UPMC Health Plan POLICY AND PROCEDURE MANUAL :

UPMC Health Plan
POLICY AND PROCEDURE MANUAL
POLICY NUMBER: PAY.124
REVISION DATE: 01/14
ANNUAL APPROVAL DATE: 03/14
PAGE NUMBER: 1 of 9
SUBJECT:
INDEX TITLE:
ORIGINAL DATE:
Non-Conventional Treatments of Glaucoma
Medical Management
March 2013
This policy applies to the following lines of business: (Check those that apply.)
COMMERCIAL
CMS-MA
DPW-MA
ANCILLARY
HMO ( )
WV ( )
Health Choices /PH ( )
Dental ( )
PPO ( )
PA ( )
Health Choices/BH ( )
Vision ( )
Fully Insured ( )
All (X)
All ( )
COBRA ( )
Self-funded/ASO ( )
All ( )
Indiv. Product ( )
PID-CHIP
WORK PARTNERS
All (X)
HMO (X)
CHIP (X)
Commercial WC ( )
PPO (X)
Disability Svcs/TPA ( )
CSNP (X)
Health Promotion ( )
DSNP (X)
All ( )
CDHP
ISNP (X)
HSA ( )
LIFE SOLUTIONS
Part D ( )
HRA ( )
LifeSolutions ( )
All ( )
HIA ( )
All ( )
I.
POLICY
It is the policy of UPMC Insurance Services Division to cover newer surgical procedures for
treatment of glaucoma in members for whom conventional courses of treatment (medications
and initial surgery, such as trabeculectomy) have failed. These newer invasive procedures
including Ex-PRESS™ Miniature (Mini) Glaucoma Shunt and Canaloplasty for the treatment
of Primary Open-Angle Glaucoma (POAG) are performed when medically necessary,
keeping with good medical practice for the indications in this policy, and covered under the
member’s specific benefit plan.
II.
DEFINITIONS
Diopters – is a unit of refractive power that is equal to the reciprocal of the focal length (in
meters) of a given lens. Used to measure the degree of myopia and severe myopia is defined
as -6 diopters or worse.
Schlemm’s canal - is the main drainage channel for the aqueous humour situated between
the iris and cornea.
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POLICY NUMBER: PAY.124
REVISION DATE: 01/14
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III.
PURPOSE
The purpose of this policy is to provide the indications/limitations for coverage of newer
invasive procedures for treatment of glaucoma in members for whom conventional treatment
has failed:
1. Ex-PRESS™ Miniature (Mini) Glaucoma Shunt and
2. Canaloplasty for the treatment of POAG.
IV.
SCOPE
This policy applies to various UPMC Insurance Services Division Departments as indicated
by the Benefit and Reimbursement Committee. These include but are not limited to Medical
Management, Benefit Configuration and Claims Departments.
V.
PROCEDURE
A. Medical Description / Background
Glaucoma describes a group of conditions in which there is progressive damage to the optic
nerve associated with abnormal rise in intraocular pressure (IOP). The treatment goal for
patients with glaucoma is preventing further vision loss by lowering the IOP to a level where
progressive optic nerve damage is slowed or completely stopped. Ophthalmic medications
are generally the initial course of treatment with more invasive procedures considered if
medication is unsuccessful. The “gold standard” surgical treatment for medically refractive
elevated IOP has been trabeculectomy.
This policy addresses newer invasive procedures for the treatment of two specific types of
glaucoma in which conventional treatment and trabeculectomy have failed:
1) Refractory open-angle glaucoma
Treatment to reduce intraocular pressure in members where documented medical and
conventional surgical treatment have failed for refractory open-angle glaucoma
consists of the Ex-PRESS™ Mini Glaucoma Shunt, manufactured by originally by
Optonol Ltd. This product was FDA-approved in 2002 to relieve intraocular pressure
in patients with glaucoma who have failed medical and surgical interventions (such as
trabeculectomy). It consists of a stainless steel tube the size of a grain of rice with a
blunt needle-shaped penetrating tip at one end and a flat, angled flange at the opposite
end. Its purpose is to capture aqueous fluid from the anterior chamber of the eye and
transport the fluid to the distal end and out of the device. From there the fluid moves
into the subconjunctival space to form a bleb for absorption into the lymph and blood
vessels around the eye. The device is implanted under a partial-thickness scleral flap.
The procedure is considered minimally invasive and can be performed under local or
topical anesthesia. The device has reportedly fewer complications than standard
trabeculectomy (the gold standard for surgically treating glaucoma), is reversible, and
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POLICY NUMBER: PAY.124
REVISION DATE: 01/14
ANNUAL APPROVAL DATE: 03/14
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can be used in combination with cataract surgery. The procedure is also felt to help
improve compliance because patients may require fewer glaucoma medications after
the procedure.
The American Academy of Ophthalmology in 2008 stated the primary indication for
use of this device is after failure of medical, laser, and conventional filtering surgery
treatment and that evidence demonstrates aqueous shunts seem to have benefits
comparable with those of trabeculectomy in the management of complex glaucomas.
2) Primary open-angle glaucoma (POAG), also known as chronic open-angle or
chronic simple glaucoma, is the most common form of glaucoma and is generally
associated with a long-term increase of pressure within the eye, reduction in visual
field (peripheral vision), and damage to the optic nerve. While trabeculectomy is
considered the “gold standard” surgical treatment for medically refractive elevated
IOP, this surgery is invasive and involves penetrating the eye by placement of new
openings that allow fluid to drain from the subconjunctival space through the
formation of a bleb. This procedure can be associated with a high incidence of postoperative complications. Newer surgical technologies have been developed and
canaloplasty is one of them.
Canaloplasty is a minimally invasive surgical procedure, similar to angioplasty,
which restores the natural trabeculocanalicular outflow pathway lowering the IOP and
reducing dependence on medications. It refines an older procedure,
viscocanalostomy, by using a microcatheter (iScience Canaloplasty System) to widen
and dilate the entire Schlemm’s canal. Canaloplasty uses an injection of highviscosity sodium hyaluronic acid, and suture loop is left in the canal to help maintain
tension and keep the canal open. High resolution intraoperative ultrasound imaging is
also used to ensure proper catheterization and provide confirmation of the success of
the procedure. This procedure can also be performed in conjunction with cataract
surgery.
A three-year study of canaloplasty demonstrated significant and sustained IOP
reduction in subjects with open angle glaucoma and had an excellent short-term and
long-term postoperative safety profile. However, canaloplasty is a very complex
procedure which requires additional surgical training and special licensure/privileges
for performing it.
B. Specific Indications:
1. Ex-PRESS™ Mini Glaucoma Shunt: Refractory open-angle glaucoma to reduce
intraocular pressure in patients where documented medical and conventional surgical
treatments have failed.
The specific model of the implanted must be FDA-approved.
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REVISION DATE: 01/14
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2. Canaloplasty is considered medically necessary for an IOP of 21 mm Hg or higher
and a diagnosis of POAG, pigmentary glaucoma, exfoliation glaucoma, or POAG
mixed with another mechanism under any of the following circumstances:
A. Failed trabeculectomy in opposite eye
B. Failed laser trabeculoplasty without scarring
C. Documented case with medical reason why target IOP is unlikely to be achieved
on maximum doses of ophthalmic medications
D. IOP has not been achieved over 6 months on maximum dose of ophthalmic
medications alone
E. Keloid formers
F. Patients with significant ocular surface disease
G. Patients with ocular pemphigoid
H. Concern about further loss of vision in patients with any of the following:
 High myopia (-6 diopters or higher)
 Advanced previous glaucoma damage = visual field lost & visual fixation is
split
 Ocular hypotony in opposite eye 2° to trabeculectomy
 Immuno-suppressed
 Anti-coagulation
 Diabetes mellitus with documented early retinopathy or diabetic macular
edema
Requirements for Canaloplasty:
1. Procedure must be completed with an FDA-approved device or system
2. Providers must have evidence of credentialing and privileges for performing
canaloplasty at the surgical facility/center where the procedure is performed
3. Ophthalmic surgeon must be formally trained with documentation of training
to perform the canaloplasty procedure
C. Limitations:
1. Contraindications to use of the Ex-PRESS™ Mini Glaucoma Shunt include any
of the following:
A. Presence of ocular disease such as uveitis, ocular infection, severe dry eye, or
severe blepharitis
B. Excessive conjunctival scarring from previous glaucoma surgeries
C. Diagnosed with narrow or angle closure glaucoma
2. Contraindications for Canaloplasty include any of the following:
A. Narrow angle glaucoma
B. Angle closure glaucoma
C. Secondary glaucoma following gross trauma
D. Prior trabeculectomy or other procedure that would prevent full 360° cannulation
of Schlemm’s canal
E. Prior implantation of aqueous shunt
F. Prior laser trabeculoplasty with scarring
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POLICY NUMBER: PAY.124
REVISION DATE: 01/14
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G. Patients unable to comply with post-op instructions
H. Patients with chronic eye inflammation
3. Any non-conventional treatment for open-angled glaucoma not mentioned in this
policy is not covered.
D. Codes
The following codes for treatments and procedures applicable to this policy are included
below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device
code(s) does not constitute or imply member coverage or provider reimbursement policy.
Please refer to the member's contract benefits in effect at the time of service to determine
coverage or non-coverage of these services as it applies to an individual member.
1. Ex-PRESS™ Mini Glaucoma Shunt:
CPT Coding:
Code:
Description:
66183
Insertion of anterior segment aqueous drainage device, without extraocular
reservoir, external approach
ICD-9 Coding:
Code:
Description:
365.10
Open angle glaucoma, unspecified
365.11
Primary open angle glaucoma
365.13
Pigmentary open angle glaucoma
365.14
Glaucoma of childhood
365.15
Residual stage of open angle glaucoma
ICD-10 Coding:
Code:
Description:
H40.10X0- Open angle glaucoma, unspecified
H40.10X4
H40.11X0- Primary open angle glaucoma
H40.11X4
H40.1310- Pigmentary open angle glaucoma
H40.1394
H40.151Residual state of open angle glaucoma
H40.159
H40.50X0- Glaucoma secondary to other eye disorders/drugs
H40.63X4
Q15.0
Congenital glaucoma
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POLICY NUMBER: PAY.124
REVISION DATE: 01/14
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2. Canaloplasty
CPT Coding:
Code:
Description:
66174
Transluminal dilation of aqueous outflow canal; without
retention of device of stent
66175
Transluminal dilation of aqueous outflow canal; with
retention device or stent
ICD-9 Coding:
Code:
Description:
365.10
Unspecified open angle glaucoma
365.11
Primary open angle glaucoma
365.13
Pigmentary open angle glaucoma
365.52
Pseudoexfoliation glaucoma
365.89Other specified glaucoma
365.90
ICD-10 Coding:
Code:
Description:
H40.10x0Unspecified open angle glaucoma
H40.10X4
H40.11X0Primary open-angle glaucoma
H40.11X4
H40.1310Pigmentary glaucoma
H40.1394
H40.1410Pseudoexfoliation glaucoma
H40.1494
H40.89-H40.9 Other specified glaucoma
E. Variations
N/A
F. Quality Audit
Quality Audit monitors policy compliance and/or billing accuracy at the request of the
UPMC Insurance Services Division’s Technology Assessment Committee or the Benefits
Reimbursement Committee.
G. Records Retention
Records Retention for documents, regardless of medium, are provided within the UPMC
Health System Policy for Records Retention, Management and Retirement, and as indicated
in the UPMC Insurance Services Division Policy and Procedure for Records Retention.
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POLICY NUMBER: PAY.124
REVISION DATE: 01/14
ANNUAL APPROVAL DATE: 03/14
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Unless otherwise mandated by Federal or State law, or unless required to be maintained for
litigation purposes, any communications recorded pursuant to this Policy are maintained for a
minimum of ten (10) years from the date of recording.
H. References
Medical Literature/Clinical Information:
1. ECRI Institute: Hotline Response-Visocanalostomy and Canaloplasty for Treating
Glaucoma, Issued December 2013.
https://members2.ecri.org/Components/Hotline/Documents/IssueFiles/11708.pdf
2. Royal National Institute of Blind People: Myopia and High Degree Myopia, Last
Updated September 5, 2012.
http://www.rnib.org.uk/eyehealth/eyeconditions/eyeconditionsdn/Pages/high_degree_my
opia.aspx
3. Wilson RP. Aqueous Shunt from the Anterior Chamber of the Eye to a Posterior
Reservoir. Last revision: June 4, 2012. At: Glaucoma Services Foundation Web Blog.
©2012, Glaucoma Service Foundation to Prevent Blindness.
http://willsglaucoma.org/aqueous-shunts-from-the-anterior-chamber-of-the-eye-to-theposterior-reservior
4. Dahan, E., Simon, G.B., & Lafuma, A. Comparison of Trabeculectomy and Ex-PRESS
Implantation in Fellow Eyes of the Same Patient: A Prospective, Randomized Study,
Eye, 2012 May;26(5):703-10. doi: 10.1038/eye.2012.13,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3351049/pdf/eye201213a.pdf
5. Salim, S. Current Variations of Glaucoma Filtration Surgery, Current Opinion
Ophthalmology, 2012 Mar;23(2):89-95. doi: 10.1097/ICU.0b013e32834ff401,
http://ovidsp.tx.ovid.com/sp3.10.0b/ovidweb.cgi?WebLinkFrameset=1&S=BABLFPDNCLDDAFCPNCNKPAMCJ
KEEAA00&returnUrl=ovidweb.cgi%3f%26Full%2bText%3dL%257cS.sh.22.23%257c0
%257c00055735-20120300000003%26S%3dBABLFPDNCLDDAFCPNCNKPAMCJKEEAA00&directlink=http%3
a%2f%2fgraphics.tx.ovid.com%2fovftpdfs%2fFPDDNCMCPACPCL00%2ffs046%2fov
ft%2flive%2fgv023%2f00055735%2f00055735-20120300000003.pdf&filename=Current+variations+of+glaucoma+filtration+surgery.&pdf_key=FP
DDNCMCPACPCL00&pdf_index=/fs046/ovft/live/gv023/00055735/00055735201203000-00003
6. Hayden FA: An Update on Canaloplasty, American Society of Cataract & Refractive
Surgery, Issued September 2011. http://www.eyeworld.org/article-an-update-oncanaloplasty
7. Lewis RA, von Wolff K, Tetz M, et al. Canaloplasty: Three-year results of
circumferential viscodilation and tensioning of Schlemm canal using a microcatheter to
treat open angle glaucoma. J Cataract Refract Surg. 2011April; 37:682-690.
doi:10.1016/j.jcrs.2010.10.055.
https://www.clinicalkey.com/#!/ContentPlayerCtrl/doPlayContent/1-s2.0S0886335011001234
8. American Academy of Ophthalmology. Preferred Practice Pattern: Primary Open-Angle
Glaucoma Suspect. October 2010. http://one.aao.org/asset.axd?id=a860f57a-0e6a-4c4fb0f7-1a42e05073ff
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POLICY NUMBER: PAY.124
REVISION DATE: 01/14
ANNUAL APPROVAL DATE: 03/14
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9. Alcon, Inc., The Ex-PRESS Glaucoma Filtration Device. Accessed: 12/16/2013. ©2010,
Alcon., http://ecatalog.alcon.com/PI/ExPress_us_en.pdf
10. Lewis RA, von Wolff K, Tetz M, et al. Canaloplasty: circumferential viscodilation and
tensioning of Schlemm canal using a flexible microcatheter for the treatment of open
angle glaucoma: two-year interim clinical study results. J Cataract Refract Surg. 2009
May; 35(5):814-824. doi: 10.1016/j.jcrs.2009.01.010.
https://www.clinicalkey.com/#!/ContentPlayerCtrl/doPlayContent/1-s2.0S0886335009001394
11. Minckler DS, Francis BA, Hodapp EA, et al. Aqueous shunts in glaucoma: a report by
the American Academy of Ophthalmology Ophthalmology. 2008 Jun;115(6):1089-98.
doi: 10.1016/j.ophtha.2008.03.031,
https://www.clinicalkey.com/#!/ContentPlayerCtrl/doPlayContent/1-s2.0S0161642008003035
12. National Institute for Health and Clinical Excellence: Canaloplasty for Primary Open
Angle Glaucoma, Issue Date May 2008. http://publications.nice.org.uk/canaloplasty-forprimary-open-angle-glaucoma-ipg260
13. Shingleton B, Tetz M, Korber N. Circumferential viscodilation and tensioning of
Schlemm canal (canaloplasty) with temporal clear corneal phacoemulsification cataract
surgery for open-angle glaucoma and visually significant cataract: one-year results. 2008
Mar;34(3):433-40. doi: 10.1016/j.jcrs.2007.11.029
https://www.clinicalkey.com/#!/ContentPlayerCtrl/doPlayContent/1-s2.0S0886335008000047.
Regulatory/Government Source:
1. U.S. Food and Drug Administration (FDA). 510 (k) Summary, Ex-PRESS™Miniature
Glaucoma Implant. (Submitter: OPTONOL, Ltd.). March 26, 2002.
http://www.accessdata.fda.gov/cdrh_docs/pdf/k012852.pdf
2. U.S. Food and Drug Administration (FDA). 510 (K) Summary, Blunt Tip Ex-PRESS™
Mini Glaucoma Shunt. (Submitter: OPTONOL, Ltd.). March 13, 2003.
http://www.accessdata.fda.gov/cdrh_docs/pdf3/k030350.pdf
3. Centers for Medicare and Medicaid Services (CMS). Medicare Learning Network: MLN
Matters No. MM6087- Revised. Revision Date: June 9, 2008.
http://www.cms.gov/Outreach-and-Education/Medicare-Learning-NetworkMLN/MLNMattersArticles/downloads/MM6087.pdf
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Disclaimer: UPMC Health Plan medical payment and prior authorization policies do not
constitute medical advice and are not intended to govern or otherwise influence the practice
of medicine. The policies constitute only the reimbursement and coverage guidelines of
UPMC Health Plan and its affiliated managed care entities. Coverage for services varies for
individual members in accordance with the terms and conditions of applicable Certificates of
Coverage, Summary Plan Descriptions, or contracts with governing regulatory agencies.
UPMC Health Plan reserves the right to review and update the medical payment and prior
authorization guidelines in its sole discretion. Notice of such changes, if necessary, shall be
provided in accordance with the terms and conditions of provider agreements and any
applicable laws or regulations.
These policies are the proprietary information of UPMC Health Plan. Any sale, copying, or
dissemination of said policies is prohibited.
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