Coverage Policy Manual
Policy #: 1998152
Category: Surgery
Initiated: January 1998
Last Review: May 2018
  Epiduroscopy

Description: The FDA issued a 510 (K) approval for the instrument used in epiduroscopy/myeloscopy 9/26/1995.  Epiduroscopy, also called spinal myeloscopy, is used in the diagnosis and treatment of spinal pain.  Epiduroscopy, performed as an outpatient procedure under sedation, involves insertion of a miniature fiberoptic scope (myeloscope) into the epidural space of the spine after local anesthesia has been applied to the skin.  Epiduroscopy is used to examine, under direct vision, structures as the dura mater spinalis, connective tissue, spinal nerve fibers, etc.  Drugs can be injected directly into specific areas.  

No CPT code is available for epiduroscopy.  CPT 64999 (unlisted procedure, nervous system) would be used.

Policy/
Coverage:
Epiduroscopy or spinal myeloscopy does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, epiduroscopy or spinal myeloscopy is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
Percutaneous Lysis of Adhesions without Spinal Endoscopy
In 2004, Manchikanti and colleagues published the results of a trial that randomized 75 patients to 1 of 3 groups, either a control group consisting of catheterization without adhesiolysis, or to adhesiolysis with or without additional hypertonic saline.  All patients received epidural injections of local anesthetic and corticosteroids. Patient selection criteria included a history of chronic low back pain of at least 2 years that had failed conservative treatment, including epidural corticosteroid injections. Outcomes were assessed at 3, 6, and 12 months based on a visual analogue scale (VAS), Oswestry Disability Index, work status, opioid intake, range of motion, and psychological exam. Unblinding was allowed at 3 months, based on treatment response, followed by crossover to another treatment group. It is not clear from the published article how this assessment was made. In the control group, 6 of the 25 patients were unblinded at 3 months, and 18 of the 25 patients were unblinded at 18 months. Once patients were unblinded they were considered withdrawn and no subsequent data were collected and the results of their last assessment were carried forward to the next assessment. For example, if a patient was unblinded at 3 months, the same outcomes were reported at 6 and 12 months. Therefore, this discussion will focus on the 3-month outcomes.
 
Significant differences in pain relief, Oswestry Disability Index, and range of motion were noted between the 2 treatment groups and the control group. For example, the mean VAS score was not significantly improved in the control group, dropping from 8.9 to 7.7, while in the treatment groups the VAS dropped from 8.8 to 4.6. A total of 40% of the control group had no response with the first treatment, compared to only 16% in the adhesiolysis group. At 3 months, no patient in the control group reported significant relief, defined as at least 50% relief, while at least 64% of patients in the treatment group reported significant relief. While this study is adequately designed and does report positive results, its small size and the fact that it is a single institution study limit interpretation. The dramatic effect reported in this study should be confirmed in a larger multi-institutional study.
 
Other reported trials have significant methodologic issues that limit interpretation. One controlled trial included 45 patients who were randomized to receive either a 1- or 3-day course of lysis of epidural adhesions, although details of the randomization and treatment protocols are not provided, and it is not clear what, if any, randomization took place. The trial also included a conservatively treated control group of 15 patients composed of patients who either refused the treatment option, or whose insurance refused to pay.  Although the study did not provide details on how pain relief was evaluated, describing only a verbal 10-point pain scale, the study concluded that a total of 97% of the treatment group reported at least 50% pain relief with 1 to 3 injections at 3 months, which fell to 93% at 6 months, and 47% at 1 year. There was no significant improvement in the control group. However, the lack of a placebo control and the obvious bias of the control group limit interpretation of these findings. One other identified article compared the use of 0.9% saline solution versus 10% saline solution, but did not control other aspects of the pain-management program.  Epidural lysis of adhesions is discussed in chapters of textbooks and in numerous review articles; however, the absence of controlled trials makes scientific conclusions impossible regarding its efficacy.  A 2005 review article focused on 3 randomized studies by Heavner and Manchikanti and concluded that there was moderate to strong evidence of the effectiveness of percutaneous adhesiolysis.  In 2005, the American Society of Interventional Pain Physicians issued evidence-based practice guidelines on the management of chronic spinal pain. These guidelines concluded that there was “strong evidence” in support of percutaneous adhesiolysis based on a discussion of the same 3 studies.  However, these 3 studies have been reviewed separately in this policy, with the conclusion that methodologic issues limit interpretation of results.
 
Percutaneous Lysis of Adhesions with Spinal Endoscopy
In 2003, a new category III CPT code was introduced to describe lysis of epidural lesions using endoscopic guidance. One randomized controlled trial was identified. Manchikanti and colleagues randomized 23 patients with back pain of greater than 6 months’ duration to receive either spinal endoscopy followed by injection of local anesthetic or corticosteroid (control group) or the above procedure with the addition of lysis of adhesions with normal saline and mechanical disruption with the fiberoptic endoscope.  The trial was double blinded. Patient selection criteria included failure of conservative management, including failure of prior attempts at lysis of adhesions using hypertonic saline. The principal outcomes included changes in the VAS scores and Oswestry Disability scale at 6 months. In the control group, the mean VAS score dropped from 8.7 at baseline to 7.6 at 6 months, while the scores in the intervention group dropped from 9.2 at baseline to 5.7 at 6 months. The difference between the control and intervention group was statistically significant. There was also a significant difference between the 2 groups in the percentage of patients experiencing at least a 50% reduction in pain. Blinding appeared to be successful as 6 of the 16 patients in the control group believed that they were in the intervention group, and 8 of 23 patients in the intervention group believed that they were in the control group. While this study reports promising results, its small size limits interpretation. Two articles were identified that retrospectively examined the outcomes of patients who underwent lysis with (n=120) or without (n=60) adjunctive endoscopy.  As these articles are authored by the same investigator, it is likely that they include overlapping patients. However, these studies did not include a control group, and thus scientific conclusions regarding the contribution of endoscopy are not possible. Finally, several other case series have been reported, but without a control group, the independent contribution of the lysis cannot be assessed.  The 2005 guidelines from the American Society of Interventional Physicians concluded that there was “strong evidence” for spinal endoscopic adhesiolysis in terms of short-term relief and “moderate” evidence for long-term relief.  These guidelines referenced the same articles as are reviewed here.
 
2006 Update
A literature review was completed in May 2006. The findings from this review did not alter the findings and conclusions noted above. While controlled studies are now being conducted, they continue to be small, single-institution studies. Larger, multi-institution studies are needed to adequately evaluate this procedure.
 
2007 Update
A search of the MEDLINE database was performed for the period of June 2006 through June 2007. One randomized single-blinded trial compared epidural lysis with physiotherapy in 99 patients with chronic low back pain.  Inclusion criteria were radicular pain with a corresponding nerve root compressing substrate, and included patients with disc protrusion and herniation as well as epidural fibrosis. The authors did not present the results according to these separate indications. Therefore, for purposes of this policy, the study results cannot be evaluated. Serious adverse events from epidural lysis have been reported.  As described above, multicenter controlled studies are needed to establish the safety and effectiveness of epidural lysis in comparison with placebo and alternative procedures.
 
The American Society of Interventional Pain Physicians updated their Practice Guidelines on the management of chronic spinal pain in 2007.  There was no change from the 2005 Guidelines, which concluded that there was “strong evidence” for short-term and “moderate evidence” for long-term effectiveness of percutaneous adhesiolysis.
 
It is unknown at this time if the identification of adhesions, etc., represent pathological processes that require treatment, or if direct application with hyaluronidase, corticosteroids, and/or hypertonic saline is effective.  There is the unanswered question of whether the heat from the fiberoptic instrument could be injurious to the spinal cord.
 
2012 Update
A literature search was conducted through May 2012. There was no new information identified that would prompt a change in the coverage statement.
 
2014 Update
A literature search conducted through December 2013 did not reveal any new information that would prompt a change in the coverage statement.
 
The latest systematic review on endoscopic adhesiolysis was published in 2013 by Helm et al. The authors included 1 randomized controlled trial (RCT) and 3 observational studies in the review and noted there is a limited amount of literature available on endoscopic adhesiolysis (Helm, 2013).
 
In 2013, Gerdesmeyer et al reported on a randomized, double-blind, placebo-controlled trial on percutaneous epidural lysis of adhesions for chronic lumbar radicular pain at 4 participating treatment centers (Gerdesmeyer, 2013). Of 381 patients screened, 90 patients were randomized in permuted blocks of 4 to 8 to adhesiolysis or placebo. Eligible patients had chronic lumbosacral radicular pain after disc protrusion or after failed back surgery and at least 4 months of unsuccessful conservative treatment. Patients in both groups received injections on each of 3 days and physical therapy after the series of injections. In the adhesiolysis group, the day 1 injection consisted of 10 mL saline with 150 U/mL hyaluronidase, plus 10 mL saline with 40 mg triamcinolone and 2 mL of 0.25% bupivacaine; this initial injection was followed by day 2 and 3 injections of saline with anesthetic. The placebo group received saline injections each of the 3 days through a catheter placed over the affected area but not into the spinal canal. Five patients were not able to complete the trial due to 1 punctured dura, 1 catheter displacement, and 3 required surgeries. After 3 months, the Oswestry Disability Index (ODI) score significantly improved in the adhesiolysis group (55.3±11.6 to 26.4±10.8) compared to the placebo group (55.4±11.5 to 41.8±14.6; p<0.01]). After 3 months, the visual analog scale (VAS) score was also significantly improved in the adhesiolysis group (6.7±1.1 to 2.9±1.9) compared to the placebo group (6.7±1.1 to 4.8±2.2; p<0.01]). The ODI and VAS scores remained significantly more improved in the adhesiolysis group compared to the control group at 6 and 12 months. In the adhesiolysis group, more patients experienced pain during the intervention and transient neurologic deficits (numbness, paralysis or motor weakness) after the intervention than the control group (34 vs 20 and 42 vs 6, respectively). All of the neurologic deficits resolved during hospitalization. Limitations of this study include failure to place the catheter near the anterolateral epidural space of the targeted pathology, the unknown effect of each component of treatment and the absence of magnetic resonance imaging after treatment. The large placebo effect seen in this study also brings into question whether placement of the catheter in the subcutaneous tissue produces a beneficial effect.
 
In the 2-year follow-up report on the study with 120 patients treated for chronic low back pain, Manchikanti and others reported 82% of patients receiving adhesiolysis had significant improvement in functional status and relief of pain of at least 50% compared to only 5% improvement in the epidural corticosteroid injection group (Manchikanti, 2012). If patients had improved functioning and pain reductions of at least 50% for at least 3 months following adhesiolysis, repeat adhesiolysis was permitted. Patients in the adhesiolysis group received an average of 6.4 adhesiolysis procedures while patients in the epidural corticosteroid injection group averaged 2.4 procedures over the 2-year period.
 
The American Society of Interventional Pain Physicians updated their practice guidelines on the management of chronic spinal pain in 2013 (Manchikanti, 2013). The guideline states that “for lumbar percutaneous adhesiolysis, the evidence is fair in managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis.” Percutaneous adhesiolysis is recommended “after failure of conservative management of physical therapy, chiropractic, drug therapy, structured exercise program, and fluoroscopically directed epidural injections.” The guideline also states spinal epidural endoscopic adhesiolysis is not discussed since there is limited evidence and the procedure is rarely used. The studies cited in the guideline have been reviewed for this policy.
 
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement..

CPT/HCPCS:
64999Unlisted procedure, nervous system
72275Epidurography, radiological supervision and interpretation

References: Blomberg RG.(1994) Epiduroscopy and spinaloscopy: endoscopic studies of lumbar spinal spaces. Acta Neurochir 1994; 61:106-107.

Gerdesmeyer L, Wagenpfeil S, Birkenmaier C et al.(2013) Percutaneous epidural lysis of adhesions in chronic lumbar radicular pain: a randomized, double-blind, placebo-controlled trial. Pain Physician 2013; 16(3):185-96.

Helm S, Hayek SM, Colson J et al.(2013) Spinal endoscopic adhesiolysis in post lumbar surgery syndrome: an update of assessment of the evidence. Pain Physician 2013; 16(2 Suppl):SE125-50.

Kawauchi Y, Yone K, Sakou T.(1996) Myeloscopic observation of adhesive arachnoiditis in patients with lumbar spinal canal stenosis. Spinal Cord 1996; 34:403-410.

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

Manchikanti L, Singh V, Cash KA et al.(2012) Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial. . J Pain Res 2012; 5:597-608.

Uchiyama S, Hasegawa K, Homma T, et al.(1998) Ultrafine flexible spinal endoscope (myeloscope) and discovery of an unreported subarachnoid lesion. Spine 1998; 23:2358-62.


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