ModifiedCommunity Health Plan WashingtonPolicy N/A

Concert Genetic Testing Oncology: Hematologic Malignancy

Defines medical necessity and coding considerations for molecular and genetic diagnostic testing related to hematologic malignancies for members of the payer; affects providers ordering and billing for these tests.

Policy Summary

PayerCommunity Health Plan Washington

PolicyConcert Genetic Testing Oncology: Hematologic Malignancy

Policy CodePolicy N/A

Change TypeCriteria updates, coverage expansions, coding additions

Effective Date

Next Review Date

Key ActionProviders should reference the updated criteria sets and the most current coding guidance when requesting authorization or submitting claims for panels and MRD testing.

SourceLink

POLICY UPDATE CHANGES

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

Panels now COVERED for acute lymphoblastic leukemia and criteria expanded to align with guidelines (multiple tumor types added).

Added CPT codes 0422U, 81457, 81458, and 81459 to the policy reference table and criteria.

Solid Tumor Minimal Residual Disease (MRD) Testing criteria: RETIRED prior criteria and replaced with two criteria sets based on LCD guidelines.

Multiple hematologic-specific criteria were updated for alignment with current NCCN guideline versions and to clarify covered indications (examples: CEBPA, CEBPA expansion to all AML eval, BCR-ABL1 clarifying Ph-positive ALL).

Hematologic MRD (CLL) criterion now requires that 'The member has completed treatment.'

51+RNA fusion panel gene threshold

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Post-treatmentMRD coverage timing

0422U, 81457-59New CPT codes added

SeveralCriteria sets restructured

Coverage Criteria for Hematologic Malignancy Testing

Coding and Procedure Codes

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 codes (examples)mixed

0364U	ClonoSEQ MRD assay
0171U	MyMRD NGS Gene Panel Assay
0450U	M-inSight® Patient Definition Assay

Single-gene and FISH example codesCPT

81170	ABL1 kinase domain analysis
81206	BCR-ABL1 FISH / qualitative testing
81352	TP53 variant analysis example code

Multigene panel codingmixed

No codes listed

Multiple myeloma FISH panel required analytesmixed

No codes listed

CLL/SLL FISH panel (peripheral blood or bone marrow)mixed

No codes listed

Newly added/updated CPT codesCPT

0422U	CPT code added for Solid Tumor Minimal Residual Disease (MRD) Testing
81457	CPT code added to criteria for Tumor-Type Agnostic Solid Tumor Molecular Profiling Panel Tests
81458	CPT code added to criteria for Tumor-Type Agnostic Solid Tumor Molecular Profiling Panel Tests
81459	CPT code added to criteria for Tumor-Type Agnostic Solid Tumor Molecular Profiling Panel Tests

Coding updates referencedmixed

No codes listed

Coding table referencedmixed

No codes listed

inv-28: RNA fusion panel gene count threshold

Minimum gene count51 genes (RNA fusion panel tests with 51 or more genes utilizing RNA analysis alone)

Indication tied to thresholdMedically necessary when performed for diagnostic workup of adult or pediatric acute lymphoblastic leukemia (ALL)

Evidence limitationNot supported by current evidence for other indications outside diagnostic ALL workup

inv-29: RNA fusion panel gene count threshold — alternate phrasing

Alternate phrasing'51 or more genes' used interchangeably to describe the RNA fusion panel minimum gene count

Panel modalityApplies to RNA-only fusion panels utilizing RNA analysis alone

Clinical applicationSpecific to hematologic malignancy testing guidance in the policy

inv-30: Required analytes for multiple myeloma FISH

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

SpecimenBone marrow FISH panel analysis must include these targets

Clinical timingRequired when member is undergoing initial diagnostic workup for multiple myeloma

inv-31: MRD criteria sets

MRD criteria restructuringPrior MRD criteria were retired and replaced with two criteria sets based on LCD guidelines

ScopeChange referenced in revision history reflecting alignment of solid tumor MRD criteria with LCDs

Approval noteDocument notes MRD criteria restructured as part of semi-annual/annual updates

inv-32: Coding table update

Coding table update summaryPolicy reference table and coding table were updated; new/updated CPT and U-codes were added to the policy reference (details in coding section)

Examples of added codes (see coding section)Newly added CPT codes referenced elsewhere in the document include 0422U, 81457, 81458, 81459

Administrative noteCoding and reference-table updates are recorded in the revision history and approval sections

inv-33: Revision Date

Revision Date(s) referencedRevision Date = 11/25 (documented in revision history) and Approval Date = 12/25 (recorded in approval/metadata)

Context of datesDates appear in revision history alongside coding/reference-table and policy changes

Review cadenceSemi-annual/annual review language present in revision notes

Provider Actions, Prior Authorization, and Billing Guidance

Billing Rule

Coding guidance and claim submission

This clinical policy references Current Procedural Terminology (CPT®). Providers must reference the most up-to-date professional coding guidance prior to claim submission. Codes and descriptions included are informational only and do not guarantee coverage. See the Concert Platform for additional registered tests.

Include appropriate panel CPT codes when multigene panels are performed.
This policy does not address liquid biopsies; use site-specific criteria for liquid biopsy testing.

Billing Rule

Coding note for multigene panels

Use appropriate panel CPT codes when submitting claims for multigene panels. The clinical criteria in this policy do not address liquid biopsies; billing and authorization for liquid biopsy-based tests should follow separate, applicable guidance.

Ensure the CPT/HCPCS codes submitted reflect the specific panel performed.

Definitions and Key Terms

inv-40: Incidental germline variation

DefinitionIncidental germline variation: germline variation that may be uncovered during somatic mutation profiling and could indicate hereditary cancer susceptibility

Provider responsibilityProviders should communicate the potential for incidental germline findings with patients prior to somatic profiling

PurposeNoted as part of Overview to inform pre-test counseling and consideration of confirmatory germline testing when appropriate

inv-41: RNA fusion panel (51+ genes)

DefinitionRNA-only fusion panel: an RNA fusion panel test that includes 51 or more genes (RNA analysis alone)

Clinical indicationMedically necessary when performed for diagnostic workup of adult or pediatric ALL

Policy Summary

PayerCommunity Health Plan Washington

PolicyConcert Genetic Testing Oncology: Hematologic Malignancy

Policy CodePolicy N/A

Change TypeCriteria updates, coverage expansions, coding additions

Effective Date

Next Review Date

Key ActionProviders should reference the updated criteria sets and the most current coding guidance when requesting authorization or submitting claims for panels and MRD testing.

SourceLink

On This Page

Confirm coding against the latest AMA CPT releases and payer-specific code lists.

Prior Authorization

Medical necessity conditions for specific FISH tests

Specific FISH panel tests are considered medically necessary only under defined clinical conditions. Submit documentation that clearly demonstrates the clinical indication(s) listed in the policy when requesting authorization or when filing claims.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) FISH Panel: medically necessary when the member is undergoing initial diagnostic workup for CLL/SLL.
Multiple Myeloma FISH Panel: 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 (qualitative FISH/PCR): medically necessary when the member is undergoing initial diagnostic workup for acute myeloid leukemia (AML).

Prior Authorization

Prior authorization and criteria update note

Coverage criteria have been updated and CPT codes added or clarified; providers should reference the updated criteria sets and policy reference tables when requesting prior authorization. Prior authorization may be required for many genetic and molecular tests covered by this policy.

Panels for acute lymphoblastic leukemia (ALL) are now covered where indicated — verify applicable CPT codes and criteria.
New CPT codes (e.g., 0422U, 81457–81459) were added to relevant criteria sets; ensure these are used when applicable.

Documentation Required

Authorization and criteria updates

Authorization requests must adhere to the revised clinical criteria across test types. Provide documentation demonstrating that all required criteria are met for the specific test or panel being requested. Failure to follow the updated criteria may result in denial or delayed authorization.

When requesting authorization for broad molecular profiling or myeloid panels, include clinical history showing diagnosis stage (e.g., newly diagnosed, relapsed, post-consolidation) as applicable.
For FISH panels and tumor-specific tests, include diagnostic workup details that match the policy's medical necessity conditions.
If a repeat panel is requested, document prior testing and clinical rationale per the policy's repeat-testing criteria.

Documentation Required

Prior authorization and criteria adherence

Providers must follow the revised criteria when requesting prior authorization for genetic and molecular testing. Submit complete clinical documentation (diagnosis, prior test results, treatment history, and indication) to support medical necessity per the current policy language.

Include prior test results (e.g., negative JAK2/CALR/MPL when relevant) when required by the criteria.
For suspected MDS or MPN, document rule-out of other causes of cytopenias or whether this is the initial genetic evaluation as specified.
For repeat testing criteria, document prior therapy and timing (e.g., relapse after allo-HCT, relapse after consolidation).

Evidence limitationNot supported by current evidence for other hematologic indications per policy

inv-42: Medical necessity criteria

Medical necessity criteria definitionConditions under which specific genetic testing is considered medically necessary for members/enrollees when related criteria are met

ApplicationUsed throughout policy to determine coverage for panels, single-gene tests, FISH, and MRD based on listed criteria

Provider actionProviders should follow the listed criteria when requesting authorization or submitting claims

inv-43: Liquid biopsies excluded

Exclusion noteThese clinical criteria are not intended to address liquid biopsies (i.e., circulating tumor DNA) — separate guidance applies

Coding implicationIf a multigene panel is performed, appropriate panel codes should be used; liquid biopsy coding/coverage is outside these criteria

Clinical scopePolicy focuses on tissue/bone marrow/peripheral blood molecular testing rather than liquid biopsy assays

inv-44: Broad molecular/NGS panels

DefinitionBroad molecular/NGS panels: multiplex NGS panels used for detection of somatic mutations and gene fusions for prognostication, therapy guidance, and ongoing management in hematologic malignancies

IndicationsMedically necessary for diagnoses including AML, ALL, MDS, suspected MPN, and for relapsed/refractory disease or post-transplant relapse as specified in criteria

Testing specimensPerformed on bone marrow or peripheral blood as appropriate

inv-45: MRD testing

DefinitionMinimal residual disease (MRD) testing: assays (flow cytometry, PCR, NGS) used at specified time points to assess residual disease burden and treatment response in leukemias and multiple myeloma

Timing examplesNCCN recommends MRD testing prior to induction, following consolidation, for serial monitoring, and at end of treatment for certain diagnoses

ModalitiesAssays may include flow cytometry, PCR, or NGS depending on clinical context

inv-46: Myeloproliferative Neoplasm (MPN)

DefinitionMyeloproliferative Neoplasm (MPN): a rare blood disease in which the bone marrow makes too many red blood cells, white blood cells, or platelets; includes subcategories such as CML, PV, PMF, ET, chronic neutrophilic leukemia, chronic eosinophilic leukemia, and MPN-U

Policy implicationMPN is defined in Definitions and example disease lists were removed from criteria sets to avoid redundancy

Testing relevanceMPN panel criteria require testing at minimum of JAK2, CALR, and MPL

inv-47: Myelodysplastic Syndrome (MDS)

DefinitionMyelodysplastic Syndrome (MDS): a disorder characterized by abnormalities of the bone marrow leading to low numbers of one or more blood cell types; WHO recognizes multiple MDS subtypes

Clinical noteMDS is an indication for broad molecular profiling during initial evaluation when cytopenias are present

Repeat testingRepeat molecular testing may be medically necessary after relapse post-allo-HCT

inv-48: MPN (policy-defined)

Policy-defined MPN noteMPN is defined within the Definitions section of the policy; example disease lists were removed from criteria sets because MPN is already defined

Editorial changeCriteria were simplified by relying on the Definitions section rather than enumerating example MPNs in each criteria set

Effect on criteriaMPN panel criteria now require at minimum testing of JAK2, CALR, and MPL without listing example MPN diagnoses

inv-49: MPN (reiteration)

Reiteration of MPN definition useMPN is consistently defined in the Definitions section; example disease lists were removed from individual criteria sets to streamline policy

Consistency noteMultiple criteria sets were edited to reference the Definitions section rather than repeating MPN examples

Administrative implicationProviders should use the Definitions section to determine whether a patient meets 'MPN' for applicable criteria