Corneal Treatments and Specialized Contact Lenses Form

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Corneal Treatments and Specialized Contact Lenses Medical Guideline

Service: Corneal Treatments and Specialized Contact Lenses (Corneal remodeling, Corneal transplant, Corneal collagen crosslinking, Intrastromal Rings- INTACS, Keratoconus treatments, Keratoplasty, Scleral lenses)

PUM 250-0041-1709

Medical Guideline Committee Approval Q4-2025 Effective Date 03/01/2026

Coverage for Corneal treatments and specialized contact lenses (corneal remodeling, corneal transplant, corneal collagen crosslinking, intrastomal rings-INTACS, keratoconus treatments, keratoplasty, scleral lenses) may vary across plans. Refer to the member’s benefit plan document for coverage details.

Related Medical Guidelines: • Glaucoma Surgical Treatments Medical Guideline • Non-Covered Services and Procedures Medical Guideline

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).

• 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. 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 to help restore the normal shape of the cornea, slow the process of keratoconus, and restore visual acuity. • Intrastromal corneal ring segments (INTACS) are prescription inserts that are fitted under the cornea to elevate the edge of the cornea to correct the corneal shape and 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.

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• Keratoplasty (Corneal Transplant) is typically performed when glasses and contact lenses are no longer helpful to correct visual acuity. 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 review by the Health Plan’s Medical Director.

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.

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 (Keratoplasty) 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 when 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.

D. Failure or rejection of previous corneal transplant.

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III. Intrastromal corneal ring segments, ICRS (INTACS) are considered medically necessary under the FDA approved humanitarian option when all of the following are met:

A. Corneal transplantation is the only remaining option to improve the individual’s functional vision.

B. Progressive deterioration in vision, such that the individual can no longer achieve adequate functional vision on a daily basis with their contact lenses or glasses.

C. Individual is age 21 years or older.

D. Clear central corneas (no scarring or disease).

E. Corneal thickness of 450 microns or greater at the proposed incision site.

IV. Conventional (epithelium-off) Corneal Collagen Cross-Linking (C-CXL) is considered medically necessary as a one-time treatment when all of the following are met:

A. Diagnosis of keratoconus with progressively worsening vision or progressive corneal ectasia (that is not the result of previous LASIK procedure/refractive eye surgery).

B. Individual is at least 14 years of age.

C. Corrected vision with eyeglasses or contact lenses is not adequate (is worse than 20/20).

D. Central corneas have no scarring or disease.

E. Corneal thickness of at least 400 microns (verified with pachymetry).

F. Procedure is performed using a U.S. Food and Drug Administration (FDA)-approved device, drug solution, and protocol. (At the time of this guideline printing, only the Glaukos iLink KXL System® used with riboflavin solution Photrexa® or Photrexa Viscous® [following the Dresden protocol that was used in the clinical trials] is FDA-approved in the United States).

Limitations of Coverage:

Benefit Limitations: Please note that in listing services or examples, when we say “this includes,” it is not our intent to limit the description to that specific list. When we do intend to limit a list of services or examples, we state specifically that the list “is limited to.”

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, it will be considered 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, it will be considered not medically necessary.

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D. Transepithelial corneal collagen cross-linking (T-CXL), partial epithelium-off corneal cross-linking (P-CXL), and any collagen cross-linking procedure other than conventional epithelium-off (C-CXL) will be considered experimental, investigational, and unproven to affect health outcomes.

E. Accelerated corneal collagen cross-linking (A-CXL) will be considered experimental, investigational, and unproven to affect health outcomes.

F. Topography-guided corneal collagen cross-linking (TG-CXL) will be considered experimental, investigational, and unproven to affect health outcomes.

G. 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.

H. Corneal Hysteresis Measurement to diagnose or monitor keratoconus will be considered experimental, investigational, and unproven to affect health outcomes. See also: Non-covered Services and Procedures medical guideline.

I. Keratoplasty performed solely for correction of refractive errors or astigmatism will be considered experimental, investigational, and unproven to affect health outcomes.

J. Conventional corneal collagen cross-linking for the treatment of LASIK-related ectasia will be considered not a covered benefit.

K. More than one conventional (epithelium-off) corneal collagen cross-linking (C-CXL) procedure per eye per individual’s lifetime will be considered experimental, investigational, and unproven to affect health outcomes.

L. Conventional corneal collagen cross-linking used in conjunction with other treatments (e.g., CXL-plus, intrastromal corneal ring segments [INTACS], PRK, phakic intra-ocular lens implantation) will be considered experimental, investigational, and unproven to affect health outcomes.

M. Conventional corneal collagen cross-linking performed with a device, drug solution, or protocol that is not U.S. Food and Drug Administration (FDA)-approved for the procedure will be considered experimental, investigational, and unproven to affect health outcomes.

N. Use of BostonSight Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) for the treatment of dry eye disease (DED) will be considered experimental, investigational, and unproven to affect health outcomes.

O. Use of keratoprosthetics requires review by the Health Plan’s Medical Director.

Documentation Required:

• Standard Written Order (SWO), prescribed by a qualified healthcare provider concerning the member’s diagnosis.
• Medical record information (including continued need/use if applicable) and medical necessity. Office notes including history, physical, ophthalmic medication and surgical history • Correct coding for the item/service that meets all the coding guidelines.

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Disclaimer: This guideline 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 or may not provide coverage for all services listed in this guideline. 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 guideline in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information.

Medical guidelines are based on constantly changing medical science and are reviewed at least 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 guideline 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, email medical.policies@wpsic.com. Coverage of all services is subject to medical necessity and services deemed experimental, investigational, and/or unproven are therefore not considered medically necessary under the terms of the clinical guidelines and will not be covered.

Corneal Treatments and Specialized Contact Lenses (Corneal remodeling, Corneal transplant, Corneal collagen crosslinking, Intrastromal Rings- INTACS, Keratoconus treatments, Keratoplasty, Scleral lenses) are considered medically necessary only when indicated per the most current medical references and specialty society guidelines, such as MCG, NCCN, etc.

State mandates, laws or benchmark supersede this medical guideline.

Guideline Review History:

Implemented 01/01/18, 01/01/19, 07/01/19, 06/01/20, 02/01/21, 02/01/22, 02/01/23, 02/01/24, 03/01/26 Medical Guideline Committee Approval 09/5/17, 09/21/18, 03/15/19, 02/27/20, 01/28/21, 01/27/22, 01/26/23, 01/25/24, Q4 2025 Reviewed 09/15/17, 09/21/18, 03/15/19, 02/27/20, 01/28/21, 01/27/22, 01/25/24., Q4 2025 Developed 09/15/17

Approved by the Medical Director

Codes: The following codes for treatments and procedures applicable to this document are included below for informational purposes.

Code Description 0402T COLLAGEN CROSS-LINKING OF CORNEA, INCLUDING REMOVAL OF THE CORNEAL EPITHELIUM AND INTRAOPERATIVE PACHYMETRY, WHEN PERFORMED (REPORT MEDICATION SEPARATELY). ONLY COVERED IF CRITERIA MET FOR CONVENTIONAL CROSS-LINKING 0671T INSERTION OF ANTERIOR SEGMENT AQUEOUS DRAINAGE DEVICE INTO THE TRABECULAR MESHWORK, WITHOUT EXTERNAL RESERVOIR, AND WITHOUT CONCOMITANT CATARACT REMOVAL, ONE OR MORE

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65710 KERATOPLASTY (CORNEAL TRANSPLANT); ANTERIOR LAMELLAR 65730 KERATOPLASTY (CORNEAL TRANSPLANT); PENETRATING (EXCEPT IN APHAKIA OR PSEUDOPHAKIA) 65750 KERATOPLASTY (CORNEAL TRANSPLANT); PENETRATING (IN APHAKIA) 65755 KERATOPLASTY (CORNEAL TRANSPLANT); PENETRATING (IN PSEUDOPHAKIA) 65756 KERATOPLASTY (CORNEAL TRANSPLANT); ENDOTHELIAL 65757 BACKBENCH PREPARATION OF CORNEAL ENDOTHELIAL ALLOGRAFT PRIOR TO TRANSPLANTATION (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) 65770 KERATOPROSTHESIS 65778 PLACEMENT OF AMNIOTIC MEMBRANE ON THE OCULAR SURFACE; WITHOUT
SUTURES 65779 PLACEMENT OF AMNIOTIC MEMBRANE ON THE OCULAR SURFACE; SINGLE LAYER, SUTURED 65780 OCULAR SURFACE RECONSTRUCTION; AMNIOTIC MEMBRANE
TRANSPLANTATION, MULTIPLE LAYERS 65785 IMPLANTATION OF INTRASTOMAL CORNEAL RING SEGMENTS 92025 COMPUTERIZED CORNEAL TOPOGRAPHY, UNILATERAL OR BILATERAL, WITH INTERPRETATION AND REPORT 92145 CORNEAL HYSTERESIS DETERMINATION, BY AIR IMPUSE STIMULATION,
UNILATERAL OR BILATERAL, WITH INTERPRETATION AND REPORT C1818 INTEGRATED KERATOPROSTHESIS J2787 RIBOFLAVIN 5’-PHOSPHATE, OPHTHALMIC SOLUTION, UP TO 3 ML L8609 ARTIFICIAL CORNEA S0810 PHOTOREFRACTIVE KERATECTOMY (PRK) USUALLY NOT COVERED BY THE HEALTH PLAN

V2530
CONTACT LENS, SCLERAL, GAS IMPERMEABLE, PER LENS (FOR CONTACT LENS MODIFICATION, SEE 92325) V2531
CONTACT LENS, SCLERAL, GAS PERMEABLE, PER LENS (FOR CONTACT LENS MODIFICATION, SEE 92325) V2627 SCLERAL COVER SHELL V2785 PROCESSING, PRESERVING AND TRANSPORTING CORNEAL TISSUE V2790 AMNIOTIC MEMBRANE FOR SURGICAL RECONSTRUCTION, PER PROCEDURE