CurrentUnitedHealthcarePolicy CS372KY.06

Molecular Oncology Hematologic Cancer Diagnosis Ky Cs

Defines UnitedHealthcare Kentucky medical policy CS372KY.06 governing coverage of molecular oncology testing (multi-gene panels, comprehensive genomic profiling, clonoSEQ MRD/clonality) for hematologic cancer diagnosis, prognosis, and treatment decisions; includes definitions, evidence summary, and applicable procedure codes.

Policy Summary

PayerUnitedHealthcare

PolicyMolecular Oncology Hematologic Cancer Diagnosis Ky Cs

Policy CodePolicy CS372KY.06

Change TypeCoverage criteria revisions (03/01/2026)

Effective DateMar 1, 2026

Next Review Date

Key ActionOrder multigene panels (≤50 genes) or clonoSEQ only when requested by a hematologist/oncologist and ensure the medical record documents relevant history, exam, and diagnostic results to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Added language to clarify 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.

Revised clonality assessment and MRD assessment with clonoSEQ® to add chronic lymphocytic leukemia as an indication.

Replaced prior language to expand proven and medically necessary CGP use to include ALL, AML, MDS, and MPN (examples of assays listed).

Changed statement that molecular tests other than clonoSEQ® are unproven and not medically necessary for MRD assessment to cover both initial clonality assessment and MRD assessment.

Added Medical Records Documentation Used for Reviews language clarifying documentation requirements and that coverage is determined by applicable laws and contracts.

Removed list examples of unproven and not medically necessary molecular tests for MRD assessment.

Updated supporting information sections: Clinical Evidence, FDA, and References to reflect current information.

Clarified that documentation must be legible, maintained in the patient's medical record, and made available upon request.

Archived previous policy version CS372KY.05.

3Covered test categories (multigene panels, CGP, clonoSEQ)

50Max genes in recommended multigene panels

4Hematologic malignancy types cited for CGP coverage

2Explicitly named unproven technologies

20+Example CPT/PLA codes listed

Coverage Summary

Policy CS372KY.06 (effective March 1, 2026) covers molecular oncology testing for hematologic cancers in Kentucky. It defines coverage for: multigene panels of ≤50 genes (proven and medically necessary at initial diagnosis and/or recurrence/relapse when ordered by a hematologist/oncologist for specified conditions), Comprehensive Genomic Profiling (CGP) for acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myeloproliferative neoplasm (MPN) (examples: FoundationOne Heme, Neo Comprehensive‑Heme, NEO AML Express), and the FDA‑cleared NGS MRD/clonality assay clonoSEQ® for clonality at diagnosis and MRD assessment (ALL, MM, and added CLL). The overall coverage stance is mixed, with these categories explicitly supported while many other molecular technologies remain unproven/not medically necessary.

Key thresholds & quick facts

Panel size threshold≤ 50 genes

MRD assay sensitivity guidanceRecommend sensitivity ≥ 10^-4; NGS assays may reach 10^-6

Number of covered test categories3 (multigene panels, CGP, clonoSEQ)

Hematologic malignancy types cited for CGPALL, AML, MDS, MPN (4 types)

Medical Necessity Criteria

Revised Coverage Criteria Highlights

Documentation and Medical Records Requirements

Benefit coverage for health services is determined by federal, state, or contractual requirements, and applicable laws that may require coverage for a specific service.

Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage but does not guarantee coverage of the services requested.

The patient's medical record must contain documentation that fully supports the medical necessity for the requested services. This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available upon request.

Documentation Required for Medical Necessity Reviews

Coding

Listed CPT/PLA/HCPCS codes referenced (reference only — inclusion does not guarantee coverage)mixed

0017M	Oncology (DLBCL), mRNA, gene expression profiling of 20 genes
0050U	Targeted genomic sequence analysis panel, AML, DNA analysis, 194 genes
0120U	Oncology (B-cell lymphoma classification), mRNA GEP 58 genes
0171U	Targeted genomic sequence analysis panel, AML/MDS/MPN, DNA analysis, 23 genes
0298U	Oncology (pan tumor), whole transcriptome sequencing
0299U	Oncology (pan tumor), whole genome optical genome mapping
0300U	Oncology (pan tumor), whole genome sequencing and optical genome mapping
0331U	Oncology (hematolymphoid neoplasia), optical genome mapping
0364U	Oncology (hematolymphoid neoplasm), genomic sequence analysis MRD quantification
0413U	Oncology (hematolymphoid neoplasm), optical genome mapping

1–10 of 20

1/2

FDA-cleared MRD test example referencedmixed

clonoSEQ

Adaptive Biotechnologies NGS-based MRD assay referenced (FDA-cleared for ALL, MM, CLL)

Example CGP tests referencedmixed

FoundationOne Heme	Comprehensive genomic profiling assay (Foundation Medicine)
Neo Comprehensive - Heme Cancers	Example CGP assay
NEO AML Express	Example CGP assay for AML

Background & Supporting Evidence

Background: This policy summarizes technologies used in molecular profiling of hematologic cancers — principally Next‑Generation Sequencing (NGS) for multigene panels and comprehensive genomic profiling (CGP), and high‑sensitivity NGS‑based MRD/clonality assays (example: clonoSEQ®). It describes how results inform diagnosis, prognosis, and treatment selection, and cites systematic reviews, clinical trials, and technology assessments (including Hayes and NICE) that evaluate diagnostic/prognostic utility and limitations. The policy also consolidates guideline recommendations (e.g., NCCN, ESMO, ASCO/CCO, CAP/ASH) on molecular testing and MRD assessment, noting variability in evidence quality and ongoing evolution of clinical utility.

Evidence / Source	Key Findings
Soderquist et al. 2024	Broad NGS/myeloid panel improved diagnostic and prognostic yield: 98% provided helpful clinical data; 89% led to/clarified diagnosis; 94% provided prognostic info; 19% detected potential therapeutic targets.
Hayes assessment FoundationOne Heme	Found actionable alterations in 32%–90% across studies; 6%–14% targetable by on‑label FDA drugs; evidence limited and lower quality; no direct comparison to targeted tests or demonstrated clinical outcomes.
Multiple MRD studies (CLL, ALL, AML, MM)	MRD negativity associated with improved PFS/OS across multiple studies and meta-analyses; clonoSEQ (NGS) has greater sensitivity vs flow or ASO‑PCR though evidence that testing improves outcomes is limited.
Jongen-Lavrencic et al. (AML NGS study)	NGS MRD detection associated with higher relapse rate; combining NGS and flow cytometry adds independent prognostic value for relapse, RFS, and OS.
Thompson et al. (CLL)	NGS with sensitivity 10^-6 detected MRD in fewer patients than flow cytometry (10^-4) and provided additional prognostic information; greater sensitivity yields extra prognostic stratification.
FDA clearance	FDA cleared clonoSEQ for MRD detection/monitoring in ALL and MM (2018) and CLL (2020/2023 communications); clinical validity demonstrated in retrospective/ongoing studies linking negative MRD to longer event-free survival.
NICE / HTA and guideline summaries	NICE and other guideline briefings note clonoSEQ improves standardization, sensitivity and specificity vs other MRD techniques but randomized outcome data are lacking; MRD is prognostic across hematologic malignancies.

Definitions

Definitions rendered as key-value items

Comprehensive Genomic Profiling (CGP)A type of NGS test able to detect all classes of genomic alterations, including cancer biomarkers, with a single sample

Measurable Residual Disease (MRD)Very small number of cancer cells or cell contents detectable during/after treatment; assessed by PCR, flow cytometry, and/or NGS

Next Generation Sequencing (NGS)Sequencing techniques that analyze multiple DNA sections simultaneously

MRD (alternate definition)Measurable Residual Disease — low levels of cancer cells remaining after treatment detectable by sensitive assays

CGP (alternate definition)Comprehensive Genomic Profiling — broad molecular profiling often using NGS to detect multiple genomic alterations

Medical necessity documentationRelevant medical history, physical exam, and results of pertinent diagnostic tests or procedures that support need for requested services; documentation must be legible and available

Revision History

03/01/2026Material RevisionLatest

Added language clarifying multigene panels (≤50 genes) at initial diagnosis and/or recurrence/relapse are proven and medically necessary when ordered by a hematologist or oncologist; revised CGP coverage to include ALL, AML, MDS, and MPN (examples: FoundationOne Heme, Neo Comprehensive‑Heme, NEO AML Express); revised clonality and MRD assessment with clonoSEQ® to add chronic lymphocytic leukemia; changed statement to indicate molecular tests other than clonoSEQ® are unproven and not medically necessary for both initial clonality assessment and MRD assessment; added Medical Records Documentation Used for Reviews language clarifying documentation requirements and that coverage is determined by applicable laws and contracts; archived prior version CS372KY.05.

03/01/2026Revision

Replaced prior language to expand proven and medically necessary CGP use to include ALL, AML, MDS, and MPN (examples listed).

Policy Summary

PayerUnitedHealthcare

PolicyMolecular Oncology Hematologic Cancer Diagnosis Ky Cs

Policy CodePolicy CS372KY.06

Change TypeCoverage criteria revisions (03/01/2026)

Effective DateMar 1, 2026

Next Review Date

SourceLink

On This Page

The following documentation elements may be requested to support medical necessity determinations and utilization review:

Relevant medical history, including presenting signs/symptoms and prior treatments

Findings from the physical examination relevant to the hematologic malignancy

Pertinent laboratory and diagnostic test results (e.g., CBC, bone marrow biopsy, flow cytometry, cytogenetics)

Results of prior molecular testing, if any, and rationale for additional or repeat testing

Clinical indication for the requested test (diagnosis, initial staging, recurrence/relapse, MRD assessment, treatment selection)

Documentation that the ordering clinician is a hematologist or oncologist when required by the policy

Operational note: Documentation may be requested prior to or after prior authorization and/or at the time of claim review to determine whether services meet coverage criteria.

Documentation Required

Clinical ordering requirement

Tests must be ordered by a hematologist or oncologist. The patient's medical record must document the relevant history, physical examination findings, and test results that support medical necessity for the requested molecular test.

Affected tests: multigene panels (≤50 genes)
clonoSEQ
Comprehensive Genomic Profiling (CGP)

Prior Authorization

Ordering requirement for multigene panels

Multigene panels of 50 genes or fewer used at initial diagnosis, recurrence, or relapse are medically necessary when ordered by a hematologist or oncologist per this policy.

Documentation Required

Medical record documentation required for coverage review

Maintain a legible, complete medical record that includes relevant history, physical examination findings, and all pertinent test results. Records must be available upon request for coverage review.

Prior Authorization

Companion diagnostic referral

For companion diagnostic testing, refer to the separate Medical Policy: "FDA Cleared or Approved Companion Diagnostic Testing (for Kentucky Only)."

Note

Use InterQual or other UHC guidelines for utilization review

InterQual, ASAM, or other UnitedHealthcare clinical guidelines and policies may be used to support utilization review decisions as applicable.

03/01/2026Revision

Revised clonality assessment and MRD assessment with clonoSEQ® to add chronic lymphocytic leukemia as an indication.

03/01/2026Revision

Changed statement that molecular tests other than clonoSEQ® are unproven and not medically necessary for MRD assessment to cover both initial clonality assessment and MRD assessment.

03/01/2026Material Revision

Added language to clarify 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.

03/01/2026Material Revision

Added Medical Records Documentation Used for Reviews language clarifying documentation requirements and that benefit coverage is determined by federal, state, or contractual requirements and applicable laws.

03/01/2026Revision

Removed list examples of unproven and not medically necessary molecular tests for MRD assessment (operational: removed list examples).

03/01/2026Revision

Updated supporting information sections: Clinical Evidence, FDA, and References to reflect current information; archived previous policy version CS372KY.05.