Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Lysis of Epidural Adhesions

Policy #:11.15.13d

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Catheter-based techniques either alone or in combination, including mechanical disruption with a catheter and/or injection of hypertonic solutions with corticosteroids, analgesics, or hyaluronidase for lysis of epidural adhesions, with or without endoscopic guidance, are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, lysis of epidural adhesions is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Epimed International was granted 510(k) status by the FDA in October 1996 to market the Racz® Catheter for administration of an anesthetic agent into the epidural space and for continuous infusion of epidural or caudal anesthesia for up to 72 hours.

Description

Lysis of epidural adhesions using percutaneous injections of saline, steroid(s) anesthetic, and/or hyaluronidase into the epidural space has been investigated as a treatment option for lower back pain due to epidural fibrosis with or without adhesive arachnoiditis. Lysis of epidural adhesions is also known as the Racz procedure, epidurolysis, epidural neuroplasty, and epidural adhesiolysis.

Epidural fibrosis most often develops as a complication of one or more spinal surgeries and may be included in the diagnosis of “failed back syndrome.” Both conditions are believed to be associated with inflammation that results in compression of nerve roots within scar tissue. Nerve roots within the lumbar spine or cauda equina are particularly affected. Lysis of epidural adhesions is typically proposed when conservative attempts to relieve radicular pain have failed.

Lysis of epidural adhesions was introduced in 1989 and required the use of a specially designed catheter, known as the Racz® Catheter, which was developed years earlier. The Racz® Catheter is currently the most commonly used catheter for lysis of epidural adhesions and includes a special wire-wound flexible tip. However, many other commercially available catheters can be used to complete the procedure. While the use of epidurography and special catheters are still effective, new advances in the administration of drugs into the epidural space, such as the use of an endoscope, have been developed. Endoscopy permits direct visualization of the contents of the epidural space during the administration of drugs and mechanical lysis. Terms used to describe percutaneous lysis of adhesions with a special endoscopic catheter include myeloscopy, spinal epiduroscopy, spinal canal endoscopy, lumbar epiduroscopy, and endoscopic adhesiolysis.

The lysing procedure is performed under local anesthesia and involves a straight entry into the epidural space through a caudal, interlaminar, or transforaminal approach. The individual is only mildly sedated in order to allow for communication with the surgeon in the event of weakness or loss of ability to move an extremity. With the aid of fluoroscopy, the catheter is advanced to the area of adhesions or scar tissue. Possible filling defects are viewed by examining the contrast material flowing around nerve roots. Saline, along with a mix of local anesthetic, steroid(s) contrast material, and hyaluronidase, is then injected to initiate lysis of adhesions and decompression. Following the procedure, the catheter may be left in place so that the intervention can be repeated on the second and third postoperative days. A variation of the procedure may include removal of the catheter either immediately or following injection on the second postoperative day. As a result of the lysing procedure, the individual may experience pain reduction within five to seven days postoperatively that continues for several months.

The peer-reviewed published medical literature contains a paucity of literature to support the safety and efficacy of the manipulation of an indwelling epidural Racz® Catheter or epidural injections of saline or hyaluronidase to relieve back pain in individuals with epidural adhesions, adhesive arachnoiditis, or failed back syndrome. The current literature contains a limited number of randomized, controlled trials with methodologic weaknesses, nearly all from the same center. Furthermore, evidence and rationale for routine use of the procedure outside of the research setting, with or without Racz® Catheter, are lacking. Evaluations done by national medical associations, consensus panels, and/or other technology evaluation bodies do not offer significant support for this procedure. Large, high-quality, multicenter controlled studies are needed to establish the safety and effectiveness of the lysis of epidural adhesions in comparison with placebo and alternative procedures.
References


American Society of Interventional Pain Physicians, Boswell MV, Trescot AM, et al. Interventional techniques: evidence based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007;10(1):7-111.

American Society of Interventional Pain Physicians (ASIPP). Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician.2009;12:699-802.

Anderson SR, Racz GB, Heavner J. Evolution of epidural lysis of adhesions. Pain Physician. 2000;3(3):262-270.

Boswell MV, Shah RV, Everett CR, et al. Interventional techniques in the management of chronic spinal pain: Evidence-based practice guidelines. Pain Physician. 2005;8(1):1-47.

Chopra P, Smith HS, Deer TR, Bowman RC. Role of adhesiolysis in the management of chronic spinal pain: A systematic review of effectiveness and complications. Pain Physician. 2005;8(1):87-100.

Chou R. Subacute and chronic low back pain: surgical treatment. Up to Date.[Up to Date Web site]. 03/11/16. Available at:http://www.uptodate.com/contents/subacute-and-chronic-low-back-pain-surgical-treatment [via subscription only]. Accessed April 11, 2017.

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

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.

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

Geurts JW, Kallewaard JW, Richardson J, Groen GJ. Targeted methylprednisolone acetate/hyaluronidase/clonidine injection after diagnostic epiduroscopy for chronic sciatica: A prospective, 1-year follow-up study. Reg Anesth Pain Med. 2002;27(4):343-352.

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

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):202-207.

Helm Ii S, Benyamin RM, Chopra P, et al. Percutaneous adhesiolysis in the management of chronic low back pain in post lumbar surgery syndrome and spinal stenosis: a systematic review. Pain Physician. 2012;15(4):E435-462.

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

Igarashi T, Hirabayashi Y, Seo N, et al. Lysis of adhesions and epidural injection of steroid/local anaesthetic during epiduroscopy potentially alleviate low back and leg pain in elderly patients with lumbar spinal stenosis. Br J Anaesth. 2004;93(2):181-187.

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. 2013;16(2 Suppl):S49-283.

Manchikanti L, Bakhit CE. Percutaneous lysis of epidural adhesions. Pain Physician. 2000;3(1):46-64.

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-E354.

Manchikanti L, Boswell MV, Rivera JJ, et al. A randomized, controlled trial of spinal endoscopic adhesiolysis in chronic refractory low back and lower extremity pain [ISRCTN 16558617]. BMC Anesthesiol. 2005;5:10.

Manchikanti L, Malla Y, Wargo BW, et al. A prospective evaluation of complications of 10,000 fluoroscopically directed epidural injections. Pain Physician. 2012;15(2):131-140.

Manchikanti L, Pakanati RR, Pampati V, et al. The value and safety of epidural endoscopic adhesiolysis. Am J Anesthesiol.2000;27(5):275-279.

Manchikanti L, Pampati V, Bakhit CE, Pakanati RR. Non-endoscopic and endoscopic adhesiolysis in post- lumbar laminectomy syndrome: A one-year outcome study and cost effectiveness analysis. Pain Physician.1999;2(3):52-58.

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):153-166.

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):177-186.

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):259-267.

Manchikanti L, Singh V, Cash KA, et al. 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.

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)E355-368.

National Institute for Health and Clinical Excellence (NICE). Therapeutic endoscopic division of epidural adhesions. [NICE Web site]. February 2010. Available at: http://www.nice.org.uk/nicemedia/pdf/IPG333Guidance.pdf. Accessed April 11, 2017.

Racz GD, Heavner JE, Raj PP. Nonsurgical management of spinal radiculopathy by the use of lysis of adhesions. In: Aronoff GM, ed. Evaluation and Treatment of Chronic Pain. Baltimore, MD: Lippincott Williams and Wilkins; 1998.

Racz GB, Heavner JE, Trescot A. Percutaneous lysis of epidural adhesions-evidence for safety and efficacy. Pain Pract. 2008;8(4):277-86.

Richardson J, McGurgan P, Cheema S, et al. Spinal endoscopy in chronic low back pain with radiculopathy. A prospective case series. Anaesthesia. 2001;56(5):454-460.

Saberski LR. A retrospective analysis of spinal canal endoscopy and laminectomy outcomes data. Pain Physician. 2000;3(2):193-196.

Staal JB, de Bie RA, de Vet HC, et al. Injection therapy for subacute and chronic low back pain: an updated Cochrane review. Spine.2009;34(1):49-59.

Trescot AM, Chopra P, Abdi S, et al. Systematic review of effectiveness and complications of adhesiolysis in the management of spinal pain: An update. Pain Physician. 2007;10(1):129-146.

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):365-369.

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):213-222.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

62263, 62264


THE FOLLOWING CODE IS USED TO REPRESENT ENDOSCOPIC LYSIS OF EPIDURAL ADHESIONS:

64999



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

This service is experimental/investigational for all diagnoses.


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.15.13d:
11/21/2018This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 02/24/2016
Version Issued Date: 02/24/2016
Version Reissued Date: 11/27/2018

Connect with Us        


© 2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.