ModifiedArizona Complete HealthPolicy N/A

Concert Genetic Testing Oncology: Hematologic Malignancy

Governs coverage criteria and coding guidance for molecular and genetic diagnostic tests used in evaluation of hematologic malignancies for members of Arizona Complete Health; applies to providers ordering such tests.

Policy Summary

PayerArizona Complete Health

PolicyConcert Genetic Testing Oncology: Hematologic Malignancy

Policy CodePolicy N/A

Change TypeMultiple additions, revisions, removals (includes new RNA fusion categories and NCCN-aligned updates)

Effective DateN/A

Next Review DateN/A

Key ActionReference the revised criteria sets (e.g., tumor-specific analyses, panel criteria, MRD criteria) when seeking prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added Targeted RNA Fusion Panel Tests and Broad RNA Fusion Panel Tests and related criteria.

Replaced 'Comprehensive' with 'Broad' for Broad Molecular Profiling Panels for Hematologic Malignancies and Myeloid Malignancy Panels.

Panels now covered for acute lymphoblastic leukemia.

Removed Tumor Type Agnostic Solid Tumor Molecular Profiling Tests with IHC and Cytogenetic Analyses and related content.

NEW criteria sets created for HPV-Related Solid Tumor MRD Testing and Evidence-Based Solid Tumor MRD Testing based on LCD.

Expanded or updated multiple coverage criteria and NCCN guideline version dates across many tumor-specific variant analyses and panels.

Hematologic MRD Testing: added criterion for CLL indication that 'The member has completed treatment.'

Tumor Specific IDH1 and IDH2 Variant Analysis criteria split into solid-tumor specific and hematologic-specific; 'investigational' language replaced with wording that 'current evidence does not support...'.

51+RNA fusion panel threshold

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JAK2/CALR/MPLMPN gene minimums

Specific FISH setMM FISH required targets

2023-2025Policy revisions span

Coverage Criteria for Hematologic Malignancy Testing

Broad RNA Fusion Panel criteria

Medically necessary when ALL of the following are met:

ALL of the following

Indication: the member/enrollee is undergoing diagnostic workup for adult or pediatric acute lymphoblastic leukemia (ALL).
Panel composition: includes >=51 genes (RNA analysis only).

ALL of the following

Current evidence does not support RNA fusion panel tests with 51 or more genes utilizing RNA analysis alone for all other indications (i.e., indications other than diagnostic workup for ALL).

RNA fusion panel criteria

Broad RNA fusion panels — specific authorization statements:

RNA fusion panel tests with >=51 genes using RNA analysis alone are considered medically necessary when the member is undergoing diagnostic workup for adult or pediatric acute lymphoblastic leukemia (ALL).

These broad RNA fusion panels are not supported by current evidence for other indications.

Broad molecular profiling criteria

Broad molecular profiling and myeloid panels are medically necessary when any of the following apply:

The member/enrollee is undergoing evaluation for acute myeloid leukemia (AML).

The member/enrollee has newly diagnosed acute lymphoblastic leukemia (ALL).

The member/enrollee has newly diagnosed myelodysplastic syndrome (MDS).

The member/enrollee has suspected MDS AND other causes of cytopenia(s) have been ruled out.

The member/enrollee is suspected to have a myeloproliferative neoplasm (MPN) AND (this is the initial genetic evaluation for suspected MPN OR previous JAK2, CALR, and MPL analysis were negative).

The member/enrollee has a diagnosis of chronic myelogenous leukemia (CML) AND (there has been progression to accelerated or blast phase OR results of BCR::ABL1 kinase domain mutation analysis were negative).

AML-focused panel criteria

Medically necessary when ALL of the following are met:

Acute myeloid leukemia (AML) focused molecular profiling panels are performed for diagnosis or evaluation of AML.

Indication: the member/enrollee has a suspected or confirmed diagnosis of acute myeloid leukemia (AML).

Not supported for other indications.

MPN panel criteria

MPN panel tests are medically necessary when ALL of the following are met:

The member/enrollee is suspected to have a myeloproliferative neoplasm (MPN).

The panel includes at minimum testing of JAK2, CALR, and MPL.

Current evidence does not support MPN molecular profiling panels for indications other than those listed above.

MRD criteria

MRD analysis is medically necessary when ALL of the following are met:

Measurable (minimal) residual disease (MRD) analysis in bone marrow or peripheral blood is being considered.

Indication: the member/enrollee has a diagnosis of Acute Lymphoblastic Leukemia (ALL) OR Multiple Myeloma OR Chronic Lymphocytic Leukemia (CLL).

For CLL: the member/enrollee has completed treatment.

Testing modalities may include flow cytometry, PCR, or NGS as appropriate per NCCN guidance for baseline, post-consolidation, end of treatment, or surveillance time points.

BCR-ABL1 and FISH criteria

Tumor-specific BCR-ABL1 testing is medically necessary when ANY of the following apply:

Tumor-specific BCR-ABL1 kinase domain analysis: the member has CML or Ph-positive ALL AND there is inadequate initial response to TKI therapy, loss of response, progression to accelerated or blast phase, or relapsed/refractory disease.

Tumor-specific BCR-ABL1 FISH, qualitative, or quantitative tests: performed when the member is suspected to have an MPN OR undergoing diagnostic workup for ALL, AML, CML, or lymphoblastic leukemia.

Quantitative BCR-ABL1 testing is medically necessary when used for monitoring of disease progression or for MRD monitoring in ALL, AML, or CML (quantitative tests only).

Tumor-specific variant criteria

Tumor-specific variant analyses are medically necessary when the listed tumor-specific indications apply:

CALR variant analysis: medically necessary when suspected MPN or suspected MDS.

CEBPA variant analysis: medically necessary when evaluating for AML.

FLT3 variant analysis: medically necessary for suspected/confirmed AML, or in diagnoses of ALL, MDS, or MPN.

IDH1/IDH2 variant analysis (hematologic): medically necessary when the member has AML.

IGHV somatic hypermutation analysis: medically necessary for workup or diagnosis of CLL, SLL, primary cutaneous B-cell lymphoma, or B-cell lymphoma.

JAK2 variant analysis: medically necessary when suspected MPN.

FISH panel criteria

FISH panel analyses are medically necessary when the following conditions are met:

CLL/SLL FISH panel analysis in peripheral blood or bone marrow is medically necessary when the member is undergoing initial diagnostic workup for CLL/SLL.

Multiple myeloma FISH panel analysis of bone marrow is medically necessary when the panel includes del(13), del(17p13), t(4;14), t(11;14), t(14;16), t(14;20), 1q21 gain/amplification, and del(1p), AND the member is undergoing initial diagnostic workup for multiple myeloma.

PML/RARA rearrangement analysis via FISH in peripheral blood or bone marrow is medically necessary when performed during initial diagnostic workup for AML.

FISH and comprehensive NGS testing for gene fusions and pathogenic mutations are recommended at diagnosis for diseases such as ALL and AML as supported by NCCN for prognostication, therapy selection, management, and in relapsed/refractory settings.

Coverage criteria for hematologic molecular testing

Coverage stance and alignment with NCCN guidance — key points:

NCCN supports comprehensive molecular testing (multiplex panels/NGS) for diagnosis, prognostication, therapy selection, surveillance, and relapse evaluation in hematologic malignancies such as ALL, AML, MDS, and MPNs.

MRD testing by flow cytometry, PCR, or NGS is recommended by NCCN at defined time points (eg, baseline, post-consolidation, end of treatment, surveillance) for ALL, Multiple Myeloma, and CLL/SLL for prognostication and response assessment.

NCCN-recommended tumor-specific gene variant testing (eg, FLT3, IDH1/2, JAK2, CALR, MPL, NPM1, CEBPA, IGHV, TP53) is indicated for evaluation, prognostication, and therapeutic decision making in the respective hematologic malignancies.

Tumor-specific testing recommendations

The policy references NCCN guidance recommending gene-specific testing, FISH, and PCR — summarized indications:

MPL: NCCN recommends molecular testing for suspected MPN; testing can be stepwise or via multigene panel including JAK2, CALR, MPL.

NPM1: NCCN recommends including NPM1 in molecular testing during evaluation for AML for prognostic and treatment implications.

TP53: NCCN recommends TP53 testing during evaluation for AML and for mantle cell lymphoma to inform prognosis and therapy selection.

Multiple Myeloma FISH: NCCN recommends FISH testing during initial workup including del(13), del(17p13), t(4;14), t(11;14), t(14;16), t(14;20), 1q21 gain/amplification, and del(1p).

PML/RARA: NCCN indicates PML/RARA rearrangement testing by FISH or PCR during initial diagnostic workup for AML.

Policy revisions and panel categorization

Policy revisions and category updates — operational notes:

Policy added new RNA fusion panel categories (Targeted RNA Fusion Panel Tests and Broad RNA Fusion Panel Tests) and replaced wording 'Comprehensive' with 'Broad' for relevant panel criteria.

Panels are now covered for acute lymphoblastic leukemia; CPT codes (eg, 0422U, 81457–81459) and coding/reference tables were updated accordingly.

Several sections were reorganized, example lists were removed and definitions updated; providers should reference Definitions for terms such as MPN when interpreting criteria.

Updated and new criteria sets for hematologic malignancy and related testing

New and updated criteria sets added to align with LCDs and NCCN guidance:

New MRD criteria sets were developed (including HPV-related and evidence-based MRD testing) and Emerging Evidence MRD criteria were created for tests lacking established clinical validity.

HLA typing for transplantation and other new criteria sets were added; investigational statements were replaced with 'Current evidence does not support...' wording where applicable.

Revised coverage criteria for hematologic malignancy testing

Selected revised coverage criteria and wording changes (high-level):

MPN-related criteria: example lists of MPNs were removed from criteria and definitions now govern MPN terminology, affecting CALR, JAK2, MPL, and BCR-ABL1 FISH criteria.

NPM1 testing indication broadened: replaced 'cytogenetically normal AML' with 'undergoing evaluation for AML'.

IDH1/2 variant analysis criteria were split between hematologic-specific and solid-tumor-specific policies; investigational language replaced with 'Current evidence does not support...' where applicable.

MRD criteria for CLL updated to add: 'The member has completed treatment.'

Coding and CPT/HCPCS Guidance

Example panel CPT codesCPT

81456	Broad RNA fusion panel example billing code
81450	Broad molecular profiling panel example billing code
81455	Broad molecular profiling panel example billing code

MRD-related CPT/HCPCS (U-codes) examplesmixed

0364U	ClonoSEQ Tracking (MRD) Assay
0171U	MyMRD NGS Gene Panel Assay
0450U	M-inSight Patient Definition Assay

Single-gene/smaller-panel codesCPT

81206	Example single-gene or small-panel sequencing code (appears in multiple gene-specific entries)
81170	ABL1 kinase domain sequencing example code
81352	TP53 variant analysis example code

Panel coding instructionmixed

If a multigene panel is performed, appropriate panel codes should be used.

Disease-specific FISH and panel testingmixedCovered

No codes listed

recently added CPT codesCPT

0422U	Added to MRD testing reference table and criteria
81457	Added to Tumor-Type Agnostic Solid Tumor Molecular Profiling Panel Tests criteria
81458	Added to Tumor-Type Agnostic Solid Tumor Molecular Profiling Panel Tests criteria
81459	Added to Tumor-Type Agnostic Solid Tumor Molecular Profiling Panel Tests criteria

Policy reference table updatesmixed

No codes listed

coding table referencedmixed

No codes listed

inv-23: gene_count_threshold_for_RNA_fusion_panel

Threshold>=51 genes

inv-24: RNA fusion panel gene count

Rule>=51 genes for RNA fusion panels using RNA analysis alone

inv-25: MPN panel minimum genes

Required genesJAK2, CALR, MPL

Provider Actions, Prior Authorization, and Billing Notes

Billing Rule

Coding Implications

This clinical policy references Current Procedural Terminology (CPT®). Providers should reference the most up-to-date sources of professional coding guidance prior to submission of claims for reimbursement. The tests, CPT codes, and ICD codes in this policy are not comprehensive and inclusion does not guarantee coverage. See the Concert Platform for additional registered tests.

Include appropriate panel CPT codes when a multigene panel is performed.
Codes referenced are informational only; verify current coding guidance prior to claim submission.

Prior Authorization

Broad RNA Fusion Panels — Prior Authorization

Broad RNA fusion panel tests with 51 or more genes utilizing RNA analysis alone that are performed on hematologic malignancies require authorization when used for diagnostic workup of adult or pediatric acute lymphoblastic leukemia (ALL). Broad RNA fusion panels with 51+ genes are not supported by current evidence for other indications.

Definitions and Terminology

inv-40: incidental germline findings

Policy noteSomatic testing may reveal clinically relevant germline variations; providers should communicate potential incidental findings to patients prior to testing

ActionDiscuss potential for incidental germline findings during pre-test counseling

ScopeApplies to somatic mutation profiling in hematologic malignancy testing

inv-41: Broad RNA Fusion Panels (>=51 genes)

DefinitionRNA fusion panel tests using RNA analysis alone that include 51 or more genes

TerminologyReferred to as 'Broad RNA Fusion Panels for Hematologic Malignancy' in criteria

Policy Summary

PayerArizona Complete Health

PolicyConcert Genetic Testing Oncology: Hematologic Malignancy

Policy CodePolicy N/A

Change TypeMultiple additions, revisions, removals (includes new RNA fusion categories and NCCN-aligned updates)

Effective DateN/A

Next Review DateN/A

Key ActionReference the revised criteria sets (e.g., tumor-specific analyses, panel criteria, MRD criteria) when seeking prior authorization.

SourceLink

On This Page

Repeat broad molecular profiling panels are considered medically necessary when: the member has MDS and relapsed after allo-HCT; OR the member has ALL with symptomatic relapse after maintenance; OR the member has AML with relapsed/refractory disease after consolidation or progression on treatment.

Current evidence does not support broad molecular profiling panels for hematologic malignancies and myeloid malignancy panels in bone marrow or peripheral blood for all other indications.

MPL variant analysis: medically necessary when suspected MPN or suspected MDS.

NPM1 variant analysis: medically necessary when undergoing evaluation for AML.

TP53 variant analysis: medically necessary in bone marrow or peripheral blood for AML, ALL, or when suspected MDS.

Panel required when MPN is suspected

Not supportedMPN panels not supported for other indications

inv-26: Required analytes for MM FISH panel

Required analytesdel(13); del(17p13); t(4;14); t(11;14); t(14;16); t(14;20); 1q21 gain/amplification; del(1p)

SpecimenBone marrow FISH panel

IndicationInitial diagnostic workup for multiple myeloma

inv-27: coverage_expansion

Coverage changePanels are now covered for acute lymphoblastic leukemia (ALL)

Related updateBroad RNA fusion panels (>=51 genes) are medically necessary when performed for diagnostic workup of adult or pediatric ALL

Coding noteCriteria sets and coding updated to add CPT codes (e.g., 0422U, 81457-81459)

inv-28: Minimum gene lists / panel composition

Panel removal reasonSome panels were removed from the policy reference table for not meeting minimum gene list requirements

ImpactReference table entries updated to reflect minimum gene list standards

Example actionPraxis Extended RAS Panel (0111U) removed for insufficient gene list

inv-29: criterion specificity

Criterion wordingSeveral criteria were broadened or generalized (e.g., specific drug names replaced with drug class names; example lists removed)

Definitions relianceExample lists (eg, of MPNs) removed from criteria and definitions section used instead

Specific changeNPM1 indication changed to 'undergoing evaluation for AML' from 'cytogenetically normal AML'

Authorization required for RNA fusion panels (≥51 genes) when used for diagnostic evaluation of adult or pediatric ALL.
These panels are considered not medically necessary for indications outside of ALL per current criteria.

Prior Authorization

Focused Panels, MRD, and BCR‑ABL1 Testing — Authorization Highlights

Broad molecular profiling panels for hematologic malignancies and myeloid malignancy panels (bone marrow or peripheral blood) require authorization when used for specific indications: evaluation for AML; newly diagnosed ALL; newly diagnosed MDS; suspected MDS after other causes of cytopenias are ruled out; suspected MPN when initial genetic evaluation or JAK2/CALR/MPL testing was negative; diagnosis of CML with progression to accelerated/blast phase or negative BCR::ABL1 kinase domain mutation analysis. Repeat broad panels are authorized in specified relapse/progression scenarios. Focused AML panels, MRD testing, and BCR-ABL1 testing also have defined authorization criteria.

Use appropriate panel CPT codes when multigene panels are performed.
Focused AML molecular profiling panels are medically necessary for suspected or confirmed AML.
MRD testing in bone marrow or peripheral blood is medically necessary for patients with ALL, multiple myeloma, or CLL who have completed treatment.
Tumor-specific BCR-ABL1 FISH/qualitative/quantitative tests are medically necessary for suspected MPN, diagnostic workup for ALL, AML, CML, lymphoblastic leukemia, and for MRD monitoring (quantitative tests) in ALL, AML, and CML.

Prior Authorization

CLL/SLL FISH Panel — Prior Authorization Note

CLL/SLL FISH panel analysis (peripheral blood or bone marrow) requires prior authorization when used for initial diagnostic workup of chronic lymphocytic leukemia/small lymphocytic lymphoma.

Authorization required for CLL/SLL FISH at initial diagnostic workup.
Ensure panel includes indicated probes per institutional/diagnostic standards.

Note

Authorization Guidance — Provider Reminder

Criteria sets have been updated — providers must confirm indications against the revised authorization criteria before submitting prior authorization requests. Check updated criteria for NCCN-aligned indications and coding changes (including new/additional CPT codes) prior to submission.

Verify the current criteria set and indications before requesting authorization.
Confirm use of updated CPT codes (and appropriate panel codes) when submitting claims.
Authorization is required for the highlighted panels and testing scenarios; inappropriate indications may be denied.

Medically necessary when performed for diagnostic workup of adult or pediatric ALL

inv-42: Broad molecular profiling panels for hematologic malignancies and myeloid malignancy panels

DefinitionBroad molecular profiling panels for hematologic malignancies and myeloid panels: multigene NGS panels performed on bone marrow or peripheral blood for evaluation of AML, ALL, MDS, MPN, and related indications

NCCN alignmentNCCN recommends multiplex gene panels and targeted NGS for prognostication, therapy selection, and management in AML and ALL

Repeat testingRepeat panels allowed in defined relapse/progression scenarios (eg, relapsed after allo-HCT, symptomatic relapse after maintenance)

inv-43: RNA fusion panel tests with 51 or more genes utilizing RNA analysis alone

DefinitionRNA fusion panel tests with 51 or more genes utilizing RNA analysis alone (i.e., panels of >=51 genes analyzed by RNA)

Coverage noteConsidered medically necessary for diagnostic ALL workup; not supported for other indications

Terminology changeCriteria name changed to 'Broad RNA Fusion Panels for Hematologic Malignancy'

inv-44: Comprehensive NGS panels recommended by NCCN

DefinitionComprehensive/Broad NGS panels: multiplex panels recommended by NCCN for gene fusion and somatic mutation testing to inform diagnosis, prognostication, therapy selection, surveillance, and relapse evaluation

UsesRecommended at diagnosis and for relapsed/refractory disease as per NCCN for AML and ALL

SpecimensPerformed on bone marrow or peripheral blood depending on disease context

inv-45: MRD testing

DefinitionMinimal residual disease (MRD) testing: flow cytometry, PCR, or NGS assays used at baseline and serially for prognostication, response assessment, and monitoring in ALL, MM, and CLL/SLL

IndicationsMRD testing medically necessary for ALL, multiple myeloma, or CLL when the member has completed treatment or at guideline-defined time points

ModalitiesFlow cytometry, PCR, or NGS (eg, ClonoSEQ) can be used

inv-46: Myeloproliferative Neoplasm (MPN)

DefinitionMyeloproliferative Neoplasm (MPN): a rare blood disease with excess production of blood cells; criteria reference MPN as defined in Definitions section

Panel requirementMPN molecular profiling panels must include at minimum JAK2, CALR, and MPL

Subtypes listedMPN subcategories include CML, PV, PMF, ET, chronic neutrophilic leukemia, chronic eosinophilic leukemia, and MPN-U

inv-47: Myelodysplastic Syndrome (MDS)

DefinitionMyelodysplastic Syndrome (MDS): disorder of bone marrow causing low blood cell counts; WHO recognizes multiple types

Testing noteMolecular testing recommended during initial evaluation of suspected MDS per NCCN

SpecimenPerformed on bone marrow or peripheral blood for somatic mutations associated with MDS

inv-48: Myeloproliferative Neoplasm (MPN)

Definition updateMPN is defined in the Definitions section and example lists were removed from criteria to rely on that definition

Impact on criteriaCALR, JAK2, MPL, and BCR-ABL1 FISH criteria updated to remove example MPN lists

AlignmentChanges made to align criteria with NCCN guidance and the Definitions section

inv-49: MPN and related terminology

Terminology updateExample lists for MPN and related terms removed from multiple criteria; definitions now authoritative

Criteria generalizationSeveral criteria generalized (eg, removal of specific example diagnoses) to rely on Definitions and guideline language

SpecificsB-cell lymphoma removed from certain points; 'Lymphoblastic lymphoma' added where indicated