Medical Affairs Policy

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1 Medical Affairs Policy Service: Corneal Treatments and Specialized Contact Lenses (Corneal remodeling, Corneal transplant, Corneal collagen crosslinking, Intrastromal Rings- INTACS, Keratoconus treatments, Keratoplasty, Scleral lenses) PUM Medical Policy Committee Approval 09/15/17 Effective Date 01/01/18 Prior Authorization Needed Yes Related Medical Policies: Glaucoma Surgical Treatments Non-Covered Services and Procedures Disclaimer: This policy is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may not provide coverage for all services listed in this policy. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical policy in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information. Medical policies are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical policy and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, Description: Keratoconus is a degenerative non-inflammatory disorder of the cornea that results in progressive thinning and abnormal protrusion of the cornea. Distortion of the cornea results in decreased visual acuity (e.g. astigmatism and myopia). Keratoconic corneas have a decrease in the content of collagen compared with normal corneas. Treatment initially includes correction of vision (refraction) with eye glasses and standard contact lenses. Rigid gas permeable contact lenses are the most commonly prescribed lenses for individuals with mild keratoconus. As the disease progresses, scarring and severe irregularities of the corneal contour make wearing of standard contact lenses intolerable and insufficient to correct visual acuity. Surgical treatments include Phototherapeutic Keratectomy (PTK) used to correct refractive errors and Keratoplasty (corneal transplant). Newer treatments include Intrastromal Corneal Ring Segments and corneal collagen cross-linking. Phototherapeutic Keratectomy (PTK) is performed to treat corneal scars, recurrent erosions, corneal dystrophies, and correct refractive errors caused by a diseased cornea such as keratoconus. This should not be confused with Photorefractive Keratectomy (PRK) or Laser In Situ Keratomileusis (LASIK). These procedures are used to correct refractive errors alone. They are considered elective procedures for individuals who choose to become less dependent upon glasses or contact lenses and are often an exclusion of the health plan. Page 1 of 5

2 PTK and corneal transplant are also performed to treat damage to the cornea caused by inflammatory, infectious, and traumatic conditions. Corneal collagen cross-linking (CXL)is a procedure that uses UV light and a photosensitizer, such as riboflavin, to strengthen collagen bonds in the cornea. This is proposed to help restore the normal shape of the cornea, slow the process of keratoconus and restore visual acuity. There are several approaches to CXL including conventional corneal cross-linking (C-CXL), transepithelial corneal cross-linking (T- CXL), accelerated corneal cross-linking (A-CXL) and partial epithelium-off corneal cross-linking (P- CXL). Intrastromal corneal ring segments (INTACS) are prescription inserts that are fitted under the cornea to elevate the edge of the cornea. These are proposed to correct the corneal shape to improve visual acuity. Scleral Shell lenses (also known as scleral lenses): Scleral Rigid Gas Permeable (RGP) lenses are very large (15 to 24 mm) lenses made to completely vault over the cornea. Scleral lenses also include prosthetic replacement of the ocular surface ecosystem (PROSE) treatment devices. These lenses are designed to extend beyond the cornea to rest on the sclera. They retain a layer of tears between the lens and the cornea. Scleral lenses are helpful for correcting vision in cases of irregular or distorted corneas, such as keratoconus, post-penetrating Keratoplasty (corneal transplant), post refractive surgery or corneal scarring, and for patients with ocular surface disease (severe dry eyes, graft-versus-host disease, Steven- Johnson syndrome, and ocular pemphigoid). Management and fitting of scleral lenses requires specialty training to evaluate the unique characteristics and potential complications that can occur with these lenses. In addition, patients wearing scleral lenses require special techniques and solutions for application and removal. Keratoplasty (Corneal Transplantation) is typically performed when glasses and contact lenses are no longer helpful to correct visual acuity. Penetrating Keratoplasty, also called perforating Keratoplasty and full thickness corneal transplant, is the most commonly performed method. Partial thickness corneal transplant, also called non-penetrating Keratoplasty and deep anterior lamellar Keratoplasty, replaces specific layers of the cornea. Lamellar techniques differ based on which layers are removed and how the donor tissue is prepared. Keratoplasty can be performed in conjunction with cataract removal. Human cadaver corneal tissue is typically used for transplant. Artificial corneas (keratoprosthetics) have been developed and are proposed in cases of repeated failed cadaver transplants. Keratoprosthetics require physician review. Indications of Coverage: Note: Many health plans have specific coverage and exclusions for vision services, contact lenses, and implantable specialty lenses. When not specified by the health plan, scleral shell lenses are considered therapeutic contact lenses. Page 2 of 5

3 I. Scleral Shell Contact Lenses Scleral shell contact lenses and fittings are considered medically necessary when there is failure of topical medications, glasses, and contact lenses and at least one of the following: A. Corneal ectatic disorders (e.g., keratoconus, keratoglobus, pellucid marginal degeneration, Terrien s marginal degeneration, Fuchs superficial marginal keratitis, post-surgical ectasia) B. Corneal scarring and/or vascularization C. Ocular surface disease (e.g., severe keratoconjunctivitis sicca (dry eye), persistent epithelial defects, neurotrophic keratopathy, exposure keratopathy, graft vs. host disease [GVHD], sequelae of Stevens Johnson syndrome, mucus membrane pemphigoid, post-ocular surface tumor excision, post-glaucoma filtering surgery) with pain and/or decreased visual acuity. D. When prescribed to support orbital tissue (e.g. eye shrunken by inflammatory disease). Replacement lenses are considered medically necessary if there is a change in the eye condition (not including refractive changes). Note: Replacement of lenses that are lost, damaged, or requested solely due to refractive changes are typically not covered under the health plan. II. Corneal Transplant using cadaver tissue is considered medically necessary for any of the following conditions in which standard conservative treatments (e.g. medications, glasses, contact lenses, and scleral shell lenses lenses) have failed or are contraindicated: A. To improve vision due to corneal opacity [(best corrected vision still causes interference with Activities of Daily Living (ADLs)] B. To remove active corneal disease including keratoconus, corneal scaring with opacity, bullous keratopathy, Fuchs and other corneal dystrophies, and infectious / inflammatory keratitis after appropriate pharmacologic therapy (e.g. severe fungal, viral, bacterial or amoebic inflammation). C. To restore altered corneal structure or prevent loss of the globe after puncture injury III. Intrastromal corneal ring segments (INTACS) are considered medically necessary under the FDA approved humanitarian option, when all the following are met in individuals who: A. Have corneal transplantation as the only remaining option to improve their functional vision B. Have progressive deterioration in vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or glasses C. Are 21 years of age or older Page 3 of 5

4 D. Have clear central corneas E. Have a corneal thickness of 450 microns or greater at the proposed incision site Limitations of Coverage: A. Review health plan and endorsements for exclusions and prior authorization or benefit requirements B. If used for a condition/diagnosis other than is listed in the Indications of Coverage, deny as experimental, investigational, and unproven to affect health outcomes. C. If used for a condition/diagnosis that is listed in the Indications of Coverage, but the criteria are not met, deny as not medically necessary D. Collagen cross linking of cornea (CXL) procedures (C-CXL, T-CXL, P-CXL, A-CXL) for treatment of keratoconus is considered experimental, investigational, and unproven to affect health outcomes E. Intrastromal corneal ring segments (INTACS) are considered experimental, investigational, and unproven to affect health outcomes unless all criteria in the indications of coverage are met F. Corneal Hysteresis Measurement to diagnose or monitor keratoconus is considered experimental, investigational, and unproven to affect health outcomes. See also Non-covered services and Procedures Medical Policy G. Corneal reconstruction using Amniotic Membrane Transplantation (AMT) is considered experimental, investigational, and unproven to affect health outcomes Documentation Required: Office notes including history, physical, ophthalmic medication and surgical history References: 1. UpToDate Overview of Contact Lenses. Literature review current through Jul Topic Last Updated Oct 4, UpToDate. Keratoconus Literature review current through Jul Topic Last Updated May 13, UpToDate. Herpes simplex keratitis. Literature review current through Aug Topic Last Updated Mar 20, UpToDate. Treatment of endophthalmitis due to molds. Literature review current through Aug Topic Last Updated Sept 29, 2016 Page 4 of 5

5 5. UpToDate. Treatment and Prevention of Fusarium infection. Literature review current through Aug Topic Last Updated July 7, UpToDate. Ocular side effects of systemic chemotherapy. Literature review current through Aug Topic Last Updated Aug 17, Hayes Directory Conventional Corneal Cross Linking for Treatment of Keratoconus. Nov 17, Hayes MTD. Intacs for treatment of Keratoconus. Annual Review Dec 2, Hayes Directory. Amniotic Membrane Transplantation (AMT) for Corneal Reconstruction. Publication Date Apr 23,2015 Annual Review Apr 4, MCG 21 st ed. ACG: A-0569 Corneal Hysteresis Measurement 11. FDA Summary of Safety and Probable Benefit. Intrastromal Corneal Ring Segments (ICRS ) Humanitarian device Exemption Accessed 29 Aug Available at: Cochrane Review. Artificial corneal devices versus human donor corneas for people undergoing repeat corneal transplantation. 5 November Available at: WPS/Arise Review History: Implemented 01/01/18 Medical Policy 09/15/17 Committee Approval Reviewed Developed 09/15/17 Approved by the Medical Director Page 5 of 5

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