selected population, the report is limited by the restricted selection criteria, retrospective review, and lack of blinding.
Image-Guided Percutaneous Minimally Invasive Lumbar Decompression (IG-MILD)
A 2010 publication describes a chart review of 90 consecutive patients treated in the U.S. (14 physicians in 12 facilities) with mild® devices under fluoroscopic guidance (Deer, 2010). No efficacy data were reported. No major adverse events (dural puncture or tear, blood transfusion, nerve injury, epidural bleeding, or hematoma) were found in the chart review. The authors state that prospective randomized studies have been initiated to evaluate the efficacy of this new procedure.
A search of in February 2010 found several ongoing trials on IG-MILD by Vertos Medical. Two studies are open label (NCT00749073, NCT00956631), the third (NCT00995371) is a randomized trial comparing minimally invasive lumbar decompression with epidural steroid injection. The study has an estimated enrollment of 40 patients with symptomatic LSS primarily caused by dorsal element hypertrophy. The estimated study completion date (26-week follow-up) is estimated for June 2010.
Posterior decompression for lumbar spinal stenosis has been evolving towards increasingly minimally invasive procedures in an attempt to minimize post-operative morbidity and spinal instability. In general, the literature comparing surgical procedures is limited. The evidence available suggests that less-invasive surgical decompression may reduce perioperative morbidity without impairing long-term outcomes when performed in appropriately selected patients. In contrast to surgical decompression, the mild® procedure is a percutaneous decompressive procedure performed solely under fluoroscopic guidance (e.g., without endoscopic or microscopic visualization of the work area). This procedure is indicated for central stenosis only, without the capability of addressing nerve root compression or disc herniation, should it be required. Due to the unknown impact of these limitations on health outcomes, randomized controlled studies in appropriate patients are needed to compare this novel procedure with the established alternatives. Although studies have been initiated, no evidence is available at this time to evaluate the efficacy of image-guided percutaneous lumbar decompression.
2011 Update
A search of the Medline database was conducted through March 2011.  There were no studies identified that would prompt a change in the coverage statement.  A summary of the literature identified for this policy update is provided.
A retrospective review reported outcomes from a consecutive series of 42 patients who underwent IG-MLD by interventional pain specialists (Lingreen, 2010). All patients met magnetic resonance imaging (MRI) criteria (spinal stenosis and ligamentum flavum hypertrophy) for IG-MLD, and had undergone previous conservative treatment to include lumbar epidural steroid injections, opioid and non-opiod medication and physical therapy. Most of the patients were considered non-surgical candidates in consultation with or referral from a spine surgeon (no further details were provided). All patients had bilateral IG-MLD with the majority (n=26) at 2 levels. VAS pain scores averaged 9.6 at baseline and 5.8 at 30 days after the procedure, with 80% of patients reporting a change in VAS of > 3. Thirty patients (71%) reported an improvement in function following IG-MLD. No major adverse events were identified.
Chopko and Caraway published 6-week follow-up of an ongoing multi-center study (NCT00956631) of IG-MLD at 14 centers (Chopko, 2010). Included were patients with symptomatic lumbar spinal stenosis that was caused primarily by dorsal element hypertrophy with a hypertrophic ligamentum flavum > 2.5 mm and central canal sectional area < 100 square mm and had failed conservative therapy. Out of 78 patients treated, 6-week follow-up was available for 75 (96%). Thirty nine of the patients (52%) were discharged from the hospital on the same day and 36 patients (48%) stayed for one night. No major device or procedure-related complications (e.g. dural tears, nerve root injury, post-op infection, hemodynamic instability, or post-op spinal structural instability) were reported. The average VAS pain score improved from 7.3 at baseline to 3.7 at the 6-week follow-up. Scores on the Oswestry Disability Index (ODI) improved from 47.4 to 29.5, a 38% improvement. Scores on the Zurich Claudication Questionnaire improved 26.8% on the symptom severity subscale and 17.5% for physical function. Scores on all subscales of the short-form 12 health survey were improved.
Chopko also reported a prospective study of IG-MLD in 14 patients who were considered at high risk for complications from open spine surgery and general anesthesia (Chopko, 2011). Comorbidities included obesity, diabetes mellitus, hypertension, chronic obstructive pulmonary disease, chemotherapy, and coronary artery disease. Nine of the 14 patients (64%) reported an improvement in VAS pain scores of 3 points or more. The average VAS score improved from 7.6 to 3.6 (53% improvement) at a mean follow-up of 23.5 weeks (range, 4 to 72 weeks). Scores on the ODI were 50% at baseline and 43.9% at follow-up; this change was not statistically significant. Two post-operative complications (calf deep venous thrombosis and pulmonary embolism) related to the procedure were observed in a single patient. One patient subsequently received open lumbar decompressive laminectomy due to continued decline in function.
A search of in February 2011 found a number of ongoing trials on IG-MLD. Three studies are Phase IV open label (NCT00956631, NCT01076244, NCT01082159) and 2 are randomized controlled trials (NCT00995371 and NCT01129921). NCT00995371 compares minimally invasive lumbar decompression with epidural corticosteroid injection. NCT01129921 is a sham controlled trial. Both of the randomized trials have an estimated enrollment of 40 patients with symptomatic lumbar spinal stenosis primarily caused by dorsal element hypertrophy, with expected completion (26-week follow-up) in 2011.
2012 Update
A literature search using the MEDLINE database was conducted through September 2012.  There was no new information identified that would prompt a change in the coverage statement.
One-year follow-up from an industry-sponsored multicenter study (NCT00956631) of 58 patients who were treated with mild® devices was reported in 2012 (Mekhail, 2012). All patients had failed conservative medical management, with 75.9% of patients treated with conservative therapy for more than 6 months. Twenty-nine patients (50%) were discharged from the surgical facility on the same day as the procedure, and none of the patients stayed longer than 24 hours. There were no reports of major intraoperative or postoperative procedure-related adverse events. The primary outcome of patient success was defined as a 2-point improvement in VAS pain, but the percentage of patients who achieved success was not reported. VAS for pain improved from a mean of 7.4 at baseline to 4.5 at 1-year follow-up. The ODI improved from 48.6 to 36.7, and there was significant improvement on all domains of the Zurich Claudication Questionnaire and the SF-12 physical component score (from 27.4 to 33.5).
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
In 2012, Brown reported a small (n=38) randomized double-blind trial of mild® compared to epidural steroid injections (Brown, 2012). The study included patients with painful lower limb neurogenic claudication and hypertrophic ligamentum flavum as a contributing factor. Patients with a history of recent spinal fractures, disabling back or leg pain from causes other than LSS, fixed spondylolisthesis greater than grade 1, disk protrusion or osteophyte formation, or excessive facet hypertrophy were excluded from the study. In order to maintain blinding, patients receiving steroid injection also received skin anesthesia with a small incision, followed by trocar placement under fluoroscopy. The primary efficacy endpoint was pain measured by VAS at 6 weeks’ post-treatment. Results showed that 76.2% of mild® treated patients had a 2-point or greater improvement in pain scores, compared with 35.3% of steroid-treated patients. The ODI improved significantly from 38.8 to 27.4 after mild®, while the steroid-treated patients showed a non-significant improvement from 40.5 to 34.8. There was no significant difference between groups on the Zurich Claudication Questionnaire (ZCQ, 2.2 for mild® vs. 2.8 for steroid) at 6 weeks. After the 6-week assessment, patients were unblinded and allowed to cross over to the other treatment. Fourteen (82%) of the steroid-treated patients crossed over to mild®. Follow-up at 12 weeks in patients treated with mild® showed no significant change in mean VAS from 6 to 12 weeks (6.3 at baseline, 3.8 at 6 weeks, and 3.4 at 12 weeks). There were no major procedure-related or device-related complications. In 2010, Chopko and Caraway reported 6-week follow-up of an ongoing multi-center study (NCT00956631) of IG-MLD at 14 centers.
Several case series on IG-MLD were reported in 2012. Deer et al. reported a prospective study of mild® in 46 consecutive patients with neurogenic claudication related to lumbar spinal stenosis that was caused primarily by ligamentum flavum hypertrophy (Deer, 2012). Complete follow-up to 1 year was available for 35 patients (76%). VAS improved from 6.9 at baseline to 4.0 at 1 year, the ODI improved from a mean of 49.4 to 32.0, and the ZCQ improved for all ZCQ domains. An independent prospective study by Mekhail et al. evaluated outcomes in 40 patients following IG-MLD (Mekhail, 2012). At 1-year follow-up, VAS had improved by 7.1 to 3.6, standing time increased from 8 to 56 minutes, and walking distance increased by 246 feet to 3,956 feet. Pain Disability Index (PDI) and Roland-Morris Disability Questionnaire (RMQ) were also significantly improved. Wilkinson and Fourney reported a prospective trial of 10 subjects with intermittent claudication because of lumbar spinal stenosis due primarily to hypertrophy of the ligamentum flavum (Wilkinson, 2012). Pain and disability were reduced in the 26-week follow-up period after mild®, but there was no evidence of significant decompression of the spinal canal observed with imaging. Recurrent claudication requiring laminectomy developed in 6 patients (60%) during an 18-month observation period.
Ongoing Clinical Trials
A search of online site found a number of trials on IG-MLD. Three studies are Phase IV open label with mild® (NCT00956631, NCT01076244, NCT01082159), and 3 are randomized controlled trials (NCT01315145, NCT00995371, NCT01129921). NCT01315145 and NCT00995371 compare mild® with epidural corticosteroid injection. NCT01129921 is a sham-controlled trial that was completed in 2012 but has not yet been published. NCT01315145 has completed recruiting with an enrollment of 138 patients and estimated completion in June 2013. . NCT00995371 has completed enrollment of an estimated 40 patients with expected completion (26-week follow-up) in 2013.
2014 Update
A literature search conducted through March 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Image-Guided Minimally Invasive Lumbar Decompression (IG-MLD)
Primary literature on image-guided minimally invasive lumbar decompression (IG-MLD) consists of 1 small controlled trial and a number of prospective and retrospective cohort studies and case series. Members of the Standards Division of the International Spine Intervention Society (ISIS) published a systematic review of the IG-MLD literature in 2014 (Kreiner, 2014). Included in the review were 1 randomized controlled trial (described next) and 12 cohort studies/series. Pain measurements using a visual analog score (VAS) or Zurich Claudication Questionnaire (ZCQ) showed a weighted mean improvement of 41% in the short-term (4-6 weeks), 46% at 3 months, 42% at 6 months, and 49% at 1 year. However, mean VAS remained greater than 3 at all times after treatment. Ten studies assessed function using the ODI or Roland-Morris Disability Questionnaire. With a baseline ODI score of 47.0, the ODI improved by a weighted mean of 16.5 at 6 weeks, 16.2 at 12 weeks, 15.4 at 6 months, and 14.0 at 1 year. One study that reported 2-year outcomes was considered to be of questionable validity, and the data were not accepted (Chopko, 2013). The mean final ODI was greater than 30 in the most of the studies, which would not meet 1 author’s definition of a minimally acceptable outcome. No direct procedure-related complications were identified in the included studies, although the possibility of damage to dura and nerve roots while performing this procedure was noted. Overall, the body of evidence addressing the IG-MLD procedure was of low quality.
2015 Update
A literature search conducted through April 2015 did not reveal any new information that would prompt a change in the coverage statement.
2016 Update
The protocol for the MiDAS ENCORE (Evidence-based Neurogenic Claudication Outcomes Research) trial (NCT02093520) was approved by the Centers for Medicare and Medicaid Services under coverage with evidence development. This non-blinded study, conducted at 26 interventional pain management centers in the United States, randomized 302 patients in a 1:1 ratio to IG-MLD or epidural steroid injections (ESIs) (Staats, 2016). This trial included Medicare beneficiaries 65 years of older who had neurogenic claudication symptoms for at least 3 months and had failed standard therapies, including: physical therapy, home exercise programs, and oral analgesics. Selection criteria required radiologic evidence of LSS with ligamentum flavum greater than 2.5 mm confirmed by preoperative magnetic resonance imaging or computed tomography. Comorbidities know to affect spinal stenosis were allowed if they were not considered severe by the treating physician. More patients in the ESI group withdrew prior to study treatment (22 vs 6), due primarily to decisions to have surgery or other nonstudy therapy (n=8) or to dissatisfaction with randomization results (n=6). This unequal dropout rate raises the possibility of bias due to patient expectations and nonblinding of patients and assessors.
At baseline, the IG-MILD group scored 53.0 on the 100-point ODI, 7.7 out of 10 points on a numeric rating scale for pain (NRS-P), and 2.9 to 3.8 on the subscales of the Zurich Claudication Questionnaire (ZCQ). Baseline scores in the control group were similar (51.7, 7.8, and 2.8 to 3.8, respectively). Six-month results were published in 2016 (Staats, 2016). Patients in the ESI group received a mean of 1.7 injections over the first 6 months of the study. Patients who withdrew from the study after treatment but before the 6-month follow-up (10 IG-MLD, 20 ESI) were considered treatment failures. The primary end point¾the proportion of responders achieving the minimally important difference (MID) of 10 on the ODI¾was significantly higher in the IG-MLD group (62.2%) than the ESI group (35.7%; p<0.001). Secondary efficacy end points were the proportion of responders achieving the MID on the NRS-P (2 of 10 points) and the ZCQ (0.5 change). For the NRS-P score, 55.9% of IG-MLD patients were responders compared with 33.3% of controls. Mean improvement in NRS-P scores were 2.9 for the IG-MLD group and 0.9 for the controls. The percentage of responders on the ZCQ was greater for the IG-MLD group than for the ESI group in all subscales. Adverse events were low (1.3% for both groups), with no serious device or procedure-related adverse events in either group. One-year follow-up is ongoing.
2017 Update
A literature search conducted through March 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
The protocol for the MiDAS ENCORE (Evidence-based Neurogenic Claudication Outcomes Research) trial (NCT02093520) published six-month and 1-year results in 2016 (Staats, 2016; Benyamin, 2016).  Patients in the ESI group were allowed up to 4 ESI treatments and received a mean of 2 injections over 1 year. The primary end point, the proportion of responders achieving the minimally important difference (MID) of at least a 10- point improvement on the Oswestry Disability Index (ODI) score, was significantly higher in the IG-MLD group than in the ESI group at both 6 months and 1 year. Secondary efficacy end points were the proportion of responders achieving the MID on the numeric rating scale for pain and the Zurich Claudication Questionnaire (ZCQ). Adverse events were low (1.3% for both groups). Responder rates in patients with spinal comorbidities were reported to be similar to overall responder rates. However, it may be difficult to separate out the effect of comorbidities, because over 80% of patients had 1 or more spinal stenosis comorbidities.
Some currently unpublished trials that might influence this review are listed below:
(NCT03072927) an industry-sponsored or cosponsored trial. MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study; planned enrollment 4000; projected completion date February 2021.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2018. No new literature was identified that would prompt a change in the coverage statement.

0275TPercutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy), any method, under indirect image guidance (eg, fluoroscopic, CT), single or multiple levels, unilateral or bilateral; lumbar
64999Unlisted procedure, nervous system
72275Epidurography, radiological supervision and interpretation
G0276Blinded procedure for lumbar stenosis, percutaneous image-guided lumbar decompression (PILD) or placebo-control, performed in an approved coverage with evidence development (CED) clinical trial

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Weinstein JN, Tosteson TD, Lurie JD et al.(2008) Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med 2008; 358(8):794-810.

Wilkinson JS, Fourney DR.(2012) Failure of percutaneous remodeling of the ligamentum flavum and lamina for neurogenic claudication. Neurosurgery 2012; 71(1):86-92.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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