Corneal Cross Linking Form

Clinical Review Criteria Related to Corneal Cross Linking Effective 2/1/2023 (Date of Last Review: 11/8/2022) Page 1 of 4 © 2010 Health New England Clinical Review Criteria Related to Corneal Cross-Linking:

Definitions:

• Keratoconus: Progressive, non-inflammatory eye disease characterized by a cone-like shape to the cornea versus the normally round cornea. Cornea begins to bulge and the cone shape deflects light that enters the eye on its way to the light sensitive retina which results in distorted vision, or blurred vision and light sensitivity. Generally, a bilateral disease.

• Conventional (epithelium off) corneal collagen cross-linking (CXL) is treatment that involves debriding of the most superficial layer of the cornea (epithelium) prior to applying medicated drops that contain riboflavin (vitamin B2) to the eye which is then followed by exposure to ultraviolet light. Only treatment approved by U.S. Food and Drug Administration (FDA).

• Corneal Ectasia: Bulging of the cornea. This results when the cornea has been structurally compromised.

Policy:

Description: Corneal Cross-Linking (CXL) Per Hayes: CXL uses a combination of riboflavin (vitamin B2) eye drops, absorbed throughout the cornea stroma, with ultraviolet A (UVA) radiation to trigger a photochemical reaction that changes the cross-links between and within collagen fibers in the corneal stroma. This is believed to strengthen and increase the biomechanical stiffness of the corneal stroma, thereby flattening the steepened cornea into a more normal shape so that vision improves.

Different approaches to remove or penetrate the corneal epithelium and different UVA light intensities have given rise to a variety of CXL approaches. Conventional CXL (C-CXL) involves removing the epithelium, after which riboflavin drops are applied to the cornea and the UVA irradiation is performed, typically for 30 minutes at an intensity of 3 milliwatts per square centimeter (mW/cm2).

I. For Commercial Policies only: Corneal cross-linking, Conventional, epithelium-off, corneal collagen crosslinking (C-CXL) using a U.S. Food and Drug Administration (FDA) approved drug/device system (e.g., Photrexa® Viscous or Photrexa® with the KXL® System) is considered medically necessary when the following criteria are met:

A. Age 14 - and older; AND

B. Progressive deterioration in vision due to keratoconus; AND

C. Either one of the following vision changes in the past 12 months

Clinical Review Criteria Related to Corneal Cross Linking Effective 2/1/2023 (Date of Last Review: 11/8/2022) Page 2 of 4 © 2010 Health New England

1. Increase of 1.00 diopters or more in the steepest keratometry (measures corneal curvature) measurement, OR

2. A reduction of uncorrected visual acuity or best spectacle corrected visual acuity by more than 1 line, AND

   D. Absence of visual disturbance from another eye disease or significant central corneal opacity; AND

   E. Corneal thickness of at least 400 microns; AND

   F. Non-pregnant individuals

   II. Required Documentation:

   A. MD documentation of progressive keratoconus and absence of contraindications for the procedure

   III. What is Not Covered/Contraindicated:

   Note: Procedure not covered under Medicare or Medicaid, below only applies to commercial policies

   A. CXL with Intacs

   B. Prior herpetic infection (because viral reactivation may occur)

   C. Concurrent infection

   D. Severe corneal scarring or opacification

   E. History of poor epithelial wound healing

   F. Severe ocular surface disease (e.g., dry eye)

   G. Autoimmune disorders

   H. The following collagen cross-linking procedures are experimental/investigational and are not covered, including, but not limited to:

3. Transepithelial corneal cross-linking (T-CXL)

4. Accelerated corneal cross-linking (A-CXL)

5. Topography-guided corneal cross-linking (TG-CXL) or partial epithelium-off corneal cross-linking (P-CXL)

Clinical Review Criteria Related to Corneal Cross Linking Effective 2/1/2023 (Date of Last Review: 11/8/2022) Page 3 of 4 © 2010 Health New England IV.
For all indications other than those listed under Criteria I, this procedure is experimental and investigational.

CPT Codes:

0402T: Collagen cross-linking of cornea (including removal of the corneal epithelium and intraoperative pachymetry when performed) Report medication separately (J2787)

0402T: Collagen cross-linking of cornea, including removal of the corneal epithelium, when performed, and intraoperative pachmetry, when performed (effective 1/1/2023)

Medical Criteria Disclaimer:

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare Advantage and Medicaid members. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.

REFERENCES:

NCQA Standard, UM 2, Clinical Criteria for Utilization Management Decisions, Element A

(Annual Review Jan. 13, 2022) Comparative Effectiveness of Corneal Cross-Linking for Treatment of Keratoconus. Retrieved August 15, 2022, from

https://evidence.hayesinc.com/report/dir.corneal1798

(2020, May 7) What is corneal cross-linking? Retrieved August 15, 2022, from

Corneal Cross-Linking (CXL) Treatment for Keratoconus Explained (webmd.com)

(Updated August 3, 2019) At a Glance: Corneal conditions. Retrieved on August 15, 2022, from

https://nei.nih.gov/health/cornealdisease

Clinical Review Criteria Related to Corneal Cross Linking Effective 2/1/2023 (Date of Last Review: 11/8/2022) Page 4 of 4 © 2010 Health New England Hersh, P. S., Stulting, R. D., Muller, D., Durrie, D. S., Rajpal, R. K., & United States Crosslinking Study Group. (2017, September). United States Multicenter Clinical Trial of Corneal Collagen Crosslinking for Keratoconus Treatment. Retrieved on August 15, 2022, from

https://www.ncbi.nlm.nih.gov/pubmed/28495149

Hashemi H, Seyedian MA, et al. Corneal collagen cross-linking with riboflavin and ultraviolet an irradiation for keratoconus: long term results, Ophthalmology Epub 2013 Apr12. PMID 23583165, Retrieved on August 15, 2022, from

https://www.ncbi.nlm.nih.gov/pubmed/23583165

Wittig-Silva C, Chan E, et al. A Randomized, controlled trial of corneal collagen cross-linking in progressive keratoconus: three-year results. Ophthalmology Epub 2014 Apr.. PMID 24393351, Retrieved on August 15, 2022, from

https://www.ncbi.nlm.nih.gov/pubmed/24393351

Sykakis, E., Karim, R., Evans, J. R., Bunce, C., Amissah-Arthur, K. N., Patwary, S., … Hamada, S. (2015, March 24). Corneal collagen cross-linking for treating keratoconus. Retrieved on August 15, 2022, from

https://www.ncbi.nlm.nih.gov/pubmed/25803325

Boxer Wachler, MD, B. Corneal cross linking types, Symptoms and treatment (Updated March 2021), Retrieved August 15, 2022, from

https://www.allaboutvision.com/conditions/corneal-crosslinking.htm

McGuiggan, Lauren, Cross-Linking FAQ: How painful is iLink™ FDA approved Cross-linking. (August 21, 2021) Retrieved on August 24, 2021, from

https://www.livingwithkeratoconus.com/blog/how-painful-is-ilink-fda-approved-cross-linking/

National Keratoconus Foundation. Retrieved August 26, 2022, from

https://nkcf.org/

Date Policy Changes 9/2022 • Added reference for National Keratoconus Foundation • CXL still not covered for Mass Health and Medicare • Clinical information re-organized in different sections • Section IV added