CurrentHealthfirstPolicy PO-RE-067v4

Evaluation of Dry Eyes

Defines coverage stance for diagnostic testing used to evaluate dry eye disease (DED) including tear osmolarity, MMP-9, lactoferrin, and other tests; applies to Healthfirst members seeking evaluation of suspected dry eye. Coverage depends on individual benefits and applicable state/federal rules.

Policy Summary

PayerHealthfirst

PolicyEvaluation of Dry Eyes

Policy CodePolicy PO-RE-067v4

Change TypeMinor review — no material changes

Effective DateJul 1, 2025

Next Review Date

Key ActionOrder tear osmolarity testing to determine severity of dry eye or monitor therapy; document clinical exam findings to support testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Tear osmolarityMeets coverage criteria in specified situations

MMP-9Does not meet coverage criteria

Lactoferrin/IgEDoes not meet coverage criteria

5-15%Estimated US population affected

≥308Osmolarity threshold (TFOS)

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Representative CPT listed

Coverage Criteria for Diagnostic Testing in Dry Eye Disease

Tear Osmolarity — Covered Indications

Covered when ANY of the following are met

Tear osmolarity coverage: Tear osmolarity testing meets coverage criteria when used to (a) help determine the severity of dry eye disease, or (b) monitor effectiveness of therapy.see clinical thresholds for interpretation

Application depends on individual benefit coverage and applicable state/federal regulations.

MMP-9, Lactoferrin, IgE, and Other Tests — Not Covered

Not covered

Not covered biomarker tests: Testing for MMP-9 protein (e.g., InflammaDry), lactoferrin and/or IgE, and all other tear film tests not discussed as covered do not meet coverage criteria due to insufficient evidence of clinical benefit.InflammaDry positive >40 ng/mL; lactoferrin cutoffs described elsewhere

Tests listed as not meeting coverage criteria may be considered investigational or unsupported for routine coverage.

Diagnostic testing for DED

Covered when testing is used as part of a clinical evaluation to diagnose or stage dry eye disease in accordance with guideline-recommended indications.

Core requirement: Testing must be interpreted alongside patient symptoms and other clinical findings per AAO/TFOS guidance.

AAO states no single test is adequate; combinations of findings are useful

Diagnostic indicators supporting DED: Any one of: tear osmolarity ≥308 mOsm/L in either eye, interocular osmolarity difference >8 mOsm/L, noninvasive tear break-up time <10 seconds, Schirmer test ≤10 mm, or ocular surface staining meeting TFOS thresholds.See TFOS/AAO diagnostic thresholds

TFOS and AAO list these as representative markers of disrupted homeostasis

Use of point-of-care assays: FDA-cleared point-of-care tests (for example, TearLab for osmolarity; InflammaDry for MMP-9; lactoferrin microassay) may be used to aid diagnosis only in conjunction with other clinical evaluation.

All other diagnostic tests for suspected dry eye disease that are not specifically addressed as covered in this policy do not meet coverage criteria. This determination is based on a lack of published scientific literature demonstrating that these tests are required and beneficial for diagnosis or treatment of an individual’s condition. Providers should not expect coverage for other tear-film or biomarker assays unless specifically listed as meeting coverage criteria.

This policy does not guarantee that services will be covered or paid. Reimbursement determinations remain subject to the member’s Evidence of Coverage, applicable state and federal mandates, and the provider’s participation agreement. In addition, coverage and payment are contingent on correct coding, billing practices, and compliance with Healthfirst and industry coding rules.

Testing for MMP-9 (for example, InflammaDry), lactoferrin, IgE, and other unspecified tear biomarker tests for evaluation of suspected dry eye are considered not medically necessary and do not meet coverage criteria per this policy due to insufficient evidence of clinical benefit.

The guidance in this policy reflects consensus clinical recommendations that no single diagnostic test is adequate to establish dry eye disease; test results must be interpreted in the context of patient symptoms and other clinical findings. While the policy lists covered and non-covered tests, it does not provide additional explicit 'not medically necessary' rules beyond stating that clinical correlation and use of multiple findings are required for diagnosis.

Applicable Codes, Thresholds, and Test Values

Applicable procedure codes referencedCPT

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.

Covered CPT CodesCPTCovered

83861

Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity.

Not covered / Not medically necessary codesCPTNot Covered

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.

inv-09: Tear osmolarity severity thresholds

Normal range270-308 mOsm/L

Mild dry eye308-316 mOsm/L

Moderate to severe dry eye>316 mOsm/L

inv-10: InflammaDry detection threshold

InflammaDry positive threshold>40 ng/mL MMP-9

Clinical contextDetects elevated MMP-9 associated with ocular surface inflammation; reported positive in a subset of DED patients

AAO note

Provider Requirements, Documentation, and Billing

Prior Authorization

Coverage headline — Tear osmolarity testing

Tear osmolarity testing MEETS COVERAGE CRITERIA when used to determine severity of dry eye disease or to monitor effectiveness of therapy. Testing for MMP-9, lactoferrin, IgE, and other tear biomarkers not specified as covered do NOT meet coverage criteria and may be denied.

Covered indication: tear osmolarity testing to determine severity of dry eye disease or to monitor effectiveness of therapy.
Not covered: MMP-9 testing (InflammaDry) does NOT meet coverage criteria.
Not covered: lactoferrin and IgE testing do NOT meet coverage criteria.
All other tear biomarker tests not discussed herein DO NOT meet coverage criteria due to insufficient published evidence.

Billing Rule

Background and Rationale

Dry eye disease (DED) is a multifactorial ocular surface disorder characterized by tear film instability, hyperosmolarity, ocular surface inflammation, and neurosensory abnormalities. DED affects vision and quality of life, and prevalence estimates in the U.S. range roughly 5–15%. Diagnosis relies on a combination of patient-reported symptoms and clinical tests because no single definitive diagnostic test exists; tests such as tear osmolarity, tear break-up time, Schirmer testing, and ocular surface staining are used together to assess tear film homeostasis and disease severity.

Definitions and Diagnostic Thresholds

inv-24: Dry eye disease (DED)

DefinitionA multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film, with tear film instability, hyperosmolarity, inflammation, and neurosensory abnormalities

SymptomsOcular symptoms such as irritation, light sensitivity, and fluctuating vision are typical

PrevalenceEstimated U.S. prevalence approximately 5–15%

inv-25: Tear osmolarity thresholds

Normal osmolarity270-308 mOsm/L

Mild DED308-316 mOsm/L

Moderate to severe DED

Policy Summary

PayerHealthfirst

PolicyEvaluation of Dry Eyes

Policy CodePolicy PO-RE-067v4

Change TypeMinor review — no material changes

Effective DateJul 1, 2025

Next Review Date

Key ActionOrder tear osmolarity testing to determine severity of dry eye or monitor therapy; document clinical exam findings to support testing.

SourceLink

On This Page

FDA approvals cite these devices as adjuncts to clinical assessment; their presence does not alone satisfy coverage for tests otherwise listed as not meeting coverage criteria.

AAO does not include MMP-9 as a standalone diagnostic in its appendix

inv-11: AXIM Eye Lactoferrin thresholds

AXIM Eye Lactoferrin - high>1.0 mg/ml

AXIM Eye Lactoferrin - low<0.8 mg/ml

Test performanceReported sensitivity 83% and specificity 98% for lactoferrin assay

inv-12: Tear osmolarity threshold

TFOS/diagnostic threshold>= 308 mOsm/L in either eye

Interocular difference>8 mOsm/L between eyes indicates abnormality

Interpretation noteOsmolarity values show variability and should be interpreted with clinical findings

inv-13: Tear break-up time threshold

TBUT abnormal cutoffLess than 10 seconds

Clinical implicationIndicates tear film instability and supports diagnosis of DED when correlated with symptoms

TFOS guidanceReduced non-invasive break-up time <10 seconds considered representative of disrupted homeostasis

inv-14: Schirmer test threshold

Schirmer test abnormal cutoff10 mm or less

Clinical useAssesses aqueous tear production; values <=10 mm suggest aqueous deficiency

Interpretation noteShould be correlated with symptoms and other objective findings per AAO guidance

Code reporting and documentation required

Coverage and reimbursement depend on proper coding and documentation. Use appropriate procedure codes and include clinical documentation supporting the indication (e.g., comprehensive eye exam findings, symptoms, and reason for testing). Procedure codes referenced in this policy are for reference and may not be exhaustive; follow Healthfirst coding and billing guidelines. Failure to follow coding/billing rules may result in denial or recoupment.

Relevant procedure codes (reference): 83861 (Microfluidic analysis, tear osmolarity); 83516, 83520, 82785 (other immunoassays/IgE) — confirm correct code for the performed test.
Document: comprehensive eye examination findings and clinical context when ordering tear osmolarity testing (symptoms, severity assessment, treatment monitoring).
Note: Tests that do not meet coverage criteria (e.g., MMP-9, lactoferrin, IgE) may be denied; do not submit these for coverage unless benefit language or coverage criteria change.

Note

Clinical pathway note

Clinical management of suspected dry eye commonly begins with non-pharmacologic measures and artificial tears; pharmacologic agents (topical cyclosporine, lifitegrast, corticosteroids) may be used when indicated. Diagnostic testing should be interpreted in the context of symptoms and other clinical findings; no single test is definitive.

Initial management: artificial tears, environmental modifications, eyelid/meibomian gland assessment.
Diagnostic approach: combine patient symptom questionnaires, tear break-up time, Schirmer test, ocular surface staining, and tear osmolarity as adjunctive data.
Interpretation: consider tear osmolarity >308 mOsm/L or inter-eye difference >8 mOsm/L as indicators of disease per TFOS guidance.

Documentation Required

Documentation guidance

Providers should document comprehensive eye examination findings, presenting symptoms, and the clinical rationale for ordering tear osmolarity testing. Include prior and current therapies and whether the test is being used to assess severity or monitor response to treatment. For tests that do not meet coverage criteria, document why the test is being considered if submitted for review.

Document: symptoms (e.g., dryness, grittiness, blurred vision), exam findings, and prior treatments.
Document purpose: indicate whether tear osmolarity is ordered to determine severity or to monitor therapy effectiveness.
Operational note: FDA-cleared devices (e.g., TearLab) are indicated to aid diagnosis in conjunction with other clinical evaluation; include device/test name when reporting.

Documentation Required

Clinical documentation and device use

Document clinical findings and the role of diagnostic tests in the patient’s overall assessment. Note FDA-cleared status of devices used (e.g., TearLab Osmolarity System) when applicable, and ensure laboratory-developed tests (LDTs) are validated per CLIA where relevant.

If using FDA-cleared devices (TearLab), document device and results in the medical record.
LDTs: labs performing in-house tests must follow CLIA '88 high-complexity requirements; include validation evidence if questioned.
Include how test results affected clinical management (e.g., change in therapy, monitoring decision).

Denial Risk

Denial triggers

Requests for MMP-9, lactoferrin, IgE, or other tear biomarker tests not discussed as covered may be denied because they DO NOT MEET COVERAGE CRITERIA. Submit complete clinical documentation if appealing denials.

MMP-9 (InflammaDry) testing is NOT covered per this policy and may be denied.
Lactoferrin and IgE testing are NOT covered and may be denied.
All other tear biomarker tests not explicitly covered are NOT covered due to insufficient evidence.

Billing Rule

Coding and billing compliance

Failure to follow proper coding, billing, and reimbursement guidelines (including use of correct CPT/HCPCS/ICD-10 codes, modifiers, and documentation) can result in claim denials or recoupment. Providers should align claims with Healthfirst and CMS coding standards.

Follow national coding standards and NCCI edits; include appropriate modifiers and supporting documentation.
Verify member benefits and coverage before ordering tests.
Keep contemporaneous records linking clinical findings to billed services to support medical necessity.

inv-26: Tear osmolarity abnormal

Diagnostic abnormality (per TFOS)Value over 308 mOsm/L in either eye

Interocular difference>8 mOsm/L between eyes indicates departure from homeostasis

Interpretation caveatNormal subjects show low variation; osmolarity should be used alongside other clinical tests

inv-27: Tear break-up time (TBUT) abnormal

Abnormal TBUT threshold< 10 seconds

Clinical meaningIndicates tear film instability and supports diagnosis of DED when correlated with symptoms

TFOS noteReduced non-invasive break-up time is one of three representative signs confirming disrupted homeostasis

inv-28: Schirmer test abnormal

Abnormal Schirmer cutoff10 mm or less

AssessesAqueous tear production; values <=10 mm considered abnormal

Use with other testsShould be interpreted in conjunction with symptoms and additional clinical findings