Medical Policy


Subject:Percutaneous and Endoscopic Spinal Surgery
Policy #:  SURG.00071Current Effective Date:  10/14/2014
Status:ReviewedLast Review Date:  08/14/2014

Description/Scope

This document addresses percutaneous and endoscopic spinal discectomy and disc decompression as well as image-guided minimally invasive lumbar decompression procedures.

During a percutaneous, endoscopic or image-guided spinal procedure, the surgeon does not have direct visualization of the anatomic site with the naked eye. Visual guidance is provided indirectly using fluoroscopy or, if an endoscope is used, a video monitor. During open and minimally invasive procedures, the surgeon is able to directly visualize the operative site. This document does not address standard open or endoscopically with direct visualization discectomy and disc decompression procedures.

Note: Please see the following related documents for additional information:

Position Statement

Investigational and Not Medically Necessary:

Percutaneous or endoscopic spinal surgical techniques are considered investigational and not medically necessary.

Rationale

Percutaneous Discectomy and Disc Decompression
Automated percutaneous lumbar discectomy (APLD) was introduced in the 1980s using a suction curettage device for disc removal. Initial case series focusing on lumbar disc disease reported encouraging results and the technique was widely adopted. However, controlled trials reported less impressive results. For example, Revel and colleagues reported on a controlled randomized study comparing chemonucleolysis and APLD (Revel, 1993). A total of 61% of those treated with chemonucleolysis reported favorable results compared to 44% in those treated with APLD. Chaterjee reported on the results of a randomized study that compared APLD with open surgical microdiscectomy (Chaterjee, 1995). A total of 29% of individuals in the APLD group reported satisfactory results compared to 80% in the microdiscectomy group.

The LAPDOG study was a randomized trial to compare APLD and open discectomy in individuals with lumbar disc herniation (Haines, 2002). This trial was designed to recruit 330 participants, but was only able to enroll 36. Of 27 evaluable participants, 41% of percutaneous discectomy group and 40% of conventional discectomy group were judged to have a successful outcome at 6 months. However, the authors concluded the trial was unable to enroll sufficient numbers to reach a definitive conclusion.

Amoretti and colleagues (2006) reported an uncontrolled case series of 50 individuals presenting with lumbar disc disease that were treated with a percutaneous discectomy probe, the DeKompressor® (Stryker, Inc., Kalamazoo, Michigan). This device, which received clearance from the U.S. Food and Drug Administration (FDA) through the 510(k) process in 2003, is used to aspirate disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine. When activated, the probe rotates to create suction and removes the nucleus pulposus. The clinical outcome measured in the Amoretti study was a visual analog scale (VAS) assessment of pain at 2, 7, 30 and 180 days following treatment. A decrease of baseline pain of more than 70% was observed in 39 of 50 individuals treated. Of the 39 individuals with a successful pain reduction outcome, 31 required no further medication therapies and the remaining 8 individuals were able to reduce medication therapies. The limitations of this study include a lack of randomization for comparison of surgical versus non-surgical therapies and its small size.

The body of literature for lumbar laser discectomy is limited to case series and review articles that describe different techniques using different types of lasers. The literature regarding cervical laser discectomy is less extensive and no controlled trials were identified for lumbar or cervical applications. Ahn and colleagues (2004) reported on a case series of 111 consecutive individuals undergoing cervical laser discectomy. With a mean follow-up of 49.4 months, the outcomes were considered either excellent or fair in 80% of individuals. Hellinger and colleagues reported on a case series of 42 individuals with thoracic discogenic pain who were treated with laser discectomy (Hellinger, 2003). At 6 weeks, 41 of the 42 individuals were considered to have a successful outcome. However, the lack of a control group and randomization limits scientific interpretation of either of these trials.

Nucleoplasty-based percutaneous discectomy is a relatively new technology and the available published literature consists of small non randomized studies and case series for lumbar and cervical disc treatment. Gerszten and colleagues (2006) reported a prospective nonrandomized longitudinal cohort study of sixty-seven participants with a contained lumbar disc herniation who underwent nucleoplasty in an outpatient setting. In this study the authors evaluated pain, functioning, and quality of life (QOL) pre and post operatively. The authors found that compared with preoperative QOL, there was a statistically significant improvement in QOL at 3 and 6 months. In another small, prospective study (n=69), Al-Zain and colleagues (2008) reported 1 year outcomes for lumbar nucleoplasty showed a statistically significant reduction in analgesic consumption, disability and occupational incapacitation. However, both of these studies were small with limited follow-up and not randomized or controlled. 

Calisaneller and colleagues (2007) studied 29 individuals who underwent lumbar nucleoplasty and found that there were statistically significant reductions (p<0.001) in VAS scores post-operatively as compared to pre-operative values. The authors concluded that although nucleoplasty appeared to be a safe minimally invasive procedure, the value of this new technique for the treatment of discogenic low-back pain remains unproven. Further randomized placebo-controlled studies with longer follow-up are needed.

Nardi and colleagues (2005) studied 50 consecutive individuals who underwent a cervical disc nucleoplasty and reported that 80% had pain resolution. Although the results were encouraging, they acknowledged the small size and limited follow-up in this study. 

Percutaneous Endoscopic Discectomy and Disc Decompression
Lee and colleagues (2009) compared percutaneous endoscopic lumbar discectomy (PELD) with open lumbar microdiscectomy (OLM) in a retrospective study. Between December 2004 and May 2006, 54 individuals who underwent surgery, either PELD (25 subjects) or repeated OLM (29 subjects), due to recurrent disc herniation at L4-5 level, were selected and divided into two groups according to the surgical methods with sequestrated disc, calcified disc, severe neurological deficit, or instability. Pain analysis before and after surgery was assessed using the VAS scoring (0-10) and function was assessed by the Oswestry Disability Index (ODI) in percent (0-100%). Radiographs and MRI imaging were also reviewed pre- and post-operatively. The PELD procedure used local anesthesia and fluoroscopic guidance to reach the treatment site. An obturator was inserted along the guide wire and hammered into place when reaching the annulus allowing a working cannula to the disc. An endoscope was inserted and the blue-stained disc material was removed. The OLM procedure was performed under general anesthesia. A 2-3 cm incision was made and paravertebral muscles were dissected. The operating field was exposed and viewed via surgical microscope for discectomy and decompression. The authors found that the outcomes were favorable in both groups; PELD having the advantage with anesthesia, operative time and hospital stay. However, due to the size and design of the study, no firm clinical conclusions could be drawn regarding efficacy.

Liu and colleagues (2010) conducted a retrospective study in consecutive subjects with lumbar disc herniation treated with percutaneous lumbar discectomy (PLD) or microendoscopic discectomy (MED) in a single hospital from January 2000 to March 2002. A total of 104 PLD subjects and 82 MED subjects were included in the study with a mean follow-up period of 6.64 ± 0.67 years and 6.42 ± 0.51 years, respectively. There were no significant differences between the two groups in age, number of lesions, major symptoms and physical signs, and radiological findings. All subjects were followed up with MacNab criteria and self-evaluation questionnaires comprising the ODI and Medical Outcomes Study 36-Item Short-Form Health Survey. The PLD procedure was performed by interventional radiologists utilizing automated percutaneous discectomy instrumentation under fluoroscopic guidance. The MED procedure was performed by orthopedists using a guidewire and serial dilators to access the operative site followed by an endoscope used as an operative channel. Ten subjects underwent subsequent open surgery in different durations after PLD (8 subjects) and 2 subjects after MED. According to the MacNab criteria, 75.96% in the PLD group and 84.15% in the MED group achieved excellent or good results, respectively; this was statistically significant (p=0.0402). Findings of the Medical Outcomes Study 36-Item Short-Form Health Survey were 75.88 (PLD) vs. 81.86 (MED) group (p=0.0582). Two subjects (2.44%) in the MED group had complications while there were no complications in the PLD group. Although both PLD and MED showed an acceptable long-term efficacy for treatment of lumbar disc herniation the long term satisfaction was lower in the PLD groups. The authors acknowledged limitations of the study in the areas of follow-up, lack of long term radiological examinations were available and that the number of participants was low given the incidence of discogenic pathology.  Other limitations included the retrospective, non-randomized study design.

Peng and colleagues (2009) indicated that while percutaneous endoscopic lumbar discectomy (PELD) is a relatively new technique, few studies have reported the clinical outcome of PELD regarding QOL and return to work. In a retrospective study of 55 subjects, clinical outcomes were reviewed using the North American Spine Score (NASS), Medical Outcomes Study Short Form-36 scores (SF-36), the VAS and return to work. The treatment sites varied as well as the disc status. Thirty nine (70.9%) subjects had L4-L5 discectomy, 12 (21.8%) had L5-S1 discectomy, 2 (3.6%) had L3-L4 and 2 (3.6%) had two levels L4-L5 and L5-S1 performed. There were 44 (80%) disc protrusions, 10 (18.2%) extrusions and 1 (1.8%) sequestrated disc. The mean follow-up period was 3.4 years (range 2.0–6.5 years). All who were working preoperatively returned to work. The mean time to return to work was 24.3 days (range 10–60 days). Back pain and lower limb symptoms were reduced NASS and VAS, (p<0.05) at 6 months and 2 years. There were improvements in QOL (SF-36, p<0.05) scores except for general health at 6 months and 2 years post surgery. The recurrence rate was 5% or 3 subjects who subsequently underwent lumbar fusion for persistent back pain. The limitations of this study were that it was retrospective, uncontrolled and limited in size. 

In a 2007 Cochrane review of 40 randomized controlled trials of surgical interventions treating spinal disc disease, Gibson and Waddell found that microdiscectomy gives broadly comparable results to standard open discectomy.  This review also concluded that considerable evidence exists that surgical discectomy provides effective clinical relief for select individuals with sciatica due to lumbar disc prolapse that fails to resolve with conservative management.  Evidence suggested that surgical discectomy provides faster relief from an acute attack of sciatica, but its impact on the long-term natural history of underlying disc disease was unclear. There was a lack of evidence to establish the efficacy and safety of automated percutaneous discectomy, coblation therapy and laser discectomy.

Coverage Policy Recommendations from the North American Spine Society (NASS) state that endoscopic discectomy should "be covered treatment of lumbar disc herniation with radiculopathy."  According to information on the NASS website, the Coverage Policy Recommendations were created using "an evidence-based approach to spinal care when possible.  In the absence of strict evidence-based criteria, policies reflect the multidisciplinary and non-conflicted experience and expertise of the authors in order to reflect reasonable standard practice indications in the United States."  The authors also state that the coverage recommendations are not representative of a "standard of care" and should not be viewed as "fixed treatment protocols" (NASS, 2014).

Microendoscopic discectomy (MED)
Microendoscopic discectomy has been proposed as treatment of symptomatic lumbar herniated disc. Schizas and colleagues (2005) reported the results of a small study of 28 individuals, 14 having MED and 14 having microdiscectomy. They found no difference of clinical significance between the outcomes of the two groups. The authors concluded that MED was as least as effective as microdiscectomy for the treatment of uncontained or large contained disc herniations.

Righesso and colleagues (2007) reported a small randomized study comparing MED with open discectomy (OD). Nineteen participants were in the OD group and 21 were assigned to the MED group. The only statistically significant differences found were for size of the incision, length of hospital stay and operative time. The former were greater in the OD group while operative time was greater in the MED group. Those differences did not affect the overall clinical and neurological outcomes which were comparable between the two groups.

Casal-Moro and colleagues (2011) reported a case series of 120 individuals who underwent MED for lumbar disk herniation in a prospective study with a 5-year follow up. The participants had symptomatic disk herniation with contained, non- contained, migrated or foraminal herniation. The most commonly affected level was L5-S1. Post operatively, statistically significant reductions in the VAS pain score (to evaluate preoperative and postoperative back and leg pain) and ODI scores (to evaluate functional state) were reported. The modified MacNab classification (see definitions) was also used as an outcome measure. Using the MacNab criteria, the authors reported good results in 89 individuals, fair results in 22 individuals and poor results in 9 individuals. No excellent results were reported. Seven participants experienced intraoperative complications. Incidental durotomy occurred in 5 individuals; of this group, 3 required open surgery for repair. Other complications included a bayonted ronguer rupture requiring open surgery and a nerve root puncture. The study was limited by the lack of a control group comparison.

Garg and colleagues (2011) conducted a randomized controlled study to compare the outcomes of microendoscopic MED versus open discectomy for lumbar disc herniation.  A total of 80 men and 32 women between the ages of 26-57 with a single-level disc herniation were randomised to undergo MED (n=55) or open (fenestration/laminotomy) discectomy (n=57).  The participants were assessed pre- and post-operatively (at week 6, month 6, and year 1).  Assessments included a clinical examination, radiological examination including MRI and an electrophysiological study.  Functional outcomes and low back pain were self-evaluated using the Oswestry low back pain disability questionnaire13 and were assessed by an independent observer.  The outcome was considered satisfactory if radicular symptoms ceased, tension signs became negative and the individual returned to his/her previous occupation or normal activities.  In the MED group, surgical and anesthesia times were significantly longer, but blood loss and hospital stay were significantly reduced.  Improvement in the Oswestry score in both groups was significant at week one, but not at other follow-ups.  The rate of complication was similar in both groups.  One participant in the MED group experienced a recurrence of disc herniation after 7 months and was treated with open discectomy.  The authors concluded that both methods are equally effective in relieving radicular pain.  MED resulted in a shorter hospital stay, less morbidity, and earlier return to work.  The authors cautioned that with the MED, the surgical technique is demanding and should not be attempted without specific instruction and training.  Limitations of this study include the short follow-up period (12–18 months) and the lack of quantitative outcome assessment.  The authors also did not describe the method of randomization.  Larger groups of participants with longer follow-up are needed to confirm these results.

Image-guided minimally invasive lumbar decompression (MILD®) for Spinal Stenosis
Image-guided minimally invasive lumbar decompression (MILD) is being investigated as a treatment for lumbar spinal stenosis. Lingreen and colleagues (2010) conducted a retrospective review of self-reported improvement and post-procedure findings after MILD. Forty-two consecutive subjects between the ages of 52-86, with spinal stenosis and ligamentum flavum hypertrophy as the primary feature on MRI, were included in the study. All of the surgical procedures were performed by two interventional pain management physicians working at the same center. The results of self reported pre- and post-procedure VAS, markers of global function, major and minor adverse events, self-reported outcomes and need for follow-up procedures were evaluated. Measurements of functional improvement were assessed by ability to stand and ambulate for greater than 15 minutes, whereas prior to the procedure 98 % reported significant functional limitations. VAS decreased by 40% from baseline and no major adverse events were reported. The most frequently reported minor adverse event was soreness lasting 3.8 days. Five of the study participants requested post procedure opioid analgesia. Thirty-six participants indicated they would recommend this procedure, one was unsure and 5 indicated they would not recommend the procedure. Eight of the participants reported marginal improvement (change <3 on VAS) yet 4/8 participants in this category still stated they would recommend MILD to others. The authors concluded that the MILD procedure appears to be a safe and likely effective option. Limitations of this study include its uncontrolled design and small size.

Chopko and colleagues (2010) assessed the safety and functional outcomes of the MILD procedure as a treatment of symptomatic central canal spinal stenosis. This multicenter, non-blinded prospective study consisted of 78 participants who underwent the MILD procedure. Measures of outcomes included the VAS, ODI, Zurich Claudication Questionnaire (ZCQ), and SF-12v2 Health Survey at baseline and at 6 weeks post-treatment. The authors reported that at 6 weeks post-treatment the VAS, ZCQ, and SF-12v2 all reflected a reduction in pain. The ODI, ZCQ, and SF-12v2 reflected an improvement in physical function and mobility. The authors concluded that the MILD procedure was safe, improved mobility and reduced the pain associated with lumbar spinal canal stenosis. Limitations of the study include the lack of a control group and short follow-up.

Brown and colleagues (2012) reported the results of a double-blind, randomized, prospective study of epidural steroid injections (ESI) and the MILD procedure at a single pain management center.  A total of 38 individuals with symptomatic lumbar spinal stenosis (LSS) participated in the study and were randomized into 2 treatment groups: 21 participants in the MILD arm and 17 individuals in the ESI arm. Outcome measures were reported using the visual analog scale (VAS), the Oswestry Disability Index (ODI) and Zurich Claudication Questionnaire (ZCQ) patient satisfaction score.  The authors reported that at 6 weeks, the MILD participants improved from an average VAS baseline of 6.3 (95% CI ± 0.7) to a mean of 3.8 (95% CI ± 1.3).  The ESI group had a mean VAS score of 6.4 (95% CI ± 1.0) at baseline compared with 6.3 (95% CI ± 1.4) at 6 weeks follow-up.  Using the ODI, at 6 weeks follow-up, participants in the MILD group demonstrated a decrease from a baseline mean ODI from 38.8 (95% CI ± 4.2) to 27.4 (95% CI ± 7.0).  In the ESI group, the initial ODI was 40.5 (95% CI ± 5.9) and at 6 weeks follow-up, the ODI was 34.8 (95% CI± 8.2).  In the MILD group, there was no significant change in the VAS and ODI scores from weeks 6 to 12.  Participants in the ESI group were not measured at week 12. The ZCQ difference between the MILD group and the ESI group was not significant at week six.  Participants were allowed to cross over from the ESI group to the MILD group before 12 weeks and eventually, all of the participants in the ESI group had the MILD procedure.  A total of 14 of the 17 participants in the cross-over ESI group experienced an improvement in their VAS scores after the MILD procedure.  Some of the limitations of the study include its small size and short follow-up.

In another study, Chopko (2013) evaluated the long-term effectiveness and safety of MILD as a treatment of neurogenic claudication associated with lumbar spinal stenosis. The 2-year data are reported for 45 participants that were treated with MILD at 11 US facilities. Outcome measurements included the VAS, ODI, and ZCQ.  Interim data on the participants are included for 1 week, 6 months, and 1-year follow-up. The authors reported that at 2 years, the subjects demonstrated a statistically significant reduction of pain as measured by VAS, and significant improvement in physical function and mobility as measured by ZQC and ODI. The authors also reported major improvement occurred by 1-week follow-up and showed no difference between each subsequent follow-up, suggesting considerable stability and durability of the initial result over time. There were no major adverse events or complications related to the procedure. Limitations of this study include its uncontrolled design and small size. 

In 2014, the Centers for Medicare & Medicaid Services (CMS) determined that percutaneous image guided lumbar decompression (PILD) for lumbar spinal stenosis (LSS) is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.  The decision memo also states the following regarding the PILD procedure for LSS:

In reviewing the evidence on PILD we are confronted with weak studies, questions about missing information, questions about adverse events and conflicts of interest. After thoroughly reviewing the evidence for PILD for LSS, we have determined the evidence does not support a conclusion of improved health outcomes for our Medicare beneficiaries. However, we recognize that LSS is a real and important source of pain and functional limitation for patients, and that the development of effective minimally invasive procedures could have a potential place in the treatment armamentarium, but that more evidence is clearly needed. In order to support additional research on the development of effective minimally invasive procedures for the treatment of LSS, we will cover this procedure under section 1862(a)(1)(E) of the Social Security Act (CMS, 2014).

Summary
Additional well-designed studies comparing conventional (open approach) procedures to endoscopic spinal discectomy and disc decompression as well as image-guided minimally invasive lumbar decompression are needed.  High quality randomized controlled trials with sufficiently large sample sizes and longer follow-up periods are needed to determine if percutaneous and endoscopic spinal surgery procedures are more effective than conventional (open approach) procedures.

Background/Overview

Spinal surgery is generally performed in the cervical and lumbar regions of the spine because the degree of mobility in these areas is greater and can cause misalignment and instability of the vertebral structures. Disc disease is most common and usually due to a protrusion (herniation) of a vertebral disc. The disc may tear through surrounding tissue (annulus fibrosus), resulting in an extruded disc, or may remain intact but stretched resulting in a contained disc prolapse, compressing one or more nerve roots and resulting in pain, numbness or weakness. Percutaneous discectomy and disc decompression have been investigated over the years as a treatment of back pain related to disc disease and bone structure.

Techniques using imaging for guidance include automated percutaneous lumbar discectomy (APLD), laser discectomy and nucleoplasty. APLD involves the percutaneous insertion of a probe into the disc space with fluoroscopic guidance and then physical removal of the disc material using a suction curettage device. For laser discectomy, a variety of different lasers have been investigated, including the YAG, KTP, holmium, argon and carbon dioxide lasers. Regardless of the type of laser, the procedure involves placement of the laser probe within the nucleus under fluoroscopic guidance. Due to differences in absorption, the energy requirements and the rate of application differ among the lasers. Additionally, it is unknown how much disc material must be removed to achieve decompression. Therefore, protocols vary according to the length of treatment, but typically the laser is activated for brief periods.

The nucleoplasty procedure is similar to the laser procedure but uses bipolar radiofrequency energy in a process referred to as Coblation technology. The technique consists of small, multiple electrodes that emit a fraction of the energy required by traditional radiofrequency energy systems. The result is that a portion of nucleus tissue is ablated not with heat, but with a low-temperature plasma field of ionized particles. These particles have sufficient energy to break organic molecular bonds within tissue, creating small channels in the disc. The proposed advantage of this Coblation technology is that the procedure provides for a controlled and highly localized ablation, resulting in minimal therapy damage to surrounding tissue. Complications following percutaneous disc procedures include reherniation, disc instability, and device malfunction.

Microendoscopic discectomy is performed by passing an endoscope or dilating tube equipped with a camera to the operative site. The operative site is viewed on a monitor. In MED, the surgeon does not view the operative site directly. This technique has a steep learning curve. The advantages of this type of surgical technique are smaller incisions, less trauma to surrounding structures and less recovery time than micro or open discectomy.

Minimally invasive lumbar decompression (MILD)
MILD (also known as image-guided minimally invasive lumbar decompression) is a percutaneous spinal decompression procedure used as a treatment of spinal stenosis. The MILD procedure is performed with the assistance of a contrast medium and fluoroscopic guidance. According to the manufacturer, the "mild Devices are designed to access the interlaminar space from the posterior lumbar spine, enabling the user to remove small portions of the lamina and preferentially resect and debulk the thickened ligamentum flavum, accomplishing a lumbar decompression." This procedure does not involve a discectomy. The procedure can be performed on an outpatient basis under local anesthesia (Vertos Medical Mild Device Kit).

The original FDA premarket approval for the X-Sten MILD Tool Kit was granted in 2006 and is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions. In 2010, the FDA granted 510(k) premarket approval (K093062) for the modification of the X-Sten MILD Tool Kit (Vertos, San Jose, CA). According to the FDA approval letter, the Vertos Medical MILD Device Kit is substantially equivalent to the X-Sten MILD Tool Kit (K062038) and the Baxano Ultra Low Profile Rongeur and Access Tools (K062711) which had been granted FDA premarket approval at an earlier date. According to the Vertos MILD instructions for use, the device should be used for tissue resection at the perilaminar space, within the interlaminar space and at the ventral aspect of the lamina. The device is not intended to be used to remove the spinal disc.

Definitions

Chemonucleolysis: An injection of a drug to dissolve the disc, facilitating removal.

Curretage: The removal of unwanted tissue using a small, spoon shaped device called a curette.

Disc decompression: Reducing pressure within the disc by reducing the volume of nuclear material inside the disc.

Disc degeneration: The normal aging process of intervertebral discs that begins soon after puberty. The degenerative process begins with loss of water content of the nucleus (the center of the disc) and progresses to include decreased height of the disc, the development of annular fissures (cracks in the outer fibers) and circumferential enlargement of the disc.

Discectomy: A surgical procedure in which the central portion of an intervertebral disc, the nucleus pulposus, is removed. This surgery is performed via an open incision (considered the gold standard) allowing the surgeon the greatest ability to see and explore the surgical site.

Discogenic pain: Pain generated by the disc itself which is externally intact, as opposed to disc prolapse or herniation which put pressure on nearby nerve roots.

Herniated disc: A condition in which a portion of the nucleus pulposus extends through the annulus (the outer disc layers). Herniated discs may additionally be classified as: contained (there is still a retained thin outer layer of annulus or ligament), extruded (the nuclear material extends into the spinal canal) or sequestrated (when a herniated fragment migrates away from the disc).

Laminectomy: A spine operation to remove all or a portion of the roof of the spinal canal; frequently performed to decompress the neural elements.

Lamina: The part of the vertebra that forms the roof of the spinal canal.

Ligamentum flavum: Any of a series of ligaments of yellow elastic tissue connecting the laminae of adjacent vertebrae from the axis to the sacrum flavum.

Lumbar stenosis: A narrowing of the lumbar spinal canal.

The MacNab Clinical Outcome Measures:

Minimally invasive lumbar decompression (MILD): A surgical procedure which involves the removal of small portions of laminae in order to debulk the enlarged ligamentum flavum and increase the diameter of the lumbar spinal canal.

Percutaneous: Access through the skin (puncture as opposed to "open" surgical incision).

Radicular pain: A type of pain that radiates to the upper or lower extremity directly along the course of a spinal nerve root. Radicular pain is caused by compression, inflammation or injury to a spinal nerve root.

Spine anatomy: The spine is divided into three major sections: the cervical (neck), the thoracic (mid-back) and lumbar spine (lower back). These sections are made up of individual bones called vertebrae, which are the primary weight bearing structures of the torso alternating with intervertebral discs.

Surgical approaches:

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT 
62287Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method utilizing needle based technique to remove disc material under fluoroscopic imaging or other form of indirect visualization, with the use of an endoscope, with discography and/or epidural injection(s) at the treated level(s), when performed, single or multiple levels, lumbar 
0274TPercutaneous 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 (eg, fluoroscopic, CT), with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; cervical or thoracic
0275TPercutaneous 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 (eg, fluoroscopic, CT), with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; lumbar
64999Unlisted procedure, nervous system [when specified as percutaneous decompression or laser procedures of cervical or thoracic spine]
  
HCPCS 
S2348Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar [DISC nucleoplasty]
  
ICD-9 Procedure[For dates of service prior to 10/01/2015]
80.59Other destruction of intervertebral disc [when specified as percutaneous lumbar disc decompression, laser discectomy, coblation nucleoplasty]
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2015]
 All diagnoses
  
ICD-10 Procedure[For dates of service on or after 10/01/2015]
0R533ZZ-0R5B4ZZDestruction of vertebral disc, percutaneous or percutaneous endoscopic approach [cervical, cervicothoracic, thoracic or thoracolumbar; includes codes 0R533ZZ, 0R534ZZ, 0R553ZZ, 0R554ZZ, 0R593ZZ, 0R594ZZ, 0R5B3ZZ, 0R5B4ZZ]
0RB33ZZ-0RBB4ZZExcision of vertebral disc, percutaneous or percutaneous endoscopic approach [cervical, cervicothoracic, thoracic or thoracolumbar; includes codes 0RB33ZZ, 0RB34ZZ, 0RB53ZZ, 0RB54ZZ, 0RB93ZZ, 0RB94ZZ, 0RBB3ZZ, 0RBB4ZZ]
0RN33ZZ-0RNB4ZZRelease vertebral disc, percutaneous or percutaneous endoscopic approach [cervical, cervicothoracic, thoracic or thoracolumbar; includes codes 0RN33ZZ, 0RN34ZZ, 0RN53ZZ, 0RN54ZZ, 0RN93ZZ, 0RN94ZZ, 0RNB3ZZ, 0RNB4ZZ]
0S523ZZ-0S544ZZDestruction of vertebral disc, percutaneous or percutaneous endoscopic approach [lumbar or lumbosacral; includes codes 0S523ZZ, 0S524ZZ, 0S543ZZ, 0S544ZZ]
0SB23ZZ-0SB44ZZExcision of vertebral disc, percutaneous or percutaneous endoscopic approach [lumbar or lumbosacral; includes codes 0SB23ZZ, 0SB24ZZ, 0SB43ZZ, 0SB44ZZ]
0SN23ZZ-0SN44ZZRelease vertebral disc, percutaneous or percutaneous endoscopic approach [lumbar or lumbosacral; includes codes 0SN23ZZ, 0SN24ZZ, 0SN43ZZ, 0SN44ZZ]
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2015]
 All diagnoses
  
References

Peer Reviewed Publications:

  1. Agarwal S, Bhagwat AS. Ho: Yag laser-assisted lumbar disc decompression: a minimally invasive procedure under local anesthesia. Neurol India. 2003; 51(1):35-38.
  2. Ahn Y, Lee SH, Lee SC, et al. Factors predicting excellent outcome of percutaneous cervical discectomy: analysis of 111 consecutive cases. Neuroradiology. 2004; 46(5):378-384.
  3. Al-Zain F, Lemcke J, Killeen T, et al. Minimally invasive spinal surgery using nucleoplasty: a 1-year follow-up study. Acta Neurochir (Wien). 2008; 150(12):1257-1262.
  4. Amoretti N, David P, Grimaud A, et al. Clinical follow-up of 50 patients treated by percutaneous lumbar discectomy. Clin Imaging. 2006; 30(4):242-244.
  5. Brown LL. A double-blind, randomized, prospective study of epidural steroid injection vs. the mild® procedure in patients with symptomatic lumbar spinal stenosis. Pain Pract. 2012; 12(5):333-341.
  6. Calisaneller T, Ozdemir O, Karadeli E, Altinors N. Six months post-operative clinical and 24 hour post-operative MRI examinations after nucleoplasty with radiofrequency energy. Acta Neurochir (Wien). 2007; 149(5):495-500.
  7. Casal-Moro R, Castro-Menéndez M, Hernández-Blanco M, et al. Long-term outcome after microendoscopic diskectomy for lumbar disk herniation: a prospective clinical study with a 5-year follow-up. Neurosurgery. 2011; 68(6):1568-1675.
  8. Chaterjee S, Foy PM, Findlay GF. Report of a controlled clinical trial comparing automated percutaneous lumbar discectomy and microdiscectomy in the treatment of contained lumbar disc disease. Spine (Phila Pa 1976). 1995; 20(6):734-738.
  9. Chopko BW. Long-term results of percutaneous lumbar decompression for LSS: two-year outcomes. Clin J Pain. 2013; 29(11):939-943.
  10. Chopko B, Caraway DL. MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study. Pain Physician. 2010; 13(4):369-378.
  11. Garg B, Nagraja UB, Jayaswal A. Microendoscopic versus open discectomy for lumbar disc herniation: a prospective randomised study. J Orthop Surg (Hong Kong). 2011; 19(1):30-34.
  12. Gerszten PC, Welch WC, King JT Jr. Quality of life assessment in patients undergoing nucleoplasty-based percutaneous discectomy. J Neurosurg Spine. 2006; 4(1):36-42.
  13. Haines SJ, Jordan N, Boen JR, et al. Discectomy strategies for lumbar disc herniation: results of the LAPDOG trial. J Clin Neurosci. 2002; 9(4): 411-417. 
  14. Hellinger J, Stern S, Hellinger S. Nonendoscopic Nd-YAG 1064 nm PLDN in the treatment of thoracic discogenic pain syndromes. J Clin Laser Med Surg. 2003; 21(2):61-66.
  15. Hermantin FU, Peters T, Quartararo L, Kambin P. A prospective, randomized study comparing the results of open discectomy with those of video-assisted arthroscopic microdiscectomy. J Bone Joint Surg Am. 1999; 81(7):958-965.
  16. Lee DY, Shim CS, Ahn Y, et al. Comparison of percutaneous endoscopic lumbar discectomy and open lumbar microdiscectomy for recurrent disc herniation. J Korean Neurosurg Soc. 2009; 46(6):515-521.
  17. Liu WG, Wu XT, Guo JH, et al. Long-term outcomes of patients with lumbar disc herniation treated with percutaneous discectomy: comparative study with microendoscopic discectomy. Cardiovasc Intervent Radiol. 2010; 33(4):780-786.
  18. Lingreen R, Grider JS. Retrospective review of patient self-reported improvement and post-procedure findings for mild (minimally invasive lumbar decompression). Pain Physician. 2010; 13(6):555-560.
  19. Nardi PV, Cabezas D, Cesaroni A. Percutaneous cervical nucleoplasty using coblation technology. Clinical results in fifty consecutive cases. Acta Neurochir Suppl. 2005; 92:73-78.
  20. Nellensteijn J, Ostelo R, Bartels R, et al. Transforaminal endoscopic surgery for symptomatic lumbar disc herniations: a systematic review of the literature. Eur Spine J. 2010; 19(2):181-204.
  21. Peng CW, Yeo W, Tan SB.  Percutaneous endoscopic discectomy: clinical results and how it affects the quality of life. J Spinal Disord Tech. 2010; 23(6):425-430.
  22. Revel M, Payan C, Vallee C, et al. Automated percutaneous lumbar discectomy versus chemonucleolysis in the treatment of sciatica. A randomized multicenter trial. Spine (Phila Pa 1976). 1993; 18(1):1-7.
  23. Righesso O, Falavigna A, Avanzi O. Comparison of open discectomy with microendoscopic discectomy in lumbar disc herniations: results of a randomized controlled trial. Neurosurgery. 2007; 61(3):545-549.
  24. Ruetten S, Komp M, Merk H, Godolias G. Full-endoscopic interlaminar and transforaminal lumbar discectomy versus conventional microsurgical technique: a prospective, randomized, controlled study. Spine (Phila Pa 1976). 2008; 33(9):931–939.
  25. Schizas C, Tsiridis E, Saksena J. Microendoscopic discectomy compared with standard microsurgical discectomy for treatment of uncontained or large contained disc herniations. Neurosurgery. 2005; 57(4 Suppl):357-360.
  26. Tassi GP. Comparison of results of 500 microdiscectomies and 500 percutaneous laser disc decompression procedures for lumbar disc herniation. Photomed Laser Surg. 2006; 24(6):694-697.
  27. Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008; 33(25):2789-2800.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Centers for Medicare and Medicaid Services. Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N). January 9, 2014. Available at: http://www.cms.gov. Accessed on July 10, 2014.
  2. Centers for Medicare and Medicaid Services. National Coverage Determinations for Laser Procedures. NCD #140.5. Effective May 1, 1997. Available at: http://www.cms.gov/medicare-coverage-database/indexes/ncd-by-chapter-and-section-index.aspx?bc=BAAAAAAAAAAA&. Accessed on July 10, 2014.
  3. Centers for Medicare and Medicaid Services. National Coverage Determination for Thermal Intradiscal Procedures (TIPs) NCD#150.11. Effective January 5, 2009. Available at: http://www.cms.gov/medicare-coverage-database/indexes/ncd-by-chapter-and-section-index.aspx?bc=BAAAAAAAAAAA&. Accessed on July 10, 2014.
  4. Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev. 2007;(2): CD001350.
  5. National Institute for Health and Clinical Excellence (NICE).Automated percutaneous mechanical lumbar discectomy. Interventional Procedure Guidance 141. 2005. Available at: http://www.nice.org.uk/Guidance/IPG141. Accessed on July 10, 2014.
  6. National Institute for Health and Clinical Excellence (NICE). Percutaneous disc decompression using coblation for lower back pain. Interventional Procedure Guidance 173. 2006.  Available at: http://www.nice.org.uk/guidance/IPG173.  Accessed on July 10, 2014.
  7. National Institute for Clinical Excellence (NICE). Percutaneous endoscopic laser thoracic discectomy. Interventional Procedures Guidance 61. 2004. Available at: http://www.nice.org.uk/Guidance/IPG61. Accessed on July 10, 2014.
  8. National Institute for Clinical Excellence (NICE). Percutaneous endoscopic laser lumbar discectomy. Interventional Procedures Guidance 300. 2009. Available at: http://www.nice.org.uk/guidance/IPG300. Accessed on July 10, 2014.
  9. North American Spine Society (NASS). Coverage Policy Recommendations. Endoscopic Discectomy (2014). Available at: https://www.spine.org/Documents/PolicyPractice/CoverageRecommendations/EndoscopicDiscectomy.pdf (2014). Accessed on July 10, 2014.
  10. U.S. Food and Drug Administration 510(k) Premarket Notification Summary. Vertos Mild Device Kit. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062038.pdf. Accessed on July 10, 2014.
  11. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Vertos Mild Device Kit Modification Premarket Notification. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093062.pdf.  Accessed on July 10, 2014.
Websites for Additional Information
  1. U.S. National Library of Medicine. Diskectomy. 2008. Updated 06/07/2012. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/007250.htm. Accessed on July 10, 2014.
  2. North American Spine Society. Know your back. Available at: http://www.knowyourback.org/Pages/Default.aspx . Accessed on July 10, 2014.
  3. Vertos Medical Mild Device Kit (no publication date provided). Available at: http://www.vertosmed.com/products/documents/IFU_2012_000.PDF  Accessed on July 10, 2014.
Index

Automated Percutaneous Lumbar Discectomy (APLD)
Coblation
Disc Decompression
Discectomy
Laser Discectomy
Microendoscopic Discectomy
Minimally Invasive Lumbar Decompression (MILD)
Nucleoplasty
Percutaneous Endoscopic Discectomy
Stryker DeKompressor®

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History
StatusDateAction
Reviewed08/14/2014Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale, References and History sections.
Reviewed08/08/2013MPTAC review. Updated document to address minimally invasive lumbar decompression (MILD). Updated Description/Scope, Rationale, Background/Overview, Definitions, References, Index and History sections.
Reviewed05/09/2013MPTAC review.  References updated.
Reviewed05/10/2012MPTAC review.  Rationale, Background, Definitions and References updated.
 01/01/2012Updated Coding section with 01/01/2012 CPT code descriptor changes.
Reviewed05/19/2011MPTAC review.  Description, Rationale, Background, Definitions and References updated.  Position statement unchanged.  Updated Coding section with 07/01/2011 CPT and HCPCS changes; removed C9729 deleted 06/30/2011.
Reviewed02/17/2011MPTAC review. Description clarified. Additional information added to Rationale and Definitions. References updated.  Updated Coding section with 04/01/2011 HCPCS changes.
 04/29/2010Information regarding the Vertos Minimally Invasive Lumbar Decompression (MILD®) device added to the Rationale. References updated.
Reviewed02/25/2010MPTAC review. Coding and references updated.
Revised02/26/2009MPTAC review. Position statement revised, title changed, rationale, background, coding and references updated.
Reviewed11/20/2008MPTAC review. Updated review date, references and history sections.  Updated Coding section with 01/01/2009 CPT changes.
Reviewed11/29/2007MPTAC review. Updated review date, rationale, background/overview, references and history sections. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."
Reviewed12/07/2006MPTAC review. Rationale and references sections updated.
Reviewed03/23/2006MPTAC review. 
 11/18/2005Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised07/14/2005MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger OrganizationsLast Review
Date
Document
Number
Title
Anthem, Inc.07/27/2004SURG.00052Chronic Spine Pain Treatments/Procedures (Minimally Invasive)
WellPoint Health Networks, Inc.09/23/20043.07.04Percutaneous Techniques for Disc Decompression