ModifiedWellCarePolicy N/A

V1.2024 Concert Genetics Oncology Cytogenetic Testing

Defines medical necessity criteria for tumor- and hematologic-specific cytogenetic testing (FISH, CISH, PCR, IHC, select NGS panels) for oncology indications, with lists of CPT and ICD groupings and references to related policies.

Policy Summary

PayerWellCare

PolicyV1.2024 Concert Genetics Oncology Cytogenetic Testing

Policy CodePolicy N/A

Change TypeMultiple revisions and additions (coding, criteria, new RET and FOLR1 sections)

Effective Date

Next Review Date

Key ActionOrder testing only when the patient meets the listed diagnostic or staging indications and ensure FISH panels include the specified probes documented in the medical record to support coverage.

SourceLink

POLICY UPDATE CHANGES

Updated title to reflect V1.2024; overview, coding, reference-table, background and references updated; 'coverage criteria' replaced with 'criteria'.

Added Tumor Specific RET Gene Rearrangement (FISH) and Tumor Specific FOLR1 Protein Analysis and related criteria.

Replaced 'Advanced or metastatic' with 'Stage IB or higher' for several lung-related indications (ALK, ROS1, PD-L1).

Multiple myeloma panel CPT codes adjusted: removed 88274 and added 88273.

16Distinct tumor/hematologic test sections

~20CPT codes referenced (approx.)

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Investigational test group

12Tests with 'medically necessary' criteria

Coverage Summary

This policy defines medical necessity criteria for tumor- and hematologic-specific cytogenetic testing modalities — including FISH, CISH, PCR, IHC, and select NGS fusion panels — used to classify tumors, provide prognostic information, and help select targeted therapies in solid tumors and hematologic malignancies. The policy references the Concert Genetics platform for a comprehensive list of registered tests and links coverage criteria to the Concert Genetics Oncology cytogenetic testing portfolio. Cross-references to related Centene/Oncology molecular testing policies (e.g., molecular analysis of solid tumors and hematologic malignancies, liquid biopsy, hereditary cancer susceptibility, and other oncology molecular policies) are included for testing contexts not fully addressed in this document.

Key statistics and dates from brief

Distinct tumor/hematologic test sections16

CPT codes referenced (approximate)~20

Investigational test group (Bladder FISH)1

Tests with explicit 'medically necessary' criteria12

Last review date2024-03-23

Policy statusMODIFIED

Medical Necessity Criteria (by test/group)

Tumor Specific ALK Gene Rearrangement (Qualitative FISH and PCR) Tests

Somatic ALK rearrangement analysis (88271, 88274) in solid tumors is considered medically necessary when:

ANY of the following

Stage IB or higher lung adenocarcinoma
Stage IB or higher large cell lung carcinoma
Stage IB or higher squamous cell lung carcinoma
Stage IB or higher non-small cell lung cancer (NSCLC) not otherwise specified (NOS)

Investigational / Not Medically Necessary Tests

Bladder Cancer Diagnostic and Recurrence FISH Tests - Investigational Determination

Bladder cancer diagnostic and recurrence FISH tests (88120, 88121) for screening, diagnosing, and monitoring bladder cancer are considered investigational.

Investigational (not considered medically necessary)

Evidence and guideline rationale note that bladder cancer urinary biomarkers, including urine-based FISH assays (e.g., UroVysion), are not recommended to replace cystoscopy for surveillance; the AUA/SUO guidance states urinary biomarker analysis should not replace cystoscopic evaluation in surveillance of non-muscle-invasive bladder cancer and that urinary biomarkers may be used to adjudicate equivocal cytology or assess response to intravesical therapy as an adjunct. Consequently, bladder diagnostic and recurrence FISH tests (CPT 88120, 88121) are considered investigational (not medically necessary) for routine screening, diagnosis, and monitoring, and may only be considered in limited adjunctive roles per guideline statements.

Coding (Grouped)

ALK common CPT codesCPTCovered

88271	FISH; probe/target specific
88274	FISH, each probe

BCR/ABL common CPT codesmixedCovered

81479	Unlisted molecular pathology procedure (PCR example listed)
88271	FISH; probe/target specific
88274	FISH, each probe
88275	FISH, each additional probe set
88291	Interpretation and report of FISH

CLL/SLL FISH panel CPT codesCPTCovered

88271	FISH; probe/target specific
88274	FISH, each probe
88275	FISH, each additional probe set
88291	Interpretation and report of FISH

ERBB2 (HER2) CPT codesCPTCovered

88360	IHC; per specimen
88377	In situ hybridization (e.g., FISH/CISH) with interpretation

Multiple myeloma FISH CPT codesCPTCovered

88271	FISH; probe/target specific
88273	Cytogenetic study, other (listed as added)
88275	FISH, each additional probe set
88291	Interpretation and report of FISH

NTRK fusion panel CPT codesCPTCovered

81191	NGS, 5-50 genes, fusion detection (panel)
81192	NGS, 51-100 genes, fusion detection (panel)
81193	NGS, >100 genes, fusion detection (panel)
81194	NGS, fusion analysis add-on

PD-L1 CPT codesCPTCovered

88341	Immunohistochemistry or immunocytochemistry, per specimen
88342	IHC per specimen, each additional single antibody stain
88360	IHC; per specimen
88361	IHC; additional per specimen

FOLR1 CPT codeCPTCovered

88360

IHC; per specimen (FOLR1 example)

PML/RARA CPT codesCPTCovered

81315	BCR-ABL1, PML-RARA RT-PCR qualitative/quantitative (listed)
81316	Additional molecular pathology code (listed)
88271	FISH; probe/target specific
88274	FISH, each probe
88275	FISH, each additional probe set
88291	Interpretation and report of FISH

RET gene rearrangement CPT codesCPTCovered

88374	In situ hybridization (other)
88377	In situ hybridization with interpretation
88271	FISH; probe/target specific
88275	FISH, each additional probe set
88291	Interpretation and report of FISH

ROS1 CPT codesCPTCovered

88271	FISH; probe/target specific
88274	FISH, each probe

Provider Actions and Documentation Requirements

Documentation Required

Panel content documentation for CLL/SLL and Multiple Myeloma

Ensure FISH panels used for CLL/SLL and multiple myeloma include the specific probe targets and document panel content in the medical record to meet medical necessity.

Affected CPT codes: 88271, 88274, 88275, 88291, 88273
Required CLL/SLL probes: +12, del(11q), del(13q), del(17p)
Required Multiple Myeloma probes: del(13), del(17p13), t(4;14), t(11;14), t(14;16), t(14;20), 1q21 gain/amplification, del(1p)

Prior Authorization

Medical necessity required by indication

Order cytogenetic or molecular testing only when the patient’s documented diagnosis or stage meets the policy’s listed diagnostic, staging, metastatic/recurrent, or initial workup indications; include this documentation in the medical record to support coverage.

Background and Evidence

Source	Notes
NCCN guideline references	Multiple NCCN guideline versions cited across the policy (e.g., NSCLC, Thyroid, AML, CLL, Myeloma, NTRK, PD-L1, ERBB2/HER2, FOLR1) supporting indicated testing uses and criteria; see reference list (e.g., Non‑Small Cell Lung Cancer v3.2023, Thyroid Carcinoma v3.2023, Acute Myeloid Leukemia v4.2023, Chronic Lymphocytic Leukemia v3.2023, Multiple Myeloma v3.2023, etc.).
AUA/SUO guideline (bladder)	Chang SS et al., AUA/SUO Guideline (2016): urine biomarkers should not replace cystoscopy for NMIBC surveillance; UroVysion FISH may be used to adjudicate equivocal cytology or assess response to intravesical BCG (expert opinion / evidence strength B).
References listed	Policy reference list includes specific citations (numbered) for NCCN guidelines and other sources: see References 1–24, 27 including NCCN guideline PDFs for NSCLC, Colon, Cervical, Thyroid, Gastric, AML, MPN, CML, ALL, Pediatric ALL, CLL, Breast, Head & Neck, Myeloma, Bladder, Vulvar, Occult Primary, Uterine, Soft Tissue Sarcoma, Neuroendocrine/Adrenal, Ovarian).

Definitions

TermAdvanced cancer

DefinitionCancer unlikely to be cured or controlled with treatment; may have spread to nearby tissue, lymph nodes, or distant sites; treatment may be palliative or to slow growth/relieve symptoms.

Revision History

2024-03-23revisedLatest

Updated title to reflect V1.2024; overview, coding, reference-table, background and references updated; 'coverage criteria' replaced with 'criteria'.

revised (coding/criteria edits)Latest

Multiple coding and criteria edits across tests (e.g., removed 88275/88291 in some areas; added RET gene rearrangement content; added/removed CPT codes for several panels; updated stage language for ROS1 and PD-L1).

Policy Summary

PayerWellCare

PolicyV1.2024 Concert Genetics Oncology Cytogenetic Testing

Policy CodePolicy N/A

Change TypeMultiple revisions and additions (coding, criteria, new RET and FOLR1 sections)

Effective Date

Next Review Date

SourceLink

On This Page

Anaplastic thyroid carcinoma

Locally recurrent, advanced, and/or metastatic papillary thyroid carcinoma

Locally recurrent, advanced, and/or metastatic follicular thyroid cancer

Bladder Cancer Diagnostic and Recurrence FISH Tests

Bladder cancer diagnostic and recurrence FISH tests (88120, 88121) for screening, diagnosing, and monitoring bladder cancer are considered:

Investigational (not considered medically necessary)

Tumor Specific BCR/ABL1 Gene Rearrangement (Qualitative FISH and PCR) Tests

Tumor specific BCR/ABL1 rearrangement analysis via FISH (88271, 88274, 88275, 88291) or PCR (81479) in peripheral blood or bone marrow is considered medically necessary when:

ANY of the following

Member/enrollee is suspected to have a myeloproliferative neoplasm (polycythemia vera, essential thrombocythemia, primary myelofibrosis, or chronic myeloid leukemia)
ONE OF
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Chronic myeloid leukemia (CML)
- B-cell lymphoma

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) FISH Panel Analysis

CLL/SLL FISH panel analysis (88271, 88274, 88275, 88291) in peripheral blood or bone marrow is considered medically necessary when:

Panel includes analysis for +12, del(11q), del(13q), and del(17p)

Member/enrollee is undergoing initial diagnostic workup for CLL/SLL

Tumor Specific ERBB2 (HER2) Deletion/Duplication (FISH and CISH)

Somatic ERBB2 (HER2) amplification analysis via ISH (FISH or CISH) or IHC (88360, 88377) in solid tumors is considered medically necessary when the patient has any of the following:

Recurrent or newly diagnosed stage I-IV invasive breast cancer

Inoperable locally advanced, recurrent, or metastatic gastric cancer when trastuzumab (or FDA-approved equivalent) is being considered

Suspected or proven metastatic colorectal cancer or documented metachronous metastases by CT, MRI, and/or biopsy

Suspected or proven metastatic esophageal and/or esophagogastric junction adenocarcinoma

Recurrent, unresectable, or metastatic salivary gland tumors

Multiple Myeloma FISH Panel Analysis

Multiple myeloma FISH panel analysis (88271, 88273, 88275, 88291) of bone marrow is considered medically necessary when:

Panel includes analysis for del(13), del(17p13), t(4;14), t(11;14), t(14;16), t(14;20), 1q21 gain/amplification, del(1p)

Member/enrollee is undergoing initial diagnostic workup for multiple myeloma

NTRK Fusion Analysis Panel

NTRK 1/2/3 fusion analysis panel (81191-81194) via FISH or IHC in solid tumors is considered medically necessary when the member/enrollee is undergoing initial diagnostic workup for or has a diagnosis of any of the following:

Initial diagnostic workup for or diagnosis of advanced or metastatic lung adenocarcinoma

Advanced or metastatic large cell lung carcinoma

Advanced or metastatic squamous cell lung carcinoma

Advanced or metastatic non-small cell lung cancer (NSCLC) NOS

Unknown primary cancers

Advanced or metastatic colorectal cancer

Cervical sarcoma

Recurrent, progressive, or metastatic vulvar cancer

Recurrent or metastatic endometrial carcinoma or diagnosis of uterine sarcoma

Recurrent unresectable or stage IV invasive breast cancer

Unresectable locally advanced, recurrent, or metastatic gastric cancer

Unresectable locally advanced, recurrent, or metastatic esophageal cancer

Anaplastic thyroid carcinoma or locally recurrent, advanced, and/or metastatic papillary, follicular, or Hurthle cell thyroid carcinoma

Acute lymphoblastic leukemia (ALL)

Soft tissue sarcoma

Unresectable or metastatic extrapulmonary poorly differentiated neuroendocrine carcinoma/large or small cell carcinoma/mixed neuroendocrine-non-neuroendocrine neoplasm

Tumor Specific PD-L1 Protein Analysis

PD-L1 protein expression analysis via IHC (88341, 88342, 88360, 88361) in solid tumors is considered medically necessary when the member/enrollee has a diagnosis of or is in the initial work up stage for any of the following:

Stage IB or higher lung adenocarcinoma

Stage IB or higher large cell lung carcinoma

Stage IB or higher squamous cell lung carcinoma

Stage IB or higher non-small cell lung cancer (NSCLC) NOS

Locally advanced or metastatic bladder cancer

Recurrent, progressive, or metastatic cervical cancer (squamous, adenocarcinoma, adenosquamous)

Recurrent or stage IV triple negative breast cancer

Tumor Specific FOLR1 Protein Analysis

Tumor specific FOLR1 protein expression analysis via IHC (88360) is considered medically necessary when:

Member/enrollee has a diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer

Elahere (mirvetuximab soravtansine) is being considered for treatment

Tumor Specific PML/RARA Gene Rearrangement (Qualitative FISH and PCR)

PML/RARA rearrangement analysis via FISH (81315, 81316, 88271, 88274, 88275, 88291) in peripheral blood or bone marrow is considered medically necessary when:

Member/enrollee is undergoing initial diagnostic workup for acute myeloid leukemia (AML)

Tumor Specific RET Gene Rearrangement Tests (FISH)

Tumor specific RET gene rearrangement testing (88374, 88377, 88271, 88275, 88291) in solid tumors is considered medically necessary when the member/enrollee has any of the following:

Suspected or proven metastatic esophageal and/or esophagogastric junction adenocarcinoma

Suspected or proven metastatic gastric adenocarcinoma

Recurrent, unresectable, oligometastatic, or metastatic nasopharyngeal cancer

Recurrent, progressive or metastatic vulvar cancer

Recurrent or persistent locoregional or metastatic medullary thyroid cancer when germline RET testing is negative or not done

Anaplastic thyroid carcinoma

Locally recurrent, advanced and/or metastatic papillary, follicular, or Hurthle cell thyroid carcinoma

Advanced or metastatic adenocarcinoma, large cell cancer, or NSCLC NOS of the lung

Locally advanced or metastatic squamous cell carcinoma of the cervix or adenocarcinoma or adenosquamous carcinoma of the cervix

Tumor Specific ROS1 Gene Rearrangement (Qualitative FISH and PCR) Tests

Somatic ROS1 rearrangement analysis via FISH (88271, 88274) in solid tumors is considered medically necessary when the member/enrollee has a diagnosis of any of the following:

Advanced or metastatic lung adenocarcinoma

Advanced or metastatic large cell lung carcinoma

Advanced or metastatic squamous cell lung carcinoma

Advanced or metastatic non-small cell lung cancer (NSCLC) NOS

Locally advanced or metastatic squamous cell carcinoma of the cervix

Locally advanced or metastatic adenocarcinoma of the cervix

Locally advanced or metastatic adenosquamous carcinoma of the cervix

Recurrent or persistent locoregional or metastatic medullary thyroid cancer when germline RET testing is negative or not done

Anaplastic thyroid carcinoma

Locally recurrent, advanced and/or metastatic papillary, follicular, or Hurthle cell thyroid carcinoma

Examples of stage thresholds: Stage IB or higher for lung cancer indications (e.g., ALK, ROS1, PD-L1)

Documentation of initial diagnostic workup, metastatic/recurrent disease, or therapeutically relevant findings must be in the medical record

Providers should note that the policy references registered tests listed on the Concert Genetics platform; before ordering, verify the specific panel content and CPT mappings on Concert Genetics and cross-check applicable Centene/Oncology molecular testing policies for any related indications or limitations. Ensure selected panels include the required probes and assays documented in the policy (e.g., CLL/SLL and multiple myeloma panel components) to meet medical necessity.

Added Tumor Specific RET Gene Rearrangement (FISH) and Tumor Specific FOLR1 Protein Analysis and related criteria (new covered indications and CPT groups).

revisedLatest

Replaced 'Advanced or metastatic' with 'Stage IB or higher' for several lung-related indications (ALK, ROS1, PD-L1) to clarify stage-based eligibility for testing.

revisedLatest

Multiple myeloma panel CPT codes adjusted: removed 88274 and added 88273 (coding change for multiple myeloma FISH panel).