Medical Policy


Subject:Percutaneous and Endoscopic Spinal Surgery
Policy #:  SURG.00071Current Effective Date:  04/21/2010
Status:ReviewedLast Review Date:  02/25/2010

Description/Scope

Percutaneous and endoscopic spinal surgery has been investigated as an alternative to open procedures such as microdiscectomy where a small incision is made and the surgeon directly visualizes the operative site through a surgical microscope. Endoscopic spinal surgery differs in that the surgeon does not have direct visualization of the operative site. This technique utilizes a small diameter scope that is equipped with a camera for magnification and illumination that is introduced through a small incision. The surgeon views the operative area on a monitor. Percutaneous spinal surgery techniques are those where a probe is introduced through the skin using imaging for guidance to reach the area to be treated, usually a vertebral disc. This document addresses percutaneous endoscopic techniques for spinal surgery.

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 techniques
Automated percutaneous lumbar discectomy (APLD) was introduced in the 1980s using a suction curettage device. 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 remove nucleus pulposus.  The clinical outcome measured 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 et al (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 et al (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 et al (2007) studied 29 individuals who underwent lumbar nucleoplasty and found that there were statistically significant reductions (p < 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 et al (2005) studied fifty consecutive individuals s 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. 

Complications following percutaneous disc procedures include reherniation, disc instability, and device malfunction.

The Vertos Minimally Invasive Lumbar Decompression (MILD®) device (Vertos Medical, Inc., Aliso Viejo, CA) received 510K clearance from the FDA in 2010 and is used for image-guided minimally invasive lumbar decompression to treat lumbar spinal stenosis. This percutaneous procedure is performed via a small incision for a dorsal approach to the spine. Under fluoroscopic image guidance, a metal tube or cannula is inserted through the incision. The device is passed through the cannula to increase the diameter of the stenosed spinal canal by removal of tissue and bone. Clinical trials are in progress to determine the clinical efficacy of this device.

Endoscopic  Techniques
Righesso et al (2007), in a small randomized controlled trial, studied 40 participants with sciatica caused by lumbar disc herniations unresponsive to conservative treatment. The participants underwent either an open discectomy (OD) or microendoscopic discectomy (MED). The only statistically significant differences found were for size of the incision, length of hospital stay, and operative time. The former two were greater in the OD group (P < 0.01 and P = 0.05, respectively), and the latter was greater in the MED group (P < 0.01). In this study, the few parameters that were found to be statistically significant between the groups did not affect the overall clinical outcome.

Haufe and Mork (2007), in a case series, studied 10 individuals who underwent unilateral endoscopic facetectomy for the treatment of severe foraminal stenosis to determine whether endoscopic facetectomies result in instability. In this small study, pre and post operative specialized computer based imaging evaluated altered mobility between the 2 sets of x-rays. Compared with controls, the imaging showed no statistically significant change in sagittal rotational or translational motion. Larger controlled studies with longer follow up are needed to validate the efficacy of this procedure.

Newer spinal endoscopic devices have become available allowing endoscopic surgeries to be performed through one incision by full endoscopy with instrumentation. The difference between basic endoscopic techniques and full endoscopic techniques is that basic endoscopy involves an incision for the endoscope and additional incisions for passage of the instruments. In full endoscopic techniques, only one incision is needed for the endoscope and instrumentation is performed through additional ports in the endoscopic device.

Rutten and colleagues studied full endoscopic modalities and reported outcomes in 2 preliminary studies. The first study was a prospective randomized, controlled trial comparing full-endoscopic posterior cervical foraminotomy (FPCF) and anterior cervical decompression and fusion (ACDF) for lateral disc herniation (Rutten, 2007). Two hundred individuals requiring cervical decompression were divided into 2 groups. One hundred participants  underwent traditional ACDF and one hundred participants underwent FPCF. Randomization assignment was accomplished by alternation in the order of presentation. The operative levels varied from C4 to T1. Post operatively, the groups were evaluated at 3, 6, 12 and 24 months. One hundred seventy-five participants (88%) were included in the 24 month follow-up (84 in the ACDF group; 91 in the FPCF group) and were evaluated by the visual analogue score (VAS), North American Spine Society Instrument Score (NASS) and Hilibrand criteria. In both groups, the measuring instruments showed an improvement (p<0.001) in arm pain and activities of daily living (ADL).  Clinical outcome measures did not differ significantly between the two treatment groups and there were no significant differences between the groups in revision and complication rate.  Regarding the procedure, the authors identified FPCF disadvantages as limited possibility to expand the operation in the event of unforeseen hindrances, the technique is limited to lateral localization of the pathology, and there is no reconstruction of the intervertebral space and no direct decompression in ventrally caused stenosis.

In the second study, Rutten and colleagues (2008) conducted a prospective randomized, controlled trial comparing full-endoscopic lumbar discectomy from a transforaminal (TF) or an interlaminar (IL) approach with conventional lumbar microdiscectomy. Two hundred individuals requiring lumbar decompression were divided into 2 groups. One hundred individuals underwent conventional microsurgical (MI) discectomy and one hundred underwent full endoscopic (FE) discectomy (41 in the TF and 59 in the IL groups). Randomization was accomplished by alternate selection to either the MI or the FE groups. Two operating surgeons selected operative access within the MI and the FE groups. The operative levels varied from L1-S1. Post operatively, participants  were evaluated at 3, 6, 12 and 24 months. One hundred seventy-eight participants (89%) were included in the 24 month follow-up evaluations [87 in the MI; 91 (38 TF, 53 IL) in the FE groups]. They were assessed using the VAS, NASS and Oswestry Low-Back Pain Disability Questionnaire (ODI). Both groups showed improvement (p<0.001) in leg pain and ADLs according to the measuring instruments. There were no significant differences in clinical outcomes or recurrent symptoms between the two treatment groups at two years.  The authors also identified the disadvantage of FE is limited possibility to expand the operation in the event of unforeseen hindrances.

Although the early results in both of these full-endoscopic spinal surgical studies are promising, the authors cautioned that there is a steep learning curve for using full endoscopic techniques. Demonstrated surgeon proficiency and larger studies with longer follow up are necessary before the clinical efficacy, safety and durable outcome advantages of full endoscopic spinal procedures can be determined.

In a 2007 Cochrane review for surgical interventions treating spinal disc disease, Gibson and Waddell found that microdiscectomy gives broadly comparable results to standard discectomy.  There was insufficient evidence for percutaneous or endoscopic discectomy techniques to draw firm conclusions.

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.

A variety of percutaneous and endoscopic instrumented techniques have been investigated over the years as a treatment of back pain related to disc disease and bone structure.

Percutaneous techniques include automated percutaneous lumbar discectomy (APLD), laser discectomy and nucleoplasty. APLD involves the percutaneous insertion of a probe into the disc space 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 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 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.

Vertebral discs and the bone structure surrounding them can be altered by disease (e.g. arthritis) or trauma. Bone structure and adjacent disc misalignment can compress neural tissue causing pain. A discectomy removes or reduces the disc material to alleviate the associated pain.  A laminectomy removes parts of the laminar bone to relieve spinal cord pressure. When large amounts of bony structures and tissue need to be removed during these procedures, the spinal region may need stabilization. The vertebra in the region can be stabilized by fusion or by the insertion of screws or spacers. Endoscopic techniques for these procedures have been proposed as an alternative to minimally invasive or traditional open procedures in an effort to decrease post operative recovery time and complications.

Definitions

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 

Discogenic pain: refers to 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: refers to 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 

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

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 

Spinal fusion: an operative procedure whose goal is to stop movement at one or more levels (a level is two vertebrae with a disc between) of the spine.  It is frequently accomplished by removing disc or joint tissue and then placing bone graft materials

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, single or multiple levels, lumbar (e.g., manual or automated percutaneous discectomy, percutaneous laser discectomy)
63020Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and/or excision of herniated intervertebral disc, including open and endoscopically-assisted approaches; 1 interspace, cervical
63030Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and/or excision of herniated intervertebral disc, including open and endoscopically-assisted approaches; 1 interspace, lumbar
63035Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and/or excision of herniated intervertebral disc, including open and endoscopically-assisted approaches; each additional interspace, cervical or lumbar (add-on)
 No specific code for 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 
80.59Other destruction of intervertebral disc [when specified as percutaneous lumbar disc decompression, laser discectomy, coblation nucleoplasty]
  
ICD-9 Diagnosis 
 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. Neuroradiol 2004; 46:378-384.
  3. Al-Zain F, Lemcke J, Killeen T, Minimally invasive spinal surgery using nucleoplasty: a 1-year follow-up study. Acta Neurochir. 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. 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. 2007; 149(5):495-500.
  6. 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 1995; 20:734-738.
  7. Coric D, Adamson T. Minimally invasive cervical microendoscopic laminoforaminotomy. Neurosurg Focus. 2008; 25(2):E2.
  8. 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.
  9. Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse: updated Cochrane Review. Spine. 2007 Jul 15; 32(16):1735-1747.
  10. 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. 
  11. Haufe SM, Mork AR. Effects of unilateral endoscopic facetectomy on spinal stability. J Spinal Disord Tech. 2007; 20(2):146-148.
  12. 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; 21:61-66.
  13. 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.
  14. Revel M, Payan C, Vallee, et al. Automated percutaneous lumbar discectomy versus chemonucleolysis in the treatment of sciatica; A randomized multicenter trial. Spine 1993; 18:1-7.
  15. 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.
  16. Ringel F, Stoffel M, Stüer C, Totzek S, Meyer B. Endoscopy-assisted approaches for anterior column reconstruction after pedicle screw fixation of acute traumatic thoracic and lumbar fractures. Neurosurgery. 2008; 62(5 Suppl 2):ONS445-452.
  17. Ruetten S, Komp M, Merk H, Godolias G. Full-endoscopic cervical posterior foraminotomy for the operation of lateral disc herniations using 5.9-mm endoscopes: a prospective, randomized, controlled study. Spine. 2008; 33(9):940-948.
  18. 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. 2008; 33(9):931-939.
  19. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Association of Neurological Surgeons (Spine Section) website. Available at: http://www.spinesection.org/index.php. Accessed on December 27, 2009.
  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.hhs.gov/mcd/index_chapter_list.asp. Accessed on December 27, 2009.
  3. Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine. 2009; 1; 34(10):1078-1093.
  4. 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 December 27, 2009.
  5. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Vertos Minimally Invasive Lumbar Decompression (MILD®). No. K093062. Rockville, MD: FDA. February 4, 2010. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093062.pdf  Accessed on: April 30, 2010.
  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/index.jsp?action=byID&o=11147.  Accessed on December 27, 2009.
  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 December 27, 2009.
  8. National Institute for Clinical Excellence (NICE). Laser lumbar discectomy. Interventional Procedures Guidance 27. 2003. Available at: http://www.nice.org.uk/Guidance/IPG027.   Accessed on December 27, 2009.
  9. U.S. National Institutes of Health. Clinical Trials: Vertos Minimally Invasive Lumbar Decompression (MILD®). Available at:   http://www.clinicaltrials.gov/ct2/results?term=Vertos+Minimally+Invasive+Lumbar+Decompression+%28mild%C2%AE%29+. Accessed on April 30, 2010.
Web Sites for Additional Information
  1. U.S. National Library of Medicine. Microdiskectomy. 2008. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/007250.htm.   Accessed on December 27, 2009.
  2. North American Spine Society. Consumer Health. Available at: http://www.spine.org/Pages/Default.aspx.  Accessed on December 24, 2009.
Index

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

Status

Date

Action

 04/29/2010Information regarding the Vertos Minimally Invasive Lumbar Decompression (MILD®) device added to the Rationale. References updated.
Reviewed02/25/2010Medical Policy & Technology Assessment Committee (MPTAC) 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 Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

07/27/2004

SURG.00052Chronic Spine Pain Treatments/Procedures (Minimally Invasive)
WellPoint Health Networks, Inc.

09/23/2004

3.07.04Percutaneous Techniques for Disc Decompression