Medical Policies - Surgery


Automated Percutaneous Discectomy and Percutaneous Endoscopic Discectomy

Number:SUR712.004

Effective Date:06-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Automated percutaneous discectomy is considered experimental, investigational and/or unproven as a technique of intervertebral disc decompression in patients with back pain and/or radiculopathy related to disc herniation in the lumbar, thoracic or cervical spine.

Percutaneous endoscopic discectomy is considered experimental, investigational and/or unproven as a technique of intervertebral disc decompression in patients with back pain and/or radiculopathy related to disc herniation in the lumbar, thoracic, or cervical spine.

Description:

Surgical management of herniated intervertebral discs most commonly involves discectomy or microdiscectomy, performed manually through an open incision. Automated percutaneous discectomy involves placement of a probe within the intervertebral disc under image guidance with aspiration of disc material using a suction cutting device. Removal of disc herniations under endoscopic visualization is also being investigated. Endoscopic discectomy involves the percutaneous placement of a working channel under image guidance, followed by visualization of the working space and instruments through an endoscope, and aspiration of disc material.

Back pain or radiculopathy related to herniated discs is an extremely common condition and a frequent cause of chronic disability. Although many cases of acute low back pain and radiculopathy will resolve with conservative care, a surgical decompression is often considered when the pain is unimproved after several months and is clearly neuropathic in origin, resulting from irritation of the nerve roots. Open surgical treatment typically consists of discectomy in which the extruding disc material is excised. When performed with an operating microscope, the procedure is known as microdiscectomy.

Minimally invasive options have also been researched, in which some portion of the disc material is removed or ablated, although these techniques are not precisely targeted at the offending extruding disc material. Ablative techniques include laser discectomy and radiofrequency (RF) decompression which are addressed in a separate policy. In addition, intradiscal electrothermal annuloplasty is another minimally invasive approach to low back pain. In this technique, RF energy is used to treat the surrounding disc annulus which is addressed in a separate policy.

This policy addresses automated percutaneous and endoscopic discectomy, in which the disc decompression is accomplished by the physical removal of disc material rather than its ablation. Traditionally, discectomy is performed manually through an open incision, using cutting forceps to remove nuclear material from within the disc annulus. This technique has been modified by automated devices that involve placement of a probe within the intervertebral disc and aspiration of disc material using a suction cutting device. Endoscopic techniques may be intradiscal or may involve the extraction of non-contained and sequestered disc fragments from inside the spinal canal using an interlaminar or transforaminal approach. Following insertion of the endoscope, the decompression is performed under visual control.

Regulatory Status

The Dekompressor® Percutaneous Discectomy Probe (Stryker), Herniatome Percutaneous Discectomy Device (Gallini Medical Devices), and the Nucleotome® (Clarus Medical) are examples of percutaneous discectomy devices that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA indication for these products is for “aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.” FDA product code: HRX.

A variety of endoscopes and associated surgical instruments have also been cleared for marketing by FDA through the 510(k) process.

Rationale:

This policy was created based on a 1990 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment. The most recent literature review was performed through March 6, 2017.

Assessment of efficacy for therapeutic intervention involves a determination whether an intervention improves health outcomes. The optimal study design for this purpose is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. Intermediate outcome measures, also known as surrogate outcome measures, may also be adequate if there is an established link between the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes, but are prone to biases such as noncomparability of treatment groups, placebo effect, and variable natural history of the condition.

A 2014 Cochrane review of literature through November 2013 evaluated 11 studies of minimally invasive discectomy (MID) compared with microdiscectomy or open discectomy. (1) Included in the MID category were 8 RCTs or quasi-RCTs on percutaneous endoscopic lumbar discectomy (PELD), 2 studies on transmuscular tubular microdiscectomy, and 1 study on automated percutaneous lumbar discectomy (APLD). Seven of the studies had a high risk of bias. For the analysis, the reviewers combined all MID procedures. They reported that MID may be inferior in terms of relief of leg and low back pain, and rehospitalizations; however, differences in pain relief appeared to be small and may not be clinically meaningful. Potential advantages of minimally invasive discectomy included lower risk of surgical site infection and shorter length of stay (LOS).

Automated Percutaneous Discectomy

Systematic Reviews

A 2015 systematic review and network meta-analysis by Lewis et al. compared trials of 21 different treatment strategies for sciatica. (2) Examples of the 21 treatment strategies included in the analysis are conservative care, disc surgery, intraoperative interventions, epidural injections, biologic agents, and percutaneous discectomy. Under the category of “percutaneous discectomy,” reviewers combined automated percutaneous discectomy, percutaneous automated nucleotomy, nucleoplasty, and laser discectomy. They searched 28 databases and trial registries through December 2009. Ninety studies were included and 10 involved the percutaneous discectomy category as an intervention. Of the 10, 4 are relevant to this evidence review: 2 case-control studies of percutaneous endoscopic discectomy (2006, 2007), 1 RCT of percutaneous endoscopic discectomy (1993), and 1 RCT of automated percutaneous discectomy (1995). The remaining studies were published in a foreign language or involved the comparators nucleolysis and chemonucleolysis, rather than open discectomy or microdiscectomy. The global effects odds ratio for the category of percutaneous discectomy compared with inactive control was 0.82 (95% confidence interval [CI], 0.39 to 1.72), which was inferior to disc surgery, epidural injections, and intraoperative interventions. The pain intensity weighted mean difference for the category of percutaneous discectomy compared with inactive control was 11.5 (95% CI, -18.6 to 41.6). Reviewers concluded that there was no support for the effectiveness of percutaneous discectomy for the treatment of sciatica. Due to the inclusion of additional interventions into the broad category of percutaneous discectomy in this review, the relevance of these results are limited.

Two systematic reviews by Manchikanti et al. were published in 2013. One investigated the effectiveness of APLD, with a search of databases from 1966 to September 2012. (3) Studies were included if the following criteria were met: for RCTs, greater than 50% of the criteria adapted from the Cochrane Back Review Group; for cohort studies, 7 of 10 criteria from the Newcastle-Ottawa Scale (NOS) for assessing the quality for cohort studies; and for case-control studies, 5 of 10 criteria from the NOS for case-control studies. No RCTs met the inclusion criteria. Nineteen observational studies met the criteria and were identified for this review. With no RCTs meeting the criteria, meta-analysis could not be performed. Within the 19 observational studies, 5515 patients underwent automated percutaneous discectomy, with 4412 reporting positive results. The range of positive results reported in the studies was 45% to 88%. Despite the large number of studies, the reviewers concluded that the literature was limited, because no RCTs met quality inclusion criteria and because the most recent study, published in 2010, reported results from a study conducted in 2000-2002. The second review by Manchikanti et al. focused specifically on disc decompression using the Dekompressor. (4) This review used the same criteria described above. No RCTs met the study inclusion criteria; 3 observational studies did and were included. Reviewers acknowledged that the Dekompressor appeared to decrease pain, but because meta-analysis could not be conducted, the 3 trials selected were relatively small (total N=164 patients), and none provided follow-up data beyond 8 years, they concluded that the evidence was limited for use of the Dekompressor device for the treatment of lumbar disc herniation.

Vorobeychik et al. (2012) (5) and Singh et al. (2009) (6) also conducted reviews on the Dekompressor. Vorobeychik et al. identified the same 3 observational studies as Manchikanti et al. plus a case series while Singh identified the same observational studies as Manchikanti et al. The authors of both reviews also concluded that pain relief was achieved, but the evidence lacked sufficient rigor to support conclusions.

In 2009, Hirsch et al. published a systematic review on APLD, searching databases from 1966 to April 2009. Cochrane review criteria (50 of 100 points were needed for inclusion) were used to assess quality of RCTs and Agency for Healthcare Research and Quality criteria (50 of 100 points were needed for inclusion) were used to assess observational studies. Reviewers assessed 4 RCTs and 76 observational studies evaluating APLD. (7) One RCT (by Revel et al. [1993]) met inclusion criteria and is detailed in the next section on RCTs. (8) The other 3 RCTs failed to meet study quality criteria. In discussing the results of the Revel trial, which showed a lower success rate than the observational studies, reviewers noted that APLD might not have been successful in this trial due to inappropriate patient selection, failure to recruit the number of patients indicated by sample size calculations, and lack of follow-up beyond 6 months. Ten observational studies met methodologic quality criteria for inclusion. Results were consistent among the observational studies, showing APLD effective among approximately 75% of patients. APLD appears to compare favorably compared with open discectomy, microdiscectomy, and chymopapain injection, though evidence lacked RCTs. The evidence for the use of APLD for short- and long-term pain relief is considered level II-2 (well-designed cohort or case-control studies), using the U.S. Preventive Services Task Force criteria.

Freeman and Mehdian assessed the evidence for 3 minimally invasive techniques used to treat discogenic low back pain and radicular pain: electrothermal therapy (intradiscal electrothermal therapy), percutaneous discectomy, and nucleoplasty in a 2008 article. (9) They reported that trials of automated percutaneous discectomy suggested clinical outcomes are at best fair and often worse than with microdiscectomy.

In 2007, Gibson and Waddell updated a Cochrane review on surgical interventions for lumbar disc prolapse, concluding that there was insufficient evidence on percutaneous discectomy techniques to draw firm conclusions. (10) In the same year, a task force of the American Society of Interventional Pain Physicians (ASIPP) reported that percutaneous disc decompression remains controversial. (11) Although all observational studies provided positive findings, the evidence from 4 randomized trials was negative. Questions also remain about appropriate patient selection criteria for this procedure, particularly related to the size and migration of the disc herniation.

The RCTs are described next are considered poor quality and, in general, did not meet most inclusion criteria of the above systematic reviews.

Randomized Controlled Trials

The 2002 LAPDOG trial compared automated percutaneous discectomy with open discectomy in patients with lumbar disc herniation. (12) Enrolled patients had no prior lumbar spinal surgery, no coexistent lumbar spinal disease, and radiographic evidence of disc herniation. The trial was designed to recruit 330 patients but enrolled 36 patients for reasons not readily apparent. Twenty-seven patients were available at follow-up, with efficacy reported by 41% of those undergoing automated percutaneous discectomy and by 40% of those undergoing open discectomy. The authors concluded that “It is difficult to understand the remarkable persistence of percutaneous discectomy in the face of a virtually complete lack of scientific support for its effectiveness in treated lumbar disc herniation.”

In 1995, Chatterjee et al. reported on 71 patients with lumbar disc herniation randomized to percutaneous discectomy or to lumbar microdiscectomy. (13) A satisfactory outcome was reported in 29% of patients undergoing percutaneous discectomy compared with 80% in the microdiscectomy group. The trial was terminated early due to the inferior outcome.

Revel et al. compared percutaneous discectomy with chymopapain injection in 141 patients with disc herniation and sciatica in a 1993 randomized trial. (8) Treatment was considered successful in 61% of patients in the chymopapain group and in 44% of patients in the percutaneous discectomy group. Thirty-two patients withdrew from the trial, citing therapeutic failure. Within 6 months of the trial, 20% of the patients underwent open laminectomy.

No additional RCTs have been identified since the 2002 LAPDOG trial. All trials have focused on lumbar disc herniation. There were no RCTs of percutaneous discectomy for cervical or thoracic disc herniation. A 2013 review of the evidence from ASIPP noted that “even though Dekompressor may be considered a new interventional modality, the early studies were published approximately 8 years ago. Consequently, one would expect that the technique’s continued use would be supported by more recent, high-quality evaluations.” (14)

Section Summary: Automated Percutaneous Discectomy

The evidence for automated percutaneous discectomy in individuals who have herniated intervertebral disc(s) includes small RCTs and systematic reviews of RCTs. Evidence from small RCTs does not support the use of this procedure. Well-designed and executed RCTs are needed to determine the benefits and risks of this procedure.

Percutaneous Endoscopic Discectomy

Systematic Reviews

In 2017, Phan et al. published a systematic review and meta-analysis comparing full endoscopic discectomy (FED) and microendoscopic discectomy (MED) with open discectomy for the treatment of lumbar disc herniation. (15) A database search through February 2016 identified 23 studies for inclusion. FED was favorable compared with open discectomy in surgery duration, hospital LOS, and blood loss. MED was favorable compared with open discectomy in terms of LOS and blood loss. Both endoscopic procedures were comparable to open discectomy, as measured on a visual analog scale (VAS) for leg pain and Oswestry Disability Index (ODI) score. In terms of patient satisfaction, FED was more favorable than open discectomy, and MED was comparable to open discectomy.

A 2016 systematic review and meta-analysis published by Li et al. compared FED with traditional discectomy surgery. (16) A literature search was conducted in January 2015 and resulted in the inclusion of 4 RCTs and 2 non-RCTs. FED for herniation (both cervical and lumbar) was favorable compared with traditional discectomy in surgery duration, blood loss, LOS, and return to work days. Clinical outcomes were comparable between FED and traditional discectomy.

A 2016 meta-analysis identified 9 RCTs (total N=1092 patients) through August 2014 that compared endoscopic to open discectomy for lumbar disc herniation. (17) Endoscopic discectomy resulted in clinical outcomes similar to open discectomy, but had significantly greater patient satisfaction, lower intraoperative blood loss, and shorter hospital length of stay (LOS).

In 2013, Smith et al. published a systematic review of endoscopic discectomy for lumbar disc herniation. (18) A search for controlled trials published through September 2012 identified 4 RCTs. None found a significant difference in ODI scores for endoscopic discectomy compared to open discectomy or microdiscectomy. The largest study (Teli et al. [2010], described below; N=240) reported an increase in the number of severe complications in the MED group. (19) Another study (Garg et al. [2011], also described below; N=112) found a shorter hospital LOS with no significant changes in ODI scores or complication rates, but recommended that microendoscopic discectomy not be attempted without appropriate training. (20) The 2 other trials included in the review were small, with 22 and 40 patients.

Several of the larger trials included in the systematic reviews above, larger trials on cervical disc herniation, and trials published subsequent to the systematic review literature searches are described in the next section.

Randomized Controlled Trials

In 2017, Gibson et al. published an RCT comparing transforaminal endoscopic discectomy (TED) with microdiscectomy. (21) Patients with single-level lumbar prolapse and radiculopathy were randomized to TED under conscious sedation (n=70) or to microdiscectomy under general anesthesia (n=70). Both procedures resulted in comparable improvements in outcomes (ODI scores, VAS back pain, VAS leg pain, 36-Item Short-Form Health Survey [SF-36] scores) at 3 months, 1 year, and 2 years compared with baseline.

Eight-year follow-up from a quasi-RCT assessing endoscopic lumbar discectomy and open discectomy was reported by Hussein et al. in 2014. (22) The trial included 185 patients with a large uncontained lumbar disc herniation. Surgery times were similar for both groups. Postsurgical mean hospital LOS was 10.4 hours for the endoscopic group and 82.38 hours (p<0.05) for the open group. Mean time to return to work/normal activities after endoscopic surgery (8.5 days) was significantly shorter than after open surgery (31.4 days; p<0.05). The percentages of adverse events were similar between groups, and 8.1% of patients in each group required reoperation during the follow-up. Improvements in leg pain, back pain, and ODI scores (1.05, 1.43, 21.5%, respectively) persisted at 8 years in the endoscopic group, but deteriorated for back pain (7.53) and ODI scores (59.6%) in the open group.

Garg et al. (2011) reported on a trial randomizing 112 patients with a single-level disc herniation to microendoscopic lumbar discectomy or to open discectomy. (20) The method of randomization and whether patients and assessors were blinded were not reported. Surgical time was significantly longer in the endoscopic group (84 minutes vs 56 minutes) while blood loss (41 mL vs 306 mL) and hospital LOS (3 days vs 12 days) were reduced. ODI scores were similar at baseline (endoscopic, 25.78 vs open discectomy, 21.02) and all follow-up visits through 1 year postoperatively (endoscopic; 1.75 vs open discectomy 2.14).

In 2010, Teli et al. reported on an RCT comparing endoscopic discectomy to microdiscectomy or open discectomy in 240 patients with posterior lumbar disc herniation. (19) Most herniations (60%) were extrusions. The average surgical time was longer in the endoscopic group (56 minutes) than in the micro- or open discectomy groups (43 minutes and 36 minutes, respectively). Follow-up assessments were performed at 6, 12, and 24 months by an independent investigator; 212 (91%) patients completed the 24-month evaluation. Intention-to-treat analysis showed no significant differences in the outcome variables (VAS, ODI, and SF-36 scores). The endoscopic procedure led to more dural tears (8.7% vs 2.7% or 3%), root injuries (3% vs 0% or 0%), and recurrent herniations (11.4% vs 4.2% or 3%) than the microdiscectomy or open approaches, respectively, although differences were not statistically significant.

In 2008 and 2009, Ruetten et al. published 4 RCTs comparing full endoscopic discectomy (FED) with conventional techniques in the lumbar and cervical spine. (23-26) All studies were randomized or quasi-randomized, with assignment described as either order of presentation or balanced block. Follow-up examinations were conducted at day 1 and at months 3, 6, 12, and 24 by physicians not involved in the surgeries. The 4 trials were not blinded due to observable differences in the surgical approaches, and are described below.

Patients with mediolateral cervical disc herniations (N=120) were randomized to full endoscopic anterior decompression (FACD) or to conventional anterior cervical decompression with fusion (ACDF). (26) Mean surgery time was 32 minutes for FACD and 62 minutes for ACDF. At 24 months, 103 (86%) patients were available for follow-up examinations. Revision rates for ACDF (6.1%) and FACD (7.4%) did not differ significantly. There were no significant differences in clinical outcomes (pain, VAS arm, VAS neck) between groups.

Patients with clinically symptomatic lateral cervical disc herniation (N=200) were randomized to full endoscopic posterior cervical foraminotomy or conventional microsurgical ACDF. (23) At 24 months postsurgery, 175 (88%) patients were available for follow-up. Ten patients had revisions due to persistent arm pain, recurrences of herniation, or failure of the implant (6 endoscopic patients, 4 ACDF). Postoperative pain was significantly reduced in the endoscopic group (data not reported), and postoperative work disability was shorter (19 days vs 34 days). Other clinical outcomes (VAS scores for neck and arm pain, a German version of the North American Spine Society [NASS] Instrument [Hilibrand criteria]) were similar between groups throughout the 24-month follow-up.

Patients with clinically symptomatic lumbar disc herniation (N=200) were randomized to FED or to conventional microdiscectomy. (24) Mean surgery time for endoscopic discectomy (22 minutes) was nearly 50% faster than for conventional microdiscectomy (43 minutes), and the complication rate was significantly lower. Postoperative pain and pain medication usage were significantly reduced in the endoscopic group (data not reported), and the postoperative work disability was shorter (25 days vs 49 days). At 24 months after surgery, 178 (89%) patients were available for follow-up. The 2 groups had similar improvements in leg pain, with 85% of endoscopic discectomy and 79% of microdiscectomy patients reporting being pain-free. More patients in the microdiscectomy group (5% vs 1%) underwent revision spinal canal expansion and fusion.

Patients with recurrent lumbar disc herniation following conventional discectomy who were in need of a revision (N=100) were randomized to FED or to conventional microdiscectomy. (25) Surgery time was significantly shorter with the endoscopic approach (24 minutes vs 58 minutes), and access-related osseous resection was much less frequent in the endoscopic group (3 [6%] cases vs 47 [94%] cases). There were 4 cases of dura injury (1 endoscopic discectomy, 3 microdiscectomy). Overall, serious complication rates were significantly higher in the microdiscectomy group (21% vs 6%). Postoperative pain and pain medication usage were significantly reduced in the endoscopic group, as was postoperative work disability (28 days vs 52 days). At 24 months, 87 (87%) patients were available for follow-up. Seventy-nine percent had no leg pain at follow-up, and there were no significant differences between groups in clinical outcomes (VAS, NASS Instrument, ODI scores).

A 1999 RCT by Hermantin et al. (27) was rated as having a low risk of bias in the 2014 Cochrane review. Sixty patients who had objective evidence of a single intracanalicular herniation of a lumbar disc were randomized into 2 groups: endoscopic microdiscectomy or open laminotomy and discectomy. A similar percentage of patients was considered to have a satisfactory outcome (97% of the microendoscopic group vs 93% of the open group). The mean duration of narcotic pain-relief use (7 days vs 25 days) and return to work (27 days vs 49 days) were significantly lower in the microendoscopic group. This trial did not use validated outcome measures.

Observational Studies

In 2016, Gotecha et al. published a prospective study on the use of transforaminal PELD for the treatment of lumbar disc herniation. (28) Efficacy and limitations of the procedure were studied on 120 patients with lumbar disc herniation. Using McNab criteria, 89% achieved excellent (no pain or restrictions) or good (occasional back/leg pain) status at 6 months of follow-up. The authors noted that a limitation of the procedure is that, during surgery on patients with L5 through S1 lumbar disc herniation, the iliac crest may interfere with the angle necessary to perform successful discectomy.

A number of observational studies have also assessed the learning curve (29-31) and the need for longer follow-up for endoscopic discectomy. (32-34) The largest and longest follow-up to date has been reported by Choi et al. (2015), who examined 10,228 patients at their institution who had had PELD over a 12-year period. (34) They found that 4.3% of cases required reoperation in the first 6 weeks due to incomplete removal of herniated discs (2.8%), recurrence (0.8%), persistent pain (0.4%), and approach-related pain (0.2%).

Section Summary: Percutaneous Endoscopic Discectomy

The evidence for percutaneous endoscopic discectomy in individuals who have herniated intervertebral disc(s) includes a number of RCTs and systematic reviews of RCTs. Many of the RCTs were conducted at a single center in Europe. Some trials have reported outcomes at least as good as traditional approaches with an open incision, while an RCT from a different center in Europe reported a trend toward increased complications and reherniations using an endoscopic approach. There are few reports from the United States. Reporting from a number of moderately large ongoing RCTs is anticipated in the next 2 to 3 years.

Summary of Evidence

For individuals who have herniated intervertebral disc(s) who receive automated percutaneous discectomy, the evidence includes randomized controlled trials (RCTs) and systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The published evidence from small RCTs is insufficient to evaluate the impact of automated percutaneous discectomy on net health outcomes. Well-designed and executed RCTs are needed to determine the benefits and risks of this procedure. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have herniated intervertebral disc(s) who receive percutaneous endoscopic discectomy, the evidence includes a number of RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Many of the RCTs were conducted at a single center in Europe. Some trials have reported outcomes at least as good as traditional approaches with an open incision, while 1 RCT from a different center in Europe reported a trend toward increased complications and reherniations using an endoscopic approach. There are few reports from the United States. Results from a number of moderately large ongoing RCTs are anticipated in the next 2 to 3 years. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (NICE) published guidance in 2005 on automated percutaneous mechanical lumbar discectomy, indicating that there was limited evidence of efficacy based on uncontrolled case series of heterogeneous groups of patients, and evidence from small RCTs showed conflicting results. (35) The guidance indicated that, in view of uncertainty about the efficacy of the procedure, it should not be done without special arrangements for consent and for audit or research. The guidance was considered for update in 2009, but failed review criteria; the 2005 guidance is therefore considered current.

A NICE guidance on percutaneous transforaminal endoscopic lumbar discectomy for sciatica was published in 2016. (36) The guidance stated that current evidence is adequate to support the use of percutaneous transforaminal endoscopic lumbar discectomy for sciatica. Choice of operative procedure (open discectomy, microdiscectomy, or percutaneous endoscopic approaches) may be influenced by symptoms, and location and size of prolapsed disc.

A NICE guidance on percutaneous interlaminar endoscopic lumbar discectomy for sciatica was also published in 2016. (37) The guidance stated that current evidence is adequate to support the use of percutaneous interlaminar endoscopic lumbar discectomy for sciatica. Choice of operative procedure (open discectomy, microdiscectomy, or percutaneous endoscopic approaches) may be influenced by symptoms, and location and size of prolapsed disc.

American Society of Interventional Pain Physicians

The 2013 guidelines from the American Society of Interventional Pain Physicians indicated that the evidence for percutaneous disc decompression with the Dekompressor was limited. (14) There were no recommended indications for the Dekompressor.

North American Spine Society

In 2014, the North American Spine Society published clinical guidelines on the diagnosis and treatment of lumbar disc herniation. (38) Table 1 summarizes recommendations specific to percutaneous endoscopic discectomy and automated percutaneous discectomy.

Table 1. NASS Recommendations for Lumbar Disc Herniation With Radiculopathy

Recommendations

Grade or LOEa

Endoscopic percutaneous discectomy is suggested for carefully selected patients to reduce early postoperative disability and reduce opioid use compared with open discectomy

B

There is insufficient evidence to make a recommendation for or against the use of automated percutaneous discectomy compared with open discectomy

I

Endoscopic percutaneous discectomy may be considered for treatment.

C

Automated percutaneous discectomy may be considered for treatment.

C

Patients undergoing percutaneous endoscopic discectomy experience better outcomes if <40 years and symptom duration <3 months.

II

LOE: level of evidence; NASS: North American Spine Society.

a Grade B: fair evidence (level II or III studies with consistent findings; grade C: poor quality evidence (level IV or V studies). Level of evidence II: lesser quality randomized controlled trial (e.g., <80% follow-up, no blinding, or improper randomization), prospective comparative study, systematic review of level II studies or level I studies with inconsistent results; level of evidence III: case control, retrospective, systematic review of level III studies; level of evidence IV: case series; level of evidence V: expert opinion.

American Pain Society

The 2009 clinical practice guidelines from the American Pain Society found insufficient evidence to evaluate alternative surgical methods to standard open discectomy and microdiscectomy, including laser or endoscopic-assisted techniques, various percutaneous techniques, coblation nucleoplasty, or the Dekompressor. (39)

Ongoing and Unpublished Clinical Trials

Currently unpublished trials that might influence this review are listed in Table 2.

Table 2. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02441959

Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc: A Prospective Multi-Center Randomized Study

200

Jul 2017

NCT01622413a

Transforaminal Endoscopic Surgery Cost Outcome Research Trial (TESCORT)

200

Sep 2018

NCT02742311

EuroPainClinics® Study V Prospective Observational Study (EPCSV)

500

Jan 2019

NCT02602093

(Cost) Effectiveness of Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Patients with Symptomatic Lumbar Disc Herniation

682

Dec 2019

NCT01997086

Percutaneous Transforaminal Endoscopic Discectomy (PTED) Versus Microendoscopic Discectomy (MED) for the Treatment of Lumbar Disc Herniation: A Prospective Randomized Controlled Study

345

Aug 2023

Unpublished

NCT02358291

Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy for the Treatment of Lumbar Disc Herniation

240

Mar 2017 (unknown)

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CPT code 62287 specifically describes a percutaneous decompression procedure of the lumbar spine. This code is specifically limited to the lumbar region. Although most percutaneous discectomies are performed on lumbar vertebrae, Food and Drug Administration labeling of the Stryker Dekompressor Percutaneous Discectomy Probe and the Nucleotome includes the thoracic and cervical vertebrae.

Effective in 2017, there is a specific CPT code for endoscopic decompression: 62380.

Percutaneous discectomy is also a component of the following CPT codes: 0274T and 0275T.

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

62287, 62380

HCPCS Codes

C2614

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Rasouli MR, Rahimi-Movaghar V, Shokraneh F, et al. Minimally invasive discectomy versus microdiscectomy/open discectomy for symptomatic lumbar disc herniation. Cochrane Database Syst Rev. 2014; 9:CD010328. PMID 25184502

2. Lewis RA, Williams NH, Sutton AJ, et al. Comparative clinical effectiveness of management strategies for sciatica: systematic review and network meta-analyses. Spine J. Jun 1 2015; 15(6):1461-1477. PMID 24412033

3. Manchikanti L, Singh V, Falco FJ, et al. An updated review of automated percutaneous mechanical lumbar discectomy for the contained herniated lumbar disc. Pain Physician. Apr 2013; 16(2 Suppl):SE151-184. PMID 23615890

4. Manchikanti L, Singh V, Calodney AK, et al. Percutaneous lumbar mechanical disc decompression utilizing Dekompressor®: an update of current evidence. Pain Physician. Apr 2013; 16(2 Suppl):SE1-24. PMID 23615884

5. Vorobeychik Y, Gordin V, Fuzaylov D, et al. Percutaneous mechanical disc decompression using Dekompressor device: an appraisal of the current literature. Pain Med. May 2012; 13(5):640-646. PMID 22494347

6. Singh V, Benyamin RM, Datta S, et al. Systematic review of percutaneous lumbar mechanical disc decompression utilizing Dekompressor. Pain Physician. May-Jun 2009; 12(3):589-599. PMID 19461825

7. Hirsch JA, Singh V, Falco FJ, et al. Automated percutaneous lumbar discectomy for the contained herniated lumbar disc: a systematic assessment of evidence. Pain Physician. May-Jun 2009; 12(3):601-620. PMID 19461826

8. 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). Jan 1993; 18(1):1-7. PMID 8434309

9. Freeman BJ, Mehdian R. Intradiscal electrothermal therapy, percutaneous discectomy, and nucleoplasty: what is the current evidence? Curr Pain Headache Rep. Jan 2008; 12(1):14-21. PMID 18417018

10. Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev. 2007(2):CD001350. PMID 17443505

11. Boswell MV, Trescot AM, Datta S, et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. Jan 2007; 10(1):7-111. PMID 17256025

12. Haines SJ, Jordan N, Boen JR, et al. Discectomy strategies for lumbar disc herniation: results of the LAPDOG trial. J Clin Neurosci. Jul 2002; 9(4):411-417. PMID 12217670

13. Chatterjee 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 herniation. Spine (Phila Pa 1976). Mar 15 1995; 20(6):734-738. PMID 7604351

14. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. Apr 2013; 16(2 Suppl):S49-283. PMID 23615883

15. Phan K, Xu J, Schultz K, et al. Full-endoscopic versus micro-endoscopic and open discectomy: A systematic review and meta-analysis of outcomes and complications. Clin Neurol Neurosurg. Mar 2017; 154:1-12. PMID 28086154

16. Li XC, Zhong CF, Deng GB, et al. Full-endoscopic procedures versus traditional discectomy surgery for discectomy: a systematic review and meta-analysis of current global clinical trials. Pain Physician. Mar 2016; 19(3):103-118. PMID 27008284

17. Cong L, Zhu Y, Tu G. A meta-analysis of endoscopic discectomy versus open discectomy for symptomatic lumbar disk herniation. Eur Spine J. Jan 2016; 25(1):134-143. PMID 25632840

18. Smith N, Masters J, Jensen C, et al. Systematic review of microendoscopic discectomy for lumbar disc herniation. Eur Spine J. Nov 2013; 22(11):2458-2465. PMID 23793558

19. Teli M, Lovi A, Brayda-Bruno M, et al. Higher risk of dural tears and recurrent herniation with lumbar micro- endoscopic discectomy. Eur Spine J. Mar 2010; 19(3):443-450. PMID 20127495

20. Garg B, Nagraja UB, Jayaswal A. Microendoscopic versus open discectomy for lumbar disc herniation: a prospective randomised study. J Orthop Surg (Hong Kong). Apr 2011; 19(1):30-34. PMID 21519072

21. Gibson JN, Subramanian AS, Scott CE. A randomised controlled trial of transforaminal endoscopic discectomy vs microdiscectomy. Eur Spine J. Mar 2017; 26(3):847-856. PMID 27885470

22. Hussein M, Abdeldayem A, Mattar MM. Surgical technique and effectiveness of microendoscopic discectomy for large uncontained lumbar disc herniations: a prospective, randomized, controlled study with 8 years of follow-up. Eur Spine J. Sep 2014; 23(9):1992-1999. PMID 24736930

23. Ruetten S, Komp M, Merk H, et al. Full-endoscopic cervical posterior foraminotomy for the operation of lateral disc herniations using 5.9-mm endoscopes: a prospective, randomized, controlled study. Spine (Phila Pa 1976). Apr 20 2008; 33(9):940-948. PMID 18427313

24. Ruetten S, Komp M, Merk H, et al. Full-endoscopic interlaminar and transforaminal lumbar discectomy versus conventional microsurgical technique: a prospective, randomized, controlled study. Spine (Phila Pa 1976). Apr 20 2008; 33(9):931-939. PMID 18427312

25. Ruetten S, Komp M, Merk H, et al. Recurrent lumbar disc herniation after conventional discectomy: a prospective, randomized study comparing full-endoscopic interlaminar and transforaminal versus microsurgical revision. J Spinal Disord Tech. Apr 2009; 22(2):122-129. PMID 19342934

26. Ruetten S, Komp M, Merk H, et al. Full-endoscopic anterior decompression versus conventional anterior decompression and fusion in cervical disc herniations. Int Orthop. Dec 2009; 33(6):1677-1682. PMID 19015851

27. Hermantin FU, Peters T, Quartararo L, et al. A prospective, randomized study comparing the results of open discectomy with those of video-assisted arthroscopic microdiscectomy. J Bone Joint Surg Am. Jul 1999; 81(7):958-965. PMID 10428127

28. Gotecha S, Ranade D, Patil SV, et al. The role of transforaminal percutaneous endoscopic discectomy in lumbar disc herniations. J Craniovertebr Junction Spine. 2016; 7(4):217-223. PMID 27891030

29. Lee DY, Lee SH. Learning curve for percutaneous endoscopic lumbar discectomy. Neurol Med Chir (Tokyo). Sep 2008; 48(9):383-388; discussion 388-389. PMID 18812679

30. Wang B, Lu G, Patel AA, et al. An evaluation of the learning curve for a complex surgical technique: the full endoscopic interlaminar approach for lumbar disc herniations. Spine J. Feb 2011; 11(2):122-130. PMID 21296295

31. Tenenbaum S, Arzi H, Herman A, et al. Percutaneous posterolateral transforaminal endoscopic discectomy: clinical outcome, complications, and learning curve evaluation. Surg Technol Int. Dec 2011; 21:278-283. PMID 22505002

32. Casal-Moro R, Castro-Menendez M, Hernandez-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. Jun 2011; 68(6):1568-1575; discussion 1575. PMID 21311384

33. Wang M, Zhou Y, Wang J, et al. A 10-year follow-up study on long-term clinical outcomes of lumbar microendoscopic discectomy. J Neurol Surg A Cent Eur Neurosurg. Aug 2012; 73(4):195-198. PMID 22825836

34. Choi KC, Lee JH, Kim JS, et al. Unsuccessful percutaneous endoscopic lumbar discectomy: a single-center experience of 10 228 cases. Neurosurgery. Apr 2015; 76(4):372-381. PMID 25599214

35. National Institute for Health and Care Excellence (NICE). Automated percutaneous mechanical lumbar discectomy-guidance [IPG141]. 2005; Available at <http://guidance.nice.org.uk> (accessed March 9, 2017).

36. National Institute for Health and Care Excellence (NICE). Percutaneous transforaminal endoscopic lumbar discectomy for sciatica [IPG556]. 2016; Available at <https://www.nice.org.uk> (accessed March 9, 2017).

37. National Institute for Health and Care Excellence (NICE). Percutaneous interlaminar endoscopic lumbar discectomy for sciatica [IPG555]. 2016; Available at <https://www.nice.org.uk> (accessed March 9, 2017).

38. Kreiner DS, Hwang SW, Easa JE, et al. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. Jan 2014; 14(1):180-191. PMID 24239490

39. Chou R, Loeser JD, Owens DK, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). May 1 2009; 34(10):1066-1077. PMID 19363457

40. Automated Percutaneous and Percutaneous Endoscopic Discectomy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (April 2017) Surgery 7.01.18.

Policy History:

Date Reason
6/15/2018 Reviewed. No changes.
2/15/2018 Document updated with literature review. Coverage has changed, the word percutaneous was added to the following coverage statement: Percutaneous endoscopic discectomy is considered experimental, investigational and/or unproven as a technique of intervertebral disc decompression in patients with back pain and/or radiculopathy related to disc herniation in the lumbar, thoracic, or cervical spine. The Title has changed from: Automated Percutaneous Discectomy and Endoscopic Discectomy.
9/15/2016 Document updated with literature review. Coverage unchanged.
7/1/2015 Reviewed. No changes.
8/1/2014 Medical document divided into: SUR712.023, SUR712.037 and SUR712.038. Document title changed from “Intervertebral Techniques to Treat Chronic Discogenic Back Pain”. Document updated with literature review. The previous coverage statement was Percutaneous discectomy by any means is considered experimental, investigational and/or unproven as a technique of intervertebral disc decompression in patients with back pain related to disc herniation in the lumbar, thoracic or cervical spine. The following was added to coverage: Endoscopic discectomy is considered experimental, investigational and/or unproven as a technique of intervertebral disc decompression in patients with back pain and/or radiculopathy related to disc herniation in the lumbar, thoracic, or cervical spine.
6/1/2012 Coverage revised, the following was added; Axial lumbosacral interbody fusion (axial LIF) is considered experimental, investigational and unproven. Description, rationale, and references updated.
12/15/2011 Document updated with literature review. Document completely revised. All references to minimally invasive interbody fusion were removed. Title was changed from “Percutaneous Intervetebral Techniques to Treat Chronic Discogenic Back pain”.
12/15/2009 Coverage revised
12/1/2008 Coverage Revised. Codes Revised/Added/Deleted
5/1/2008 Revised/Updated Entire document
6/1/2006 Revised/Updated Entire Document
11/1/2004 New Medical Document

Archived Document(s):

Back to Top