CurrentPremera BluecrossPolicy 2.04.520

MEDICAL POLICY 2.04.520

Defines coverage stance for a broad list of laboratory diagnostic, prognostic, and risk-assessment tests not addressed in other specific policies; when a separate policy exists that supersedes this one. Lists many HCPCS (U) and CPT codes considered investigational due to insufficient evidence of clinical utility.

Policy Summary

PayerPremera Bluecross

PolicyMEDICAL POLICY 2.04.520

Policy CodePolicy 2.04.520

Change TypeCoding updates & code transfers

Effective DateJan 1, 2025

Next Review Date

Key ActionProviders must follow the specific medical policy for a test if one exists; this investigational policy is superseded by a separate policy that addresses the same test.

SourceLink

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 Summary

Scope: This policy defines the coverage stance for a broad list of laboratory diagnostic, prognostic, and risk-assessment tests (many HCPCS (U) and CPT codes) when no separate specific policy exists. Effective date: 2025-01-01. Last review: 2025-10-01. Overall coverage stance: Investigational / Not covered. Lead-in: All tests listed in this policy are considered investigational when there is no separate policy that addresses the same test; if a separate policy exists it supersedes this policy.

Policy summary — Investigational laboratory tests

Number of tests/codes listed100+

Coverage status for listed testsInvestigational

Regulatory requirementCLIA (laboratories must be licensed for high-complexity testing)

Policy number2.04.520

Effective date2025-01-01

Last review2025-10-01

Medical-Necessity / Coverage Criteria

Medically Necessary / Investigational Determination

All tests listed in this policy are considered investigational as there is insufficient evidence to determine that the technology results in an improvement in the net health outcome

ALL of the following

Test is not covered (investigational) when it is one of the tests listed in this policy
If a separate policy exists for the same test, that separate policy supersedes this policy

Coverage determination

Policy statement (from available text in this part):

All tests listed in this policy are considered investigational.

Investigational / Not Covered Tests

All tests listed in this policy are designated investigational because there is insufficient or non-evaluable clinical utility and limited evidence of clinical validity for each listed test. When a separate, specific policy for the same test exists, that separate policy supersedes this investigational listing.

Investigational / Not Covered HCPCS (U) codes listed in policy part 1HCPCSNot Covered

0002U	Oncology (colorectal), quantitative assessment of three urine metabolites ... (PolypDX)
0016M	Oncology (bladder), mRNA, microarray gene expression profiling of 209 genes ... (Decipher Bladder TURBT+G54)
0019M	Cardiovascular disease, plasma, analysis of protein biomarkers by aptamer-based microarray ... 4-year likelihood of coronary event
0112U	Infectious agent detection and identification, targeted sequence analysis (16S and 18S rRNA genes) with drug-resistance gene (MicroGenDx)
0163U	Oncology (colorectal) screening, ELISA of 3 plasma/serum proteins (TDGF-1, CEA, ECM) algorithm reported as likelihood of CRC or advanced adenomas (BeScreened-CRC)
0174U	Oncology (solid tumor), mass spectrometric 30 protein targets ... prognostic/predictive algorithm (LC-MS/MS Targeted Proteomic Assay)
0176U	Cytolethal distending toxin B (CdtB) and vinculin IgG antibodies by immunoassay (IBSchek)
0180U	Red cell antigen (ABO blood group) genotyping (Navigator ABO Sequencing) [listed as 018OU in doc]
0181U	Red cell antigen (Colton blood group) genotyping (Navigator CO Sequencing)
0182U	Red cell antigen genotyping exons 1-10 (Navigator CROM Sequencing)

1–10 of 118

1/12

Investigational / Not Covered - CPT codes listed in policy history and additionsCPTNot Covered

0112U
0365U
0366U
0367U
0406U
0415U
0418U
0371U
0372U
0373U

1–10 of 95

1/10

Provider Actions & Billing Impact

Documentation Required

Check for separate specific policy

Providers must follow the specific medical policy for a test if one exists; this investigational policy is superseded by a separate policy that addresses the same test.

Denial Risk

Claims for listed tests considered investigational

Claims submitted for any test listed in this policy are considered investigational and may be denied as not medically necessary due to insufficient evidence of clinical utility.

Claims for tests listed in this policy may be denied as not medically necessary.

Documentation Required

Investigational designation - documentation of medical necessity

Background & Definitions

Background: This policy applies to both laboratory-developed tests and commercial tests that are diagnostic, prognostic, or risk-assessment in nature when no separate policy exists. These tests are considered investigational because they are often proprietary, in a developmental phase, and there is limited or insufficient evidence of clinical validity and/or clinical utility to demonstrate an improvement in net health outcome.

Definitions

Evidence Summary

Medicare Determinations

Medicare determinations: None - no NCD for these tests.

Revision History

01/01/25coding_change

Added multiple CPT codes moved from policy 10.01.533 during 01/01/25 update; policy statement remained unchanged.

multiple dates 09/01/23–10/01/25coding_change

Frequent coding updates added and removed many CPT codes on listed dates.

06/06/25coding_change

Coding update removing CPT code 81515.