CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Corneal Collagen Crosslinking

Defines coverage for corneal collagen cross-linking (riboflavin + UVA) for commercial products and BlueCHiP for Medicare, including clinical criteria for progressive keratoconus and post-refractive surgery ectasia, prior authorization recommendation for commercial products, and Medicare noncoverage per CMS determinations.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Corneal Collagen Crosslinking

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 15, 2017

Next Review Date

Key ActionPrior authorization is recommended for Commercial products via the online tool for participating providers.

SourceLink

POLICY UPDATE CHANGES

No material changes to policy coverage or clinical criteria.

2Indications addressed (keratoconus, post-refractive ectasia)

1CPT code referenced

0Medicare coverage (BlueCHiP)

Coverage summary

Coverage stance: mixed. Commercial products consider corneal collagen cross-linking (CXL) medically necessary for progressive keratoconus or corneal ectasia after refractive surgery when specified criteria are met, while BlueCHiP for Medicare does not cover CXL for any indications. Commercial coverage requires failure of conservative treatment and documentation of progression using defined thresholds. The applicable CPT is 0402T for commercial medical necessity when criteria are met; the same CPT is not covered under BlueCHiP for Medicare.

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Key thresholds and quick facts

Thresholds - Increase in steepest keratometry>= 1 D

Thresholds - Increase in regular astigmatism>= 1 D (subjective manifest refraction)

Thresholds - Back zone radius change (rigid contact lens wearers)Decrease >= 0.1 mm

Thresholds - Myopic shift (spherical equivalent)>= 0.50 D (subjective manifest refraction)

Stats summary - Indications addressed2 (keratoconus, post-refractive ectasia)

Stats summary - CPT code referenced0402T

Stats summary - Medicare coverage (BlueCHiP)Not covered for all indications

Status / CurrentCURRENT; covered for commercial products when criteria met, Medicare (BlueCHiP) not covered

Commercial products — Medical necessity

Commercial Products - Medical Necessity Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of progressive keratoconus OR corneal ectasia after refractive surgery
Failure of conservative treatment (e.g., spectacle correction or rigid contact lens)
Progressive defined as
- An increase of 1 D in the steepest keratometry value>= 1 D
- An increase of 1 D in regular astigmatism evaluated by subjective manifest refraction>= 1 D (subjective manifest refraction)
- Decrease ≥ 0.1 mm in the back zone radius in rigid contact lens wearers where other information was not availableDecrease >= 0.1 mm
- Myopic shift (decrease in the spherical equivalent) of 0.50 D on subjective manifest refraction>= 0.50 D (subjective manifest refraction)

Definitions relevant to commercial criteria: Progressive keratoconus or corneal ectasia is defined by one or more of the following: increase of 1 D in the steepest keratometry; increase of 1 D in regular astigmatism (subjective manifest refraction); decrease ≥ 0.1 mm in back zone radius in rigid contact lens wearers when other information is unavailable; or a myopic shift ≥ 0.50 D in spherical equivalent on subjective manifest refraction. Operational technique terms: Epithelium-off CXL (epithelium removed, ~8 mm central) and Epithelium-on (transepithelial) CXL (epithelium left intact or partially disrupted).

BlueCHiP for Medicare — Coverage position

BlueCHiP for Medicare

Coverage stance per Medicare policy

Corneal collagen cross-linking (riboflavin + UVA) is considered not covered for all indications due to insufficient evidence

Denial Risk

BlueCHiP for Medicare noncoverage

Claims for corneal collagen cross-linking under BlueCHiP for Medicare are not covered and may be denied based on Medicare policy. Providers should be aware that Medicare considers CXL not covered for all indications, so Medicare claims for CPT code 0402T may be denied.

0402T
BlueCHiP for Medicare coverage determination: considered not covered for all indications

Provider actions and requirements

Prior Authorization

Prior authorization recommended for Commercial products

Prior authorization is recommended for Commercial products via the online tool for participating providers.

0402T
Use the online prior authorization tool for participating providers

Documentation Required

Document progression criteria

Provider must document failure of conservative treatment and at least one progression metric (one or more of the defined keratometry/astigmatism/back zone radius/myopic shift thresholds) to meet medical necessity.

Failure of conservative treatment (e.g., spectacle correction or rigid contact lens)
Progression defined by one or more of: increase ≥ 1 D in steepest keratometry; increase ≥ 1 D in regular astigmatism (subjective manifest refraction); decrease ≥ 0.1 mm in back zone radius in rigid contact lens wearers when other information unavailable; myopic shift ≥ 0.50 D (subjective manifest refraction)
Affected code: 0402T

Operational note: The FDA-approved protocol is the epithelium-off technique (central epithelial removal to promote riboflavin stromal penetration). The epithelium-on (transepithelial) approach is not FDA-approved. Commercial medical necessity language and documentation requirements assume use of accepted (FDA-approved) protocols when indicating CXL.

Background and evidence summary

Mechanism and evidence: CXL uses the photosensitizer riboflavin plus UVA irradiation to produce reactive oxygen species that create additional covalent crosslinks between collagen molecules, increasing corneal stiffness. The only FDA-approved CXL treatment is the epithelium-off method; epithelium-on techniques are not FDA-approved. Multiple randomized controlled trials, systematic reviews, and nonrandomized studies demonstrate that CXL results in a meaningful improvement in net health outcome for progressive keratoconus and for corneal ectasia after refractive surgery.

Evidence and regulatory notes

Evidence summaryMultiple RCTs, systematic reviews, and nonrandomized studies indicate CXL results in meaningful improvement for progressive keratoconus and corneal ectasia after refractive surgery.

FDA-approved protocolEpithelium-off (epi-off) is FDA-approved; epithelium-on (transepithelial) is not FDA-approved.