CurrentColorado Rocky Mountain Health PlansPolicy 2025R8207A

Reimbursement for biomarker testing billed on CMS 1500/UB04

Governs reimbursement methodology for biomarker testing associated with autoimmune rheumatic disease for UnitedHealthcare Medicare Advantage plans; applies to services billed on UB04 (CMS 1450) and CMS 1500 forms and their electronic equivalents.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyReimbursement for biomarker testing billed on CMS 1500/UB04

Policy CodePolicy 2025R8207A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must submit accurate claims; reimbursement follows the code(s) that correctly describe services and denial criteria apply per date of service.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3procedure code groups denied

3ANA/ENA procedure codes listed

1cell-bound complement code listed

3proprietary panel codes listed

per datedenial criteria application

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Coverage Criteria — Biomarker Testing for Autoimmune Rheumatic Disease

Antinuclear Antibodies (ANA) and Extractable Nuclear Antigen (ENA)

UnitedHealthcare will not consider reimbursement for ANA and ENA testing in the following scenarios:

NOT covered when ANY of the following apply:

Test is an antinuclear antibody (ANA) or extractable nuclear antigen (ENA) procedure code (e.g., CPT 86038, 86039, 86235) and the service is billed for a general encounter without abnormal findings per date of service.
Test is an antinuclear antibody (ANA) or extractable nuclear antigen (ENA) procedure code (e.g., CPT 86038, 86039, 86235) and is submitted in conjunction with a listed preventive procedure code for the same date of service.

Preventive procedure codes include, but are not limited to: 99429, 99411, 99412, 99401, 99402, 99403, 99404, 99381–99387, 99391–99397 (when billed on the same date of service).

Cell-Bound Complement Activation

UnitedHealthcare will not consider reimbursement for cell-bound complement activation products.

Procedure code 0312U for cell-bound complement activation products (e.g., Avise Lupus) is not considered for reimbursement.

Proprietary Serum Biomarker Panels

UnitedHealthcare will not consider reimbursement for serum biomarker panel testing with proprietary algorithms and index scores for diagnosis of systemic lupus erythematosus or connective tissue diseases when submitted for those conditions.

Proprietary serum biomarker panel procedure codes (e.g., 0062U, 0446U, 0447U) that use algorithms or index scores for diagnosis of systemic lupus erythematosus or connective tissue diseases are not considered for reimbursement when submitted for those conditions.

Application of Per-Date-of-Service Criteria

Denial criteria apply per date of service regardless of billing or rendering provider for the same member.

Apply the coverage/denial criteria on a per date of service basis for each individual member regardless of billing provider, rendering provider, or facility.

Coding — Affected Procedure Codes and Examples

ANA/ENA testing codesCPTNot Covered

86038	Antinuclear antibodies; IFA
86039	Antibodies, other methods; e.g., ELISA
86235	Extractable nuclear antigen (ENA) antibodies

Cell-bound complement activationCPTNot Covered

0312U

Cell-bound complement activation product

Proprietary serum biomarker panels with algorithms/index scoresCPTNot Covered

0062U	Proprietary serum biomarker panel (SLE/connective tissue disease)
0446U	Proprietary serum biomarker panel (index/algorithm)
0447U	Proprietary serum biomarker panel (index/algorithm)

Preventive procedure codes (examples)CPT

99429

Preventive service code example (list includes multiple preventive codes)

Preventive encounter exclusion — ANA/ENA testing

ThresholdANA/ENA testing is not reimbursed for a general encounter without abnormal findings or when submitted in conjunction with a listed preventive procedure code per date of service.

Affected CPT codes (ANA/ENA)86038 (Antinuclear antibodies; IFA), 86039 (Antibodies, other methods; e.g., ELISA), 86235 (Extractable nuclear antigen [ENA] antibodies).

Preventive procedure code examplesIncludes codes such as 99429, 99411–99412, 99401–99404, 99381–99387, 99391–99397 (see full list in policy).

Provider Actions and Billing Responsibilities

Billing Rule

Provider billing responsibility and policy updates

Providers are responsible for submission of accurate claims that correctly describe the health care services provided. This reimbursement policy uses CPT, CMS, and other coding guidelines for definitional purposes and to guide correct coding and reimbursement. Providers and facilities should follow industry-standard coding methodology, regulatory requirements, and applicable contractual and benefit design provisions when billing. Note that other factors (legislative mandates, facility/provider contracts, the enrollee's benefit coverage documents, and other reimbursement, medical or drug policies) may supplement, modify, or supersede this policy.

Applies to services billed on UB04 (CMS 1450) and CMS 1500 forms or electronic equivalents.
Policy may be modified at any time to comply with CMS or national coding guideline changes; check the payer website for the latest version.
UnitedHealthcare Medicare Advantage reimbursement policies do not denote prior authorization requirements — check member benefit documents or payer authorization resources as applicable.

Definitions and Scope

Policy applicability

Plan applicabilityApplies to UnitedHealthcare Medicare Advantage Plans offered by UnitedHealthcare and its affiliates.

Billing formsApplies to services billed on UB04 forms (CMS 1450) and CMS 1500 forms, including electronic equivalents or successor forms.

ScopeReimbursement policy governs coding and payment for the services described and aligns with CPT and CMS coding guidance.

Not considered for reimbursement

Not considered for reimbursement — ANA/ENA in general encountersANA and ENA testing procedure codes will not be considered for reimbursement for a general encounter without abnormal findings or when submitted with listed preventive procedure codes per date of service.

Not considered for reimbursement — Cell-bound complement activation