BlueCross and BlueShield of Montana Medical Policy/Codes
Percutaneous Lysis of Epidural Adhesions
Chapter: Medicine: Treatments
Current Effective Date: December 27, 2013
Original Effective Date: October 13, 2011
Publish Date: December 27, 2013
Revised Dates: December 16, 2013
Description

Lysis of epidural adhesions, also called the Racz procedure, involves passage of a catheter (Racz catheter) endoscopically or percutaneously under fluoroscopic guidance into the epidural space under general anesthetic or conscious sedation. Various protocols for breaking up adhesions and reducing pain and inflammation have been described. The catheter may then be manipulated to mechanically break up adhesions, and various agents, that may include anesthetics, corticosteroids, hyaluronidase, and hypertonic saline, are injected. In some early protocols, the catheter was left in place and injections repeated over several days.

Epidural fibrosis with or without adhesive arachnoiditis most commonly occurs as a complication of spinal surgery and may be included under the diagnosis of "failed back surgery syndrome." Both result from manipulation of the supporting structures of the spine. Epidural fibrosis can occur in isolation, but adhesive arachnoiditis is rarely present without associated epidural fibrosis. Arachnoiditis is most frequently seen in patients who have undergone multiple surgical procedures.

Both conditions are related to inflammatory reactions that result in the entrapment of nerves within dense scar tissue, increasing the susceptibility of the nerve root to compression or tension. The condition most frequently involves the nerves within the lumbar spine and cauda equina. Signs and symptoms indicate the involvement of multiple nerve roots and include low back pain, radicular pain, tenderness, sphincter disturbances, limited trunk mobility, muscular spasm or contracture, and motor sensory and reflex changes. Typically, the pain is characterized as constant and burning. In some cases, the pain and disability are severe, leading to analgesic dependence and chronic invalidism.

Lysis of epidural adhesions, using fluoroscopic guidance, with epidural injections of hypertonic saline in conjunction with corticosteroids and analgesics, has been investigated as a treatment option. Theoretically, the use of hypertonic saline results in a mechanical disruption of the adhesions. It may also function to reduce edema within previously scarred and/or inflamed nerves. Finally, manipulating the catheter at the time of the injection may disrupt adhesions. Spinal endoscopy has been used to guide the lysis procedure. Prior to the use of endoscopy, adhesions could be identified as nonfilling lesions on fluoroscopy. Using endoscopy guidance, a flexible fiberoptic catheter is inserted into the sacral hiatus, providing 3-D visualization to steer the catheter toward the adhesions, to more precisely place the injectate in the epidural space and onto the nerve root. Various protocols for lysis have been described; in some situations, the catheter may remain in place for several days for serial treatment sessions.

Endoscopic epidurolysis is also being investigated for the treatment of degenerative chronic low back pain, including spondylolisthesis, stenosis, and hernia associated with radiculopathy. Along with mechanical adhesiolysis, hyaluronidase, ciprofloxacin and ozone have been applied.

Policy

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.

Coverage

Percutaneous lysis of epidural adhesions may be considered medically necessary after failure of ALL conservative treatment therapies used in the treatment of chronic low back pain including:

  • Physical therapy; AND
  • Nonsteroidal anti-inflammatory medications; AND
  • Antidepressants medications; AND
  • Failure of minor nerve blocks (e.g., facet joint, caudal and/or transforaminal epidural steroid injections).

It should be noted, along with failure of ALL conservative treatment therapies, a patient's willingness to participate in a post-procedure multidisciplinary rehabilitation program is an integral component of recovery.

Other uses of percutaneous lysis of epidural adhesions are considered experimental, investigational and unproven.

Policy Guidelines

The CPT codes discussed in this policy are all inclusive of the injections for contrast with epidurography, fluoroscopic guidance with localization, contrast media, medications and any other supply.

Rationale

A 2005 review article (1) focused on 3 randomized studies by Heavner and Manchikanti and concluded that there was moderate to strong evidence of the effectiveness of percutaneous adhesiolysis. A 2007 update of that review also concluded that there was strong evidence for short-term and moderate evidence of long-term effectiveness of percutaneous adhesiolysis and spinal endoscopy. (2) In a 2008 paper, Racz and colleagues concluded, based on the literature (randomized trials and case series) and expert opinion, that evidence was strong for short-term (3 months) efficacy and moderate for long-term (>3 months) efficacy. (3) Two systematic reviews were published in 2009, one focused on endoscopic adhesiolysis and the other on the percutaneous method. Hayek et al. concluded that, based on level II-1 or II-2 evidence (1 randomized trial and 5 observational studies), endoscopic adhesiolysis provides short- and long-term relief of pain based on the U.S. Preventive Services Task Force (USPSTF) criteria. (4) Epter with Hayek and others concluded that there is level-I or -II evidence (3 randomized trials and 4 observational studies) for percutaneous adhesiolysis. (5) The studies cited in the reviews were reviewed individually for this policy (see following sections).

The evidence for lysis of epidural adhesions consists of single-center studies, most of them from a single U.S. pain management group.

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. (6) 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 analog scale (VAS), Oswestry Disability Index (ODI), work status, opioid intake, range of motion, and psychological examination. 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, ODI, 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.

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. (7) 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. The lack of a placebo control and bias of the control group limit interpretation of these findings. Another study compared the use of 0.9% saline solution versus 10% saline solution but did not control other aspects of the pain management program. (8)

Percutaneous Lysis of Adhesions with Spinal Endoscopy

One small randomized, controlled trial was identified in 2003 by Manchikanti and colleagues. Twenty-three patients with back pain of greater than 6 months’ duration were randomized 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. (9) 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 ODI 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.

Two 2009 papers by Manchikanti and colleagues (10, 11) report 1-year outcomes of 2 comparative effectiveness RCTs currently underway. Patients in one trial had failed back surgery syndrome (planned enrollment, 200 patients), and patients in the other had chronic low back pain (planned enrollment, 120 patients). The reason for reporting preliminary results is not given, but the authors note that in the larger study of patients with failed back surgery, having 60 patients in each group was determined to be adequate, and there are no controlled trials of patients receiving lysis of epidural adhesions for back pain related to spinal stenosis reported in the literature. The comparator in both trials was epidural corticosteroid injection. In both studies, the procedure in the intervention group included epidurography, introduction of the Racz catheter to the level of defect, adhesiolysis and/or targeted catheter positioning, repeat epidurography with confirmation of ventral and lateral filling, and injection of lidocaine, all performed in the operating room, followed by transfer to the recovery room and injection of 10% sodium chloride solution and injection of betamethasone. The control group received epidurography, introduction of the catheter up to S3 or S2, repeat epidurography, and injection of lidocaine in the operating room and injection of normal saline and betamethasone in the recovery room. For the patients with failed back surgery, significant pain relief as defined by a greater than 50% reduction in VAS was achieved by 73% of patients in the lysis group compared to 12% in the control group (p<0.001). For patients with spinal stenosis, there were no outcomes reported at the time of publication.

A randomized single-blinded trial compared epidural lysis with physiotherapy in 99 patients with chronic low back pain. (13) 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.

In 2011, Di Donato et al. reported 48-month follow-up from a prospective case series of 234 patients with chronic low back pain due to failed back surgery syndrome, spondylolisthesis, stenosis, or hernia. (14) In addition to mechanical removal of adherences, targeted ozone, hyaluronidase and ciprofloxacin were applied. Efficacy was prospectively evaluated by an independent investigator at 1 week and 3, 6, 12, 24, 36, and 48 months. Significant improvements in VAS and ODI scores were reported throughout the 48 month follow-up. Adverse events included 32 patients (13.7%) who had sacral pain lasting at least 2 weeks and 13 patients (5.5%) who experienced a non-painful paresthesia and subsequently underwent surgical intervention.

Two additional articles by Manchikanti and colleagues were identified that retrospectively examined the outcomes of patients who underwent lysis with (n=120) or without (n=60) adjunctive endoscopy. (15, 16) As these articles are authored by the same investigator, it is likely that they include overlapping patients. These studies did not include a control group.

Summary

Lysis of epidural adhesions involves passage of a catheter endoscopically or percutaneously under fluoroscopic guidance into the epidural space to break up adhesions and reduce pain and inflammation. The evidence for lysis of epidural adhesions with or without endoscopy is limited to a small number of randomized, controlled trials with methodologic weaknesses, nearly all from the same center.

Practice Guidelines and Position Statements

The American Society of Interventional Pain Physicians updated their practice guidelines on the management of chronic spinal pain in 2009. (18) The guideline states that “evidence for percutaneous adhesiolysis is strong in managing chronic low back and lower extremity pain in post-surgery syndrome. The evidence is moderate in managing low back and lower extremity pain secondary to disc herniation producing radiculopathy. The evidence is limited in managing back and/or lower extremity pain secondary to spinal stenosis.” It further states that “the evidence is Level II-1 or II-2 for endoscopic adhesiolysis in post lumbar laminectomy syndrome in management of pain secondary to post-lumbar surgery syndrome based on one randomized controlled trial.” The studies cited in the guideline have been reviewed for this policy.

The American Pain Society clinical practice guideline on Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain, published in 2009, does not include a discussion or conclusion on adhesiolysis and stated that “for other interventions or specific clinical circumstances, the panel found insufficient evidence from randomized controlled trials to reliably judge benefits or harms.” (19)

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.

Rationale for Benefit Administration
 
ICD-9 Codes
03.6, 349.0-349.9
ICD-10 Codes

G96.8, G96.9, G97.1, G98.8, 00NW3ZZ, 00NW4ZZ, 00NX3ZZ, 00NX4ZZ, 00NY3ZZ, 00NY4ZZ

Procedural Codes: 01936, 62263, 62264, 64999
References
  1. Chopra P, Smith HS, Deer TR et al. Role of adhesiolysis in the management of chronic spinal pain: a systematic review of effectiveness and complications. Pain Physician 2005; 8(1):87-100.
  2. Trescot AM, Chopra P, Abdi S et al. Systematic review of effectiveness and complications of adhesiolysis in the management of chronic spinal pain: an update. Pain Physician 2007; 10(1):129-46.
  3. Racz GB, Heavner JE, Trescot A. Percutaneous lysis of epidural adhesions--evidence for safety and efficacy. Pain Pract 2008; 8(4):277-86.
  4. Hayek SM, Helm S, Benyamin RM et al. Effectiveness of spinal endoscopic adhesiolysis in post lumbar surgery syndrome: a systematic review. Pain Physician 2009; 12(2):419-35.
  5. Epter RS, Helm S, 2nd, Hayek SM et al. Systematic review of percutaneous adhesiolysis and management of chronic low back pain in post lumbar surgery syndrome. Pain Physician 2009; 12(2):361-78.
  6. Manchikanti L, Rivera JJ, Pampati V et al. One day lumbar epidural adhesiolysis and hypertonic saline neurolysis in treatment of chronic low back pain: a randomized, double-blind trial. Pain Physician 2004; 7(2):177-86.
  7. Manchikanti L, Pampati V, Fellows B et al. Role of one day epidural adhesiolysis in management of chronic low back pain: a randomized clinical trial. Pain Physician 2001; 4(2):153-66.
  8. Heavner JE, Racz GB, Raj P. Percutaneous epidural neuroplasty: prospective evaluation of 0.9% NaCl versus 10% NaCl with or without hyaluronidase. Reg Anesth Pain Med 1999; 24(3):202-7.
  9. Manchikanti L, Rivera JJ, Pampati V et al. Spinal endoscopic adhesiolysis in the management of chronic low back pain: a preliminary report of a randomized, double-blind trial. Pain Physician 2003; 6(3):259-67.
  10. Manchikanti L, Cash KA, McManus CD et al. The preliminary results of a comparative effectiveness evaluation of adhesiolysis and caudal epidural injections in managing chronic low back pain secondary to spinal stenosis: a randomized, equivalence controlled trial. Pain Physician 2009; 12(6):E341-54.
  11. Manchikanti L, Singh V, Cash KA et al. A comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing lumbar post surgery syndrome: a randomized, equivalence controlled trial. Pain Physician 2009; 12(6):E355-68.
  12. Staal JB, de Bie RA, de Vet HC et al. Injection therapy for subacute and chronic low back pain: an updated Cochrane review. Spine (Phila Pa 1976) 2009; 34(1):49-59.
  13. Veihelmann A, Devens C, Trouillier H et al. Epidural neuroplasty versus physiotherapy to relieve pain in patients with sciatica: a prospective randomized blinded clinical trial. J Orthop Sci 2006; 11(4):365-9.
  14. Di Donato A, Fontana C, Pinto R et al. The effectiveness of endoscopic epidurolysis in treatment of degenerative chronic low back pain: a prospective analysis and follow-up at 48 months. Acta Neurochir Suppl 2011; 108:67-73.
  15. Manchikanti L, Pampati V, Bakhit CE et al. Non-endoscopic and endoscopic adhesiolysis in post-lumbar laminectomy syndrome: a one-year outcome study and cost effectiveness analysis. Pain Physician 1999; 2(3):52-8.
  16. Manchikanti L, Pakanati RR, Pampati V. The value and safety of epidural endoscopic adhesiolysis. Am J Anesthesiol 2000; 27(5):275-9.
  17. Wagner KJ, Sprenger T, Pecho C et al. [Risks and complications of epidural neurolysis -- a review with case report]. Anasthesiol Intensivmed Notfallmed Schmerzther 2006; 41(4):213-22.
  18. Manchikanti L, Boswell MV, Singh V et al. American Society of Interventional Pain Physicians. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician 2009; 12(1):699-802. 2009/08/01:699-802. Available at: www.asipp.org (accessed November 2012).
  19. 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) 2009; 34(10):1066-77.
  20. Lysis of Epidural Adhesions. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 December) Therapy 8.01.18.
History
October 2011  New policy: CPT codes for lysis of epidural lesions already pend investigational
December 2013 Policy formatting and language revised.  Title changed from "Lysis of Epidural Adhesions" to "Percutaneous Lysis of Epidural Adhesions".  Policy statement changed from investigational to include medically necessary criteria.  Removed HCPCs code J7130.
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Percutaneous Lysis of Epidural Adhesions