CurrentBlue Cross Blue Shield - TennesseePolicy N/A

Evaluation of Dry Eyes (Diagnostic Testing for Dry Eye Disease)

This policy governs coverage for diagnostic tests used to evaluate suspected dry eye disease (DED) and applies to Blue Cross Blue Shield - Tennessee members; coverage depends on individual benefits and Medicare/Medicaid specifications referenced elsewhere in the full policy.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyEvaluation of Dry Eyes (Diagnostic Testing for Dry Eye Disease)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionDocument correlation of tear osmolarity and other test results with clinical findings and verify member benefits before ordering.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5-15%estimated US prevalence

308 mOsm/Losmolarity cut-off

40 ng/mLMMP-9 threshold

3FDA-cleared devices referenced

~20peer-reviewed refs

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Coverage Criteria

Coverage stance by test type

Coverage determinations for diagnostic tests in suspected dry eye disease:

Tear Osmolarity: Testing of tear osmolarity in patients suspected of having dry eye MEETS COVERAGE CRITERIA to aid in determining the severity of dry eye disease as well as monitor effectiveness of therapy.see thresholds module

Associated clinical context and variability discussed in Background and Tear Osmolarity sections.

MMP-9 Testing: Testing for MMP-9 protein in human tears DOES NOT MEET COVERAGE CRITERIA to aid in the diagnosis of patients suspected of having dry eye disease based on comprehensive eye examination.InflammaDry >40 ng/mL detects elevated MMP-9

Clinical studies show variable sensitivity, sample-volume dependence, and limited differentiation from other ocular surface inflammatory disease.

Lactoferrin and IgE Testing: Testing for lactoferrin and/or IgE to aid in the diagnosis of patients suspected of having dry eye disease DOES NOT MEET COVERAGE CRITERIA.manufacturer and literature values cited but not validated for coverage

TearScan manufacturer claims vs third-party reviews summarized in background.

Other Tests: All other testing used in the diagnosis of patients suspected of having dry eye disease DOES NOT MEET COVERAGE CRITERIA due to lack of published literature confirming clinical benefit.

Standard clinical tests (TFBUT, Schirmer, staining, questionnaires) remain part of diagnosis but other novel tests lack coverage support in this policy excerpt.

Diagnostic criteria and appropriate use

Covered when diagnostic testing is used in conjunction with clinical evaluation and symptoms to establish DED or guide management, per specialty society recommendations.

Combined diagnostic approach: Diagnosis should not rely on a single test; results must be correlated with symptoms and other clinical findings (AAO, TFOS).

Supported by AAO and TFOS guidance

Homeostasis markers indicating DED: Presence of any one of: reduced non-invasive break-up time (<10s), elevated tear osmolarity (>=308 mOsm/L in either eye) or interocular difference >8 mOsm/L, or ocular surface staining (per TFOS spot counts) confirms disrupted homeostasis.TBUT <10s; osmolarity >=308 mOsm/L or interocular difference >8 mOsm/L

TFOS DEWS II criteria

Inflammation marker: Elevated MMP-9 (~>40 ng/mL) indicates ocular surface inflammation and may be useful for more severe cases to guide anti-inflammatory therapy.~40 ng/mL

Testing for MMP-9, lactoferrin, IgE, and other non‑osmolarity biomarker assays for evaluation of suspected dry eye disease are excluded from coverage. The policy states explicitly that "Testing for MMP-9 protein in human tears DOES NOT MEET COVERAGE CRITERIA" and that "Testing for lactoferrin and/or IgE ... DOES NOT MEET COVERAGE CRITERIA." Further, "All other testing used in the diagnosis of patients suspected of having dry eye disease DOES NOT MEET COVERAGE CRITERIA" due to lack of published evidence demonstrating clinical benefit.

The policy emphasizes that diagnosis should not be based on a single diagnostic test. Clinical guidance cited notes high variability and lack of a gold standard, and the American Optometric Association highlights a "lack of a defined diagnostic test or protocol" and incongruity between symptoms and tests. The policy requires that diagnostic testing results be correlated with patient symptoms and other clinical findings rather than used in isolation.

Some reference sections in the policy provide literature citations and background but do not themselves establish explicit coverage exclusions. Those reference-only excerpts summarize evidence and guidelines without listing additional exclusions beyond the coverage statements in Section II.

The policy specifically states that testing beyond tear osmolarity does not meet coverage criteria. By contrast, testing of tear osmolarity "MEETS COVERAGE CRITERIA to aid in determining the severity of dry eye disease as well as monitor effectiveness of therapy," whereas MMP-9, lactoferrin, IgE and other non‑osmolarity tests are not covered.

The policy notes that reliance on a single diagnostic test (for example, the Schirmer test) is insufficient because many tests have high variability and no single gold‑standard exists. The Schirmer test is described as "an extremely variable test, so it should not be used as the only diagnostic test."

Within the provided excerpts there are literature and guideline references that inform the coverage stance, but no standalone statements elsewhere in the reference lists explicitly frame additional procedures as "not medically necessary" beyond the coverage decisions already stated in Section II.

Coding

Procedure codes (listed)CPT

82785

Gammaglobulin (immunoglobulin); IgE

Immunoassay / Tear osmolarity codesCPT

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 identifiers citedmixed

K934473	FDA PMN identifier referenced (device approval record)
K132066	FDA document identifier referenced

Tear osmolarity severity thresholds

Normal range270–308 mOsm/L

Mild dry eye308–316 mOsm/L

Moderate–severe dry eye>316 mOsm/L

MMP-9 assay detection threshold

Assay detection threshold>40 ng/mL (InflammaDry detection limit)

Clinical implicationPositive results indicate elevated MMP-9 associated with ocular surface inflammation

Performance noteMay be more likely positive in more severe dry eye; sensitivity variable across studies

Tear osmolarity thresholds

Elevated osmolarity — either eye≥308 mOsm/L in either eye

Interocular differenceInterocular difference greater than 8 mOsm/L

InterpretationEither criterion indicates departure from tear film homeostasis and supports DED diagnosis

Tear break-up time threshold

Abnormal TBUT thresholdTear break-up time < 10 seconds considered abnormal

Test methodEvaluated with fluorescein dye observing time to first discontinuity of tear film

Role in diagnosisReduced TBUT is a homeostasis marker that supports DED when correlated with symptoms

Schirmer test abnormal threshold

Abnormal Schirmer threshold≤10 mm wetting considered abnormal for aqueous tear production

Test methodFilter paper placed in lower eyelid; length of wetting measured in mm

Clinical caveatHighly variable test; should not be used alone to establish diagnosis

MMP-9 positivity threshold (~40 ng/mL)

Positive MMP-9>~40 ng/mL considered positive on point-of-care InflammaDry

Biologic significanceIndicates ocular surface inflammation and may guide anti-inflammatory therapy in more severe cases

Test limitationsVariable sensitivity; may not differentiate dry eye from other inflammatory ocular surface disease

Provider Actions / Billing Guidance

Prior Authorization

Prior Authorization / Benefit Verification

Prior authorization is not specified in this section. Benefit verification is required since coverage depends on an individual's benefits and applicable Medicare/Medicaid rules.

Benefit verification required — confirm member-specific and state/Federal (LCD/NCD/Medicaid) rules prior to testing.
If a conflict exists between this policy and any applicable government policy (LCD/NCD or state Medicaid), the government policy governs and claims may be denied if they conflict.

Denial Risk

Denial Risk for Specific Biomarker Tests

Testing for MMP-9, lactoferrin, and IgE to aid in the diagnosis of dry eye disease does not meet coverage criteria and may be denied. All other tests not meeting coverage criteria are likewise non-covered.

Denial triggers include claims for MMP-9 protein testing, lactoferrin testing, and IgE (e.g., CPT 82785) when billed to support diagnosis of dry eye disease.
Claims for other diagnostic biomarkers/tests not supported by published evidence may be denied as not meeting coverage criteria.

Billing Rule

Billing / Procedure Codes

Procedure codes referenced in the policy are for informational/billing guidance; they may not be all-inclusive. Providers should bill using appropriate CPT/HCPCS codes and follow payer billing rules.

CPT 83861 — Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity (listed).
CPT 83516, 83520 — Immunoassay codes for qualitative/quantitative analytes (may apply to immunoassays).
CPT 82785 — Gammaglobulin (IgE) referenced in policy; use with caution given non-coverage for IgE testing for dry eye diagnosis.

Documentation Required

Guidelines, Literature, and Documentation

This section contains literature references and guideline citations that inform the coverage stance. Providers should document correlation of test results with clinical findings when using tear osmolarity and adhere to guideline-recommended diagnostic sequencing.

Document correlation of tear osmolarity results with patient symptoms and other clinical findings; single osmolarity values should not be the sole basis for diagnosis.
Guidelines recommend screening (symptom questionnaire and tear osmolarity) before subtype-specific testing; follow recommended diagnostic sequencing (osmolarity -> inflammation assessment -> further tests).
Literature cited includes validation and diagnostic accuracy studies relevant to coverage determinations and provider rationale.

Step Therapy

Step Therapy / Quantity Limits

No step therapy rules or quantity limits are described in this section of the policy.

No step therapy or prior authorization step rules are provided for tear osmolarity or other dry eye diagnostic tests in this section.

Definitions

Definition of Dry Eye Disease (DED)

DefinitionDry eye disease (DED) is a multifactorial disease of the ocular surface characterized by loss of tear film homeostasis accompanied by ocular symptoms; tear film instability, hyperosmolarity, inflammation, and neurosensory abnormalities contribute etiologically.

SynonymsAlso referred to as dysfunctional tear syndrome (DTS)

EpidemiologyEstimated prevalence in U.S. adults: 5–15%

Biomarkers/tests referenced

Referenced biomarkers/testsTear osmolarity (TearLab), MMP-9 (InflammaDry), lactoferrin (TearScan)

Additional clinical testsTear break-up time, Schirmer test, ocular surface staining

RoleUsed in combination with symptoms and exam — no single test is diagnostic

Elevated tear osmolarity definition

Threshold — single-eye value>=308 mOsm/L in either eye

Threshold — interocular difference>8 mOsm/L difference between eyes

Clinical interpretationValues indicate departure from tear film homeostasis and support diagnosis of DED

MMP-9 positivity (~40 ng/mL)

Positivity cut-off>~40 ng/mL on InflammaDry considered positive for MMP-9

ImplicationSuggests ocular surface inflammation and may be more likely positive in severe dry eye

LimitationsDoes not reliably differentiate dry eye from other inflammatory ocular surface disease

Tear break-up time (TBUT) — abnormal <10 seconds

Abnormal TBUTTear break-up time (TBUT) < 10 seconds considered abnormal

MeasurementAssessed using fluorescein dye to time tear film discontinuity

Diagnostic roleReduced TBUT is a marker of tear film instability and supports DED when combined with symptoms

Schirmer test — ≤10 mm abnormal

Abnormal valueSchirmer test wetting ≤10 mm considered abnormal

ProcedureFilter paper placed in lower eyelid and wetting length measured in mm

LimitationsHighly variable; should not be used as sole diagnostic test

MMP-9 biomarker description

Biomarker identityMMP-9 is a matrix metalloproteinase produced by corneal epithelial cells and associated with inflammation and wound healing

MeasurementDetected in tears by point-of-care immunoassay (InflammaDry); positive >~40 ng/mL

Clinical useIndicates ocular surface inflammation and may help guide anti-inflammatory therapy in select patients

Tear osmolarity description

What it measuresTear osmolarity quantifies salt concentration (osmolarity) of the tear film

Clinical relevanceTear hyperosmolarity is a validated marker of dry eye and reflects loss of tear film homeostasis

Device/exampleTearLab is a point-of-care system that measures tear osmolarity and has shown variable results across studies