CurrentCentenePolicy N/A

Concert Genetics Oncology: Cytogenetic Testing

Defines medical necessity criteria for tumor-specific cytogenetic and protein expression testing (FISH, CISH, IHC, PCR, selected panels) in solid tumors and hematologic malignancies, with listed CPT codes and tumor/diagnosis-specific indications. Part 1 of 2 — contains overview, coding implications, multiple tumor-specific criteria, definitions, background, and revision history through 04/24.

Policy Summary

PayerCentene

PolicyConcert Genetics Oncology: Cytogenetic Testing

Policy CodePolicy N/A

Change TypeRevised (V2.2024) — clinical expansions and coding updates

Effective Date

Next Review Date

Key ActionProvider must document the specific tumor diagnosis and stage or clinical scenario that meets the listed criteria to support medical necessity and consult the Concert Genetics Platform for registered tests and preauthorization requirements.

SourceLink

POLICY UPDATE CHANGES

Policy updated to V2.2024 with multiple clinical/coverage expansions and coding table changes up through 04/24.

Replaced 'coverage criteria' wording with 'criteria' throughout and clarified test modality language (e.g., added IHC for ERBB2/HER2).

Replaced 'advanced or metastatic' language with 'Stage IB or higher' and similar staging updates across multiple tumor-specific analyses.

Added Tumor Specific FOLR1 Protein Analysis and related criteria.

Added PML/RARA CPT codes 81315 and 81316 under Tumor Specific PML/RARA Gene Rearrangement tests.

Added Tumor Specific RET Gene Rearrangement (FISH) tests and related criteria.

Expanded coverage criteria for ALK, ERBB2 (HER2) deletion/duplication, NTRK fusion panel, ROS1 and other rearrangement tests to include additional tumor types.

Combined BCR/ABL1 criteria with Solid Tumor and Hematological Malignancies policy.

Background and rationale updated to reference ALK testing recommendations and multiple NCCN guideline versions.

12+Tumor-specific test sections included (partial count from Part 1)

1Investigational indication (Bladder FISH)

40+Example CPT codes referenced

MultipleTests Affected

V2.2024Policy Version

2024-04-24Date of Last Revision

Coverage Summary

This policy defines medical necessity criteria for tumor-specific cytogenetic and protein expression testing — including FISH, CISH, IHC, PCR, and selected panels — used to classify tumors and identify somatic driver mutations to guide targeted therapy and prognosis. It applies to both solid tumors and hematologic malignancies and describes diagnosis- and stage-specific indications, example CPT codes, and related administrative considerations (e.g., preauthorization and test registration). This document is Part 1 of 2 and contains the overview, coding implications, multiple tumor-specific criteria, background, and revision history through 04/24 (V2.2024).

Key policy facts

Policy VersionV2.2024

Date of Last Revision2024-04-24

StatusCURRENT

Policy subjectConcert Genetics Oncology: Cytogenetic Testing

Tests Affected (summary)Multiple tumor-specific cytogenetic and protein-expression tests updated (ALK, RET, ROS1, NTRK, ERBB2/HER2, FOLR1, PD-L1, PML/RARA, multiple myeloma panels, bladder FISH noted investigational); coding table revised (added/removed specific CPT codes) and tumor-specific criteria expanded.

Medical-Necessity Criteria (Tumor-Specific Tests)

Coding (Grouped CPT Codes)

Examples - ALK Gene Rearrangement common CPT codesCPTCovered

88271	FISH, probe interpretation (used for ALK rearrangement testing example)
88274	FISH, each additional probe (used for ALK rearrangement testing example)

Bladder cancer diagnostic/recurrence FISHCPTNot Covered

88120	Cytopathology, FISH (UroVysion example)
88121	Cytopathology, FISH (additional)

CLL/SLL FISH panel - common CPT codesCPTCovered

88271	FISH, probe interpretation
88274	FISH, each additional probe
88275	FISH, each additional probe or panel code
88291	Interpretation of FISH, maybe used in panel

ERBB2 (HER2) testing codesCPTCovered

88360	Immunohistochemistry (IHC) with interpretation (HER2 example)
88377	In situ hybridization (ISH) such as FISH or CISH (HER2 example)

Multiple myeloma FISH panel codesCPTCovered

88271	FISH probe interpretation
88273	FISH, enumeration (added in revision)
88275	FISH additional/complex panel
88291	FISH interpretation/reporting

NTRK fusion panel codesCPTCovered

81191	NGS, fusion panel - NTRK (example)
81192	NGS, fusion panel - NTRK (additional)
81193	NGS, fusion panel - NTRK (additional)
81194	NGS, fusion panel - NTRK (additional)

PD-L1 protein analysis codesCPTCovered

88341	Immunohistochemistry, each antibody (PD-L1 example)
88342	IHC, multiple antibodies (PD-L1 example)
88360	IHC with interpretation
88361	IHC interpretation, additional procedures

FOLR1 protein analysis codeCPTCovered

88360

IHC with interpretation (FOLR1 example)

PML/RARA rearrangement codesCPTCovered

81315	PML-RARA rearrangement molecular test (example)
81316	PML-RARA rearrangement molecular test (example)
88271	FISH probe interpretation
88274	FISH additional probe
88275	FISH panel
88291	FISH interpretation

RET gene rearrangement codesCPTCovered

88374	In situ hybridization with interpretation (RET example)
88377	In situ hybridization (alternative) (RET example)
88271	FISH probe interpretation
88275	FISH additional/probe/panel
88291	FISH interpretation

ROS1 gene rearrangement codesCPTCovered

88271	FISH probe interpretation (ROS1 example)
88274	FISH additional probe (ROS1 example)

Added/Referenced CPT codesCPT

81315	PML-RARA (retinoic acid receptor alpha) (eg, acute promyelocytic leukemia), rearrangement analysis; by molecular genetics method (eg, PCR)
81316	PML-RARA (retinoic acid receptor alpha) (eg, acute promyelocytic leukemia), rearrangement analysis; by molecular cytogenetics method (eg, FISH)

The CPT codes shown in the policy are provided as examples for common tests and are not exhaustive; inclusion or exclusion of codes does not guarantee coverage. This revision updated the coding table — removing and later adjusting some codes (for example, removal of 88275 and 88291 in earlier edits and the later addition of 88273 for multiple myeloma) and adding tumor-specific molecular codes such as 81315 and 81316 for PML/RARA testing. Providers should consult the plan administrator and the Concert Genetics Platform for the comprehensive list of registered tests and the appropriate codes to submit.

Provider Actions / Billing & Documentation

Documentation Required

Document diagnostic stage/indication

Document the specific tumor diagnosis and clinical stage or scenario that meets the policy criteria to support medical necessity for testing. Examples should be included in the medical record (e.g., Stage IB or higher for lung cancers; recurrent, platinum-resistant epithelial ovarian cancer when ordering FOLR1 IHC; initial diagnostic workup for AML when ordering PML/RARA testing).

Stage IB or higher for lung (e.g., Stage IB non-small cell lung cancer)
Recurrent, platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer
Initial diagnostic workup for acute myeloid leukemia (AML) when ordering PML/RARA testing

Prior Authorization

Prior authorization for panel tests (implied)

Background & Evidence

Cytogenetic analysis (FISH/CISH/PCR/IHC) is used to classify tumors and identify somatic driver mutations to guide targeted therapy and prognosis; molecular analysis can also aid in establishing specific malignancy diagnoses for both solid tumors and hematologic cancers. This policy supplies medically necessary criteria for tumor-specific cytogenetic and protein testing and cross-references related molecular testing policies (such as Oncology: Molecular Analysis of Solid Tumors and Hematologic Malignancies) and the Concert Genetics Platform for a comprehensive list of registered tests. Guideline sources (for example, multiple NCCN guideline versions) inform the indications and staging references included in the policy.

Guidelines & definitions

Guideline referencesMultiple NCCN guideline versions cited (examples include NSCLC v2.2024, Colon v1.2024, Thyroid v4.2023, AML v6.2023, Multiple Myeloma v2.2024, Ovarian v1.2024)

Definition - Advanced cancerCancer that is unlikely to be cured or controlled with treatment; may have spread to nearby tissue, lymph nodes, or distant parts of the body; treatment may aim to shrink tumor, slow growth, or relieve symptoms.

Revision History

2024-04revisedLatest

Policy updated to V2.2024 with multiple clinical/coverage expansions and coding table changes up through 04/24. Revisions include addition of Tumor Specific RET Gene Rearrangement content; removal/addition of specific CPT codes (e.g., removed 88275, 88291 in reference table then later adjusted; added 88273 for multiple myeloma); added 81315 and 81316 for PML/RARA.

2024-04revisedLatest

Replaced 'advanced or metastatic' language with 'Stage IB or higher' (and staging language such as 'Stage IB-IIIA/IIIB' where specified) across multiple lung and PD‑L1 related criteria to align with current guideline staging language.

Policy Summary

PayerCentene

PolicyConcert Genetics Oncology: Cytogenetic Testing

Policy CodePolicy N/A

Change TypeRevised (V2.2024) — clinical expansions and coding updates

Effective Date

Next Review Date

SourceLink

On This Page

Consult the Concert Genetics Platform and the member's plan requirements for preauthorization and for the list of registered tests before ordering panel or named CPT-coded tests. The tests and CPT codes shown in this policy are examples; plan administrative processes and preauthorization requirements apply.

Documentation Required

Align testing indication with stage and tumor type

Order tumor-specific molecular and cytogenetic tests consistent with the revised staging language and updated criteria in this policy (for example, replace prior 'advanced or metastatic' language with 'Stage IB or higher' or the specified stage ranges where noted) and ensure the indication aligns with the listed tumor types and guideline-based recommendations.

Documentation Required

Use updated CPT codes for PML/RARA testing

For PML/RARA gene rearrangement testing, document and bill using the updated CPT codes appropriate to the method: use 81315 for molecular genetic methods (e.g., PCR) and 81316 for molecular cytogenetic methods (e.g., FISH); bill additional or supporting FISH interpretation/related CPT codes as applicable per method and reporting.

81315
81316
Bill molecular (PCR) vs cytogenetic/FISH methods to the corresponding CPT code

Note

Follow guideline-recommended testing expansions

When ordering expanded testing for ALK, RET, ROS1, NTRK, ERBB2 (HER2), FOLR1, PD-L1 and BCR/ABL1, follow current guideline recommendations (for example, NCCN) and the specific tumor-type indications listed in the policy to determine when testing is medically necessary.

2024-04addedLatest

Added Tumor Specific FOLR1 Protein Analysis and related criteria (clarified ovarian cancer pathology and indication for mirvetuximab soravtansine).

2024-04addedLatest

Added Tumor Specific RET Gene Rearrangement (FISH) tests and related criteria (minor expansions to include additional tumor types consistent with guidelines).

2024-04revisedLatest

Expanded coverage criteria for ALK, ERBB2 (HER2) deletion/duplication, NTRK fusion panel, ROS1 and other rearrangement tests to include additional tumor types consistent with guidelines.

2024-04addedLatest

Specified both molecular (PCR) and cytogenetic (FISH) billing codes and added PML/RARA CPT codes 81315 and 81316 under Tumor Specific PML/RARA Gene Rearrangement tests.

2024-04clarifiedLatest

Administrative and wording clarifications across overview, coding, and criteria; replaced 'coverage criteria' wording with 'criteria' throughout and clarified test modality language (e.g., added IHC for ERBB2/HER2).

2024-04movedLatest

Combined/moved BCR/ABL1 criteria with Solid Tumor and Hematological Malignancies policy to align with clinical use.

2024-04revisedLatest

Reference and background updates: added ALK testing recommendation and updated many guideline citations and staging language; minor rewording for clarity; coding, reference‑table, background and references updated.