Currentblue cross blue shield - louisianaPolicy AHS - G2138

Evaluation of Dry Eyes

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Defines coverage policy for diagnostic tests used to evaluate dry eye disease (DED), specifying which tear film biomarker tests meet or do not meet coverage criteria and intended for clinicians and laboratories submitting claims to Blue Cross Blue Shield of Louisiana.

Policy Summary

Payerblue cross blue shield - louisiana

PolicyEvaluation of Dry Eyes

Policy CodePolicy AHS - G2138

Change TypeNo material change

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review DateAug 1, 2026

Key ActionVerify the member's benefit coverage at time of request before ordering tear diagnostic tests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Tear osmolarityPrimary covered test

Not coveredMMP-9 status

Not coveredLactoferrin/IgE status

5-15%Estimated prevalence

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Currentblue cross blue shield - louisianaPolicy AHS - G2138

Evaluation of Dry Eyes

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Policy Summary

Payerblue cross blue shield - louisiana

PolicyEvaluation of Dry Eyes

Policy CodePolicy AHS - G2138

Change TypeNo material change

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review DateAug 1, 2026

Key ActionVerify the member's benefit coverage at time of request before ordering tear diagnostic tests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Tear osmolarityPrimary covered test

Not coveredMMP-9 status

Not coveredLactoferrin/IgE status

5-15%Estimated prevalence

82785,83516,83520,83861

Coverage Criteria for Tear Film Biomarker Testing

Tear osmolarity — Covered

Testing of tear osmolarity MEETS COVERAGE CRITERIA when any of the following apply:

Tear osmolarity coverage indications: a) Individuals suspected of having dry eye disease; b) To help determine the severity of dry eye disease; c) To monitor effectiveness of therapy.

From policy Indications and/or Limitations of Coverage.

MMP-9 testing — Not covered

MMP-9 protein testing in tears DOES NOT MEET COVERAGE CRITERIA for individuals suspected of having DED.

MMP-9 not covered: Testing for MMP-9 protein in human tears for suspected dry eye disease.

Policy explicitly states MMP-9 testing does not meet coverage criteria.

Lactoferrin and IgE testing — Not covered

Testing for lactoferrin and/or IgE in tears DOES NOT MEET COVERAGE CRITERIA for individuals suspected of having DED.

Lactoferrin/IgE not covered: Testing for lactoferrin and/or IgE in individuals suspected of DED.

Policy explicitly denies coverage for these tests; lactoferrin test characteristics are described in the policy.

Other tests — Not covered

All other tear tests not discussed in the policy DO NOT MEET COVERAGE CRITERIA due to insufficient published literature confirming benefit.

Other tests not covered: Any other testing for suspected DED not specifically discussed in this policy.

Catch-all denial from policy due to lack of evidence of clinical benefit.

Diagnostic criteria and testing role

Diagnostic testing for DED is supported when used as part of a combined clinical assessment (symptoms plus signs) and to determine subtype and severity.

Combined assessment requirement: Diagnosis should integrate patient symptoms and other clinical findings; no single test is adequate alone.

AAO and TFOS DEWS III recommend combining diagnostic tests with symptoms and clinical exam.

Homeostasis markers confirming DED: Presence of any one of: reduced non-invasive TBUT (<10 seconds), tear film hyperosmolarity (>=308 mOsm/L or inter-eye difference >8 mOsm/L), or positive ocular surface staining in either eye confirms disrupted homeostasis.

TFOS DEWS III criteria for confirming disrupted tear film homeostasis.

Use of MMP-9 testing: MMP-9 testing may be used to assess ocular surface inflammation and help guide anti-inflammatory therapy selection, but is most likely to be positive in more severe disease.MMP-9 >= ~40 ng/mL

TFOS and DTS Panel note MMP-9 is typically positive above ~40 ng/mL and may be most useful in more severe cases; be aware of sample volume limitations.

Coverage criteria status

No new or modified coverage criteria in this revision

Coverage criteria unchanged: Literature review did not necessitate any modifications to coverage criteria.

Refer to prior sections for specific coverage criteria; review/revision history states criteria were unchanged.

The policy explicitly excludes several targeted tear biomarker tests from coverage. Testing for MMP-9 protein in human tears DOES NOT MEET COVERAGE CRITERIA for individuals suspected of having dry eye disease. Similarly, testing for lactoferrin and/or IgE in tears DOES NOT MEET COVERAGE CRITERIA. The policy further states that all other tear tests not discussed in the policy DO NOT MEET COVERAGE CRITERIA due to insufficient published literature demonstrating clinical benefit.

Not all tear biomarker assays are FDA-approved; many laboratory-developed tests (LDTs) are regulated under CLIA as high-complexity tests and require in-house validation. The document notes that FDA clearance or approval is not required for clinical use of an LDT, but when FDA-approved/cleared devices exist (for example, the TearLab Osmolarity System and InflammaDry), those approvals are documented in the policy.

Within the provided document segments and the review/revision history, there are no additional explicit exclusions beyond those already stated for MMP-9, lactoferrin, IgE, and the catch‑all exclusion for tests not discussed. The literature reviews noted in the revision history did not require changes to coverage criteria or introduce new exclusions.

Tests specifically identified in the policy as not meeting coverage criteria — including MMP-9, lactoferrin, and IgE assays, as well as any other tear tests not discussed — are considered outside coverage and may be treated as not medically necessary when billed for evaluation of dry eye disease.

Although the policy describes tests that do not meet coverage criteria, the provided segments do not include separate, explicit wording that uses the phrase 'not medically necessary' beyond the implication of non-coverage; review and revision notes confirm no modifications that would add explicit 'not medically necessary' statements in these excerpts.

Procedure Codes, Thresholds, and Device References

Applicable CPT/HCPCS procedure codesmixed

No codes listed

Applicable CPT/HCPCS Procedure CodesCPT

82785	Gammaglobulin (immunoglobulin); IgE.
83516	Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method.
83520	Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified.
83861	Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity

FDA device submissions referencedmixed

K934473	FDA device identifier cited in references
K083184	OcuSense/TearLab Osmolarity System - FDA 510(k) document referenced
K132066	FDA 501(k) Summary of Safety and Effectiveness referenced

Tear osmolarity severity thresholds

Normal270-308 mOsm/L

Mild308-316 mOsm/L

Moderate–Severe>316 mOsm/L

InflammaDry detection threshold

InflammaDry detection threshold>40 ng/mL MMP-9 (qualitative positive at levels >40 ng/mL)

Clinical contextPositive result indicates elevated MMP-9 associated with ocular surface inflammation but does not distinguish DED from other inflammatory ocular surface diseases

Actions, Documentation, and Billing Considerations for Providers

Prior Authorization

Verify member benefits before ordering

Verify member benefit coverage at the time the test is ordered; coverage is applied based on the individual's benefit and Medicare/Medicaid specifications are in the Applicable State and Federal Regulations section.

Billing Rule

Include and verify applicable procedure codes

Reference the listed procedure codes when submitting claims and confirm any payer-specific prior authorization rules separately for these services.

82785 — Gammaglobulin (immunoglobulin); IgE
83516 — Immunoassay; qualitative or semiquantitative, multiple step method

Background on Dry Eye Disease and Diagnostic Testing

Dry eye disease (DED) is described as a multifactorial ocular surface disorder characterized by tear film instability, hyperosmolarity, and inflammation. Diagnosis requires integrating patient symptoms with clinical signs because no single test is sufficient. The policy supports use of diagnostic testing such as tear osmolarity for individuals suspected of having DED, to assess severity, and to monitor therapy, while noting that literature reviews through the most recent policy revision did not necessitate changes to the stated coverage criteria.

Definitions and Device Summaries

DED definition

TermDry eye disease (DED) — a multifactorial disease of the ocular surface characterized by loss of tear film homeostasis and associated symptoms

Key featuresTear film instability, hyperosmolarity, inflammation, damage, and neurosensory abnormalities

SynonymDysfunctional tear syndrome (DTS)

Tear Osmolarity

DefinitionMeasurement of solute concentration in tears; hyperosmolarity is a validated marker of dry eye

Common devicesTearLab (TearLab Osmolarity System) and similar point-of-care osmolarity systems

Clinical role

Review and Revision History

2026-08-01clinical_advisory_board_reviewLatest

Clinical Advisory Board meeting; background, guidelines, recommendations, and evidence references updated; literature review did not necessitate modifications to coverage criteria; CC1 edited for clarity and consistency.

2025-07-01policy_update

CC1 edited for clarity and consistency; background, guidelines, recommendations, and evidence references updated; literature review did not necessitate modifications to coverage criteria.

2024-10-01

Policy Summary

Payerblue cross blue shield - louisiana

PolicyEvaluation of Dry Eyes

Policy CodePolicy AHS - G2138

Change TypeNo material change

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review DateAug 1, 2026

Key ActionVerify the member's benefit coverage at time of request before ordering tear diagnostic tests.

SourceLink

On This Page

Use noteMost likely positive in more severe disease; panel noted validity primarily past 40 ng/mL

Lactoferrin thresholds (AXIM)

High lactoferrin>1.0 mg/mL

Low lactoferrin<0.8 mg/mL

AXIM test performanceReported sensitivity 83% and specificity 98% (AXIM Eye Lactoferrin)

Tear osmolarity threshold

Abnormal osmolarity cutoff>= 308 mOsm/L in either eye

Inter-eye difference criterionInter-eye difference > 8 mOsm/L

RoleValues indicate departure from tear film homeostasis and support DED diagnosis in conjunction with clinical assessment

MMP-9 positivity threshold

MMP-9 positivity thresholdApproximately 40 ng/mL (InflammaDry positive ≈40 ng/mL)

InterpretationPositive indicates ocular surface inflammation; may be absent in milder disease

Sampling caveatSmall tear sample volumes can produce false negatives—ensure adequate collection

83520 — Immunoassay; quantitative, not otherwise specified

83861 — Microfluidic analysis; tear osmolarity

Prior Authorization

Confirm prior authorization requirement (none specified)

No prior authorization requirements or specific affected codes are stated in the provided policy segments; verify separately with payer authorization resources if needed.

Note

Place testing in therapeutic context

Consider diagnostic results in the context of standard dry eye treatments—first-line artificial tears and, when indicated, anti-inflammatories including topical corticosteroids, topical cyclosporine A, or lifitegrast.

Artificial tears as primary therapy
Corticosteroids and topical cyclosporine A for inflammatory disease
Lifitegrast ophthalmic solution 5% as an approved anti-inflammatory therapy

Step Therapy

Use test results to guide treatment escalation

Use diagnostic testing (e.g., tear osmolarity, TBUT, staining, MMP-9 where relevant) to guide progression to pharmacologic treatments such as topical cyclosporine or lifitegrast when clinical findings and test results indicate inflammation or severity warranting these therapies.

Integrate test results with symptoms and signs before initiating anti-inflammatory drugs
MMP-9 may inform anti-inflammatory therapy selection but is more often positive in severe disease (≈40 ng/mL)

Documentation Required

Order tests as part of a comprehensive eye exam

Order tear testing within the context of a comprehensive eye examination and clinical assessment; tear osmolarity is indicated for suspected DED, severity assessment, or monitoring therapy.

Ensure testing complements symptom assessment and other clinical findings
Tear osmolarity indicated to help determine severity or monitor therapy

Documentation Required

Document test values and clinical correlation

Document numeric test values and correlate results with symptoms and ocular surface examination; for osmolarity record mOsm/L (including inter-eye differences) and for MMP-9 record positive/negative (and band density if available) and any repeat testing performed.

Record tear osmolarity value and note if ≥308 mOsm/L or inter-eye difference >8 mOsm/L
Document MMP-9 result (positive ≈40 ng/mL) and any sample limitations or repeats
Correlate all diagnostic results with symptoms and ocular surface signs in the medical record

Note

Reference review and revision history

Note updates recorded in the review/revision history: background, guidelines, recommendations, and evidence references were updated (08/01/2026) and literature review did not require changes to coverage criteria.

08/01/2026: Clinical Advisory Board meeting summary; background and evidence references updated
Multiple prior reviews noted literature review did not necessitate modifications to coverage criteria

Denial Risk

Avoid billing for excluded tear tests (denial risk)

Do not order or submit claims for MMP-9, lactoferrin, IgE, or other tear biomarker tests not discussed in the policy without confirming medical necessity, as these tests do not meet coverage criteria and are at risk for denial.

MMP-9 testing in tears DOES NOT MEET COVERAGE CRITERIA
Lactoferrin and/or IgE testing in tears DOES NOT MEET COVERAGE CRITERIA
All other tear tests not discussed also DO NOT MEET COVERAGE CRITERIA

Denial Risk

Ensure adequate tear sample volume for MMP-9 testing

Be aware that MMP-9 immunoassay (InflammaDry) reliability is sample-volume dependent; sample volumes less than 6 μL can produce false-negative results and should be documented if suspected.

Manufacturer and study data note <6 μL sample volumes may yield false negatives
Document sample volume issues and consider repeat testing or alternative assessments if low volume suspected

Note

Coverage criteria unchanged after literature review

Literature reviews cited during policy updates did not change coverage criteria; continue to follow current coverage statements for tear osmolarity (covered) and MMP-9/lactoferrin/IgE/other tests (not covered).

Coverage criteria remained unchanged across multiple review dates
Refer to policy sections for specific coverage stance

Used to aid diagnosis, assess severity, and monitor therapy in conjunction with other clinical tests

MMP-9

DefinitionMatrix metalloproteinase-9 (MMP-9) — an inflammatory mediator measurable in tears

DetectionInflammaDry is a point-of-care immunoassay that detects elevated MMP-9 (positive at ~40 ng/mL)

Clinical noteElevated MMP-9 indicates ocular surface inflammation but does not specifically distinguish DED from other inflammatory ocular surface diseases

Lactoferrin

DefinitionLactoferrin — tear biomarker used to assess lacrimal gland secretory function

Clinical relevanceLow lactoferrin correlates with aqueous-deficient dry eye

AXIM thresholdsHigh >1.0 mg/mL; Low <0.8 mg/mL (AXIM Eye Lactoferrin)

Dry eye disease (DE/DED)

Short definitionDry eye disease (DE/DED) — a multifactorial, symptomatic disease characterized by loss of tear film homeostasis involving tear film instability, hyperosmolarity, inflammation, damage, and neurosensory abnormalities (TFOS DEWS III)

Diagnostic implicationDiagnosis requires integration of symptoms and clinical signs; no single test is adequate alone

Subtype focusDistinguish aqueous-deficient vs evaporative etiologies to guide management

InflammaDry (MMP-9 immunoassay)

Device typeInflammaDry — a point-of-care rapid immunoassay for qualitative detection of elevated MMP-9 in tears

Regulatory statusFDA-approved (Nov 20, 2013) for prescription point-of-care use to aid dry eye diagnosis in conjunction with other evaluations

Intended useVisual, qualitative detection of elevated MMP-9 to indicate ocular surface inflammation

TearLab Osmolarity System

DeviceTearLab Osmolarity System — device to measure osmolality of human tears to aid diagnosis of DED

Regulatory statusFDA-cleared (May 14, 2009) with indication to aid diagnosis of DED in conjunction with other clinical evaluation

FunctionCollects tear sample and reports osmolarity (used for severity assessment and monitoring alongside other tests)

TFOS DEWS II / DEWS III

ReportsTFOS DEWS II / DEWS III — international consensus reports on definition, classification, management, and therapy of dry eye disease

Role in policyCited as key evidence and guidance for diagnostic criteria and testing recommendations

Recommendation summaryRecommend integrating symptoms and multiple signs; specific homeostasis markers (including osmolarity and TBUT) support diagnosis

Tear osmolarity testing

Test typePoint-of-care diagnostic measurement of tear film osmolarity

Devices mentionedTearLab and ScoutPro (TearLab Osmolarity System referenced in FDA summaries)

Clinical utilityUsed to detect hyperosmolarity, assess severity (thresholds cited) and monitor therapy when combined with clinical assessment

MMP-9 immunoassay

DefinitionPoint-of-care immunoassay to detect elevated MMP-9 in tears as a marker of ocular surface inflammation

Test performance notesMultiple studies assessed sensitivity and specificity; InflammaDry detects levels >40 ng/mL

LimitationsDoes not distinguish DED from other inflammatory conditions; small sample volumes can cause false negatives

Literature review did not necessitate any modifications to coverage criteria.

2023-06-01literature_review

Literature review did not necessitate changes to coverage criteria; policy edited for clarity and consistency.

2023-01-01literature_review

Literature review did not necessitate modification to coverage criteria.

2022-05-15policy_implementation

Initial policy implementation.