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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 statement unchanged; codes moved from policy 10.01.533 into this policy (list provided).
Multiple CPT code additions across 2023-2025 coding updates (codes enumerated in history).
CPT code 81515 removed on 06/06/25 as noted in coding history.
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.
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
Coverage determination
Policy statement (from available text in this part):
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.
| 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) |
| 0112U | |
| 0365U | |
| 0366U | |
| 0367U | |
| 0406U | |
| 0415U | |
| 0418U | |
| 0371U | |
| 0372U | |
| 0373U |
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.
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.
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: None - no NCD for these tests.
Added multiple CPT codes moved from policy 10.01.533 during 01/01/25 update; policy statement remained unchanged.
Frequent coding updates added and removed many CPT codes on listed dates.
Coding update removing CPT code 81515.
Regulatory status
Investigational designation - documentation of medical necessity
Tests listed in this policy are considered investigational; providers should be aware that claims for these CPT codes may be denied as not medically necessary per policy.