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Defines coverage and medical necessity criteria for molecular/genomic testing (multigene panels, comprehensive genomic profiling, MRD/clonality testing) for hematologic cancers for UnitedHealthcare Community Plan members in Louisiana, plus required genetic counseling and documentation standards.
Added language to clarify the use of multigene panels (50 genes or fewer) at initial diagnosis and/or recurrence or relapse is proven and medically necessary when ordered by a hematologist or oncologist for individuals with any of the listed conditions.
Replaced stricter wording ('strongly suspected') with 'suspected' for MDS/myeloproliferative neoplasm; broadened CGP indications to multiple hematologic malignancies; changed statement that molecular tests other than clonoSEQ are unproven for MRD to unproven for initial clonality assessment or MRD.
Removed list examples of unproven and not medically necessary molecular tests for assessment of MRD.
Added language indicating benefit coverage is determined by federal, state, or contractual requirements and that medical record documentation may be required.
Archived previous policy version CS372LA.E.
Scope: Coverage and medical necessity criteria for molecular/genomic testing in hematologic cancers for UnitedHealthcare Community Plan members in Louisiana, including multigene panels (≤50 genes), comprehensive genomic profiling (CGP), and clonality/MRD testing (clonoSEQ).
Subject & Policy number: Molecular oncology testing for hematologic cancers (Louisiana); Policy Number CS372LA.F; Effective Date March 1, 2026.
Payer & stance: UnitedHealthcare Community Plan (Louisiana) policy with a mixed coverage stance — specific tests/uses are designated as proven and medically necessary for listed indications, while other molecular tests are unproven/not medically necessary for certain uses.
Key thresholds and requirements: MRD assay sensitivities referenced include 10^-4, 10^-5, and 10^-6; multigene panel size threshold is ≤50 genes; genetic counseling is required before and after all genetic testing and must include obtaining a structured family genetic history, genetic risk assessment, and counseling about diagnosis/prognosis/treatment.
Ordering/documentation requirements: Multigene panels, CGP, and clonoSEQ MRD/clonality testing are specified as medically necessary only when ordered by a hematologist or oncologist, and medical records must document relevant history, exam, and diagnostic test results to support medical necessity.
Genetic Counseling Requirement
Genetic counseling before and after all genetic testing is required and must include all of the following:
ALL of the following
Multigene Panels (≤50 genes) - Initial diagnosis and/or recurrence/relapse
Proven and medically necessary when ordered by a hematologist or oncologist for individuals with ANY of the following:
ANY of the following
Use of Multigene Panels (50 genes or fewer) - Medically Necessary
Covered when ALL of the following are met:
ALL of the following
Added language clarifying ordering clinician requirement (03/01/2026).
Multigene panels (50 genes or fewer) at initial diagnosis and/or recurrence or relapse are proven and medically necessary when ordered by a hematologist or oncologist (03/01/2026).
The policy references 'listed conditions' elsewhere in the policy; this part clarifies panels are necessary for those indications.
Comprehensive Genomic Profiling (CGP)
Proven and medically necessary for individuals with ANY of the following hematologic diagnoses:
ANY of the following
Comprehensive Genomic Profiling (CGP) - Medically Necessary (revised)
Covered when ALL of the following are met:
ALL of the following
Replaced prior language to expand CGP indications (03/01/2026).
Policy text indicates CGP is proven and medically necessary for these conditions.
Clonality assessment and MRD assessment (clonoSEQ)
Proven and medically necessary when ordered by a hematologist or oncologist for individuals with ANY of the following:
ANY of the following
Clonality Assessment with clonoSEQ and MRD Assessment with clonoSEQ - Medically Necessary
Covered when ALL of the following are met:
ALL of the following
Language updated to add chronic lymphocytic leukemia as an indication (03/01/2026).
Policy revised to require ordering by hematologist/oncologist.
Guideline and evidence context provided; clonoSEQ is FDA-cleared for certain MRD uses per cited trials/FDA review.
Unproven / Not Medically Necessary
Tests considered unproven and not medically necessary:
ALL of the following
Language revised to include initial clonality assessment (03/01/2026).
examples include
Molecular tests other than clonoSEQ for clonality or MRD
Policy stance:
ALL of the following
Language revised from prior version to include initial clonality assessment (03/01/2026).
Ordering provider specialty requirement
Tests must be ordered by a hematologist or oncologist.
Medical records documentation requirement
REQUIRE medical record documentation to support medical necessity, including relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures; records must be legible and available upon request.
Genetic counseling documentation required
Genetic counseling before and after all genetic testing is required and must be documented in the medical record.
Verify benefit and contractual coverage
Coverage is governed by federal, state, and contractual requirements and applicable laws; check the applicable benefit determinations and contractual requirements prior to ordering tests.
| 0017M | Oncology (diffuse large B-cell lymphoma [DLBCL]), mRNA, gene expression profiling by fluorescent probe hybridization of 20 genes... |
| 0050U | Targeted genomic sequence analysis panel, acute myelogenous leukemia, DNA analysis, 194 genes... |
| 0120U | Oncology (B-cell lymphoma classification), mRNA, gene expression profiling by fluorescent probe hybridization of 58 genes... |
| 0171U | Targeted genomic sequence analysis panel, acute myeloid leukemia, myelodysplastic syndrome, and myeloproliferative neoplasms, DNA analysis, 23 genes... |
| 0298U | Oncology (pan tumor), whole transcriptome sequencing of paired malignant and normal RNA specimens... |
| 0299U | Oncology (pan tumor), whole genome optical genome mapping of paired malignant and normal DNA specimens... |
| 0300U | Oncology (pan tumor), whole genome sequencing and optical genome mapping... |
| 0331U | Oncology (hematolymphoid neoplasia), optical genome mapping for copy number alterations and gene rearrangements... |
| 0364U | Oncology (hematolymphoid neoplasm), genomic sequence analysis using multiplex (PCR) and NGS with algorithm, quantification of dominant clonal sequence(s), reported as presence or absence of MRD... |
| 0413U | Oncology (hematolymphoid neoplasm), optical genome mapping for copy number alterations, aneuploidy, and balanced/complex structural rearrangements... |
| 0017M | Not on State of Louisiana Medicaid Fee Schedule |
| 0050U | Not on State of Louisiana Medicaid Fee Schedule |
| 0120U | Not on State of Louisiana Medicaid Fee Schedule |
| 0171U | Not on State of Louisiana Medicaid Fee Schedule |
| 0298U | Not on State of Louisiana Medicaid Fee Schedule |
| 0299U | Not on State of Louisiana Medicaid Fee Schedule |
| 0300U | Not on State of Louisiana Medicaid Fee Schedule |
| 0331U | Not on State of Louisiana Medicaid Fee Schedule |
| 0364U | Not on State of Louisiana Medicaid Fee Schedule |
| 0413U | Not on State of Louisiana Medicaid Fee Schedule |
Molecular profiling technologies used in hematologic cancers include but are not limited to Next Generation Sequencing (NGS), Comprehensive Genomic Profiling (CGP), multigene panels, optical genome mapping, and whole transcriptome sequencing.
These technologies evaluate varying amounts of genetic material (single genes up to whole exome/genome) and can inform diagnosis, prognostication, and targeted therapy selection.
Detection of measurable residual disease (MRD) using sensitive assays (PCR, flow cytometry, NGS) is consistently associated with prognostic outcomes — MRD negativity correlates with improved progression-free survival (PFS) and overall survival (OS) across hematologic malignancies (e.g., CLL, AML, MM) in multiple systematic reviews, trials, and pooled analyses.
| Study / Source | Key finding |
|---|---|
| Soderquist et al. 2024 | 98% of test outcomes provided helpful clinical data; 89% led to or clarified diagnosis; 19% detected a potential therapeutic target when using broad myeloid NGS panels (50-gene or similar). |
| Hayes assessment (FoundationOne Heme) | Found 32%–90% had potentially actionable alterations; 6%–14% targetable by on‑label FDA drugs, 49%–56% by off‑label FDA drugs; overall evidence low quality with limited clinical outcome data. |
| Short et al. / Pulsipher / clonoSEQ evaluations (Multiple studies) | NGS MRD assays (including clonoSEQ) demonstrated greater sensitivity (down to 10^-6) and prognostic value: NGS MRD negativity associated with substantially lower relapse and improved survival compared with less sensitive methods (e.g., flow cytometry at 10^-4). |
| Thompson et al. 2019 (CLL) | NGS (sensitivity 10^-6) provided additional prognostic information versus flow cytometry (10^-4); only 27% were undetectable by NGS among those undetectable by flow, and NGS MRD negativity predicted improved outcomes. |
| Jongen‑Lavrencic et al. 2018 (AML) | NGS MRD detection after induction associated with higher relapse and lower RFS/OS after excluding DTA mutations; combining NGS and flow cytometry provided independent prognostic value. |
| FDA / clonoSEQ review and clearances | FDA reviewed clonoSEQ data showing clinical validity in ALL and MM and cleared clonoSEQ for MRD detection/monitoring (later cleared for CLL based on trials including CLL14); undetectable MRD per clonoSEQ associated with substantially reduced progression risk. |
| Systematic reviews / meta‑analyses for MRD (CLL, AML, MM) | MRD negativity consistently associated with improved PFS/OS across CLL, AML, and MM; reported MRD sensitivity thresholds and methods vary (examples: 10^-4, 10^-5, 10^-6) and assay standardization/timing remain important limitations. |
Comprehensive Genomic Profiling (CGP): An NGS-based test able to detect all classes of genomic alterations, including cancer biomarkers, from a single sample.
Measurable Residual Disease (MRD): A term for a very small number of cancer cells or cell contents detectable during or after treatment by sensitive assays (PCR, flow cytometry, NGS); presence can be associated with relapse risk.
Next Generation Sequencing (NGS): Sequencing techniques that quickly analyze multiple sections of DNA simultaneously, enabling broad genomic profiling.
MRD (Measurable Residual Disease): (duplicate term) Low levels of cancer cells remaining after treatment detectable by sensitive assays such as NGS, flow cytometry, or PCR; sensitivity thresholds referenced include 10^-4 to 10^-6 depending on modality.
Added language clarifying that multigene panels (50 genes or fewer) at initial diagnosis and/or recurrence or relapse are proven and medically necessary when ordered by a hematologist or oncologist for individuals with the listed conditions.
Revised coverage criteria: replaced 'strongly suspected' with 'suspected' for MDS/myeloproliferative neoplasm; broadened CGP indications from relapsed/recurrent AML to include acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, and myeloproliferative neoplasm; added chronic lymphocytic leukemia to clonoSEQ indications; changed statement that molecular tests other than clonoSEQ are unproven for MRD to unproven for initial clonality assessment or MRD.
Policy clean-up/streamlining: removed list examples of unproven and not medically necessary molecular tests for assessment of MRD.
Administrative clarifications added: benefit coverage determined by federal, state, or contractual requirements; medical record documentation may be required and must support medical necessity.
Archived previous policy version CS372LA.E.