Centene oncology cytogenetics coverage update

Coverage Criteria — Tumor-specific and Hematologic Testing

Tumor Specific ALK Gene Rearrangement

Covered when ALL of the following are met

ALK FISH/PCR indication

Eligible diagnoses: 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); Anaplastic thyroid carcinoma; locally recurrent, advanced, and/or metastatic papillary thyroid carcinoma; locally recurrent, advanced, and/or metastatic follicular thyroid carcinoma; pediatric diffuse high-grade glioma (when indicated)

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma FISH Panel

Covered when ALL of the following are met

CLL/SLL panel: FISH panel includes analysis for +12, del(11q), del(13q), and del(17p) AND the member is undergoing initial diagnostic workup for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

Tumor Specific ERBB2 (HER2) Deletion/Duplication

Covered when ANY listed cancer indication is present

HER2 testing indications: Somatic ERBB2 (HER2) amplification analysis via ISH (FISH or CISH) or IHC is medically necessary when the member has any of the enumerated cancer types or stages, including recurrent or newly diagnosed stage I-IV invasive breast cancer; inoperable locally advanced, recurrent or metastatic gastric or esophagogastric junction adenocarcinoma if trastuzumab is being considered; suspected or proven metastatic colorectal or appendiceal adenocarcinoma; recurrent, unresectable, or metastatic salivary gland tumors; recurrent, advanced or metastatic cervical carcinoma; serous endometrial carcinoma or endometrial carcinosarcoma; resectable/borderline/locally advanced/metastatic pancreatic adenocarcinoma; recurrent ovarian/fallopian tube/primary peritoneal cancer; recurrent or metastatic vaginal cancer; Stage IIIB or higher muscle invasive bladder cancer; metastatic small bowel adenocarcinoma

Multiple Myeloma FISH Panel Analysis

Covered when ALL of the following are met

Multiple myeloma panel: Panel includes del(13), del(17p13), t(4;14), t(11;14), t(14;16), t(14;20), 1q21 gain/amplification, del(1p) AND the member is undergoing initial diagnostic workup for multiple myeloma

NTRK Fusion Analysis Panel

Covered when ANY of the following are met

NTRK fusion testing: NTRK 1/2/3 fusion analysis panel (81191–81194) via FISH or IHC (or NGS with fusion detection) is medically necessary when the member is undergoing initial diagnostic workup for or has an advanced, progressive, or metastatic solid tumor; has cancer not amenable to surgical resection; has an unknown primary; OR has one of the listed diagnoses at any stage (cervical sarcoma, anaplastic thyroid carcinoma, acute lymphoblastic leukemia, pediatric diffuse high-grade glioma)

Tumor Specific PD-L1 Protein Analysis

Covered when ALL of the following are met

PD-L1 testing: PD-L1 protein expression analysis via IHC (88341, 88342, 88360, 88361) is medically necessary when the member has a diagnosis of or is in the initial workup for specified cancers and stages, including Stage IB or higher lung adenocarcinoma, large cell lung carcinoma, squamous cell lung carcinoma, NSCLC NOS; locally advanced or metastatic bladder cancer; and other tumor types per NCCN (gastric, head & neck, vulvar, cervical, triple negative breast, vaginal) where PD-L1 status informs therapy selection

Tumor Specific FOLR1 Protein Analysis

Covered when ALL of the following are met

FOLR1 testing: Tumor-specific FOLR1 protein expression analysis via IHC (88360) is medically necessary when the member has recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer AND Elahere (mirvetuximab soravtansine) is being considered

PD-L1 Protein Analysis (IHC)

PD-L1 protein expression analysis via IHC is considered medically necessary when ALL of the following apply for listed tumor types:

PD-L1 general requirement

Eligible diagnoses/stages: 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 NSCLC NOS; Locally advanced or metastatic bladder cancer; other tumor types per NCCN guidance (gastric, head & neck, vulvar, cervical, triple negative breast, vaginal) where PD-L1 status informs therapy

FOLR1 Protein Analysis (IHC)

FOLR1 IHC is considered medically necessary when ALL of the following are met

FOLR1 requirement: Member has recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer AND Elahere (mirvetuximab soravtansine) is being considered for treatmentplatinum-resistant recurrent disease

Include FOLR1 if prior testing did not include this marker

PML/RARA Gene Rearrangement (FISH/PCR)

PML/RARA rearrangement analysis via FISH/PCR is medically necessary for peripheral blood or bone marrow when any of the listed criteria apply

PML/RARA eligible diagnoses: Recurrent, progressive, or metastatic cervical cancer (squamous, adenocarcinoma, adenosquamous); recurrent unresectable or stage IV triple negative breast cancer; locally advanced, recurrent, or metastatic esophageal/esophagogastric junction adenocarcinoma; locally advanced, recurrent, or metastatic gastric adenocarcinoma; recurrent, unresectable, oligometastatic, or metastatic nasopharyngeal cancer; recurrent, progressive, or metastatic squamous cell vulvar cancer; recurrent or metastatic vaginal cancer

RET Gene Rearrangement (FISH)

RET gene rearrangement testing via FISH is medically necessary when ANY of the following apply (with specified conditional requirements):

RET testing indications: 1) Recurrent or persistent locoregional or metastatic medullary thyroid cancer AND germline RET testing is negative or has not been done; OR 2) Anaplastic thyroid carcinoma; OR 3) Locally recurrent, advanced and/or metastatic papillary, follicular, or oncocytic (Hurthle cell) thyroid carcinoma; OR 4) Advanced or metastatic adenocarcinoma, large cell, or NSCLC NOS of the lung; OR 5) Locally advanced/recurrent/metastatic cervical cancers; OR 6) Recurrent unresectable or stage IV breast cancer; OR 7) Suspected or confirmed metastatic colon cancer; OR 8) Resectable/borderline/locally advanced/metastatic pancreatic adenocarcinoma; OR 9) Locally advanced/recurrent/metastatic esophageal or esophagogastric junction cancer; OR 10) Locally advanced/recurrent/metastatic gastric cancer; OR 11) Recurrent or metastatic vaginal cancer

Document germline RET testing negative or not performed when ordering for medullary thyroid cancer; RNA-based NGS preferred for fusion detection

ROS1 Gene Rearrangement (FISH)

ROS1 gene rearrangement analysis via FISH is medically necessary when ANY of the following diagnoses are present

ROS1 indications: Advanced or metastatic lung adenocarcinoma, large cell lung carcinoma, squamous cell lung carcinoma, NSCLC NOS; locally advanced or metastatic ampullary adenocarcinoma; resectable/borderline/locally advanced/metastatic pancreatic adenocarcinoma; pediatric (≤18 years) diffuse high-grade glioma

NTRK Fusion Analysis Panel

NTRK fusion analysis (panel/NGS with fusion detection) is considered medically necessary per guideline recommendations

NTRK indications: Anaplastic thyroid cancer and certain recurrent/advanced thyroid carcinomas; metastatic colorectal adenocarcinoma; advanced/metastatic NSCLC and select lung histologies; cervical sarcoma; recurrent/metastatic vulvar squamous cell carcinoma; recurrent/metastatic endometrial carcinoma or uterine sarcoma; recurrent unresectable or stage IV breast cancer when eligible for NTRK-targeted therapy; gastric, esophageal, pancreatic, small bowel, hepatocellular carcinoma, GIST and other advanced/metastatic tumors where NTRK fusion-positive status would direct entrectinib, larotrectinib, or repotrectinib use

ERBB2 (HER2) Deletion/Duplication (FISH and CISH/IHC)

ERBB2/HER2 testing (FISH or IHC) is considered medically necessary when ALL of the following apply for listed tumor contexts:

HER2 indications: Inoperable locally advanced, recurrent or metastatic esophageal/esophagogastric adenocarcinoma if trastuzumab is being considered; recurrent/metastatic salivary gland tumors prior to treatment; suspected or proven metastatic colorectal or appendiceal adenocarcinoma; inoperable locally advanced, recurrent or metastatic gastric adenocarcinoma if trastuzumab is considered; all newly diagnosed primary or metastatic breast cancer; recurrent, advanced or metastatic cervical carcinoma; serous and carcinosarcoma endometrial tumors (IHC with reflex to FISH); pancreatic, ovarian, vaginal, bladder, small bowel cancer contexts per NCCN where HER2 amplifications or overexpression would affect therapy

Hematologic FISH Panels

Hematologic malignancy FISH panels are considered medically necessary per guideline recommendations for initial workup or prognostic use

CLL/SLL FISH panel: FISH testing for +12; del(11q); del(13q); del(17p) during diagnostic workup of CLL/SLL is recommended for prognosis and treatment planning

NCCN recommends these targets during initial diagnostic workup

Multiple myeloma FISH panel: FISH testing during initial workup of multiple myeloma including del(13), del(17p13), t(4;14), t(11;14), t(14;16), t(14;20), 1q21 gain/amplification, and 1p deletion is recommended for prognostic purposes

Tumor Specific PD-L1 Protein Analysis

PD-L1 testing covered when aligned with NCCN recommendations for specified tumor types and stages

PD-L1 indications: PD-L1 testing is indicated per NCCN for multiple tumor types (gastric, head & neck, bladder, vulvar, esophageal, cervical, NSCLC, breast, vaginal) during workup for documented or suspected metastatic or stage-specified disease as citedstage-based per guideline

See referenced NCCN guidance

Tumor Specific FOLR1 Protein Analysis

FOLR1 (folate receptor alpha) protein analysis covered for ovarian cancer when testing will inform use of mirvetuximab soravtansine

FOLR1 indication: For ovarian, fallopian tube, or primary peritoneal cancer, tumor molecular analysis should include FOLR1 testing for platinum-resistant recurrent disease and when prior testing did not include this marker; testing is medically necessary when Elahere (mirvetuximab soravtansine) is being consideredplatinum-resistant recurrent disease

Tumor Specific RET Gene Rearrangement Tests (FISH)

RET gene rearrangement testing covered when aligned with NCCN recommendations for specific tumor types and clinical settings

RET fusion indications: RET somatic testing recommended for recurrent or persistent medullary thyroid carcinoma (if germline wild type or unknown) and for anaplastic thyroid cancer; recommended for advanced/locally recurrent non-RAI treatable thyroid cancers; recommended for advanced/metastatic lung adenocarcinoma and other NSCLC subtypes; considered for cervical, breast, colon, pancreatic, esophageal, gastric, and vaginal cancers as listed; RNA-based NGS preferred for fusion detectionadvanced/locally recurrent/metastatic or when systemic therapy considered

Document germline RET testing negative or not performed when ordering for medullary thyroid cancer

Tumor Specific ROS1 Gene Rearrangement

ROS1 fusion testing covered when aligned with NCCN guidance in lung and select other cancers

ROS1 fusion indications: ROS1 rearrangement testing is recommended in advanced or metastatic NSCLC (adenocarcinoma, large cell, NSCLC NOS) and considered for squamous cell carcinoma; also considered in ampullary and pancreatic adenocarcinoma and in pediatric diffuse high-grade gliomas where fusion detection is indicatedadvanced/metastatic/locally advanced when systemic therapy considered

NCCN references cited

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

PML/RARA gene rearrangement testing coverage for AML evaluation

PML-RARA in AML: All patients with acute myeloid leukemia (AML) should be tested for relevant mutations including PML-RAR alpha as part of the recommended evaluation to guide prognosis and managementAML diagnosis

NCCN AML guidelines cited

General application

Policy intent and application

policy_application: This clinical policy is a guide to medical necessity and should be applied in conjunction with member coverage documents, state Medicaid provisions, and applicable NCDs/LCDs; providers must use professional judgment and document clinical indications and stage when ordering tests

Coverage decisions subject to plan terms, state/federal requirements and applicable LCDs/NCDs

Bladder cancer diagnostic and recurrence FISH tests (CPT 88120, 88121) are addressed with specific coverage conditions. They are medically necessary when either: (A) the member has hematuria and prior diagnostic studies have failed to identify the etiology and no more than one bladder FISH has been ordered in the prior 12 months; or (B) the test is ordered for post-treatment surveillance and the ordering frequency adheres to specified limits (no more than 4/year in years 1–2; 3/year in year 3; 2 in year 4; then 1/year up to 15 years). The policy explicitly states that use of bladder FISH testing for general screening of members with hematuria is investigational.

The policy specifies that bladder cancer diagnostic and recurrence FISH tests (CPT 88120, 88121) are considered investigational for indications not enumerated in the coverage section. In other words, indications outside the diagnostic hematuria pathway or the post-treatment surveillance schedule described in the criteria are not supported by the clinical policy.

Per the referenced CMS MolDX LCD, bladder tumor marker testing—including FISH and other technologies—is not covered for screening all patients with hematuria. The LCD requires that bladder FISH be performed using validated assays (the UroVysion Bladder Cancer Kit is cited as the FDA-approved validated assay) and documents the same surveillance frequency limits adopted in this policy (4/year in years 1–2; 3/year in year 3; 2/year in year 4; then 1/year up to 15 years).

Policy revisions described in the document reflect minor expansions and coding/reference updates (for example, addition of RET content and updated NCCN/LCD alignments) and do not introduce additional explicit exclusions in the excerpt provided. The revision history notes updates to criteria wording and CPT/code edits but does not list new categorical exclusions beyond those already stated for bladder FISH utilization and investigational uses.

Where state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence. Providers should apply the policy in the context of applicable state and federal requirements and the member’s coverage documents.

Taken together, the document’s intent is that use of bladder FISH for hematuria screening is investigational and not supported except where the coverage criteria for diagnostic evaluation or the defined surveillance indications are met. The policy and the CMS LCD require validated assays and adherence to specified surveillance frequency limits when bladder tumor marker FISH testing is used.

Document revisions summarized in the policy history expanded coverage in some areas and added criteria (for example, alignment with MolDX/LCD that changed bladder FISH status from non-covered to covered under specified conditions). The excerpt does not list additional items labeled explicitly as 'not medically necessary' beyond the investigational statements for bladder FISH screening and uses not described in the coverage section.

Disease- and stage-specific molecular/cytogenetic testing (summary)

Disease- and stage-specific testing summary: Disease- and stage-specific molecular/cytogenetic testing enumerated per section (e.g., ALK for stage IB+ lung cancers; bladder FISH for diagnostic/monitoring by criteria; CLL/SLL and multiple myeloma FISH panels at initial workup; HER2 testing for listed solid tumors; NTRK in advanced/unknown/selected cancers; PD-L1 for specified lung and bladder indications; FOLR1 when considering Elahere)

Covered Indications by Disease and Test

NTRK fusion testing — guideline-aligned indications

NTRK fusion testing for patients with advanced, metastatic, recurrent, or specific histologies where targeted NTRK inhibitors are potential therapies

NTRK indication details: Consider NTRK fusion testing for anaplastic thyroid cancer, select recurrent/advanced thyroid carcinomas, metastatic colorectal adenocarcinoma, advanced/metastatic NSCLC, cervical sarcoma, vulvar recurrent/metastatic squamous cell carcinoma, recurrent/metastatic endometrial carcinoma or uterine sarcoma, recurrent unresectable or stage IV breast cancer, gastric, esophageal, pancreatic, small bowel, hepatocellular carcinoma, GIST and other advanced/metastatic tumors where NTRK-positive status would direct entrectinib, larotrectinib, or repotrectinib therapy

ALK rearrangement testing — guideline-aligned indications

ALK rearrangement testing in listed thyroid, lung, pancreatic, and pediatric CNS tumors per NCCN

ALK guideline indications: ALK testing recommended for anaplastic thyroid cancer; locally recurrent, advanced or metastatic papillary and follicular thyroid carcinoma; Stage IB or higher NSCLC subtypes (and selected perioperative stage-based indications); pancreatic adenocarcinoma when systemic therapy is considered; pediatric diffuse high-grade gliomas as part of broad molecular testing

Coding Guidance and Example Codes

Example CPT codes referenced for tumor-specific FISHCPT

88271	FISH analysis (example for ALK, ROS1 etc.)
88274	FISH analysis (example)

IHC/ISH CPT codes referencedCPT

88360	IHC/ISH (example: HER2, FOLR1)
88377	In situ hybridization (ISH) technical/interpretation (example)

NGS fusion panel CPT codes (examples)CPT

81191	NTRK fusion analysis panel (example)
81192	NTRK fusion analysis panel (example)
81193	NTRK fusion analysis panel (example)
81194	NTRK fusion analysis panel (example)

Additional gene rearrangement CPT codesCPT

81315	Gene rearrangement testing (example: PML/RARA, RET)
81316	Gene rearrangement testing (example)

Bladder FISH CPT codesCPT

88120	Bladder cancer diagnostic and recurrence FISH test
88121	Bladder cancer diagnostic and recurrence FISH test

Multiple myeloma FISH CPT examplesCPT

88237

FISH analysis (multiple myeloma panel example)

Tumor Protein IHC Codes (covered)CPTCovered

88341	Immunohistochemistry; per specimen (as listed in document)
88342	Immunohistochemistry; per specimen (as listed in document)
88360	Immunohistochemistry (IHC) analysis — referenced for multiple tumor-specific protein analyses
88361	Immunohistochemistry (IHC) with interpretation (as referenced)

Gene Rearrangement / FISH CodesmixedCovered

81315	PML/RARA gene rearrangement analysis (FISH) — listed
81316	PML/RARA gene rearrangement analysis (FISH) — listed
88271	FISH, probe, per specimen; including interpretation
88274	FISH, probe, each additional specimen
88275	FISH, probe, each additional specimen/slide
88291	Microtomy/processing of tissue for FISH
88374	FISH interpretation/technical code referenced for RET testing
88377	FISH technical/interpretation code referenced for RET testing

ROS1 FISH CodesCPTCovered

88271	FISH, probe, per specimen (ROS1 listed)
88274	FISH, probe, additional (ROS1 listed)

Added molecular procedure codes (policy edits)CPT

81315	PML/RARA gene rearrangement (added)
81316	PML/RARA gene rearrangement (added)

FISH/Cytogenetic CPT codes (policy edits)CPT

88273

Cytogenetic analysis (added to multiple myeloma panel)

Regulatory and coverage document identifiers referencedmixed

P150013S014	PMA Number for PD-L1 IHC 22C3 pharmDx (Supplement S014)
P150013S020	PMA Number for PD-L1 IHC 22C3 pharmDx (Supplement S020)
L33420	CMS MolDX Local Coverage Determination: Bladder/Urothelial Tumor Markers
A53095	CMS MolDX Billing and Coding Article: Lab: Bladder/Urothelial Tumor Markers

inv-42: Lung cancer stage for ALK/PD-L1 testing (stage thresholds)

Stage thresholdStage IB or higher for lung cancer ALK testing (applies to lung adenocarcinoma, large cell, squamous cell, and NSCLC NOS)

Applicable tests (examples)FISH/PCR codes 88271, 88274

Clinical contextCovered when member is diagnosed with or in initial workup for the listed tumor types

inv-43: Bladder tumor marker testing frequency (post-treatment surveillance limits)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization may be required per plan rules for the oncology cytogenetic and fusion panel tests listed in this policy. Providers should follow their specific payer prior authorization process and submit requests with supporting clinical documentation as required by the plan.

Prior authorization required per plan rules for listed CPT-coded oncology cytogenetic and fusion panel tests.
Policy references LCDs and guideline-based indications; payer processes may require prior authorization.

Prior Authorization

Indication-Linked Prior Authorization/Claims Documentation

Prior authorization or claims submission should include documentation that the test is being ordered for one of the tumor‑specific indications listed in the policy. Testing that does not meet a listed tumor‑specific diagnosis or indication may be denied or considered investigational.

Claims should include the tumor-specific diagnosis or indication that meets the criteria in the relevant tumor-specific section.
Testing must be associated with the listed clinical indications and the disease stage/setting per the tumor-specific criteria.

Eligibility Requirements and Applicability

ELIGIBILITY REQUIREMENTS: The policy ties test eligibility to disease-specific clinical indications and staging. For example, somatic RET testing is conditioned on documented diagnoses such as recurrent/persistent medullary thyroid cancer (with germline RET negative or not done) or advanced/metastatic NSCLC subtypes, and FISH/IHC/NGS tests are indicated for listed tumor types and clinical settings per NCCN guidance.

ELIGIBILITY REQUIREMENTS: For bladder FISH specifically, eligibility for diagnostic testing requires hematuria with prior nondiagnostic workup and limits testing to no more than one test per 12 months; surveillance eligibility requires prior treatment for bladder cancer and adherence to the policy’s frequency caps. The policy references the CMS LCD utilization guidance for these limits.

ELIGIBILITY REQUIREMENTS: Tumor protein IHC testing (e.g., PD-L1, FOLR1) is eligible when ordered for the tumor types and disease stages specified in the policy—PD-L1 per NCCN-listed cancers and stage thresholds, and FOLR1 in recurrent platinum-resistant ovarian/fallopian tube/primary peritoneal cancer when mirvetuximab is being considered.

ELIGIBILITY REQUIREMENTS: Fusion and gene rearrangement panels (e.g., ALK, NTRK panels) are eligible when used for initial diagnostic workup or when identifying actionable fusions in advanced, metastatic, recurrent, unresectable, or selected tumor histologies as enumerated in the policy and supported by NCCN guidance.

ELIGIBILITY REQUIREMENTS: Prior testing constraints are specified for certain indications—for bladder FISH, diagnostic testing requires prior nondiagnostic studies; for RET in medullary thyroid cancer, germline RET testing must be negative or not performed before somatic RET FISH.

Not Covered / Investigational

NOT COVERED: Bladder cancer diagnostic and recurrence FISH tests (CPT 88120, 88121) used for general hematuria screening are listed as investigational and not covered unless the diagnostic criteria are met. The policy references the CMS LCD position that bladder tumor markers performed by any technology are not covered for screening all patients with hematuria.

NOT COVERED: The CMS LCD states that bladder tumor markers—by FISH, molecular, or immunoassay—are not covered for screening all patients with hematuria. Only validated assays (for example, the UroVysion Bladder Cancer Kit) are supported under the LCD and surveillance testing must meet the LCD’s frequency limits.

NOT COVERED: The policy history documents that some previously non-covered items (notably bladder cancer diagnostic and recurrence FISH) were changed to covered under specific LCD-aligned criteria. The excerpt does not enumerate remaining non-covered laboratory tests beyond the investigational statements already cited.

Background and Scope

BACKGROUND: Cytogenetic and molecular analyses—including FISH, CISH, PCR, immunohistochemistry (IHC), and NGS fusion panels—are used in solid tumors and hematologic malignancies to classify tumor type, identify somatic driver alterations relevant to targeted therapy selection, provide prognostic information, and assist diagnostic clarification. Testing may be performed on tissue, blood, or bone marrow depending on the clinical context.

Definitions and Key Terms

inv-62: driver mutations — Somatic oncogenic 'driver' mutations

DefinitionSomatic oncogenic 'driver' mutations - tumor-acquired genetic alterations that can drive cancer growth and inform targeted therapy selection

ApplicationIdentification of driver mutations helps classify tumor type, guide targeted therapies, and inform prognosis

Testing sourcesDriver mutations may be detected in tumor tissue or via circulating tumor DNA/CTCs (see related policies)

inv-63: ctDNA / CTC — Circulating tumor DNA or circulating tumor cells used for non-tissue molecular analysis

DefinitionctDNA/CTC = circulating tumor DNA or circulating tumor cells used for non-tissue molecular analysis (liquid biopsy)

Use caseAlternative to tumor tissue testing for molecular analysis in solid tumors; see related policies for specifics

Additional Provider Notes

Billing Rule

Coding and billing reminders — verify prior authorization and payer code acceptance

Verify payer acceptance of the CPT codes referenced across the policy and obtain prior authorization when required; codes provided are examples and not comprehensive.

Check payer-specific coding/billing guidance before submitting claims.
If uncertain, contact the plan for clarification on acceptable CPT codes for the requested test.

Note

Policy Revision History and Material Changes

11/24revision

Bladder cancer diagnostic and recurrence FISH tests coverage status changed from non-covered to covered to align with MolDX/LCD guidance; updated references and expanded tumor-type coverage across multiple sections.

10/23revision

Added Tumor Specific RET Gene Rearrangement (FISH) and related criteria; replaced 'advanced or metastatic' language with stage-based wording (e.g., Stage IB or higher) across PD-L1 and ALK sections and added Tumor Specific FOLR1 Protein Analysis.

03/23revision

OpenPayer

Genetic Oncology: Cytogenetic Testing (FISH/IHC/NGS Fusion Panels)

Coverage Criteria — Tumor-specific and Hematologic Testing

Covered Indications by Disease and Test

Coding Guidance and Example Codes

Provider Actions, Prior Authorization, and Documentation

Eligibility Requirements and Applicability

Not Covered / Investigational

Background and Scope

Definitions and Key Terms

Additional Provider Notes

Policy Revision History and Material Changes