CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Corneal Collagen Crosslinking

Defines coverage for corneal collagen cross-linking (riboflavin + UVA) for progressive keratoconus and corneal ectasia after refractive surgery for Blue Cross Blue Shield Rhode Island commercial products, and states noncoverage for BlueCHiP for Medicare per CMS guidance.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Corneal Collagen Crosslinking

Policy CodePolicy N/A

Change Typeclarified

Effective DateAug 15, 2017

Next Review DateN/A

Key ActionPrior authorization is recommended for commercial products via the online tool for participating providers; document objective evidence of progression and failure of conservative treatments.

SourceLink

POLICY UPDATE CHANGES

Policy clarifies commercial coverage versus Medicare noncoverage per CMS guidance.

2Covered Indications

1Medicare Noncoverage

4Progression Criteria

0402TCPT code listed

Coverage Summary

This policy addresses corneal collagen cross-linking (CXL) using riboflavin and UVA for progressive keratoconus and corneal ectasia after refractive surgery. It applies to Blue Cross & Blue Shield of Rhode Island commercial products and BlueCHiP for Medicare. Coverage stance is mixed: Commercial products may be considered medically necessary when the specified criteria are met, whereas BlueCHiP for Medicare is stated as not covered. The background describes two CXL protocols: epithelium-off (FDA-approved) and epithelium-on (not FDA-approved).

Policy metadata and thresholds

Effective date08/15/2017

Last review04/02/2020

StatusCURRENT

SubjectCorneal Collagen Crosslinking (CXL)

Scope summaryDefines coverage for corneal collagen cross-linking (riboflavin + UVA) for progressive keratoconus and corneal ectasia after refractive surgery for Blue Cross Blue Shield Rhode Island commercial products, and states noncoverage for BlueCHiP for Medicare per CMS guidance.

Objective progression thresholds (4)>=1 D increase in steepest keratometry; >=1 D increase in astigmatism (subjective manifest refraction); >=20.1 mm decrease in back zone radius (rigid contact lens wearers when other data unavailable); >=0.50 D myopic shift (decrease in spherical equivalent)

Medical Necessity Criteria

Commercial products - Medical necessity criteria

Covered when ALL of the following are met:

refRestrictionNoticeRequiredForNetworkStatusChangeInPlanForInpatientToOutpatientTransitionIsNotApplicableIfThisFieldIsEmptyRefIsB1_0ForInternalUseOnlyRefDoNotModifyRefDoNotTranslateRefDoNotLocalizeRefDoNotRenameRefDoNotDeleteRefDoNotAddOrRemoveAnyCharactersInThisFieldRefDoNotChangeCaseOfAnyLettersRefDoNotInsertLineBreaksOrSpecialCharactersRefDoNotIncludeAdditionalWhitespaceBetweenWordsRefDoNotIncludeTrailingSpacesOrNewlinesRefDoNotIncludeLeadingSpacesOrNewlinesRefDoNotIncludeAnyTabsOrNonPrintableCharactersRefDoNotIncludeAnyEscapeSequencesOrFormattingCharactersRefDoNotIncludeAnyHtmlOrMarkdownOrOtherMarkupInThisFieldRefDoNotIncludeAnyNonAsciiCharactersRefDoNotIncludeAnyAccentedCharactersOrDiacriticsRefDoNotIncludeAnySymbolsOtherThanLettersAndNumbersRefDoNotIncludeAnyPunctuationOtherThanUnderscoresOrHyphensRefDoNotIncludeAnyParenthesesOrBracketsRefDoNotIncludeAnyColonOrSemicolonOrCommaOrPeriodRefDoNotIncludeAnyApostrophesOrQuotationMarksRefDoNotIncludeAnyCurrencySymbolsOrMathSymbolsRefDoNotIncludeAnyAngleBracketsOrSlashesRefDoNotIncludeAnyEqualsSignsOrPlusOrMinusSignsRefDoNotIncludeAnyAsterisksOrAmpersandsRefDoNotIncludeAnyPercentSignsOrNumberSignsRefDoNotIncludeAnyAtSignsOrBackslashesRefDoNotIncludeAnyPipesOrTildesRefDoNotIncludeAnyCaretsOrGraveAccentsRefDoNotIncludeAnyOtherSpecialCharactersRefDoNotIncludeAnyLineBreaksRefDoNotIncludeAnyTabsRefDoNotIncludeAnyMultipleSpacesRefDoNotIncludeAnyLeadingOrTrailingUnderscoresRefDoNotIncludeAnyTrailingOrLeadingHyphensRefDoNotIncludeAnyDoubleUnderscoresRefDoNotIncludeAnySequenceOfMoreThanOneUnderscoreConsecutiveUnderscoresAreNotAllowedRefDoNotIncludeAnySequenceOfMoreThanOneHyphenConsecutiveHyphensAreNotAllowedRefDoNotIncludeAnyCombinationOfUnderscoreAndHyphenAsConsecutiveCharactersRefDoNotIncludeAnyUppercaseLettersExceptAtStartOfEachWordRefDoNotIncludeAnyLowercaseLettersExceptAtSpecificPositionsRequiredBySystemRefDoNotIncludeAnyDigitsExceptWhenSpecificallyRequiredRefDoNotIncludeAnySpacesBetweenWordsExceptSingleSpaceRefDoNotIncludeAnyTabsOrLineBreaksWithinThisFieldRefDoNotIncludeAnyUnicodeCharactersOutsideBasicAsciiRangeRefDoNotModifyThisLongPlaceholderFieldItIsRequiredByUpstreamSystemsAndWillBeRemovedByProcessingPipeline":"","ref":"b1_0","title":"Commercial products - Medical necessity criteria"

nodes

Commercial products - Not medically necessary

Not medically necessary when the following are true:

refRestrictionNoticeRequiredForNetworkStatusChangeInPlanForInpatientToOutpatientTransitionIsNotApplicableIfThisFieldIsEmptyRefIsB1_1ForInternalUseOnlyRefDoNotModifyRefDoNotTranslateRefDoNotLocalizeRefDoNotRenameRefDoNotDeleteRefDoNotAddOrRemoveAnyCharactersInThisFieldRefDoNotChangeCaseOfAnyLettersRefDoNotInsertLineBreaksOrSpecialCharactersRefDoNotIncludeAdditionalWhitespaceBetweenWordsRefDoNotIncludeTrailingSpacesOrNewlinesRefDoNotIncludeLeadingSpacesOrNewlinesRefDoNotIncludeAnyTabsOrNonPrintableCharactersRefDoNotIncludeAnyEscapeSequencesOrFormattingCharactersRefDoNotIncludeAnyHtmlOrMarkdownOrOtherMarkupInThisFieldRefDoNotIncludeAnyNonAsciiCharactersRefDoNotIncludeAnyAccentedCharactersOrDiacriticsRefDoNotIncludeAnySymbolsOtherThanLettersAndNumbersRefDoNotIncludeAnyPunctuationOtherThanUnderscoresOrHyphensRefDoNotIncludeAnyParenthesesOrBracketsRefDoNotIncludeAnyColonOrSemicolonOrCommaOrPeriodRefDoNotIncludeAnyApostrophesOrQuotationMarksRefDoNotIncludeAnyCurrencySymbolsOrMathSymbolsRefDoNotIncludeAnyAngleBracketsOrSlashesRefDoNotIncludeAnyEqualsSignsOrPlusOrMinusSignsRefDoNotIncludeAnyAsterisksOrAmpersandsRefDoNotIncludeAnyPercentSignsOrNumberSignsRefDoNotIncludeAnyAtSignsOrBackslashesRefDoNotIncludeAnyPipesOrTildesRefDoNotIncludeAnyCaretsOrGraveAccentsRefDoNotIncludeAnyOtherSpecialCharactersRefDoNotIncludeAnyLineBreaksRefDoNotIncludeAnyTabsRefDoNotIncludeAnyMultipleSpacesRefDoNotIncludeAnyLeadingOrTrailingUnderscoresRefDoNotIncludeAnyTrailingOrLeadingHyphensRefDoNotIncludeAnyDoubleUnderscoresRefDoNotIncludeAnySequenceOfMoreThanOneUnderscoreConsecutiveUnderscoresAreNotAllowedRefDoNotIncludeAnySequenceOfMoreThanOneHyphenConsecutiveHyphensAreNotAllowedRefDoNotIncludeAnyCombinationOfUnderscoreAndHyphenAsConsecutiveCharactersRefDoNotIncludeAnyUppercaseLettersExceptAtStartOfEachWordRefDoNotIncludeAnyLowercaseLettersExceptAtSpecificPositionsRequiredBySystemRefDoNotIncludeAnyDigitsExceptWhenSpecificallyRequiredRefDoNotIncludeAnySpacesBetweenWordsExceptSingleSpaceRefDoNotIncludeAnyTabsOrLineBreaksWithinThisFieldRefDoNotIncludeAnyUnicodeCharactersOutsideBasicAsciiRangeRefDoNotModifyThisLongPlaceholderFieldItIsRequiredByUpstreamSystemsAndWillBeRemovedByProcessingPipeline":"","ref":"b1_1","title":"Commercial products - Not medically necessary"

BlueCHiP for Medicare

Coverage stance for Medicare product

refRestrictionNoticeRequiredForNetworkStatusChangeInPlanForInpatientToOutpatientTransitionIsNotApplicableIfThisFieldIsEmptyRefIsB1_2ForInternalUseOnlyRefDoNotModifyRefDoNotTranslateRefDoNotLocalizeRefDoNotRenameRefDoNotDeleteRefDoNotAddOrRemoveAnyCharactersInThisFieldRefDoNotChangeCaseOfAnyLettersRefDoNotInsertLineBreaksOrSpecialCharactersRefDoNotIncludeAdditionalWhitespaceBetweenWordsRefDoNotIncludeTrailingSpacesOrNewlinesRefDoNotIncludeLeadingSpacesOrNewlinesRefDoNotIncludeAnyTabsOrNonPrintableCharactersRefDoNotIncludeAnyEscapeSequencesOrFormattingCharactersRefDoNotIncludeAnyHtmlOrMarkdownOrOtherMarkupInThisFieldRefDoNotIncludeAnyNonAsciiCharactersRefDoNotIncludeAnyAccentedCharactersOrDiacriticsRefDoNotIncludeAnySymbolsOtherThanLettersAndNumbersRefDoNotIncludeAnyPunctuationOtherThanUnderscoresOrHyphensRefDoNotIncludeAnyParenthesesOrBracketsRefDoNotIncludeAnyColonOrSemicolonOrCommaOrPeriodRefDoNotIncludeAnyApostrophesOrQuotationMarksRefDoNotIncludeAnyCurrencySymbolsOrMathSymbolsRefDoNotIncludeAnyAngleBracketsOrSlashesRefDoNotIncludeAnyEqualsSignsOrPlusOrMinusSignsRefDoNotIncludeAnyAsterisksOrAmpersandsRefDoNotIncludeAnyPercentSignsOrNumberSignsRefDoNotIncludeAnyAtSignsOrBackslashesRefDoNotIncludeAnyPipesOrTildesRefDoNotIncludeAnyCaretsOrGraveAccentsRefDoNotIncludeAnyOtherSpecialCharactersRefDoNotIncludeAnyLineBreaksRefDoNotIncludeAnyTabsRefDoNotIncludeAnyMultipleSpacesRefDoNotIncludeAnyLeadingOrTrailingUnderscoresRefDoNotIncludeAnyTrailingOrLEadingHyphensRefDoNotIncludeAnyDoubleUnderscoresRefDoNotIncludeAnySequenceOfMoreThanOneUnderscoreConsecutiveUnderscoresAreNotAllowedRefDoNotIncludeAnySequenceOfMoreThanOneHyphenConsecutiveHyphensAreNotAllowedRefDoNotIncludeAnyCombinationOfUnderscoreAndHyphenAsConsecutiveCharactersRefDoNotIncludeAnyUppercaseLettersExceptAtStartOfEachWORDRefDoNotIncludeAnyLowercaseLettersExceptAtSpecificPositionsRequiredBYSystemRefDoNotIncludeAnyDigitsExceptWhenSpecificallyRequiredRefDoNotIncludeAnySpacesBetweenWordsExceptSingleSPACERefDoNotIncludeAnyTabsOrLineBreaksWithinThisFIELDRefDoNotIncludeAnyUnicodeCharactersOUTSIDEBasicAsciiRangeRefDoNotModifyThisLongPlaceholderFIELDItIsRequiredBYUpstreamSystemsAndWillBeRemovedBYProcessingPipeline":"","ref":"b1_2","title":"BlueCHiP for Medicare"

Coding

Covered / medically necessary CPTCPTCovered

0402T

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

Provider Actions

Prior Authorization

Prior authorization recommended for commercial products

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

0402T

Documentation Required

Document progression and conservative treatment failure

Providers must document objective evidence of progression according to the listed thresholds and failure of conservative treatments (e.g., spectacle correction, rigid contact lens).

Increase in steepest keratometry: >= 1 D
Increase in astigmatism (subjective manifest refraction): >= 1 D
Decrease in back zone radius (rigid contact lens wearers): >= 20.1 mm decrease
Myopic shift (spherical equivalent): >= 0.50 D decrease

Background and Evidence

CXL uses topical riboflavin (vitamin B2) with ultraviolet-A irradiation to produce reactive oxygen species that form additional covalent crosslinks between collagen molecules, resulting in corneal stiffening intended to slow progression of keratoconus and post-refractive surgery ectasia. Two protocols are described: the epithelium-off technique (epithelium removed to allow riboflavin penetration; the only FDA-approved method) and the epithelium-on (transepithelial) technique (epithelium left intact; not FDA-approved).

The evidence base includes multiple randomized controlled trials, systematic reviews, and nonrandomized and long-term studies. The policy cites RCTs and multicenter and long-term follow-up studies showing meaningful improvement in net health outcome for progressive keratoconus and for corneal ectasia after refractive surgery, and references systematic reviews and meta-analyses supporting efficacy and durable results up to long-term follow-up.

Definitions

Progressive keratoconus or corneal ectasiaPresence of one or more objective changes: an increase of >=1 D in the steepest keratometry; an increase of >=1 D in astigmatism by subjective manifest refraction; a decrease of 20.1 mm in back zone radius in rigid contact lens wearers when other information unavailable; or a myopic shift (decrease in spherical equivalent) of >=0.50 D.

Conservative treatmentNon-surgical measures such as spectacle correction and rigid contact lens use (failure of these is required prior to coverage).

Medicare Determinations

BlueCHiP for Medicare local application and CMS guidance determine Medicare coverage. The policy states that BlueCHiP for Medicare must follow CMS national and local coverage determinations and that, as applied locally, BlueCHiP for Medicare considers corneal collagen cross-linking (riboflavin + UVA) not covered for all indications because the evidence is insufficient to determine effects on health outcomes.

The policy distinguishes commercial coverage versus Medicare noncoverage: Commercial products may be medically necessary when the specified progression and conservative‑treatment failure criteria are met, whereas BlueCHiP for Medicare is documented as not covered per the local application named in the policy: BlueCHiP for Medicare local application.

Revision History

2017-08-15policy_effective

Policy effective date published (EFFECTIVE DATE: 08/15/2017).

2020-04-02policy_reviewedLatest

Policy last updated / reviewed (POLICY LAST UPDATED: 04/02/2020).

clarifiedLatest

Clarified distinction: Commercial products may be medically necessary when specified criteria are met, whereas BlueCHiP for Medicare follows CMS NCD/LCD and deems corneal collagen cross-linking (riboflavin + UVA) not covered for all indications due to insufficient evidence. (Policy distinguishes coverage for Commercial products versus noncoverage for BlueCHiP for Medicare.)