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Date Printed: December 21, 2014: 07:45 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2014, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2014 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-92000-24

Original Effective Date: 01/15/13

Reviewed: 08/28/14

Revised: 09/15/14

Subject: Aqueous Shunts and Stents for Glaucoma

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates Decision Tree   Previous Information

DESCRIPTION:

Glaucoma surgery is intended to reduce intraocular pressure (IOP) when the target IOP cannot be reached with medications. Due to complications with established surgical approaches such as trabeculectomy, a variety of devices, including aqueous shunts, are being evaluated as alternative surgical treatments for patients with inadequately controlled glaucoma. Micro-stents are also being evaluated in patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication.

Surgical procedures for glaucoma aim to reduce intraocular pressure (IOP) resulting from impaired aqueous humor drainage in the trabecular meshwork and/or Schlemm’s canal. In the primary (conventional) outflow pathway from the eye, aqueous humor passes through the trabecular meshwork, enters a space lined with endothelial cells (Schlemm’s canal), drains into collector channels, and then into the aqueous veins. Increases in resistance in the trabecular meshwork and/or the inner wall of Schlemm’s canal can disrupt the balance of aqueous humor inflow and outflow, resulting in an increase in IOP and glaucoma risk.

Surgical intervention may be indicated in patients with glaucoma when the target IOP cannot be reached pharmacologically. Trabeculectomy (guarded filtration surgery) is the most established surgical procedure for glaucoma, allowing aqueous humor to directly enter the subconjunctival space. This procedure creates a subconjunctival reservoir, which can effectively reduce IOP, but commonly results in filtering “blebs” on the eye, and is associated with numerous complications (e.g., leaks or bleb-related endophthalmitis) and long-term failure.

Aqueous shunts may also be placed between the anterior or posterior chamber to facilitate drainage of aqueous humor. These devices differ depending on explant surface areas, shape, plate thickness, the presence or absence of a valve, and details of surgical installation. Complications of anterior chamber shunts include corneal endothelial failure and erosion of the overlying conjunctiva. The primary indication for aqueous shunts is when prior medical or surgical therapy has failed, although some ophthalmologists have advocated their use as a primary surgical intervention, particularly for selected conditions such as congenital glaucoma, trauma, chemical burn, or pemphigoid.

POSITION STATEMENT:

Insertion of an anterior segment aqueous drainage device (shunt or stent) approved by the U.S. Food and Drug Administration (FDA) meets the definition of medical necessity as a method to reduce intraocular pressure in individuals with glaucoma where medications have failed to adequately control intraocular pressure.

Insertion of an anterior segment aqueous drainage device (shunt or stent) when intraocular pressure is adequately controlled by medications does not meet the definition of medical necessity.

Use of an anterior segment aqueous drainage device (shunt or stent) for all other conditions is considered experimental or investigational. There is insufficient clinical evidence in the peer-reviewed literature to support the safety and effectiveness of this procedure for indications other than glaucoma.

Implantation of a single FDA-approved anterior segment micro-stent in conjunction with cataract surgery meets the definition of medical necessity in individuals with mild to moderate open-angle glaucoma that are currently treated with medications to control intraocular pressure.

Use of a micro-stent for all other conditions is considered experimental or investigational. There is insufficient clinical evidence in the peer-reviewed literature to support the safety and effectiveness of this procedure for indications other than glaucoma.

Insertion of an anterior segment aqueous drainage device into the suprachoroidal space is considered experimental or investigational. There is insufficient clinical evidence in the peer-reviewed literature to support its safety and effectiveness.

BILLING/CODING INFORMATION:

CPT Coding:

66180

Aqueous shunt to extraocular reservoir (eg, Molteno, Schocket, Denver-Krupin)

66183

Insertion of anterior segment aqueous drainage device, without extraocular reservoir, external approach

66185

Revision of aqueous shunt to extraocular reservoir

0191T

Insertion of anterior segment aqueous drainage device, without extraocular reservoir; internal approach, into the trabecular meshwork

0253T

Insertion of anterior segment aqueous drainage device, without extraocular reservoir; internal approach, into the suprachoroidal space (investigational)

ICD-9 Diagnosis Codes That Support Medical Necessity:

365.10-365.9

Glaucoma

ICD-10 Diagnosis Codes That Support Medical Necessity:

H40.40X0H40.43X4

Glaucoma secondary to eye inflammation

H40.10X0H40.10X4

Unspecified open-angle glaucoma

H40.11X0 H40.11X4

Primary open-angle glaucoma

H40.1210H40.1294

Low-tension glaucoma

H40.1310H40.1394

Pigmentary glaucoma

H40.1410H40.1494

Capsular glaucoma with pseudoexfoliation of lens

H40.151H40.159

Residual stage of open-angle glaucoma

H40.20X0H40.20X4

Unspecified primary angle-closure glaucoma

H40.211H40.219

Acute angle-closure glaucoma

H40.2210H40.2294

Chronic angle-closure glaucoma

H40.231H40.239

Intermittent angle-closure glaucoma

H40.241H40.249

Residual stage of angle-closure glaucoma

H40.30X0H40.33X4

Glaucoma secondary to eye trauma

H40.50X0H40.53X4

Glaucoma secondary to other eye disorders

H40.60X0H40.63X4

Glaucoma secondary to drugs

H40.811H40.819

Glaucoma with increased episcleral venous pressure

H40.821H40.829

Hypersecretion glaucoma

H40.831H40.839

Aqueous misdirection

H40.89

Other specified glaucoma

H40.9

Unspecified glaucoma

H42

Glaucoma in diseases classified elsewhere

Q15.0

Congenital glaucoma

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage: The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Non-covered Services (L29288) located at fcso.com.

DEFINITIONS:

None applicable.

RELATED GUIDELINES:

01-92000-17, Scanning Computerized Ophthalmic Diagnostic Imaging

OTHER:

Index terms:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

AquaFlow™
Ahmed™
Baerveldt®
CyPass®
Ex-PRESS™
Hydrus™
Krupin
Molteno®
iStent®
iStent inject®
Trabectome™

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ). Guideline Summary NGC-8198: Primary open-angle glaucoma. American Academy of Ophthalmology, 2010.
  2. Agency for Healthcare Research and Quality (AHRQ). Guideline Summary NGC-8555: Care of the patient with open angle glaucoma. American Optometric Association, 2010.
  3. American Academy of Ophthalmology. Preferred practice pattern: Primary open-angle glaucoma 2010. Accessed at: http://one.aao.org/ce/default.aspx. on 08/07/14.
  4. American Glaucoma Society. Position statement on new glaucoma surgical procedures (2012). Accessed at http://www.americanglaucomasociety.net/ on 08/07/14.
  5. Arriola-Villalobos P, Martínez-de-la-Casa JM, Díaz-Valle D, Fernández-Pérez C, García-Sánchez J, García-Feijoó J. (2012). Combined iStent trabecular micro-bypass stent implantation and phacoemulsification for coexistent open-angle glaucoma and cataract: a long-term study. British Journal of Ophthalmology, 96(5), 645-649.
  6. Blue Cross Blue Shield Association Medical Policy Reference Manual. 9.03.21, Aqueous Shunts and Stents for Glaucoma. September 2013. (Accessed 08/07/14).
  7. Boland MV, Ervin AM, Friedman DS, et al. Comparative effectiveness of treatments for open-angle glaucoma: A systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013;158(4):271-279.
  8. Boland MV, Ervin AM, Friedman D et al. Treatment for Glaucoma: Comparative Effectiveness. Comparative Effectiveness Review No. 60. AHRQ Publication No. 12-EHC038-EF. Rockville, MD: Agency for Healthcare Research and Quality, April 2012.
  9. Blue Cross and Blue Shield Association Medical Policy Reference Manual. 9.03.21 Aqueous Shunts and Stents for Glaucoma, September 2013.
  10. Brandão LM, Grieshaber MC. Update on Minimally Invasive Glaucoma Surgery (MIGS) and New Implants. J Ophthalmol. 2013;2013:705915.
  11. ClinicalTrials.gov. NCT00834223: A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG), 2011.
  12. ClinicalTrials.gov. NCT00847158: A Clinical Trial of Phacoemulsification Versus Phacoemulsification & the iStent Implantation in POAG Patients, 2009.
  13. ClinicalTrials.gov. NCT01252849: Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects, 2012.
  14. ClinicalTrials.gov. NCT01461278: Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery (2013).
  15. ClinicalTrials.gov. NCT01252914. A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent (2013).
  16. Craven ER, Katz LJ, Wells JM, Giamporcaro JE. (2012). Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. Journal of Cataract & Refractive Surgery, 38(8), 1339-1345.
  17. de Jong L et al. Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma. Clinical Ophthalmology (Auckland, NZ) 5 (2011): 527.
  18. ECRI Institute Emerging Technology Evidence Report. Trabecular Micro-bypass Stent (iStent) for Treating Open-angle Glaucoma (03/11/13).
  19. ECRI Institute Health Technology Forecast. Micro-bypass Implant (iStent) for Treating Glaucoma. October 2012.
  20. Fea AM. (2010). Phacoemulsification versus phacoemulsification with micro-bypass stent implantation in primary open-angle glaucoma: randomized double-masked clinical trial. Journal of Cataract & Refractive Surgery, 36(3), 407-412.
  21. Fea AM, Belda JI, Rękas M, Jünemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May 7;8:875-82.
  22. First Coast Service Options (FCSO) Medical Policy. Noncovered Services, LCD L29288. (last revised 06/30/14).
  23. Francis BA, Winarko J. Ab interno Schlemm's canal surgery: trabectome and i-stent. Dev Ophthalmol. 2012;50:125-36.
  24. Hoeh H, Ahmed II, Grisanti S, Grisanti S, Grabner G, Nguyen QH, Rau M, Yoo S, Ianchulev T. Early postoperative safety and surgical outcomes after implantation of a suprachoroidal micro-stent for the treatment of open-angle glaucoma concomitant with cataract surgery. J Cataract Refract Surg. 2013 Mar;39(3):431-7.
  25. Knape RM, Szymarek TN, Tuli SS, Driebe WT, Sherwood MB, Smith MF. Five-year outcomes of eyes with glaucoma drainage device and penetrating keratoplasty. J Glaucoma. 2012 Dec;21(9):608-14.
  26. Koval MS, et al. Clinical Study. Risk Factors for Tube Shunt Exposure: A Matched Case-Control Study. Journal of Ophthalmology Volume 2013, Article ID 196215.
  27. Mosaed S, Dustin L, Minckler DS. Comparative Outcomes between Newer and Older Surgeries for Glaucoma. Trans Am Ophthalmol Soc. 2009 December; 107: 127–133.
  28. Minckler DS, Francis BA, Hodapp EA et al. Aqueous shunts in glaucoma: a report by the American Academy of Ophthalmology. Ophthalmology 2008; 115(6):1089-98.
  29. National Institute for Health and Clinical Evidence (NICE). Interventional Procedure Guidance 396 (IPG396). Trabecular stent bypass microsurgery for open angle glaucoma (May 2011). Accessed at: http://www.nice.org.uk/nicemedia/live/13157/54571/54571.pdf on 10/01/13.
  30. National Institute for Health and Clinical Evidence (NICE). Clinical Guidance 85 (CG85). Glaucoma: Diagnosis and management of chronic open angle glaucoma and ocular hypertension (April 2009). Accessed http://www.nice.org.uk/ on 10/01/13.
  31. Nehal MS, El Gendy MBB, Song JC. Long term comparison between single stage Baerveldt and Ahmed glaucoma implants in pediatric glaucoma. Saudi Journal of Ophthalmology (2012) 26, 323–326.
  32. Nguyen QH. Primary surgical management refractory glaucoma: tubes as initial surgery. Current opinion in ophthalmology 20.2 (2009): 122-125.
  33. Nichamin LD. Glaukos iStent® Trabecular Micro-Bypass. Middle East Afr J Ophthalmol. 2009 Jul-Sep; 16(3): 138–140.
  34. Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE. (2011). Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology, 118(3), 459-467.
  35. Sarkisian Jr, SR. Tube shunt complications and their prevention. Current Opinion in Ophthalmology 20.2 (2009): 126-130.
  36. Thieme H. Current status of epibulbar anti-glaucoma drainage devices in glaucoma surgery. Dtsch Arztebl Int. 2012 Oct;109(40):659-64.
  37. U.S. Food and Drug Administration. FDA Executive Summary P080030: Glaucos, Inc. iStent Trabecular Micro-Bypass Stent. 2010. Accessed at http://www.fda.gov/ on 10/29/12.
  38. U.S. Food and Drug Administration (FDA). PMA P080030a; P080030c : Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and Inserter (GTS-100i). Accessed at http://www.fda.gov/ on 03/24/14
  39. Voskanyan L, García-Feijoó J, Belda JI, Fea A, Jünemann A, Baudouin C. (2014). Prospective, Unmasked Evaluation of the iStent® Inject System for Open-Angle Glaucoma: Synergy Trial. Advances in therapy, 1-13.
  40. Wang W, Zhou M, Huang W, Zhang X. Ex-PRESS implantation versus trabeculectomy in uncontrolled glaucoma: a meta-analysis. PLoS One. 2013 May 31;8(5):e63591.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 08/28/14.

GUIDELINE UPDATE INFORMATION:

01/15/13

New Medical Coverage Guideline.

11/15/13

Scheduled review. Revised description section, position statement, program exceptions section and index terms. Updated references and reformatted guideline.

01/01/14

Annual CPT update. Added 66183; deleted 0192T.

05/15/14

Revision; updated position statement. Revised CPT coding and index terms. Updated references and reformatted guideline.

09/15/14

Scheduled review. Position statement maintained. Revised CPT, ICD9 and ICD10 coding. Updated references. Reformatted guideline.

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2013 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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Date Printed: December 21, 2014: 07:45 AM