Corneal Collagen Cross-Linking
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This policy governs medical necessity and prior authorization for corneal collagen cross-linking to treat progressive keratoconus and corneal ectasia following refractive surgery. It applies differently across Medicare Advantage, ACO, One Care/SCO, Commercial, and Qualified Health Plan members.
Coverage was extended to include the epithelium-on corneal collagen cross-linking protocol when the epithelium-off protocol is contraindicated or unavailable.
The policy added an exclusion for retreatment of an eye previously treated with corneal collagen cross-linking.
The code list and ACO section were updated, including instructions to use code 66999 instead of 0402T for Mass General Brigham ACO members.
The summary of evidence and references were updated to address epithelium-on treatment and newer evidence for Epioxa.
Medical Necessity Criteria
Progressive Keratoconus
Covered when all of the following are met for progressive keratoconus.
Progressive keratoconus criteria
- Diagnosis of keratoconus based on keratometry and corneal mapping.
Documented progression within 24 months
- Steepest keratometry progression: Increase of 1.00 diopters (D) or more in the steepest keratometry measurement.≥1.00 D within 24 months
- Manifest cylinder progression: Increase of 1.00 D or more in manifest cylinder.≥1.00 D within 24 months
- MRSE progression: Increase of 0.50 D or more in manifest refraction spherical equivalent (MRSE).≥0.50 D within 24 months
- Age: Member is age 14 years or older.≥14 years
- Visual acuity: Corrected distance visual acuity (CDVA) is worse than 20/20 with properly fitted spectacles or contact lenses.Worse than 20/20
- Corneal thickness is 300 microns or more.≥300 microns
- Healing risk: No history of corneal or systemic disease that would interfere with healing post-procedure.
Corneal Ectasia Following Refractive Surgery
Covered when all of the following are met for corneal ectasia following refractive surgery.
Post-refractive-surgery corneal ectasia criteria
- Age: Member is age 14 years or older.≥14 years
- Axial topography: Consistent axial topography pattern, including relative inferior steepening with an inferior-superior difference of at least 1.5 diopters.Inferior-superior difference ≥1.5 D
- Visual acuity: Corrected distance visual acuity is worse than 20/20.Worse than 20/20
- Corneal thickness is at least 300 micrometers at the thinnest area.≥300 micrometers at thinnest area
- Healing risk: No history of corneal or systemic disease that would interfere with healing post-procedure.
Retreatment exclusion: Coverage is not provided for retreatment of an eye previously treated with corneal collagen cross-linking.
Criteria exclusion: Coverage is not provided for corneal collagen cross-linking when the condition does not meet the applicable policy criteria.
Codes and Clinical Thresholds
| 0402T | Collagen cross-linking of cornea (including removal of the corneal epithelium and intraoperative pachymetry when performed). |
| J2787 | Riboflavin 5'-phosphate, ophthalmic solution, up to 3 mL. |
| J2789 | Riboflavin 5'-phosphate, ophthalmic solution (epioxahd/epioxa), up to 2 ml. |
| 66999 | Other procedures of the anterior segment of the eye (Mass General Brigham ACO only). |
Authorization and Submission Requirements
Prior Authorization Required
The treating specialist must request prior authorization for corneal collagen cross-linking.
Medicare Advantage
Prior authorization is required for Medicare Advantage members. Mass General Brigham Health Plan uses applicable CMS guidance for medical-necessity determinations; when CMS provides no guidance, the Plan's medical policies apply. CMS had no guidance for corneal collagen cross-linking at the most recent policy review, so refer to the Commercial and Qualified Health Plan medical-necessity requirements.
- CMS sources include National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs), and documentation in Medicare manuals.
Mass General Brigham ACO
Prior authorization is required for Mass General Brigham ACO members. Determine medical necessity using the MassHealth Drug List criteria for Epioxa/Epioxa HD.
One Care and SCO
Prior authorization is required for One Care and Senior Care Options (SCO) members. Apply CMS guidance first; when CMS guidance is unavailable or the member does not meet all CMS-based medical-necessity criteria, apply MassHealth criteria.
- CMS sources include NCDs, LCDs, LCAs, and documentation in Medicare manuals.
- If Medicare Advantage criteria are not met, apply MassHealth criteria; see the Medicare Advantage criteria and exclusions above.
Commercial and Qualified Health Plans
Prior authorization is required for Commercial and Qualified Health Plan members. Coverage is limited to medically necessary corneal collagen cross-linking for progressive corneal thinning caused by progressive keratoconus or corneal ectasia following refractive surgery.
- The requested treatment must satisfy the applicable medical-necessity criteria for progressive keratoconus or post-refractive-surgery corneal ectasia.
Preferred Treatment Protocol
The epithelium-off protocol is preferred. The epithelium-on protocol may be approved only when the epithelium-off protocol is contraindicated or unavailable.
Prior Cross-Linking Treatment
Do not approve retreatment of an eye that was previously treated with corneal collagen cross-linking.
- Coverage is excluded for retreatment of a previously treated eye.
Criteria Not Met
Deny coverage when the requested corneal collagen cross-linking treatment does not meet the applicable medical-necessity criteria.
- Coverage is excluded for conditions that do not meet the criteria specified in this policy.
Progressive Keratoconus Criteria
For progressive keratoconus, the request may be denied if the required diagnosis, documented progression, age, visual acuity, corneal thickness, or healing-related criteria are not demonstrated.
- Diagnosis must be based on keratometry and corneal mapping.
- Within the prior 24 months, there must be an increase of at least 1.00 D in steepest keratometry, or at least 1.00 D in manifest cylinder, or at least 0.50 D in MRSE.
- Member must be age 14 or older.
- CDVA must be worse than 20/20 with properly fitted spectacles or contact lenses.
- Corneal thickness must be at least 300 microns.
- There must be no history of corneal or systemic disease that would interfere with post-procedure healing.
Post-Surgical Corneal Ectasia Criteria
For corneal ectasia following refractive surgery, the request may be denied if the required age, axial topography, visual acuity, corneal thickness, or healing-related criteria are not demonstrated.
- Member must be age 14 or older.
- Axial topography must show a consistent pattern, including relative inferior steepening with an inferior-superior difference of at least 1.5 D.
- CDVA must be worse than 20/20.
- Corneal thickness at the thinnest area must be at least 300 micrometers.
- There must be no history of corneal or systemic disease that would interfere with post-procedure healing.
Clinical Background
Corneal collagen cross-linking uses riboflavin and ultraviolet light to strengthen corneal collagen bonds and stabilize progressive corneal thinning. The policy addresses progressive keratoconus and corneal ectasia that develops after refractive surgery.
Key Terms
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