RetiredUnitedHealthcarePolicy CS152LA.AA

Molecular Oncology Testing for Solid Tumor Cancer Diagnosis, Prognosis, and Treatment Decisions (for Louisiana Only)

State-specific UnitedHealthcare policy for Louisiana governing coverage of molecular/genomic testing (tissue and liquid biopsy) for diagnosis, prognosis, and treatment decisions in solid tumor cancers, including gene expression profiling (GEP) and lists of proven vs unproven tests and extensive applicable codes. Applies Feb 1, 2026 to Mar 31, 2026 and is retired Apr 1, 2026.

Policy Summary

PayerUnitedHealthcare

PolicyMolecular Oncology Testing for Solid Tumor Cancer Diagnosis, Prognosis, and Treatment Decisions (for Louisiana Only)

Policy CodePolicy CS152LA.AA

Change TypeRetirement; code updates

Effective DateFeb 1, 2026

Next Review Date

Key ActionDocument genetic counseling before and after all genetic testing including structured family history, risk assessment, and counseling about diagnosis/prognosis/treatment.

POLICY UPDATE CHANGES

Policy marked as Retired effective April 1, 2026; effective coverage window listed Feb 1, 2026 - Mar 31, 2026.

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

Updated list of applicable CPT codes to reflect annual edits; added 0611U, 0612U, 0613U, and 81524.

Archived previous policy version CS152LA.Z.

LouisianaGeographic scope

3Highlighted breast assays

multipleApplicable assay codes listed

Added CPT/HCPCS Codes

1Policy Retirement Notices

Coverage Summary & Scope

State-specific UnitedHealthcare (Louisiana) coverage criteria for molecular/genomic testing for solid tumors (tissue and liquid biopsy) — including GEP, targeted NGS/CGP, and ctDNA — described as mixed coverage. Policy effective window: 02/01/2026–03/31/2026, with policy RETIRED effective 04/01/2026 and Louisiana membership disenrolled on that date. Geographic scope: Louisiana only. High-level stance: selective/proven coverage for specified indications (e.g., certain breast, prostate, thyroid, uveal melanoma, and limited NSCLC settings) and broad exclusions for other molecular tests judged unproven; overall coverage posture characterized as mixed.

Policy attributes

Policy numberCS152LA.AA

Effective date2026-02-01

Retirement dateRetired effective 2026-04-01 (Louisiana membership disenrolled Apr 1, 2026)

Geographic scopeLouisiana

StatusRETIRED

Coverage stancemixed

Scope summaryState-specific UnitedHealthcare policy for Louisiana governing coverage of molecular/genomic testing (tissue and liquid biopsy) for diagnosis, prognosis, and treatment decisions in solid tumor cancers; lists proven vs unproven tests and applicable codes; applies Feb 1, 2026 to Mar 31, 2026 and retired Apr 1, 2026.

Medically Necessary Criteria (grouped)

Genetic counseling requirement

Genetic counseling before and after all genetic testing is required. Counseling must consist of at least the following and be documented in the medical record:

Obtaining a structured family genetic history;

Genetic risk assessment;

Counseling of the enrollee and family about diagnosis, prognosis, and treatment

Breast cancer GEP — proven and medically necessary

Use of breast cancer gene expression profiling (GEP) is proven and medically necessary to inform adjuvant chemotherapy or extended endocrine therapy decisions for select patients with invasive breast cancer when the following nested criteria are met:

One of the following clinical scenarios must apply:

Newly diagnosed (within the last 6 months)

Unproven and Not Medically Necessary Tests

Tests considered unproven/not medically necessary for solid tumors (summary)

Due to insufficient evidence, the policy summarizes a set of tests/assay types considered unproven/not medically necessary for solid tumors (examples):

Tests/assay types considered unproven: Measurable residual disease (MRD) ctDNA assays (tumor-informed or tumor-naïve, e.g., Signatera, RaDaR, Guardant Reveal); Multi-cancer early detection (MCED) tests (e.g., Galleri); Whole exome/genome/transcriptome sequencing (WES/WGS/WGTA, Tempus, CancerVision); Broad cfDNA panels and large CGP panels (>50 genes) when not otherwise specified; Numerous named assays listed in policy (NavDx, ColonSentry, PancreaSeq, PancraGEN, Percepta GSC, Decipher Bladder, DecisionDx-Melanoma, DermTech PLA, myPath Melanoma, etc.)

Policy lists many specific proprietary assays and assay types as unproven

Overarching exclusion stance: all other molecular testing for solid tumors (tissue or liquid biopsy) not specified as proven/medically necessary is considered unproven and not medically necessary. Key excluded categories include: NGS/CGP panels >50 genes (unless used consistent with FDA-cleared/approved companion diagnostic policy); Measurable residual disease (MRD) assays (tumor-informed or tumor‑naïve, e.g., Signatera, Invitae Personalized Cancer Monitoring, RaDaR, Guardant Reveal, Haystack MRD); multi-cancer early detection (MCED) tests (e.g., Galleri and similar methylation-based blood tests); whole-genome/transcriptome/exome approaches (WGTA/WES/WGS) for routine profiling (e.g., Tempus WGTA, OncoExTra); and named examples from policy lists such as DecisionDx‑Melanoma, DermTech PLA, NavDx, Oncotype DX Colon Recurrence Score, PancraGEN, PancreaSeq, Percepta GSC, Tempus Immune Profile Score. This exclusion also notes other specifically listed marketed assays when used outside proven indications.

Applicable Codes & Code Groups

Provider Actions, Documentation & Billing

Documentation Required

Document genetic counseling

Genetic counseling before and after all genetic testing must be documented in the medical record. Documentation must include a structured family genetic history, a genetic risk assessment, and counseling of the enrollee and family about diagnosis, prognosis, and treatment.

Structured family genetic history
Genetic risk assessment
Counseling of the enrollee and family about diagnosis, prognosis, and treatment

Billing Rule

Report appropriate CPT/HCPCS code for molecular assay

Bill using the specific CPT/HCPCS code corresponding to the assay performed. Providers should report the exact code for the molecular assay submitted with the claim.

Background, Evidence Summaries & Guidelines

Background and scope: policy addresses molecular and genomic tests for solid tumor cancers — including gene expression profiling (GEP), targeted NGS panels, comprehensive genomic profiling (CGP), and liquid biopsy (cfDNA/ctDNA) — to define proven/medically necessary versus unproven/not medically necessary uses. Louisiana-specific requirement: genetic counseling before and after all genetic testing is required and must be documented (structured family history, genetic risk assessment, counseling about diagnosis/prognosis/treatment). Applicability: this policy applies only to the state of Louisiana and reflects Louisiana Medicaid coverage requirements where specified.

High-level evidence synthesis: per-assay and general findings summarized — breast assays (Oncotype DX, MammaPrint, Prosigna, EndoPredict, Breast Cancer Index) have substantive evidence for prognostic use and select predictive value (Oncotype DX has highest level of evidence for predicting chemotherapy benefit; MammaPrint/BluePrint have prospective data such as MINDACT supporting chemo de‑escalation in selected groups); EndoPredict and BCI provide prognostic/extended‑endocrine therapy information with more limited evidence. Prostate classifiers (Genomic Prostate Score/Oncotype DX GPS, Decipher, Prolaris) show prognostic associations (metastasis, biochemical recurrence) and selective utility for decision making (e.g., Decipher for post‑RP adjuvant considerations), but randomized outcome evidence is limited and guideline recommendations are conditional. Thyroid tests (ThyroSeq v3, Afirma GSC/XA) demonstrate high sensitivity/NPV in many series for indeterminate nodules but performance and utility depend on prevalence and follow‑up; evidence quality varies. Cutaneous/uveal melanoma GEPs (DecisionDx, 31‑GEP, 15‑GEP/DecisionDx‑UM, PLA tape‑strip) show prognostic associations and potential to influence management (e.g., SLNB decisions), but clinical‑utility evidence for outcome improvement remains limited. ctDNA/MRD assays (tumor‑informed and tumor‑naïve, e.g., Signatera, Guardant Reveal) and MCED tests show prognostic or stage‑dependent detection performance and early detection capability, but robust prospective evidence that testing changes long‑term outcomes or should be used for population screening is insufficient; guideline and HTA groups call for prospective trials. Detailed citations and study summaries are available in the evidence list.

Definitions & Terminology

term	definition
GEP	Gene Expression Profiling: analyzes mRNA patterns to determine gene activity.
CGP	Comprehensive Genomic Profiling: NGS test detecting all classes of genomic alterations.
cfDNA / ctDNA	Cell-free circulating tumor DNA used in plasma 'liquid biopsy' testing to detect tumor-derived genetic or epigenetic alterations.
MRD	Measurable Residual Disease: detection of small numbers of cancer cells or tumor DNA after treatment indicating residual disease or early recurrence.
NGS	Next Generation Sequencing: high-throughput techniques to analyze multiple DNA sections simultaneously for sequence variants, fusions, CNVs, TMB, MSI.
FFPE	Formalin-fixed paraffin-embedded tissue used as a specimen type for many tumor-based molecular assays.
GPS	Genomic Prostate Score (Oncotype DX GPS): 17-gene test to predict prostate cancer outcomes and assist treatment decisions.
GC	Genomic classifier: multi-gene expression test (e.g., Decipher) to predict outcomes such as metastasis or recurrence.
MCD / MCED	Multi-Cancer Detection / Multi-Cancer Early Detection: blood tests (eg, cfDNA methylation) intended to detect multiple cancer types from a single sample.
WGTA	Whole Genome and Transcriptome Analysis: combined DNA and RNA sequencing to identify somatic variations and expression-based findings; used in comprehensive tumor profiling.
GEP / GEA	Gene expression profiling / gene expression assay: molecular tests measuring expression patterns to classify tumor risk or tissue of origin.
Liquid Biopsy	Testing on bodily fluids (commonly plasma) to identify tumor-derived cells, cfDNA/ctDNA or other tumor biomarkers for detection, genotyping, or monitoring.

Selected Evidence & Outcomes (highlights)

Major trial/registry highlights and implications: MINDACT and subsequent analyses (MammaPrint) showed that selected clinically high‑risk but genomically low‑risk women may safely avoid chemotherapy with age‑dependent effects (implication: GEP can support de‑escalation decisions in specific breast cancer subgroups). TAILORx and related Oncotype DX analyses demonstrated prognostic value of the 21‑gene Recurrence Score and informed chemotherapy benefit stratification, particularly with age/menopausal interactions. G‑MINOR (Decipher) randomized trial found higher genomic classifier scores associated with increased adjuvant treatment odds but no overall difference in adjuvant treatment rates at 18 months versus usual care, underscoring uncertain impact on outcomes. PATHFINDER and SYMPLIFY (MCED studies) demonstrated feasibility of multi‑cancer blood testing with high specificity but modest positive predictive value and stage‑dependent sensitivity; these results highlight potential for earlier detection but confirm the need for prospective studies demonstrating mortality benefit and optimized diagnostic pathways. Overall implication: some assays can influence management decisions, but prospective trials linking use to improved long‑term outcomes remain limited; coverage should reflect proven indications and evidence gaps.

Selected study metrics

MINDACT 8-year DMFS (intention-to-treat)92.0% with chemotherapy vs 89.4% without chemotherapy

FLEX (MammaPrint concordance CNB vs SR)90.9% total agreement (κ = 0.817)

Shield cfDNA CRC sensitivity

Revision History & Material Changes

2026-04-01policy_retirementLatest

Policy marked as Retired effective April 1, 2026; effective coverage window listed Feb 1, 2026 - Mar 31, 2026. Retirement status included in header.

2026-04-01membership_actionLatest

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

2026-02-01codes_update

Policy Summary

PayerUnitedHealthcare

PolicyMolecular Oncology Testing for Solid Tumor Cancer Diagnosis, Prognosis, and Treatment Decisions (for Louisiana Only)

Policy CodePolicy CS152LA.AA

Change TypeRetirement; code updates

Effective DateFeb 1, 2026

Next Review Date

Key ActionDocument genetic counseling before and after all genetic testing including structured family history, risk assessment, and counseling about diagnosis/prognosis/treatment.

On This Page

Lymph node negative (including lymph nodes with micrometastases no greater than 2 mm) or 1-3 positive ipsilateral axillary lymph nodes
No distant metastases
Hormone receptor-positive (estrogen receptor positive, progesterone receptor positive, or both)
HER2 receptor negative
Adjuvant chemotherapy is not precluded due to any other factor (e.g., advanced age and/or significant comorbidities)

Currently receiving adjuvant hormonal therapy

Hormone receptor-positive (estrogen receptor positive, progesterone receptor positive, or both)
HER2 receptor negative
Individual and treating physician have discussed potential results and plan to use results to guide decision regarding extended adjuvant hormonal therapy

ALL of the following

Permitted predictive GEP tests include MammaPrint, Oncotype DX Breast, Prosigna (PAM-50), Breast Cancer Index (BCI), and EndoPredict
Use of more than one predictive GEP for the same tumor is unproven and not medically necessary (insufficient evidence), except BCI may be used once to evaluate the role of extended endocrine therapy even if a prior GEP was used to determine adjuvant chemotherapy

Breast cancer GEP — unproven/not medically necessary indications

GEP for breast cancer for indications other than those above (including DCIS) is unproven and not medically necessary. Examples include:

BluePrint

DCISionRT

Oncotype DX Breast DCIS Score

Lung cancer (NSCLC) — proven and medically necessary

Multigene molecular profiling for non–small cell lung cancer (NSCLC) is proven and medically necessary when performed on tumor tissue or via liquid biopsy with the following constraints:

ALL of the following

Specimen source: tumor tissue specimen OR liquid biopsy (cell-free DNA/circulating tumor DNA)
Panel size: panels of ≤ 50 genes are covered; panels with > 50 genes are covered only when used consistent with the FDA Cleared or Approved Companion Diagnostic Testing policy for Louisiana

Prostate GPS — proven and medically necessary

Oncotype DX Genomic Prostate Score (GPS) is proven and medically necessary for untreated, localized prostate adenocarcinoma to inform decisions between active surveillance and definitive therapy when all of the following are met:

Test ordered by a physician specializing in organ-confined prostate cancer (urology/surgical oncology, radiation oncology, or medical oncology);

Results will be used to assist with treatment decision-making prior to any treatment and the individual is a candidate for either active surveillance or definitive therapy;

Life expectancy > 10 years;

Risk group is one of: Very Low-Risk, Low-Risk, or Favorable Intermediate-Risk Prostate Cancer

Prolaris / Decipher prostate biopsy prognostic tests — proven and medically necessary

Prolaris (cell-cycle progression; CCP/CCR) and Decipher genomic classifiers on prostate biopsy are proven and medically necessary for biopsy-proven, untreated, localized prostate adenocarcinoma to inform treatment decisions when all of the following are met:

Test ordered by a physician specializing in organ-confined prostate cancer (urology/surgical oncology, radiation oncology, or medical oncology);

Results will be used to assist with treatment decision-making prior to any treatment and the individual is a candidate for either active surveillance or definitive therapy;

Life expectancy > 10 years;

Risk group is one of: Very Low-Risk, Low-Risk, Favorable Intermediate-Risk, Unfavorable Intermediate-Risk, or High-Risk Prostate Cancer

Decipher Prostate RP — post-prostatectomy adjuvant decision support

Decipher Prostate RP genomic classifier is proven and medically necessary to inform adjuvant treatment after radical prostatectomy when any of the following adverse features or findings are present:

ANY of the following

Adverse pathologic features (e.g., high-grade disease, Gleason score 8 or higher, extracapsular extension, positive surgical margins, seminal vesicle invasion)
Postoperative PSA greater than zero at any point following prostatectomy

Prostate molecular screening panels — unproven/not medically necessary

Molecular screening panel tests and urine/other biomarker panels for prostate cancer early detection or population screening are unproven and not medically necessary due to insufficient evidence. Examples include (non-exhaustive):

ExoDx (EPI) Prostate Test

MyProstateScore (MPS) and MPS 2.0

Confirm mdx

Select mdx

Thyroid indeterminate nodules — proven and medically necessary

Molecular testing for indeterminate thyroid nodules is proven and medically necessary when used to guide decisions about the need for surgery under the following conditions:

Follicular-pattern cytology on fine needle aspiration is indeterminate (Bethesda III or IV);

Results will be used to make decisions about further surgery

Note: Comprehensive genomic profiling (CGP) of confirmed anaplastic thyroid cancer is proven and medically necessary

Uveal melanoma GEP (DecisionDx-UM) — proven and medically necessary

Gene expression profiling for uveal melanoma (e.g., DecisionDx-UM) is proven and medically necessary when all of the following are met:

Primary, localized uveal melanoma

No evidence of metastatic disease

Individual has not previously had DecisionDx-UM testing for the current diagnosis

Unproven molecular tests — general list and limitations

The following molecular tests, assay types, and uses are considered unproven and not medically necessary due to insufficient evidence of efficacy, including for screening, surveillance, or general prognostic use:

NGS panels of > 50 genes or comprehensive genomic profiling (CGP) unless otherwise specified

Afirma Xpression Atlas (XA)

CancerTYPE ID

Blood-based colorectal cancer screening tests (e.g., ColoHealth, Signal-C, Guardant Shield)

Decipher Bladder

DecisionDx-Melanoma, DiffDx-Melanoma, DecisionDx-SCC, DermTech PLA, Merlin (SkylineDx), myPath Melanoma

ExoDx Prostate Test, MyProstateScore, MyProstateScore 2.0, Confirm mdx, Select mdx, TMPRSS2 fusion gene assays for screening

Measurable residual disease (MRD) assays in solid tumors (tumor-informed or tumor-naïve) such as Signatera, RaDaR, Guardant Reveal, Haystack MRD

Multi-cancer early detection/screening tests (e.g., Galleri)

NavDx

Oncotype DX Colon Recurrence Score, Genefx Colon (ColDx), ColonSentry

PancraGEN, PancreaSeq Genomic Classifier

Percepta GSC

Solid tumor profiling that includes whole exome, whole genome, or whole transcriptome sequencing (e.g., Tempus xE/xR, OncoExTra)

Tempus Immune Profile Score (IPS)

Whole genome methylation profiling

81519
81521
81504
81445
81455
81599
G0327

Prior Authorization

Prior authorization may be required (not specified in this part)

Prior authorization may be required for genomic assay claims; because this policy section does not list explicit PA rules, providers must follow plan-specific PA processes.

Documentation Required

Counseling and informed consent for molecular testing

Provide counseling and informed consent regarding molecular testing. Counsel patients on benefits, limitations, uncertainties, and that molecular testing may not definitively rule in or out malignancy; document the discussion and informed consent.

Counseling and informed consent for molecular testing
Document benefits, limitations, and uncertainties and planned use of results

Denial Risk

Risk of non-coverage for routine surveillance/testing (MRD, MCED, NavDx, Signatera, WGTA)

Routine use of MRD assays, MCED tests, NavDx, Signatera, and whole-genome/transcriptome profiling may be denied outside established indications or clinical trials due to insufficient evidence of clinical utility. If ordering these tests for off-label or investigational purposes, provide documentation that results will alter management and note clinical trial enrollment when applicable.

Assays such as MRD (Signatera/etc.), MCED/MCD (e.g., Galleri), NavDx, and WGTA/WES/WGS are unproven for routine use and may be denied
Document clinical rationale and evidence for off-trial/off-label requests; cite planned management changes or trial enrollment

Assay / Test	Primary Intended Use	Policy stance
Oncotype DX Breast	Predict adjuvant chemotherapy benefit and 10-year distant recurrence risk in ER+/HER2- early breast cancer (21-gene RS); used for node-negative and selected 1-3 node positive	Proven/Medically Necessary
MammaPrint	Prognostic classification (70-gene) to identify genomic low/high distant recurrence risk and guide chemo decisions in ER+/HER2- early breast cancer	Proven/Medically Necessary
Prosigna (PAM50)	Prognostic ROR score (50-gene) for postmenopausal HR+, early breast cancer to estimate 10-year DR risk	Proven/Medically Necessary
Decipher	Genomic classifier to prognosticate metastasis/BCR and inform adjuvant therapy decisions post-radical prostatectomy and biopsy risk stratification	Proven/Medically Necessary
Genomic Prostate Score (GPS)	17-gene assay to assist risk stratification and treatment decision-making for biopsy-proven localized prostate adenocarcinoma (active surveillance vs definitive therapy)	Proven/Medically Necessary
ThyroSeq v3	Molecular classifier for indeterminate thyroid nodules (Bethesda III/IV) to inform need for surgery	Proven/Medically Necessary
Afirma GSC	Genomic sequencing classifier for indeterminate thyroid nodules (Bethesda III/IV) to rule-out malignancy and guide management	Proven/Medically Necessary
Signatera	Tumor‑informed ctDNA MRD monitoring to detect minimal residual disease/early recurrence in solid tumors	Unproven/Not Medically Necessary
Guardant/Shield (cfDNA MCED examples)	Cell-free DNA-based multi-cancer detection / colorectal cancer cfDNA screening assays (plasma) for early detection/screening	Unproven/Not Medically Necessary
Galleri (MCED)	Multi-cancer early detection blood test using cfDNA methylation signatures for population screening or symptomatic triage	Unproven/Not Medically Necessary

Guideline and HTA positions (summary bullets): ASCO — supports selected use of genomic assays (Oncotype DX, MammaPrint, BCI, EndoPredict) to guide adjuvant decisions in specified early‑stage breast cancer populations and recommends BCI for extended endocrine therapy decisions in some patients. NCCN — recognizes gene expression assays as complementary prognostic/predictive tools (Oncotype DX preferred for predicting chemo benefit), encourages broad NGS panels where appropriate in NSCLC but notes plasma ctDNA should not replace tissue diagnosis and is generally for advanced/metastatic settings. ESMO — endorses GEP when clinical/pathologic uncertainty remains to inform adjuvant chemotherapy decisions and calls for individualized decision‑making. NICE — issued conditional recommendations (2024) specifying EndoPredict, Oncotype DX or Prosigna may guide adjuvant chemo in post‑menopausal/men/trans individuals with 1‑3 nodes under defined conditions and advises MammaPrint not be used for 1‑3 positive node chemo decisions. CAP/AMP and allied lung panels — recommend validated PD‑L1 testing and caution on TMB use; endorse multiplexed sequencing over single‑gene tests in many settings. HTA/assessments (e.g., Hayes, NICE, ECRI) emphasize limited clinical‑utility evidence for many assays (Percepta GSC, many MRD/MCD tests, some melanoma/tape‑strip tests) and call for more prospective outcome data.

Key numeric thresholds

MyProstateScore threshold10 (sensitivity 97%, NPV 98% for grade group ≥2)

EPI / ExoDx cut-points (examples)15.6 (avoid ~26% unnecessary biopsies, NPV 89%, miss 7% ≥ GG2); 20 (avoid ~40% unnecessary biopsies, NPV 89%, miss 11% ≥ GG2)

Shield cfDNA (Guardant) sensitivity for CRC83.1% overall; 87.5% for stage I-III

Shield cfDNA specificity (any advanced neoplasia)~89.6%

PATHFINDER MCD positive rate1.4% (92/6621)

PATHFINDER positive predictive value38% (35/92)

83.1% overall (87.5% for stage I-III)

PATHFINDER MCD positive predictive value38% (35/92); median diagnostic resolution 79 days (IQR 37-219)

Applicable Codes section updated on 2026-02-01: updated list of applicable CPT/HCPCS codes to reflect annual edits; added 0611U, 0612U, 0613U, and 81524.

2026-02-01version_archive

Previous policy version archived as of 2026-02-01 (archived version CS152LA.Z).