ModifiedEmblemHealthPolicy AHS-G2138

Evaluation of Dry Eyes - Lab Benefit Program (LBM)

Defines coverage and reimbursement guidance for laboratory tests used to evaluate suspected dry eye disease for EmblemHealth products, including which tests meet or do not meet coverage criteria.

Policy Summary

PayerEmblemHealth

PolicyEvaluation of Dry Eyes - Lab Benefit Program (LBM)

Policy CodePolicy AHS-G2138

Change TypeLBM expansionclarifying editstemplate transfer

Effective DateMar 1, 2023

Next Review Date

Key ActionUse tear osmolarity testing to determine severity of dry eye or to monitor therapy; other listed tests do not meet coverage criteria.

SourceLink

POLICY UPDATE CHANGES

Lab Benefit Program (LBM) expanded to include EmblemHealth HMO/PPO (Non-City) Commercial, Medicare and Medicaid plans effective 10/1/2024.

Updated for clarity; no changes to coding or coverage criteria.

Transferred policy content to individual company-branded template; no changes to policy title or policy number.

meetstear osmolarity stance

not coveredMMP-9 stance

not coveredlactoferrin/IgE stance

5-15%prevalence (US)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

(untitled)

Application of coverage criteria is dependent upon an individual's benefit coverage at the time of the request. Specifications pertaining to Medicare and Medicaid can be found in the Applicable State and Federal Regulations section of this policy document.

ALL of the following

For individuals suspected of having dry eye, testing of tear osmolarity MEETS COVERAGE CRITERIA in any of the following situations:
ONE of
- To help determine the severity of dry eye disease.
- To monitor effectiveness of therapy.
For individuals suspected of having dry eye disease based on comprehensive eye examination, testing for MMP-9 protein in human tears DOES NOT MEET COVERAGE CRITERIA.

LBM coverage notes — Policy revisions and Lab Benefit Program scope updates relevant to coverage.

Evaluation of Dry Eyes - Lab Benefit Program (LBM). Note: Policy scope and plan inclusion updated per revision history; coverage is dependent on member benefit and program applicability.

ALL of the following

For individuals suspected of having dry eye disease, testing for lactoferrin and/or IgE DOES NOT MEET COVERAGE CRITERIA.
All other testing not discussed above DOES NOT MEET COVERAGE CRITERIA due to a lack of available published scientific literature confirming that the test(s) is/are required and beneficial for the diagnosis and treatment of an individual's illness.
Lab Benefit Program (LBM) scope was expanded to include EmblemHealth HMO/PPO (Non-City) Commercial, Medicare and Medicaid plans effective 10/1/2024; applicability of LBM reimbursement and coverage determinations remain subject to individual member benefits.

Coding and Test Thresholds

Applicable procedure codesmixed

No codes listed

FDA-cleared devices and summaries referencedmixed

No codes listed

Tear osmolarity thresholds

Normal270-308 mOsm/L

Mild dry eye308-316 mOsm/L

Moderate to severe dry eye>316 mOsm/L

InflammaDry MMP-9 positive threshold

InflammaDry (MMP-9) positive cutoff>40 ng/mL

Clinical notePoint-of-care MMP-9 immunoassay detects elevated ocular surface inflammation but is cited as having variable utility in studies.

Coverage stance

Provider Actions and Operational Notes

Prior Authorization

Prior authorization / coverage summary

Tear osmolarity testing MEETS COVERAGE CRITERIA when used to help determine the severity of dry eye disease or to monitor effectiveness of therapy. MMP-9 protein testing in human tears, lactoferrin/IgE testing, and all other tests not discussed in the policy do NOT meet coverage criteria.

Note

LBM diagnostics referenced

The Lab Benefit Program (LBM) references point-of-care assays in the evidence base for dry eye evaluation, including tear osmolarity measurement and a point-of-care MMP-9 immunoassay.

Definitions

DED — Dry eye disease

DefinitionDry eye disease (DED) is a multifactorial ocular surface disease characterized by variable signs and symptoms affecting the tear film and ocular surface.

Clinical assessmentDiagnosis typically requires a combination of clinical assessment and diagnostic testing.

Related termsIncludes concepts from DEWS, OSS, TBUT and other ocular surface metrics referenced in definitions.

MMP-9 — Matrix metallopeptidase-9

TermMatrix metallopeptidase-9 (MMP-9)

RoleEnzyme associated with ocular surface inflammation; increased production/activity seen in dysfunctional tear syndrome and dry eye.

Policy Summary

PayerEmblemHealth

PolicyEvaluation of Dry Eyes - Lab Benefit Program (LBM)

Policy CodePolicy AHS-G2138

Change TypeLBM expansionclarifying editstemplate transfer

Effective DateMar 1, 2023

Next Review Date

Key ActionUse tear osmolarity testing to determine severity of dry eye or to monitor therapy; other listed tests do not meet coverage criteria.

SourceLink

On This Page

MMP-9 protein testing in tears does NOT meet coverage criteria per policy.

Lactoferrin cutoffs

High lactoferrin>1.0 mg/ml

Low lactoferrin<0.8 mg/ml

Test performanceAXIM Eye Lactoferrin test reported sensitivity 83% and specificity 98%.

Test performance considerations

Tear osmolarity variabilitySignificant measurement variability reported with point-of-care TearLab; overlapping values between normal and dry eye limit standalone interpretation.

Correlation limitationsOsmolarity may correlate with some severity metrics but often lacks consistent correlation with other objective signs and symptoms.

MMP-9 test factorsMMP-9 immunoassay performance can be influenced by tear volume and shows variable sensitivity/specificity across studies.

Clinical utility summaryBoth tear osmolarity and MMP-9 point-of-care tests are discussed in the evidence base but have limitations that affect diagnostic utility.

Measured via point-of-care immunoassay to detect inflammation related to dry eye.

Tear osmolarity — definition and units (mOsm/L)

DefinitionTear osmolarity measures the concentration of dissolved solutes in the tear film (units: mOsm/L).

Clinical significanceHyperosmolarity is a recognized and validated marker of dry eye; thresholds are used to suggest severity but have interpretation limitations.

Measurement noteTearLab collects a small tear sample and assesses electrical impedance to determine osmolarity.

Lactoferrin — biomarker description and clinical correlation

BiomarkerLactoferrin is a tear biomarker used to assess lacrimal gland secretory function and is associated with inflammation and healing.

Clinical correlationLow lactoferrin levels directly correlate with aqueous deficiency; normal levels indicate normal lacrimal gland function.

Test performanceAXIM Eye Lactoferrin test reported sensitivity 83% and specificity 98%.

MMP-9 immunoassay — point-of-care immunoassay description

DescriptionA point-of-care immunoassay that qualitatively detects elevated MMP-9 levels in tears to identify ocular surface inflammation associated with dry eye.

Clinical considerationsStudies report variable sensitivity and specificity; test positivity can be influenced by tear volume and clinical context.

EvidenceMultiple clinical studies and reviews cited assessing MMP-9 assay utility in dry eye diagnosis and management.

Tear osmolarity test — point-of-care measurement description

DescriptionPoint-of-care measurement of tear film osmolarity (mOsm/L) used as an objective diagnostic marker for dry eye; commonly performed with the TearLab system.

Measurement methodTearLab collects ~50 µL tear sample and analyzes electrical impedance to estimate osmolarity.

LimitationsConsiderable measurement variability and overlap between normal and diseased eyes can limit standalone diagnostic accuracy.