ModifiedPremera BluecrossPolicy ROUTINE TEST MANAGEMENT POLICY - 15.01.007

Evaluation of Dry Eyes (diagnostic testing for dry eye disease)

This policy governs coverage and reimbursement for diagnostic tests used in evaluation of dry eye disease (DED), specifying which tear biomarkers and osmolarity tests are reimbursable and which are not, for Premera Blue Cross members.

Policy Summary

PayerPremera Bluecross

PolicyEvaluation of Dry Eyes (diagnostic testing for dry eye disease)

Policy CodePolicy ROUTINE TEST MANAGEMENT POLICY - 15.01.007

Change TypeNew policy addedmaterial change

Effective DateFeb. 6, 2026

Next Review Date

Key ActionFor individuals suspected of having dry eye, perform tear osmolarity testing only when used to determine disease severity or to monitor effectiveness of therapy and document clinical intent.

SourceLink

POLICY UPDATE CHANGES

New policy added to Routine Test Management Policy stating tear osmolarity testing is reimbursable for individuals suspected of having dry eye when used to determine disease severity or monitor therapy.

5-15%US population affected

308 mOsm/LOsmolarity cut-off

40 ng/mLMMP-9 threshold

11/01/25 → 02/06/26Policy timeline

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 and Medical Necessity Criteria

Reimbursable testing

Covered when ANY of the following are met

Reimbursable tear osmolarity: Testing of tear osmolarity is reimbursable for individuals suspected of having dry eye when used to help determine severity of disease.CPT 83861

Per Indications: reimbursable when used to determine disease severity.

Reimbursable tear osmolarity for monitoring: Testing of tear osmolarity is reimbursable for individuals suspected of having dry eye when used to monitor effectiveness of therapy.CPT 83861

Per Indications: reimbursable when used to monitor therapy effectiveness.

Non-reimbursable testing

Not reimbursable tests

Non-reimbursable biomarkers: Testing for MMP-9 protein, lactoferrin, and/or IgE in individuals suspected of having dry eye disease is not reimbursable.CPT 82785, 83516, 83520

Policy explicitly lists these tests as not reimbursable.

Tear osmolarity testing - covered use

Covered when ALL of the following are met

Coverage conditions: Individual is suspected of having dry eye disease.

Clinical suspicion documented by comprehensive eye examination or equivalent.

Coverage conditions: Tear osmolarity testing is used to determine disease severity or to monitor effectiveness of therapy.CPT 83861

Testing must be performed with the indicated clinical intent to be reimbursable.

Coverage conditions: Testing is performed in conjunction with other clinical evaluation as appropriate per professional guidelines (e.g., correlation with clinical findings, inter-eye differences, and other diagnostic signs).

TFOS and AAO guidance recommend correlating osmolarity with clinical findings; abnormal thresholds include >308 mOsm/L in either eye or interocular difference >8 mOsm/L.

All other diagnostic tests for dry eye disease not specifically discussed in this policy do not meet coverage criteria and are not reimbursable. This exclusion applies when available published scientific literature does not confirm that the test is required and beneficial for diagnosis or treatment of an individual with suspected dry eye disease.

This medical policy is part of Premera's routine test management guidance and does not apply to Medicare Advantage. Coverage and reimbursement remain subject to the limits and conditions of the member benefit plan; providers and members should consult the member benefit booklet or contact customer service to determine specific benefit limitations.

Testing for MMP-9 protein, lactoferrin, and/or IgE in individuals suspected of having dry eye disease is not reimbursable. These biomarker assays are explicitly listed in the policy as non-reimbursable and therefore may be denied when billed (see applicable CPT codes such as 82785, 83516, and 83520).

Tests for tear osmolarity or other dry eye diagnostics performed without documentation that they were used to determine disease severity or to monitor effectiveness of therapy, or performed outside applicable member benefit limits and notification requirements, may not meet medical necessity for reimbursement. Claims should include clinical documentation supporting suspicion of dry eye and the test's intended purpose (severity assessment or monitoring) consistent with routine test management guidance.

Coding, Thresholds, and Test References

Coding 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 Codesmixed

No codes listed

FDA-cleared devices/tests referenced (not CPT codes)neutral

No codes listed

Tear osmolarity severity thresholds

Normal270-308 mOsm/L

Mild308-316 mOsm/L

Moderate–Severe>316 mOsm/L

MMP-9 assay detection threshold

InflammaDry detection cutoff>40 ng/mL

Clinical implicationTest positivity reported only above ~40 ng/mL, may indicate ocular surface inflammation

Use caseCan help identify patients with autoimmune disease and ocular surface inflammation

Lactoferrin test cutoffs

High lactoferrin>1.0 mg/mL

Low lactoferrin<0.8 mg/mL

Test performance (AXIM Eye)98% specificity / 83% sensitivity

Tear osmolarity threshold

Primary threshold>308 mOsm/L in either eye

Interocular difference>8 mOsm/L between eyes

InterpretationValues meeting either criterion indicate departure from tear film homeostasis

MMP-9 positivity threshold

Positive thresholdApproximately >40 ng/mL

Clinical notePositive results may reflect more severe inflammation and are less sensitive for mild disease

Test exampleInflammaDry reports positivity above this level

Provider Billing, Documentation, and Denial Risk

Denial Risk

Reimbursement contingent on indicated use

Tear osmolarity testing (CPT 83861) is considered reimbursable only when performed for individuals suspected of having dry eye to determine disease severity or to monitor the effectiveness of therapy. Testing performed for other indications or when not aligned with routine test management guidance may be denied.

Affected CPT: 83861 (Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity).
Non-reimbursable tear biomarker tests: MMP-9, lactoferrin, and IgE testing are not reimbursable for suspected dry eye.
Providers should verify member benefits as coverage may vary by contract.

Documentation Required

Documentation for reimbursable tear osmolarity

For tear osmolarity testing to be reimbursable, the claim and medical record must document that the test was performed for an individual suspected of having dry eye and that the clinical intent was to determine disease severity or to monitor response to therapy.

Include the clinical indication (suspected dry eye) and the specific intent (assess severity or monitor therapy) in the claim and chart notes.
Link test results to a comprehensive eye examination or other supporting clinical evaluation in the medical record.
Retain documentation showing how test results influenced management (e.g., treatment changes or continuation).

Documentation Required

Clinical intent documentation

Claims should explicitly state the clinical intent — that tear osmolarity testing was used to determine the severity of dry eye disease or to monitor the effectiveness of therapy — to support reimbursement and reduce denial risk.

Preferred claim language: 'Tear osmolarity performed to assess severity of dry eye' or 'Tear osmolarity performed to monitor therapy effectiveness'.
If testing is used serially to monitor therapy, document dates of prior tests and treatment changes tied to results.
Do not submit claims or documentation that imply use for investigational or non-covered indications.

Clinical Background and Rationale

Dry eye disease (DED) is a multifactorial ocular surface disorder characterized by loss of tear film homeostasis, tear film instability, hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities. Diagnosis typically relies on symptoms plus objective testing (for example, tear breakup time, Schirmer testing, and ocular surface staining), while quantitative tools such as tear osmolarity and point-of-care inflammatory biomarkers have been developed to aid assessment. In this policy, tear osmolarity testing (CPT 83861) is considered reimbursable when performed for individuals suspected of having dry eye to determine disease severity or to monitor effectiveness of therapy, provided testing is performed in conjunction with appropriate clinical evaluation. Biomarker tests for MMP-9, lactoferrin, and IgE are not reimbursable per the indications herein.

Definitions and Test Descriptions

DED (definition)

DefinitionDry eye disease (DED): a multifactorial disease of the ocular surface characterized by loss of tear film homeostasis, tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities.

SynonymsDysfunctional tear syndrome (DTS)

PrevalenceEstimated 5–15% of US population

Tear osmolarity

What it measuresConcentration of dissolved solutes in tears (mOsm/L)

Validated markerElevated osmolarity is a validated marker of dry eye

Key thresholds>308 mOsm/L in either eye or interocular difference >8 mOsm/L indicate disrupted homeostasis

MMP-9

What it isMatrix metallopeptidase-9 (MMP-9), an inflammatory mediator measurable in tears

Detection cutoffInflammaDry detects MMP-9 >40 ng/mL

Clinical roleMay indicate ocular surface inflammation and can guide anti-inflammatory treatment selection

Lactoferrin

What it reflectsLactoferrin: tear biomarker reflecting lacrimal gland secretory function; low levels correlate with aqueous deficiency

Use in testingPoint-of-care assays (e.g., AXIM) and microassays exist but require standardized collection protocols

Research findingPooled mean difference shows decreased lactoferrin in DED (0.62, 95% CI 0.35–0.89)

Tear osmolarity (clinical context)

Measure typeQuantitative measure of tear film solute concentration (mOsm/L)

Clinical significanceElevated values and increased inter-eye variability indicate disrupted tear film homeostasis and support DED diagnosis

Practical noteCorrelation with other clinical findings improves diagnostic accuracy

MMP-9 (clinical context)

Assay typePoint-of-care immunoassay detecting MMP-9 in tears

Positivity thresholdReported only above approximately 40 ng/mL

Clinical implicationPositive result may reflect more severe inflammation and support targeted anti-inflammatory therapy

Lactoferrin (clinical context)

Clinical observationLactoferrin concentration can be reduced in DED and has been studied as a diagnostic biomarker

Testing considerationsPoint-of-care lactoferrin assays and microassays exist but require standardized tear collection protocols for reliable results

ImplicationLow lactoferrin correlates with aqueous-deficient dry eye

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