|Subject:||Percutaneous and Endoscopic Spinal Surgery|
|Policy #:||SURG.00071||Current Effective Date:||07/10/2012|
|Status:||Reviewed||Last Review Date:||05/19/2012|
This document addresses percutaneous and endoscopic spinal discectomy and disc decompression procedures. During a percutaneous or endoscopic 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 minimally invasive (MIS) or standard open discectomy and disc decompression procedures.
Note: Please see the following related documents for additional information:
Investigational and Not Medically Necessary:
Percutaneous or endoscopic spinal surgical techniques are considered investigational and not medically necessary.
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 one 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 less than 0.001) in Visual Analogue Scale (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 fifty 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 Visual Analogue Scale (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 Oswestry Disability Index 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 (eight 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 quality of life 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 Visual Analogue Scale (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 less than 0.05) at 6 months and 2 years. There were improvements in Quality of Life (SF-36, p less than 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.
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 Visual Analog Scale (VAS) pain score (to evaluate preoperative and postoperative back and leg pain) and Oswestry Disability Index (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.
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.
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.
The MacNab Clinical Outcome Measures:
Percutaneous: 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
The following codes for treatments and procedures applicable to this document are included below for informational purposes. A draft of future ICD-10 Coding (effective pending final Health and Human Services [HHS] compliance date) related to this document, as it might look today, is included below for your reference. 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.
|62287||Decompression 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|
|0274T||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 (eg, fluoroscopic, CT), with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; cervical or thoracic|
|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 (eg, fluoroscopic, CT), with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; lumbar|
|64999||Unlisted procedure, nervous system [when specified as percutaneous decompression or laser procedures of cervical or thoracic spine]|
|S2348||Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar [DISC nucleoplasty]|
|80.59||Other destruction of intervertebral disc [when specified as percutaneous lumbar disc decompression, laser discectomy, coblation nucleoplasty]|
|ICD-10 Procedure||ICD-10-PCS draft codes; effective pending final HHS compliance date:|
|0R533ZZ-0R5B4ZZ||Destruction of vertebral disc, percutaneous or percutaneous endoscopic approach [cervical, cervicothoracic, thoracic or thoracolumbar; includes codes 0R533ZZ, 0R534ZZ, 0R553ZZ, 0R554ZZ, 0R593ZZ, 0R594ZZ, 0R5B3ZZ, 0R5B4ZZ]|
|0RB33ZZ-0RBB4ZZ||Excision of vertebral disc, percutaneous or percutaneous endoscopic approach [cervical, cervicothoracic, thoracic or thoracolumbar; includes codes 0RB33ZZ, 0RB34ZZ, 0RB53ZZ, 0RB54ZZ, 0RB93ZZ, 0RB94ZZ, 0RBB3ZZ, 0RBB4ZZ]|
|0RN33ZZ-0RNB4ZZ||Release vertebral disc, percutaneous or percutaneous endoscopic approach [cervical, cervicothoracic, thoracic or thoracolumbar; includes codes 0RN33ZZ, 0RN34ZZ, 0RN53ZZ, 0RN54ZZ, 0RN93ZZ, 0RN94ZZ, 0RNB3ZZ, 0RNB4ZZ]|
|0S523ZZ-0S544ZZ||Destruction of vertebral disc, percutaneous or percutaneous endoscopic approach [lumbar or lumbosacral; includes codes 0S523ZZ, 0S524ZZ, 0S543ZZ, 0S544ZZ]|
|0SB23ZZ-0SB44ZZ||Excision of vertebral disc, percutaneous or percutaneous endoscopic approach [lumbar or lumbosacral; includes codes 0SB23ZZ, 0SB24ZZ, 0SB43ZZ, 0SB44ZZ]|
|0SN23ZZ-0SN44ZZ||Release vertebral disc, percutaneous or percutaneous endoscopic approach [lumbar or lumbosacral; includes codes 0SN23ZZ, 0SN24ZZ, 0SN43ZZ, 0SN44ZZ]|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective pending final HHS compliance date:|
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Web Sites for Additional Information|
Automated Percutaneous Lumbar Discectomy (APLD)
Percutaneous Endoscopic Discectomy
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.
|Reviewed||05/10/2012||Medical Policy & Technology Assessment Committee (MPTAC) review. Rationale, Background, Definitions and References updated.|
|01/01/2012||Updated Coding section with 01/01/2012 CPT code descriptor changes.|
|Reviewed||05/19/2011||MPTAC 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.|
|Reviewed||02/17/2011||MPTAC review. Description clarified. Additional information added to Rationale and Definitions. References updated. Updated Coding section with 04/01/2011 HCPCS changes.|
|04/29/2010||Information regarding the Vertos Minimally Invasive Lumbar Decompression (MILD®) device added to the Rationale. References updated.|
|Reviewed||02/25/2010||MPTAC review. Coding and references updated.|
|Revised||02/26/2009||MPTAC review. Position statement revised, title changed, rationale, background, coding and references updated.|
|Reviewed||11/20/2008||MPTAC review. Updated review date, references and history sections. Updated Coding section with 01/01/2009 CPT changes.|
|Reviewed||11/29/2007||MPTAC 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."|
|Reviewed||12/07/2006||MPTAC review. Rationale and references sections updated.|
|11/18/2005||Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).|
|Revised||07/14/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|07/27/2004||SURG.00052||Chronic Spine Pain Treatments/Procedures (Minimally Invasive)|
|WellPoint Health Networks, Inc.||09/23/2004||3.07.04||Percutaneous Techniques for Disc Decompression|