Corneal Collagen Cross-Linking
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Policy governing coverage of corneal collagen cross-linking (riboflavin + UVA) for progressive keratoconus and corneal ectasia after refractive surgery, including indications considered investigational and product/regulatory context.
Epioxa (epithelium-on corneal collagen cross-linking) was approved in 2025 and is anticipated to enter the market in early 2026.
Photrexa products are planned to be discontinued from the market effective January 20, 2026 with manufacturing set to end February 2026.
Coverage Criteria
Medically necessary indications
Covered when ALL of the following are met:
Diagnosis must be one of the covered ICD-10-CM codes for keratoconus or corneal ectasia (see coding).
Cross-linking is considered after conservative measures have failed.
Evidence of progression
- Progression criteria (any one): An increase of 1 diopter (D) in the steepest keratometry value; OR an increase of 1 D in regular astigmatism on subjective manifest refraction; OR a myopic shift (decrease in spherical equivalent) of 0.50 D on subjective manifest refraction; OR a decrease ≥0.1 mm in back optical zone radius in rigid contact lens wearers where other information is not available.1 D; 1 D; 0.50 D; ≥0.1 mm
These progression thresholds are those used in trials leading to FDA approval and cited in policy guidance.
Applies to riboflavin + UVA cross-linking procedures; verify prior authorization and appropriate procedure/drug codes.
Investigational / Not covered indications
Corneal collagen cross-linking using riboflavin and ultraviolet A is considered investigational for all other indications due to insufficient evidence to support benefit.
Use of corneal collagen cross-linking outside of the specified disease indications is not supported by this policy. The policy defines covered use as corneal collagen cross-linking with riboflavin plus ultraviolet A for progressive keratoconus or corneal ectasia after refractive surgery in individuals who have failed conservative treatment (e.g., spectacle correction, rigid contact lens). Procedures performed for any other diagnosis or clinical indication are considered outside the scope of coverage in this document and may be denied.
This policy has undergone multiple reviews and code updates. A major review on 06/18/2025 changed the title to “Corneal Collagen Cross-Linking,” updated Background, Rationale, Definitions and References, and removed a number of previously listed criteria (e.g., Corneal Pachymetry, Corneal Endothelial Microscopy). As part of that update and subsequent administrative updates, numerous diagnosis and procedure codes were removed from the policy and are no longer listed as covered within this document (examples include many H40.*, H17.*, and H18.* variants and other codes).
Administrative and consensus reviews since 2022 have continued to update references and coding; the document history lists earlier removals and additional code deletions and updates through the 10/09/2025 administrative update and the 03/05/2026 consensus review.
Corneal collagen cross-linking using riboflavin and ultraviolet A is considered investigational for all other indications because there is insufficient evidence to conclude that it provides health benefit for diagnoses other than progressive keratoconus or corneal ectasia after refractive surgery.
Coding
| H18.601 | Keratoconus, unspecified, right eye |
| H18.602 | Keratoconus, unspecified, left eye |
| H18.603 | Keratoconus, unspecified, bilateral |
| H18.609 | Keratoconus, unspecified, unspecified eye |
| H18.611 | Keratoconus, stable, right eye |
| H18.612 | Keratoconus, stable, left eye |
| H18.613 | Keratoconus, stable, bilateral |
| H18.619 | Keratoconus, stable, unspecified eye |
| H18.621 | Keratoconus, unstable, right eye |
| H18.622 | Keratoconus, unstable, left eye |
| H18.711 | Corneal ectasia, right eye |
| H18.712 | Corneal ectasia, left eye |
| H18.713 | Corneal ectasia, bilateral |
| H18.719 | Corneal ectasia, unspecified eye |
| H18.601 | Keratoconus, unspecified, right eye |
| H18.602 | Keratoconus, unspecified, left eye |
| H18.603 | Keratoconus, unspecified, bilateral |
| H18.609 | Keratoconus, unspecified, unspecified eye |
| H18.611 | Keratoconus, stable, right eye |
| H18.612 | Keratoconus, stable, left eye |
| H18.613 | Keratoconus, stable, bilateral |
| H18.619 | Keratoconus, stable, unspecified eye |
| H18.621 | Keratoconus, unstable, right eye |
| H18.622 | Keratoconus, unstable, left eye |
| H18.711 | Corneal ectasia, right eye |
| H18.712 | Corneal ectasia, left eye |
| H18.713 | Corneal ectasia, bilateral |
| H18.719 | Corneal ectasia, unspecified eye |
Provider Actions and Requirements
Obtain prior authorization and include listed procedure/diagnosis codes
Prior authorization is required per member benefit for corneal collagen cross‑linking; when requesting authorization use the listed procedure code(s) and diagnosis codes (e.g., CPT/HCPCS 0402T and the supported ICD‑10‑CM keratoconus and corneal ectasia codes).
- Use procedure code 0402T when requesting prior authorization.
- Include an appropriate ICD‑10‑CM diagnosis from the listed keratoconus (H18.601–H18.629) or corneal ectasia (H18.711–H18.719) codes.
Perform CXL only after failure of conservative treatment
Offer corneal collagen cross‑linking only after conservative treatments have failed; conservative options include spectacle correction and rigid (hard) contact lenses.
- Confirm prior attempts at conservative management (e.g., spectacles, rigid contact lenses) are documented before proceeding.
Document objective progression before CXL
Include objective documentation of disease progression per policy-defined thresholds to support medical necessity for CXL.
- Progression may be defined by one or more of the trial-based measures listed in the policy (see examples below).
Examples of documentation supporting progression
Document one or more of the policy progression criteria in the medical record (examples provided by the trials leading to FDA approval).
- Increase of 1 diopter (D) in the steepest keratometry value.
- Increase of 1 D in regular astigmatism by subjective manifest refraction.
- Myopic shift (decrease in spherical equivalent) of 0.50 D on subjective manifest refraction.
- Decrease ≥0.1 mm in back optical zone radius (in rigid contact lens wearers when other data unavailable).
Medical record must support 0402T and listed ICD‑10‑CM diagnosis
Ensure medical records substantiate the use of procedure code 0402T and an appropriate listed ICD‑10‑CM diagnosis for keratoconus or corneal ectasia when billing or requesting authorization.
- Link 0402T to one of the covered keratoconus codes (e.g., H18.601–H18.629) or corneal ectasia codes (H18.711–H18.719) in documentation.
- Retain records of prior conservative treatment and objective progression measures to support coding.
Do not bill CXL for non‑covered indications (investigational)
Do not bill corneal collagen cross‑linking as a covered service for indications other than progressive keratoconus or corneal ectasia after refractive surgery; such uses are considered investigational.
- Procedures for other indications may be denied as investigational and are not covered under this policy.
Claims missing 0402T, J‑codes, or listed ICD‑10 diagnoses risk denial
Claims that do not include the procedure code 0402T and the appropriate J‑codes and ICD‑10 diagnosis codes for keratoconus or corneal ectasia are at risk of denial.
Background
Keratoconus is a progressive corneal disorder characterized by thinning and anterior bulging of the cornea that leads to steepening of the corneal curvature and progressive visual impairment. Corneal ectasia describes a similar process that can occur after refractive surgery. Traditional management focuses on correcting refractive error (spectacles, rigid contact lenses) or addressing advanced disease with procedures such as intracorneal ring segments or penetrating keratoplasty, but these are not disease-modifying. Corneal collagen cross-linking uses the photosensitizer riboflavin with ultraviolet A irradiation to increase corneal stiffness and has the potential to slow or halt progression in appropriately selected patients.
Definitions
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