Currentblue cross blue shield - tennesseePolicy N/A

Evaluation of Dry Eyes — Coverage Criteria for Tear Diagnostic Tests

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Defines coverage stance for diagnostic tests used in evaluating dry eye disease (DED), specifying which tear assays meet or do not meet coverage criteria for Blue Cross Blue Shield - Tennessee members.

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Currentblue cross blue shield - tennesseePolicy N/A

Evaluation of Dry Eyes — Coverage Criteria for Tear Diagnostic Tests

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Sign up for all blue cross blue shield - tennessee policy alerts

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Policy Summary

Payerblue cross blue shield - tennessee

PolicyEvaluation of Dry Eyes — Coverage Criteria for Tear Diagnostic Tests

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionOrder tear osmolarity testing to assess severity and monitor therapy; do not order MMP-9, lactoferrin, or IgE tear tests as they do not meet coverage criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1covered diagnostic test

3excluded diagnostic tests

4procedure codes listed

7/1/2023effective date

5-15%prevalence cited

Coverage Criteria for Dry Eye Diagnostic Tests

Tear Osmolarity - Covered

Covered when ALL of the following are met

Tear osmolarity testing coverage: Testing of tear osmolarity in patients suspected of having dry eye meets coverage criteria to aid in determining the severity of dry eye disease and to monitor effectiveness of therapy.See thresholds: normal 270-308 mOsm/L; mild 308-316 mOsm/L; moderate–severe >316 mOsm/L. Abnormal defined as either eye >308 mOsm/L or inter-eye difference >8 mOsm/L.

Policy cites TearLab as an example and notes variability of measurements; clinicians should interpret results in clinical context and correlate with symptoms and other diagnostic tests.

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

Tests NOT covered

Excluded dry eye biomarker tests: Testing for MMP-9 protein, lactoferrin, and IgE in tears does not meet coverage criteria to aid in the diagnosis of patients suspected of having dry eye disease.InflammaDry detects MMP-9 >40 ng/mL (not covered).

Rationale includes limited specificity (does not differentiate dry eye from other inflammatory ocular surface disease), variability related to sample volume and band density, and insufficient published evidence of clinical benefit.

Other Dry Eye Tests - Not Covered

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 scientific literature confirming that the tests are required and beneficial for diagnosis and treatment.

Includes unspecified advanced tear diagnostics and novel biomarker assays unless explicitly supported elsewhere in this policy.

Diagnostic and Coverage Criteria (professional guidance)

Coverage rationale and diagnostic approach as outlined by multiple professional societies:

Combined assessment recommended: Diagnosis should be based on a combination of patient symptoms and multiple diagnostic tests rather than a single test result.

AAO and other societies state test results should be considered within the context of symptoms and other clinical findings.

TFOS homeostasis markers: Presence of any one of the following indicates disrupted tear film homeostasis: reduced non-invasive break-up time (<10 seconds), elevated tear osmolarity (>308 mOsm/L in either eye or interocular difference >8 mOsm/L), or ocular surface staining consistent with TFOS criteria.

TFOS diagnostic criteria support using any one of these markers to confirm DED when correlated with symptoms.

ASCRS preoperative screening: For preoperative screening prior to refractive surgery, initial evaluation should include the SPEED II questionnaire, tear osmolarity, and MMP-9 testing; an abnormal result on any initial screen indicates risk and need for further evaluation.

ASCRS recommends this screening sequence for surgeons evaluating ocular surface disease risk before surgery.

The policy excludes testing for tear biomarkers other than tear osmolarity. Specifically, MMP-9, lactoferrin, IgE assays and all other non-specified dry eye biomarker tests are stated to not meet coverage criteria for diagnosing patients suspected of having dry eye disease because there is insufficient published evidence showing these tests are required and beneficial for diagnosis and treatment. (See policy Reimbursement statements.)

The document notes that no single diagnostic test is a gold standard for dry eye disease; therefore, an isolated abnormal test value without corroborating clinical findings or additional testing may be insufficient to establish a diagnosis or support coverage. Test results should be interpreted within the broader clinical context, including symptom questionnaires and objective ocular surface assessments.

The policy explicitly states that the U.S. Food and Drug Administration has not approved or cleared this test (singular reference in the policy), while noting that FDA clearance is not required for clinical use. This lack of FDA approval/clearance is recorded as part of the policy rationale.

Use of MMP-9, lactoferrin, IgE assays and other tear biomarker tests that are not specifically supported by published evidence is considered not medically necessary / does not meet coverage criteria for the diagnosis of dry eye disease. The policy designates tear osmolarity testing as the covered tear assay and excludes these alternative biomarker tests from coverage.

The policy summarizes evidence that while some studies report associations between MMP-9 immunoassay results and clinical signs of dry eye, quantitative analyses of immunoassay band density have failed to show consistent correlation with clinical signs and symptoms in at least some investigations. This inconsistency undermines the validity of quantitative band-density approaches for clinical decision-making.

Within the cited sections there are no explicit statements labeling tests as 'not medically necessary' beyond the policy's coverage determinations; the policy records FDA approval status but does not frame those chunks as direct 'not medically necessary' declarations.

Procedure Codes and Thresholds

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

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

Tear osmolarity severity thresholds — inv-13

Normal range270-308 mOsm/L

Mild dry eye308-316 mOsm/L

Moderate to severe dry eye>316 mOsm/L

InflammaDry detection threshold — inv-14

InflammaDry detection threshold>40 ng/mL MMP-9

Clinical contextDetects elevated MMP-9 associated with ocular surface inflammation

Study finding

Provider Guidance and Billing Actions

Prior Authorization

Coverage summary for tear tests

Testing of tear osmolarity in patients suspected of having dry eye MEETS COVERAGE CRITERIA to aid in determining the severity of dry eye disease and to monitor effectiveness of therapy; testing for MMP-9, lactoferrin, IgE, and other non‑specified dry eye biomarker tests DO NOT MEET COVERAGE CRITERIA.

Tear osmolarity is covered to determine severity and monitor therapy.
MMP-9, lactoferrin, IgE, and other biomarker tests are excluded from coverage.

Note

Confirm prior authorization for listed CPT/HCPCS codes

Procedure codes listed in the policy (82785, 83516, 83520, 83861) are provided as reference; providers should confirm whether prior authorization is required for these codes under the member’s benefit.

82785, 83516, 83520, 83861 are referenced in Section VIII.
Confirm payer-specific prior authorization rules before submitting requests.

Background and Scope

Background: Dry eye disease (DED) is a multifactorial disorder of the ocular surface characterized by loss of tear film homeostasis, tear film instability, hyperosmolarity, inflammation, and neurosensory abnormalities. It commonly affects older adults, presents with variable signs and symptoms, and typically requires a combination of symptom assessment and multiple objective tests (for example questionnaires, tear break-up time, Schirmer testing, ocular surface staining, and tear osmolarity) for diagnosis because no single definitive diagnostic test exists.

Definitions and Test Descriptions

DED — Dry eye disease definition from DEWS — inv-31

Definition (DEWS II)A multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, accompanied by symptoms where tear film instability, hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.

Population impactEstimated US prevalence 5-15%

Clinical implicationDiagnosis typically requires combination of symptom assessment and multiple tests; no single definitive diagnostic test exists.

Tear osmolarity — measurement and clinical relevance — inv-32

MeasurementMeasurement of dissolved solute concentration in tears (osmolarity) using devices such as TearLab; sample analyzed by electrical impedance.

Clinical relevance

Policy Summary

Payerblue cross blue shield - tennessee

PolicyEvaluation of Dry Eyes — Coverage Criteria for Tear Diagnostic Tests

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionOrder tear osmolarity testing to assess severity and monitor therapy; do not order MMP-9, lactoferrin, or IgE tear tests as they do not meet coverage criteria.

SourceLink

On This Page

MMP-9 utility: MMP-9 testing may have utility primarily in more severe cases, with InflammaDry positivity generally occurring above ~40 ng/mL.

Professional panels note limitations in specificity and recommend interpreting MMP-9 in the broader clinical context.

InflammaDry positive in ~40% of confirmed dry eye patients in cited study

Tear osmolarity thresholds — inv-15

Abnormal osmolarity — either eye>308 mOsm/L

Inter-eye difference>8 mOsm/L

Interpretation noteTFOS/consensus treat either condition as indicative of loss of tear film homeostasis

MMP-9 positivity threshold — inv-16

MMP-9 positive threshold>40 ng/mL

Test typePoint-of-care immunoassay (InflammaDry) detects levels above this threshold

Clinical implicationIndicates ocular surface inflammation but may not distinguish dry eye from other inflammatory ocular surface diseases

Schirmer test threshold — inv-17

Schirmer test abnormal threshold≤10 mm wetting

PurposeQuantifies aqueous tear production by strip wetting length in mm

Test variabilityHighly variable; should not be used as sole diagnostic test

Prior Authorization

Prior authorization for listed procedure codes

Use of CPT/HCPCS codes 82785, 83516, 83520, and 83861 is referenced for the diagnostic tests in this policy; follow the payer’s prior authorization processes where applicable for these codes.

Codes referenced: 82785 (IgE), 83516, 83520 (immunoassays), 83861 (tear osmolarity).
Obtain prior authorization per member benefits and payer procedures when required.

Step Therapy

Clinical evaluation pathway

Clinical evaluation typically begins with assessment of symptoms and standard tests such as patient symptom questionnaires, tear film break-up time (TFBUT), Schirmer test, ocular surface staining, and meibomian gland evaluation prior to advanced diagnostics.

Symptom questionnaires and physical findings are essential because no single definitive diagnostic test exists.
Standard tests: TFBUT, Schirmer, ocular surface staining, and meibomian gland functionality.

Step Therapy

Recommended screening sequence

ASCRS recommends initial screening before refractive surgery with the SPEED II questionnaire, tear osmolarity, and MMP-9 testing; if any initial screening test is abnormal, perform additional diagnostic testing as indicated.

Initial screening: SPEED II questionnaire, tear osmolarity, and MMP-9 per ASCRS.
Abnormal initial results warrant further testing to determine dry eye sub-type.

Documentation Required

Required documentation considerations

Document the clinical indication demonstrating why tear osmolarity testing is medically necessary for assessing disease severity or monitoring response to therapy in patients suspected of having dry eye disease.

Include clinical context showing how results will affect management.
Reference that other novel/biomarker tests lack sufficient published evidence per policy rationale when applicable.

Documentation Required

Clinical correlation required

Document how tear test results correlate with the patient’s symptoms and other clinical findings; interpret results within the overall clinical context rather than as a sole diagnostic determinant.

AAO states test results should be considered within context of symptoms and other findings.
No single test is adequate; combine findings from multiple diagnostic tests.

Billing Rule

Coding and claim submission

When submitting claims, reference the procedure codes listed in the policy (82785, 83516, 83520, 83861) and include documentation supporting medical necessity as required by the payer.

Include applicable CPT/HCPCS code on the claim.
Attach supporting clinical documentation to justify medical necessity for covered tests.

Denial Risk

Denial triggers for excluded tests

Claims for MMP-9, lactoferrin, IgE, and other non‑specified dry eye biomarker tests may be denied because these tests DO NOT MEET COVERAGE CRITERIA per the policy.

MMP-9, lactoferrin, and IgE testing are explicitly listed as not meeting coverage criteria.
All other testing used in diagnosis of suspected dry eye disease does not meet coverage criteria.

Denial Risk

Conflicts with government coverage

If this policy conflicts with applicable government coverage (e.g., LCDs/NCDs or state Medicaid), the government policy governs determinations and should be followed to avoid coverage denials.

Government policies (LCDs/NCDs, state Medicaid) take precedence over this policy.
Consult CMS or state Medicaid resources for the most up-to-date applicable rules.

Note

FDA approval status noted

The policy notes that the U.S. Food and Drug Administration has not approved or cleared this test, although FDA clearance or approval is not currently required for clinical use; lack of FDA approval is identified in the policy.

Policy statement: FDA has not approved or cleared this test, but clearance is not required for clinical use.

Tear hyperosmolarity is a validated marker of dry eye and correlates with severity though variability exists; thresholds inform severity classification.

Practical noteTearLab collects small tear sample (~50 µL); studies report variability and overlapping values between healthy and DED patients—interpret with clinical correlation.

MMP-9 — description and InflammaDry threshold — inv-33

Marker descriptionMatrix metallopeptidase-9 (MMP-9) is an inflammatory enzyme produced by corneal epithelial cells and elevated in tears with ocular surface inflammation.

InflammaDry detectionInflammaDry detects MMP-9 levels >40 ng/mL

Clinical limitationsMMP-9 may indicate inflammation but does not differentiate dry eye from other inflammatory ocular surface diseases and has variable sensitivity/specificity across studies.

Abnormal tear osmolarity — inv-34

Abnormal criteria>308 mOsm/L in either eye

OrInterocular difference >8 mOsm/L

Consensus sourceTFOS DEWS II and supporting studies endorse these cutoffs as indicative of disrupted tear film homeostasis.

MMP-9 positive — inv-35

Positive test definitionMMP-9 testing (InflammaDry) is typically positive when MMP-9 concentration exceeds approximately 40 ng/mL.

Clinical meaningIndicates ocular surface inflammation; may be useful in more severe cases where levels exceed threshold.

LimitationsPositivity does not necessarily confirm dry eye specifically and should be interpreted with other clinical findings.

Schirmer test abnormal — inv-36

Abnormal wettingSchirmer strip wetting of 10 mm or less is considered abnormal

PurposeAssesses aqueous tear production by measuring length of wetting on filter paper strip over a set time period.

Interpretation caveatTest is highly variable and should not be relied upon as the sole diagnostic measure.

Tear osmolarity — measurement of tear film salt concentration — inv-37

What it measuresTear osmolarity measures the salt concentration of the tear film and is used as an objective test for dry eye.

Clinical utilityLow variation in normal subjects affords high specificity; elevated osmolarity (>308 mOsm/L) or large interocular disparity (>8 mOsm/L) indicate disrupted homeostasis.

Device referenceTearLab is cited as an example device; studies report variability and recommend clinical correlation when interpreting results.

MMP-9 immunoassay — point-of-care detection — inv-38

Assay typePoint-of-care immunoassay for MMP-9 (e.g., InflammaDry)

Intended detectionDetects elevated MMP-9 as a marker of ocular surface inflammation

Interpretive noteUseful for identifying inflammation, often positive above ~40 ng/mL, but has limitations in specificity and clinical correlation across studies.