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This medical policy (medical coverage guideline) is Copyright 2017, 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 2017 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.

02-65000-18

Original Effective Date: 07/15/14

Reviewed: 06/23/16

Revised: 10/01/16

Next Review: 06/22/17

Subject: Viscocanalostomy and Canaloplasty

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  
           

DESCRIPTION:

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 individuals 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 with a filtering “bleb” on the eye, which can effectively reduce IOP, but is associated with numerous and sometimes sight-threatening complications (e.g., leaks, hypotony, choroidal effusions and hemorrhages, hyphemas or bleb-related endophthalmitis) and long-term failure.

The Trabectome™, an electrocautery device with irrigation and aspiration, has been used to selectively ablate the trabecular meshwork and inner wall of Schlemm’s canal without external access or creation of a subconjunctival bleb. IOP with this ab interno procedure is typically higher than the pressure achieved with standard filtering trabeculectomy. Aqueous shunts may also be placed to facilitate drainage of aqueous humor. Complications of anterior chamber shunts include corneal endothelial failure and erosion of the overlying conjunctiva.

Alternative nonpenetrating methods that are being evaluated for glaucoma are viscocanalostomy and canaloplasty. Viscocanalostomy is a variant of deep sclerectomy and unroofs and dilates Schlemm’s canal without penetrating the trabecular meshwork or anterior chamber. A high-viscosity viscoelastic solution, such as sodium hyaluronate, is used to open the canal and create a passage from the canal to a scleral reservoir. It has been proposed that viscocanalostomy may lower IOP while avoiding bleb-related complications.

Canaloplasty was developed from viscocanalostomy and involves dilation and tension of Schlemm’s canal with a suture loop between the inner wall of the canal and the trabecular meshwork. This ab externo procedure uses the iTrack™ illuminated microcatheter to access and dilate the length of Schlemm’s canal and to pass the suture loop through the canal. An important difference between viscocanalostomy and canaloplasty is that canaloplasty attempts to open the entire length of Schlemm’s canal, rather than one section of it.

Since aqueous humor outflow is pressure-dependent, the pressure in the reservoir and venous system is critical for reaching the target IOP. Therefore, some procedures may not be able to reduce IOP below the pressure of the distal outflow system used, e.g., below 15 mm Hg, and are not indicated for individuals for whom very low IOP is desired (e.g., those with advanced glaucoma). Health outcomes of interest are the IOP achieved, reduction in medications, ability to convert to trabeculectomy if the procedure is unsuccessful, complications, and durability of the procedure.

POSITION STATEMENT:

Canaloplasty meets the definition of medical necessity as a method to reduce intraocular pressure in individuals with chronic primary open-angle glaucoma under the following conditions:

Medical therapy has failed to adequately control intraocular pressure, AND

• The individual is not a candidate for any other intraocular pressure lowering procedure (e.g. trabeculectomy or glaucoma drainage implant) due to a high risk for complications.

Canaloplasty is considered experimental or investigational for all other conditions, including angle-closure glaucoma. There is a lack of clinical data to permit conclusions regarding net health outcomes.

Viscocanalostomy is considered experimental or investigational for any condition. There is a lack of clinical data to permit conclusions regarding net health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

66174

Transluminal dilation of aqueous outflow canal; without retention of device or stent

66175

Transluminal dilation of aqueous outflow canal; with retention of device or stent

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

H40.10X0 – H40.10X4

Unspecified open-angle glaucoma

H40.1110 – H40.1194

Primary open-angle glaucoma, staged

H40.1210 – H40.1294

Low-tension glaucoma

H40.1310 – H40.1394

Pigmentary glaucoma

H40.151 – H40.159

Residual stage of open-angle 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 products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

01-92000-24, Aqueous Shunts and Stents for Glaucoma

OTHER:

None applicable.

REFERENCES:

  1. AHRQ National Guideline Clearinghouse. Guideline Summary NGC-8198: Primary open-angle glaucoma. San Francisco (CA): American Academy of Ophthalmology. (2010).
  2. AHRQ National Guideline Clearinghouse. Guideline Summary NGC-8555: Care of the patient with open angle glaucoma. St. Louis (MO): American Optometric Association. (2010).
  3. American Academy of Ophthalmology Glaucoma Panel. Preferred Practice Pattern® Guidelines. Primary Open-Angle Glaucoma. San Francisco, CA: American Academy of Ophthalmology; 2010. Accessed at: www.aao.org/ppp on 04/22/14.
  4. American Academy of Ophthalmology. Primary Open-Angle Glaucoma Summary Benchmarks for Preferred Practice Pattern® Guidelines; 2013. Accessed at: www.aao.org/ppp on 04/22/14.
  5. American Optometric Association. Care of the patient with open angle glaucoma. St. Louis (MO): American Optometric Association; 2010.
  6. Blue Cross Blue Shield Association. Medical Policy Reference Manual. 9.03.26, Viscocanalostomy and Canaloplasty. (March 2016).
  7. Brandão LM, Grieshaber MC. Update on Minimally Invasive Glaucoma Surgery (MIGS) and New Implants. J Ophthalmol. 2013;2013:705915.
  8. Brandao LM, Schötzau A, Grieshaber MC. Suture Distension of Schlemm's Canal in Canaloplasty: An Anterior Segment Imaging Study. J Ophthalmol. 2015; 2015: 457605.
  9. Brusini P. Canaloplasty in open-angle glaucoma surgery: a four-year follow-up. ScientificWorldJournal. 2014 Jan 16;2014:469609.
  10. Cagini C, Peruzzi C, Fiore T, Spadea L, Lippera M, Lippera S. Canaloplasty: Current Value in the Management of Glaucoma. Journal of Ophthalmology. 2016 Apr 30;2016.
  11. Cheng JW, Cheng SW, Cai JP, Li Y, Wei RL. Systematic overview of the efficacy of nonpenetrating glaucoma surgery in the treatment of open angle glaucoma. Med Sci Monit. 2011 Jul;17(7):RA155-63.
  12. Eid TM, Tantawy WA.Combined Viscocanalostomy-Trabeculectomy for management of Advanced Glaucoma - A Comparative Study of the Contralateral Eye: A Pilot Study. Middle East Afr J Ophthalmol. 2011 Oct;18(4):292-7.
  13. Francis A, et al. Novel Glaucoma Procedures:A Report by the American Academy of Ophthalmology. Ophthalmology Volume 118, Issue 7 , 1466-1480, July 2011.
  14. Ghate D, Wang X. Surgical interventions for primary congenital glaucoma. Cochrane Database Syst Rev. 2015 Jan 30;1:CD008213.
  15. Gunenc U, Ozturk T, Arikan G, Kocak N. Long-term results of viscocanalostomy and phacoviscocanalostomy: a twelve-year follow-up study. International journal of ophthalmology. 2015;8(6):1162.
  16. Khaimi MA. Canaloplasty: A Minimally Invasive and Maximally Effective Glaucoma Treatment. Journal of ophthalmology. 2015 Oct 1;2015.
  17. Klink T, et al. Quality of life following glaucoma surgery: canaloplasty versus trabeculectomy. Clin Ophthalmol. 2015; 9: 7–16.
  18. Matlach J, Freiberg FJ, Leippi S, Grehn F, Klink T. Comparison of phacotrabeculectomy versus phacocanaloplasty in the treatment of patients with concomitant cataract and glaucoma. BMC Ophthalmol. 2013 Jan 29;13:1.
  19. National Institute for Health and Clinical Evidence (NICE). Interventional Procedure Guidance 260: Canaloplasty for primary open-angle glaucoma. 2008. Accessed at: http://www.nice.org.uk on 04/22/14.
  20. Yu Y, Liu ZL, Cao L, Nie QZ. Clinical effect of improved viscocanalostomy for the treatment of primary congenital glaucoma. Int J Ophthalmol. 2012;5(4):466-8.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 06/23/16.

GUIDELINE UPDATE INFORMATION:

07/15/14

New Medical Coverage Guideline.

06/15/15

Scheduled review. Position Statement maintained. Revised ICD9/ICD10 coding and updated references.

11/01/15

Revision: ICD-9 Codes deleted.

07/15/16

Scheduled review. Maintained Position statement section. Updated references.

10/01/16

ICD-10 coding update: deleted codes H40.11X0 – H40.11X4; added codes H40.1110 – H40.1194.

Date Printed: June 28, 2017: 11:48 PM