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VISCOCANALOSTOMY, CANALOPLASTY AND
ANTERIOR SEGMENT AQUEOUS DRAINAGE DEVICES
HS-126
Easy Choice Health Plan, Inc.
Harmony Health Plan of Illinois, Inc.
Missouri Care, Inc.
‘Ohana Health Plan, a plan offered by
WellCare Health Insurance of Arizona, Inc.
WellCare Health Insurance of Illinois, Inc.
WellCare Health Plans of New Jersey, Inc.
WellCare Health Insurance of Arizona, Inc.
WellCare of Florida, Inc.
WellCare of Connecticut, Inc.
WellCare of Georgia, Inc.
WellCare of Kentucky, Inc.
WellCare of Louisiana, Inc.
Viscocanalostomy,
Canaloplasty and Anterior
Segment Aqueous
Drainage Devices
WellCare of New York, Inc.
WellCare of South Carolina, Inc.
WellCare of Texas, Inc.
Policy Number: HS-126
Original Effective Date: 8/20/2009
WellCare Prescription Insurance, Inc.
Windsor Health Plan
Windsor Rx Medicare Prescription Drug Plan
Revised Date(s): 8/20/2010; 8/2/2011;
8/2/2012; 4/11/2013; 4/3/2014; 7/10/2014;
9/4/2014; 6/5/2015
APPLICATION STATEMENT
The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS)
National and Local Coverage Determinations and state-specific Medicaid mandates, if any.
VISCOCANALOSTOMY, CANALOPLASTY AND
ANTERIOR SEGMENT AQUEOUS DRAINAGE DEVICES
HS-126
DISCLAIMER
The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of
Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions
related to the top/ic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes
the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans
and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the
benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid
mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult www.wellcare.com/Providers/CCGs for list of current LOBs.
BACKGROUND
Viscocanalostomy
Viscocanalostomy is a procedure used to treat glaucoma that involves surgical incisions and injection of a viscous,
elastic material into the eye. The goal of this procedure is to reduce intraocular pressure by creating a channel that
allows excess fluid to drain from the eye. Viscocanalostomy can be performed under peribulbar or retrobulbar
anesthesia and should be performed by an ocular surgeon who has been specifically trained in this technique.
During this procedure, a limbal-based, halfthickness scleral flap is dissected deeply into clear cornea and a second
flap is dissected near the ciliary body. Schlemm’s canal is unroofed by gentle pulling on the scleral flap and by
simultaneously peeling the fibrotic lining from the bottom of the canal and the juxtacanalicular trabecular meshwork.
After the membrane is cleaved from the cornea to create a corneal “window,” the inner scleral flap is excised. A
cannula is then inserted in Schlemm’s canal, the canal is filled with sodium hyaluronate, the cannula is removed,
1,2
and the flaps are sutured closed.
Canaloplasty
Transluminal dilation of aqueous outflow canal also known as canaloplasty is a new non-penetrating surgical
procedure to treat glaucoma. It has some similarities to viscocanalostomy. A canaloplasty is a 360 degree
viscodilation of the Schlemm's canal with an illuminated beacon-tipped microcatheter. The microcatheter is used to
place an intracanalicular suture that cinches and stretches the trabecular meshwork inwards while permanently
opening Schlemm's canal. The difference between a viscocanalostomy and a canaloplasty is that the canaloplasty
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aims at opening the entire length of the canal, not just one section of it.
1
Hayes issued a statement on canaloplasty:
The canaloplasty procedure iTrack 250A Canaloplasty Microcatheter has been developed as a minimally
invasive surgical technique which attempts to widen the eye's natural drainage canal, and reestablish normal
eye pressure. During the procedure, a microcatheter with a light on the end is inserted into the eye's internal
drainage duct, known as the canal of Schlemm. The canal is circular, and the ophthalmologic surgeon can view
the illuminated tip of the catheter as it is advanced around 360°. As the catheter is advanced, a viscoelastic fluid
is injected to dilate the canal. Once the catheter emerges from the end of the canal, a suture is attached, then
retracted back through the canal, and tied in a loop. The suture puts tension on the inner wall of the canal to
widen it, allowing more fluid to drain out of the eye. Ultrasound is then used to visualize the canal and ensure
correct placement of the suture. Patients usually undergo this procedure under local anesthesia on an outpatient
basis. Overall, results of the seven available prospective studies provide preliminary evidence that canaloplasty
is a relatively safe and efficacious surgical procedure for the treatment of POAG. In the only controlled trial
comparing different surgical procedures, canaloplasty showed superior efficacy to viscocanalostomy in reducing
IOP, with a similar safety profile. A controlled trial comparing two suture sizes for distension of Schlemm's canal
confirmed the success of using a 10-0 Prolene suture for the procedure. Several multicenter, uncontrolled trials
provide further evidence that canaloplasty is an efficacious procedure for lowering IOP, and reducing
antiglaucoma medication use, in POAG patients, with few complications. Overall, the quality of the evidence is
low since most studies lacked controls, and therefore, have inherent weaknesses. Future studies, particularly
randomized controlled trials, are needed to compare canaloplasty with other interventions, such as optimal
medical therapy, laser surgery, and trabeculectomy, to evaluate the long-term safety and efficacy profile of the
Clinical Coverage Guideline
Original Effective Date: 8/20/2009 - Revised: 8/20/2010, 8/2/2011, 8/2/2012; 4/11/2013, 4/3/2014, 7/10/2014, 9/4/2014, 6/5/2015
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VISCOCANALOSTOMY, CANALOPLASTY AND
ANTERIOR SEGMENT AQUEOUS DRAINAGE DEVICES
HS-126
procedure, and to determine patient selection criteria.
Anterior Segment Aqueous Drainage Devices, Without Extraocular Reservoir
Glaucoma filtering surgery is indicated when glaucomatous damage progresses despite pharmacological and/or
surgical treatment. Trabeculectomy is the most widely used form of filtering surgical treatment for primary openangle glaucoma. Glaucoma drainage implants designed to shunt the aqueous fluid posteriorly represent an
alternative method for lowering intraocular pressure in glaucomatous patients and are commonly used in refractory
glaucoma or after failure of filtration surgery. An anterior segment aqueous drainage device, without extraocular
reservoir, implanted under a partial thickness scleral flap may be a safe alternative or adjunct to standard guarded
trabeculectomy, especially for patients with advanced glaucoma in need of low intraocular pressures with a high risk
3
for hypotonous complication.
Professional Statements
In their Preferred Practice Pattern for primary open-angle glaucoma, the American Academy of Ophthalmology
(AAO) cites limited studies of nonpenetrating glaucoma surgery but does not specifically address canaloplasty. The
AAO concludes: "The precise role of nonpenetrating surgery in the surgical management of glaucoma remains to be
4
determined."
The National Institute for Health and Clinical Excellence (NICE) issued guidance on canaloplasty and stated:
"Current evidence on the safety and efficacy of canaloplasty for primary open-angle glaucoma is inadequate in both
quality and quantity. Therefore, this procedure should only be used in the context of research or formal prospective
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data collection."
The Centers for Medicare and Medicaid Services states that for open angle glaucoma, usage of FDA-approved
6
devices must be consistent with clinical usage patterns; FDA labeling will serve as the basis for medical necessity.
To illustrate:


The Ex-PRESS mini-shunt (implantation via CPT 66183) is indicated for the reduction of intraocular
pressure (IOP) in patients with glaucoma where medical and conventional surgical treatments have failed.
The iSTENT Trabecular Micro-Bypass stent is indicated for use in conjunction with cataract surgery for the
reduction of IOP in adult subjects with mild to moderate open-angle glaucoma currently treated with ocular
hypotensive medication.
POSITION STATEMENT
Applicable To:
Medicaid
Medicare
Viscocanalostomy is considered experimental and investigational for the treatment of all conditions, including
primary open-angle glaucoma.
Canaloplasty is covered for the treatment primary open-angle glaucoma only when the following criteria is met:
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
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Failed trabeculectomy in opposite eye OR;
Failed laser trabeculoplasty without scarring OR;
Cases where target IOP is unlikely to be achieved or has not been achieved over 6 months to a year by
medication alone OR;
Patients who are keloid formers OR;
Patients who are unable to tolerate post-op blurred vision OR;
Clinical Coverage Guideline
Original Effective Date: 8/20/2009 - Revised: 8/20/2010, 8/2/2011, 8/2/2012; 4/11/2013, 4/3/2014, 7/10/2014, 9/4/2014, 6/5/2015
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VISCOCANALOSTOMY, CANALOPLASTY AND
ANTERIOR SEGMENT AQUEOUS DRAINAGE DEVICES
HS-126
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Patients with significant ocular surface disease OR;
Patients with ocular pemphigoid OR;
Patients with pigmentary or exfoliation glaucoma or POAG mixed with another mechanism OR;
Concern about further loss of vision in patients with any of the following:
o High myopia
o Advanced previous glaucoma damage = visual field lost & visual fixation is split
o Ocular hypotony in opposite eye 2° to trabeculectomy
o Immuno-suppressed
o Anti-coagulation
o Diabetes mellitus with early retinopathy or diabetic macular edema
iSTENT Procedure
The use of the iStent Trabecular Micro-Bypass Stent System is considered medically necessary and a covered
benefit for the treatment of members with mild or moderate open-angle glaucoma and a cataract when medication
therapies (e.g., ocular hypotensive medication) have failed to control intra ocular pressure.
The iSTENT Trabecular Micro-Bypass stent is indicated for use in conjunction with cataract surgery for the reduction
of IOP in adult subjects with mild to moderate open-angle glaucoma currently treated with ocular hypotensive
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medication.
Canaloplasty is considered experimental and investigational for the treatment of all other conditions.
CODING
Covered CPT®* Level III Codes
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
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
66183 Insertion of anterior segment aqueous drainage device, without extraocular reservoir, external approach
Covered ICD-9-CM Procedure Codes
12.91 Therapeutic evacuation of anterior chamber
Covered HCPCS Codes
C1729 Catheter, drainage
C1783 Ocular implant, aqueous drainage assist device
Covered ICD-9-CM Diagnosis Codes for Canaloplasty External Approach
365.10
Open angle glaucoma unspecified
365.11
Primary open angle glaucoma
365.12
Low tension open angle glaucoma
365.13
Pigmentary open angle glaucoma
365.14
Glaucoma of childhood
365.15
Residual stage of open angle glaucoma
365.70 - 365.74 Glaucoma Stage
Draft Covered ICD-10-CM Diagnosis Codes for Canaloplasty External Approach
H40-H42
Glaucoma
Clinical Coverage Guideline
Original Effective Date: 8/20/2009 - Revised: 8/20/2010, 8/2/2011, 8/2/2012; 4/11/2013, 4/3/2014, 7/10/2014, 9/4/2014, 6/5/2015
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VISCOCANALOSTOMY, CANALOPLASTY AND
ANTERIOR SEGMENT AQUEOUS DRAINAGE DEVICES
HS-126
DRAFT ICD-10-PCS Codes Refer to the following ICD-10-PCS table(s) for specific PCS code assignment based on physician documentation.
NOTE: Per ICD-10-PCS Coding Guidelines, “ICD-10-PCS codes are composed of seven characters.
Each character is an axis of classification that specifies information about the procedure performed.
Within a defined code range, a character specifies the same type of information in that axis of classification.
One of 34 possible values can be assigned to each axis of classification in the seven-character code”.
089230Z
08923ZZ
089330Z
08933ZZ
Drainage of Right Anterior Chamber with Drainage Device, Percutaneous Approach
Drainage of Right Anterior Chamber, Percutaneous Approach
Drainage of Left Anterior Chamber with Drainage Device, Percutaneous Approach
Drainage of Left Anterior Chamber, Percutaneous Approach
*Current Procedural Terminology (CPT®) ©2015 American Medical Association: Chicago, IL.
REFERENCES
1. Hayes Directory. (2011, September 16). Canaloplasty (iTrack 250A canaloplasty microcatheter; iScience Interventional Inc.) for primary
open-angle glaucoma [reviewed September 27, 2013]. Retrieved from http://www.hayesinc.com
2. Lewis, R.A., von Wolff, K., Tetz, M., & et al. (2007). Canaloplasty: circumferential viscodilation and tensioning of Schlemm's canal using a
3.
4.
5.
6.
7.
8.
flexible microcatheter for the treatment of open-angle glaucoma in adults: interim clinical study analysis. Journal of Cataract and Refractive
Surgery, 33(7), 1217-1226.
Centers for Medicare and Medicaid Services. (2009, July 1). Local coverage article for educational article: insertion of anterior segment
aqueous drainage device, without extraocular reservoir (A49182) [revised on January 1, 2012]. Retrieved from
http://www.cms.hhs.gov/mcd/search.asp
American Academy of Ophthalmology. (2005). Preferred practice pattern guidelines: primary open-angle glaucoma. Retrieved from
http://one.aao.org/CE/PracticeGuidelines/PPP_ Content.aspx?cid=e2387c8a-e51c-4c21-be20-c30fbf4f3260
National Institute for Health and Clinical Excellence. (2008). Canaloplasty for open-angle glaucoma: interventional procedure guidance 260.
Retrieved from http://www.nice.org.uk/guidance/IPG260
Centers for Medicare and Medicaid Services. (2014, March 26). Local coverage determination: Glaucoma treatment with aqueous drainage
device (L32733). Retrieved from http://www.cms.hhs.gov/mcd/search.asp
UPMC Health Plan. (2012). Canaloplasty for primary open-angle glaucoma. Retrieved from
http://www.upmchealthplan.com/pdf/PandP/MP.052.pdf
Hayes Directory. (2013, March 2). iStent trabecular micro-bypass stent (Glaukos Corp.) for treatment of primary open-angle glaucoma
[reviewed March 6, 2014]. Retrieved from http://www.hayesinc.com
MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS
Date
Action
6/5/2015
9/4/2014
7/10/2014
4/3/2014
4/1/2013
8/2/2012
12/1/2011
8/2/2011
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Approved by MPC. No changes.
Approved by MPC. Included coverage for iSTENT.
Approved by MPC. Added items re: anterior segment aqueous drainage devices.
Approved by MPC. No changes.
Approved by MPC. Added criteria pertaining to anterior segment aqueous drainage devices.
Approved by MPC. Changed coverage to include canaloplasty for POAG.
New template design approved by MPC.
Approved by MPC.
Clinical Coverage Guideline
Original Effective Date: 8/20/2009 - Revised: 8/20/2010, 8/2/2011, 8/2/2012; 4/11/2013, 4/3/2014, 7/10/2014, 9/4/2014, 6/5/2015
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