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. Proprietary and Confidential Information of UPMC Health Plan © 2014 UPMC All Rights Reserved POLICY NUMBER: PAY.124 REVISION DATE: 01/14 ANNUAL APPROVAL DATE: 03/14 PAGE NUMBER: 2 of 9 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 Proprietary and Confidential Information of UPMC Health Plan © 2014 UPMC All Rights Reserved POLICY NUMBER: PAY.124 REVISION DATE: 01/14 ANNUAL APPROVAL DATE: 03/14 PAGE NUMBER: 3 of 9 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. Proprietary and Confidential Information of UPMC Health Plan © 2014 UPMC All Rights Reserved POLICY NUMBER: PAY.124 REVISION DATE: 01/14 ANNUAL APPROVAL DATE: 03/14 PAGE NUMBER: 4 of 9 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 Proprietary and Confidential Information of UPMC Health Plan © 2014 UPMC All Rights Reserved POLICY NUMBER: PAY.124 REVISION DATE: 01/14 ANNUAL APPROVAL DATE: 03/14 PAGE NUMBER: 5 of 9 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 Proprietary and Confidential Information of UPMC Health Plan © 2014 UPMC All Rights Reserved POLICY NUMBER: PAY.124 REVISION DATE: 01/14 ANNUAL APPROVAL DATE: 03/14 PAGE NUMBER: 6 of 9 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. Proprietary and Confidential Information of UPMC Health Plan © 2014 UPMC All Rights Reserved POLICY NUMBER: PAY.124 REVISION DATE: 01/14 ANNUAL APPROVAL DATE: 03/14 PAGE NUMBER: 7 of 9 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 Proprietary and Confidential Information of UPMC Health Plan © 2014 UPMC All Rights Reserved POLICY NUMBER: PAY.124 REVISION DATE: 01/14 ANNUAL APPROVAL DATE: 03/14 PAGE NUMBER: 8 of 9 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 Proprietary and Confidential Information of UPMC Health Plan © 2014 UPMC All Rights Reserved POLICY NUMBER: PAY.124 REVISION DATE: 01/14 ANNUAL APPROVAL DATE: 03/14 PAGE NUMBER: 9 of 9 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. Proprietary and Confidential Information of UPMC Health Plan © 2014 UPMC All Rights Reserved
© Copyright 2024