CurrentFidelis CarePolicy FC.CG.PP.11

Payment Policy: Non-Genetic Immunology and Rheumatology Testing

Defines coverage and payment policy for non-genetic immunology and rheumatology laboratory tests (e.g., ANA, ANA subserologies, rheumatoid factor/anti-CCP, SLE algorithmic tests) for Fidelis Care Medicaid and Health Insurance Marketplace products and specifies covered indications and non-covered uses.

Policy Summary

PayerFidelis Care

PolicyPayment Policy: Non-Genetic Immunology and Rheumatology Testing

Policy CodePolicy FC.CG.PP.11

Change TypeNo material change

Effective Date

Next Review Date

Key ActionOrder ANA testing for members with signs or symptoms of autoimmune/systemic rheumatic disease and reflex to ANA subserologies when the initial ANA is positive.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Medicaid, MarketplaceProduct types

3Major named test groups

~30+CPT/HCPCS/PLA codes listed

02/2026Last review

Coverage Criteria for Immunology and Rheumatology Tests

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Antinuclear Antibody (ANA) Tests

Covered when ALL of the following are met

ANA coverage: The member/enrollee has signs or symptoms of autoimmune/systemic rheumatic disease.

ANA tests are not covered for monitoring disease status, isolated fatigue, fibromyalgia, or screening of asymptomatic individuals.

Antinuclear Antibody (ANA) Subserology Tests

Covered when ANY of the following conditions are met (with one AND condition nested)

ANA subserologies coverage: A. The member/enrollee has signs or symptoms of autoimmune/systemic rheumatic disease AND the member/enrollee has a positive antinuclear (ANA) test;

ANA subserologies include antibodies to dsDNA, histone, SS-A (Ro), SS-B (La), Smith, Smith/RNP, Scl-70, Jo-1, and centromeric proteins. Automatic reflex from initial ANA testing when appropriate for initial workup is considered appropriate.

ANA subserologies coverage: B. The member/enrollee has signs or symptoms of myositis;

ANA subserologies coverage: C. The member/enrollee is being monitored after diagnosis with an autoimmune/systemic rheumatic disease.

Systemic Lupus Erythematosus Diagnostic and Prognostic Algorithmic Tests

SLE algorithmic tests: The use of systemic lupus erythematosus diagnostic and prognostic algorithmic tests is not covered for all indications.

No covered indications specified in this section.

Rheumatoid Factor and/or Anti-Cyclic Citrullinated Peptide (anti-CCP) Tests

Covered when ALL of the following are met

RF/anti-CCP coverage: A. The member/enrollee has synovitis of at least one joint; AND B. The member's/enrollee's synovitis is NOT better explained by another diagnosis (e.g., injury, overuse/strain, gout).

RF and/or anti-CCP tests are not covered for other indications, including screening of asymptomatic individuals.

The policy specifies that Antinuclear Antibody (ANA) tests are not covered for routine or non-indicated uses. Examples of non-covered uses include testing for monitoring disease status, evaluation of isolated fatigue, assessment of fibromyalgiascreening of asymptomatic individuals. Similarly, ANA subserology tests and algorithmic SLE panels are only covered for the limited indications listed in the policy and are not covered for all other uses. Rheumatoid factor and anti-CCP testing is restricted to the documented synovitis indication and is not covered for screening asymptomatic individuals.

This payment policy is intended as a guide to payment and does not guarantee payment. Coverage and payment decisions remain subject to the member’s plan terms, evidence of coverage, and any applicable state or federal requirements. Providers should verify benefits and applicable exclusions, limitations, prior authorization rules, and plan-level administrative policies before submitting claims.

Use of the listed immunology and rheumatology tests outside the specific covered indications in this policy is considered not medically necessary and may be denied. Examples include routine screening of asymptomatic individuals, performing ANA or ANA subserologies for monitoring when monitoring is not an allowed indication, and ordering SLE algorithmic diagnostic/prognostic panels which the policy states are not covered for all indications. Claims submitted for tests performed outside the policy’s allowed indications are subject to denial and to the terms, conditions, exclusions and limitations of the member’s coverage documents.

Coding and Test Codes

Referenced CPT/HCPCS/PLA Codes (examples listed)mixed

82040	Albumin; serum, plasma or whole blood.
82042	Albumin; other source, quantitative, each specimen.
82784	Gammaglobulin (immunoglobulin); IgA, IgD, IgG, IgM, each.
86038	Antinuclear antibodies (ANA).
86039	Antinuclear antibodies (ANA); titer.
86200	Cyclic citrullinated peptide (CCP), antibody.
86430	Rheumatoid factor; qualitative.
86431	Rheumatoid factor; quantitative.
86225	Deoxyribonucleic acid (DNA) antibody; native or double stranded.
0039U	Deoxyribonucleic acid (DNA) antibody, double stranded, high avidity.

1–10 of 12

1/2

HLA antibody testing CPT codesCPT

86828	Antibody to human leukocyte antigens (HLA), solid phase assays; qualitative assessment of presence or absence of antibody(ies) to HLA Class I and Class II antigens
86829	Antibody to HLA, solid phase assays; qualitative assessment of presence or absence of antibody(ies) to HLA Class I or Class II antigens
86830	Antibody to HLA, solid phase assays; antibody identification by qualitative panel using complete HLA phenotypes, HLA Class I
86831	Antibody to HLA, solid phase assays; antibody identification by qualitative panel using complete HLA phenotypes, HLA Class II
86832	Antibody to HLA, solid phase assays; high definition qualitative panel for identification of antibody specificities, HLA Class I
86833	Antibody to HLA, solid phase assays; high definition qualitative panel for identification of antibody specificities, HLA Class II
86834	Antibody to HLA, solid phase assays; semi-quantitative panel (eg, titer), HLA Class I
86835	Antibody to HLA, solid phase assays; semi-quantitative panel (eg, titer), HLA Class II

Additional immunology/transfusion/flow/cytology CPT codesCPT

86849	Unlisted immunology procedure
86850	Antibody screen, RBC, each serum technique
86860	Antibody elution (RBC), each elution
86870	Antibody identification, RBC antibodies, each panel for each serum technique
86999	Unlisted transfusion medicine procedure
88184	Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; first marker
88341	Immunohistochemistry or immunocytochemistry, per specimen; each additional single antibody stain procedure
88342	Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain procedure

Category I/III/Proprietary laboratory tests (HCPCS U-codes)HCPCS

0039U	Deoxyribonucleic acid (DNA) antibody, double stranded, high avidity
0077U	Immunoglobulin paraprotein (M-protein), qualitative, immunoprecipitation and mass spectrometry, blood or urine, including isotype
0312U	Autoimmune diseases (eg, SLE), analysis of 8 IgG autoantibodies and 2 cell-bound complement activation products with algorithmic SLE-likelihood assessment
0431U	Glycine receptor alpha1 IgG, serum or CSF, live cell-binding assay (LCBA), qualitative
0432U	Kelch-like protein 11 (KLHL11) antibody, serum or CSF, cell-binding assay, qualitative
0521U	Rheumatoid factor IgA and IgM, cyclic citrullinated peptide (CCP) antibodies, and scavenger receptor A (SR-A) by immunoassay, blood
0604U	Allergy and immunology (chronic recurrent angioedema), 4 bradykinin peptides, LC-MS/MS, whole blood, quantitative

Test descriptions without codemixed

unspecified

Neurofilament light chain (NfL), ultra-sensitive immunoassay, serum or CSF (descriptor present without a code in this excerpt)

Reflex testing condition

Reflex conditionReflex to ANA subserologies when the initial ANA test is positive; this automatic reflex approach is considered appropriate for the initial workup of autoimmune/systemic rheumatic disease.

Covered indication (linked)Member has signs or symptoms of autoimmune/systemic rheumatic disease AND the member has a positive ANA test.

Included subserologiesANA subserologies include antibodies to dsDNA, histone, SS-A (Ro), SS-B (La), Smith, Smith/RNP, Scl-70, Jo-1, and centromeric proteins.

Non-covered noteUse of ANA subserology tests is not covered for indications other than those listed in the policy.

Provider Actions, Documentation & Prior Authorization

Prior Authorization

Prior Authorization May Be Required

Prior authorization may be required for select algorithmic or novel tests. Providers should verify Health Plan prior authorization requirements before ordering tests that utilize proprietary algorithms or novel methodologies (examples include, but are not limited to, codes such as 0312U, 0039U, 0077U).

Examples of algorithmic/novel test codes: 0312U, 0039U, 0077U
Check member's coverage document and Health Plan prior authorization portal

Prior Authorization

Prior Authorization Guidance

This payment policy is a guide to payment and coverage; prior authorization determinations are made by the Health Plan. Even when a test is described as covered in this policy, the Health Plan may require prior authorization or other administrative approvals. Providers must follow the plan's prior authorization process and verify benefit coverage prior to performing testing.

Policy describes payment guidance; prior authorization decisions are plan-determined
For Medicaid members, state Medicaid provisions may take precedence

Denial Risk

ANA Tests — Denial Triggers

Antinuclear antibody (ANA) testing is covered only when the member has signs or symptoms of an autoimmune/systemic rheumatic disease. ANA testing is not covered for monitoring disease status, isolated fatigue, fibromyalgia, screening of asymptomatic individuals, or other non-specified indications.

Covered indication: signs or symptoms of autoimmune/systemic rheumatic disease
Not covered: monitoring disease status; isolated fatigue; fibromyalgia; screening asymptomatic individuals

Denial Risk

ANA Subserologies — Denial Triggers

ANA subserology testing is covered when the member has signs or symptoms of autoimmune/systemic rheumatic disease AND a positive ANA, or when signs/symptoms of myositis are present, or for monitoring after diagnosis. ANA subserologies are not covered for other indications and reflex testing rules apply — automatic reflex to subserologies is considered appropriate when used as part of the initial workup of autoimmune/systemic rheumatic disease.

ANA subserologies include dsDNA, histone, SS-A (Ro), SS-B (La), Smith, Smith/RNP, Scl-70, Jo-1, centromeric proteins
Reflex testing: automatic reflex from a positive ANA to subserologies is appropriate for initial workup

Documentation Required

Required Clinical Documentation

Documentation must support the member's signs or symptoms of an autoimmune/systemic rheumatic disease. Clinical records should include relevant signs/symptoms (see definitions) and test rationale to demonstrate medical necessity for the ordered immunology or rheumatology tests.

Document presenting signs/symptoms (e.g., joint pain/swelling, morning stiffness, muscle weakness, multisystemic features)
Include clinical rationale linking the test to suspected autoimmune/systemic rheumatic disease

Documentation Required

RF / Anti-CCP Documentation Requirements

For rheumatoid factor (RF) and anti-CCP testing, documentation must show synovitis of at least one joint and that the synovitis is not better explained by another diagnosis (for example, injury, overuse/strain, or gout).

Documented synovitis of ≥1 joint
Documentation ruling out alternate explanations for synovitis (injury, overuse, gout, etc.)

Documentation Required

Documentation and Regulatory Alignment

Follow the Health Plan's terms and all applicable state and federal regulatory requirements when submitting claims and documentation. For Medicaid members, state Medicaid provisions override this policy where conflicts exist. For Medicare members, applicable NCDs and LCDs should be reviewed prior to applying this policy.

State Medicaid rules take precedence over this payment policy when conflicts exist
Review applicable Medicare NCDs and LCDs for Medicare members

Billing Rule

Testing Sequence — ANA then Reflex

When evaluating for autoimmune/systemic rheumatic disease, perform initial ANA testing first when signs or symptoms are present; if ANA is positive, reflex testing to ANA subserologies is appropriate as part of the initial workup. Follow coverage rules above for when reflex subserology testing is allowed.

Testing sequence: initial ANA test first; reflex to subserologies if ANA positive
Reflex testing considered appropriate for initial workup when indicated

Step Therapy

No step therapy requirements are specified in this payment policy.

Step therapy: none specified

Definitions and Key Clinical Signs

Signs or symptoms of autoimmune/systemic rheumatic disease

Definition summaryMultisystem manifestations that may include musculoskeletal (joint pain/swelling, morning stiffness, muscle weakness), cardiopulmonary (pericarditis, interstitial lung disease, Raynaud), hematologic abnormalities, dermatologic findings (hair loss, oral ulcers, rashes), neuropsychiatric manifestations, and kidney dysfunction.

Musculoskeletal featuresJoint pain or swelling (synovitis/arthritis, particularly polyarthritis), morning joint stiffness, and muscle weakness.

Cardiopulmonary featuresPericardial effusion or pericarditis, interstitial lung disease/interstitial pneumonia, pulmonary hypertension, and vasculitis.

Other system findingsHematologic abnormalities (leukopenia, thrombocytopenia, hemolysis), dermatologic lesions (malar rash, discoid lupus), neuropsychiatric symptoms (delirium, psychosis, seizures), and kidney dysfunction (proteinuria, nephritis).

Signs or symptoms of myositis

Core myositis featuresMuscle weakness and elevated muscle enzymes (especially creatine kinase [CK]).

Pulmonary involvementInterstitial lung disease and other pulmonary disease may be present.

Associated musculoskeletal/autoimmune featuresInflammatory arthritis and characteristic dermatologic eruptions (eg, heliotrope, Gottron papules, periungual changes, mechanic's hands).

Additional findingsNailfold capillary abnormalities and Raynaud phenomenon may be seen.

Synovitis

Clinical definitionInflammation of the synovial membrane (joint lining).

Typical presenting featuresPain, stiffness, swelling, erythema (redness), and/or warmth of the affected joint(s).

Clinical context for testingSynovitis of at least one joint is a required documentation element for RF/anti-CCP testing per the policy (testing not covered if synovitis better explained by another diagnosis).

HLA antibody testing (solid phase assays)

Assay typesSolid phase assays (eg, microspheres/beads, ELISA, flow cytometry) used for qualitative or semi-quantitative detection of antibodies to HLA Class I and II antigens.

CPT code rangeRelevant CPT codes include 86828–86835 for qualitative and semi-quantitative HLA antibody solid phase assays and identification panels.

Panel descriptionsCodes cover qualitative presence/absence assessments, antibody identification panels using HLA phenotypes, high-definition antigen-specific panels, and semi-quantitative titer panels.

Related proceduresPolicy also references related immunology/transfusion and flow cytometry procedures (eg, 86849, 86850, 88184) in the coding section.

Algorithmic autoimmune panels (example: 0312U)

Test compositionMulti-analyte autoantibody panels combining ELISA, flow cytometry, indirect immunofluorescence, and cell-bound complement activation product results with an algorithmic SLE-likelihood assessment (example: CPT/PLA 0312U).

Example code0312U: analysis of 8 IgG autoantibodies and 2 cell-bound complement activation products with algorithmic SLE-likelihood assessment.

Additional proprietary panelsOther HCPCS/PLA codes listed include 0039U and 0077U among category I/III/proprietary laboratory tests referenced in the policy.

Coverage stanceSystemic lupus erythematosus diagnostic and prognostic algorithmic tests are not covered for all indications (no covered indications specified).

OpenPayer

Payment Policy: Non-Genetic Immunology and Rheumatology Testing

Coverage Criteria for Immunology and Rheumatology Tests

Coding and Test Codes

Provider Actions, Documentation & Prior Authorization

Clinical Background

Definitions and Key Clinical Signs