CurrentUnitedHealthcarePolicy CS373NE.E

Fda Companion Diagnostic Testing Ne Cs

Policy governing coverage of FDA-cleared or -approved companion diagnostic molecular oncology tests (tissue and liquid biopsy) for use with specific targeted therapeutic products in Nebraska. Specifies which named CDx tests/indication-drug pairings are considered proven and medically necessary, criteria for other FDA-cleared/approved CDx tests, concurrent testing rules, and documentation requirements.

Policy Summary

PayerUnitedHealthcare

PolicyFda Companion Diagnostic Testing Ne Cs

Policy CodePolicy CS373NE.E

Change TypeRevised; Added; Clarified

Effective DateMar 1, 2026

Next Review Date

Key ActionVerify the test is FDA-cleared/approved for the intended therapeutic product and document medical necessity in the medical record before coverage determination.

SourceLink

POLICY UPDATE CHANGES

Policy language revised to specify that it applies to tests granted approval as FDA cleared or approved Companion Diagnostic (CDx) tests and to identify specific CDx assays proven and medically necessary for listed indication/drug pairings.

Concurrent tissue-based and liquid biopsy CDx testing coverage added for advanced/metastatic (stage IV) breast cancer and NSCLC when CDx criteria are met.

Added CPT codes 0211U and 0523U to applicable codes.

Medical records documentation language added specifying documentation may be required to assess coverage.

Removed definitions for Comprehensive Genomic Profiling (CGP) and Next Generation Sequencing (NGS); added definition for 'Concurrent Testing' and updated other definitions.

Clarified that FDA approval alone is not a basis for coverage; FDA approvals list provided for informational purposes.

Coverage Summary

This policy applies only to the State of Nebraska and addresses coverage of FDA-cleared or FDA-approved companion diagnostic (CDx) molecular oncology tests. The policy stance is covered_with_criteria, listing specific named CDx assays and indication/drug pairings that are considered proven and medically necessary. The policy is limited to molecular oncology CDx tests that detect alterations in >=5 genes (i.e., five or more genes) and are listed in the FDA List of Cleared or Approved Companion Diagnostic Devices and/or have an approval order in the FDA Premarket Approval Database. Headline points: it names multiple validated CDx assays (e.g., FoundationOne CDx and FoundationOne Liquid CDx among others) and specifies concurrent tissue + liquid CDx testing coverage for select advanced/metastatic cancers; documentation requirements and state-specific applicability are emphasized.

Key thresholds and quick facts

Tumor Mutational Burden (TMB) high definition>= 10 mutations/Mb

Concurrent testing timingTissue-based and liquid biopsy ordered within a 30-day period

Effective dateMarch 1, 2026

Policy statusCURRENT

SubjectFDA cleared or approved companion diagnostic (CDx) testing (Nebraska only)

Named CDx tests listedMultiple (e.g., FoundationOne CDx, FoundationOne Liquid CDx, Guardant360 CDx, TruSight Oncology Comprehensive, xT CDx, Oncomine Dx series, oncoReveal CDx, MI Cancer Seek)

Cancer types allowed for concurrent testing2 (Advanced/metastatic [stage IV] breast cancer; Advanced/metastatic [stage IV] NSCLC)

Genes detected threshold for covered CDx tests>=5 genes

Proven / Covered and Unproven Uses

Not medically necessary / Unproven uses

Due to insufficient evidence of efficacy, all other uses of the listed FDA cleared or approved CDx tests are unproven and not medically necessary.

Any use of the listed CDx tests for indication/drug pairings not specified above or not meeting the stated criteria

Proven and Medically Necessary - FDA cleared/approved CDx tests

Covered when ALL of the following are met:

ALL of the following

The test results will be used to inform the use of a targeted oncology therapeutic product or group of products in an individual with the corresponding clinical indication
One of the following (evidence of FDA CDx status)

Applicable CPT / Proprietary Codes (reference)

Applicable CPT / Proprietary codes (reference only)mixed

0022U	Targeted genomic sequence analysis panel, non-small cell lung neoplasia, DNA and RNA analysis, 23 genes
0037U	Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes
0211U	Oncology (pan-tumor), DNA and RNA by NGS, FFPE tissue, interpretative report
0239U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free DNA, analysis of 311+ genes
0242U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 55-74 genes
0473U	Oncology (solid tumor), NGS of DNA from FFPE tissue with matched normal specimen, 648 genes
0523U	Oncology (solid tumor), DNA, qualitative, NGS of SNV and indels in 22 genes, FFPE tissue
0543U	Oncology (solid tumor), NGS of DNA from FFPE tissue of 517 genes
81479	Unlisted molecular pathology procedure

Added CPT codesCPT

0211U	Added CPT code per policy changes
0523U	Added CPT code per policy changes

Removed CPT/CodesCPT|HCPCS|mixed

0179U	Removed from policy
81445	Removed from policy
81449	Removed from policy
81450	Removed from policy
81451	Removed from policy
81455	Removed from policy
81456	Removed from policy
81599	Removed from policy

Provider Actions & Requirements

Documentation Required

Medical record documentation

The patient's medical record must contain documentation that fully supports medical necessity for the requested CDx testing. Required documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. Documentation must be legible, maintained in the patient's medical record, and made available upon request. Note: medical records documentation may be required to assess whether the member meets clinical criteria but does not guarantee coverage.

Prior Authorization

State-specific application

This policy applies only to members in the State of Nebraska. Verify the member's state and specific plan prior to initiating prior authorization or making coverage determinations to ensure applicability.

Background, Evidence, and Definitions

A Companion Diagnostic (CDx) test provides information essential for the safe and effective use of a corresponding therapeutic product. This policy is limited to FDA cleared or approved molecular oncology CDx tests that detect alterations in five or more genes in tumor tissue or liquid biopsy and that are listed in the FDA List of Cleared or Approved Companion Diagnostic Devices and/or the FDA Premarket Approval Database for use with a specific therapeutic product or group of products.

Evidence	Summary
KEYNOTE-158 TMB	Objective response rate 29% (95% CI, 21%-39%) in TMB-high (≥10 mut/Mb); 57% of responses ≥12 months; pembrolizumab approval for TMB-high based on KEYNOTE-158 using FoundationOne CDx cutpoint of ≥10 mut/Mb.
FoundationOne Liquid CDx validation metrics	Analytical validation: 95% LOD 0.40% VAF for select substitutions/indels; reproducibility 99.59%; positive percent agreement 96.3%; negative percent agreement >99.9%; false positive rate 0.013%.
Guardant360 CDx ORR/DCR	Full analysis set ORR 37.1% (46/124); Guardant360-positive cohort ORR 36.4% (28/77). Disease control rate: full analysis set 80.6% (100/124); Guardant360-positive cohort 77.9% (60/77).
Tempus xT concordance	Concurrent tissue and ctDNA testing concordance 66.4% overall; ctDNA-unique actionable variants 9.3%; tissue-unique actionable variants 24.2% among actionable variants.

Term	Definition
Advanced Cancer	Cancer that is unlikely to be cured, but in some cases can be controlled with treatment (National Cancer Institute, 2025).
Companion Diagnostic	A tool essential for safe and effective use of a corresponding therapeutic drug; as used in this policy, an FDA cleared or approved test for use with a specific drug or group of drugs (CDx).
Concurrent Testing	Tissue-based testing and Liquid Biopsy ordered for the same clinical indication within a 30-day period.
Liquid Biopsy	Testing performed on a sample of bodily fluid to identify tumor-derived cells or circulating tumor DNA/RNA. (NCI definition cited in policy).

Revision History

03/01/2026material_changeLatest

Revised policy language to specify it applies to tests granted approval as FDA cleared or approved Companion Diagnostic (CDx) tests and named multiple specific CDx assays (e.g., FoundationOne CDx, FoundationOne Liquid CDx, TruSight Oncology Comprehensive, xT CDx, Guardant360 CDx, Oncomine Dx assays, oncoReveal CDx, MI Cancer Seek) and expanded lists of indication/drug pairings across tumor types.

03/01/2026material_changeLatest

Added coverage for concurrent testing: Concurrent tissue-based and liquid biopsy CDx testing considered proven and medically necessary for advanced/metastatic (stage IV) breast cancer and advanced/metastatic (stage IV) non-small cell lung cancer when CDx criteria are met.

Policy Summary

PayerUnitedHealthcare

PolicyFda Companion Diagnostic Testing Ne Cs

Policy CodePolicy CS373NE.E

Change TypeRevised; Added; Clarified

Effective DateMar 1, 2026

Next Review Date

Key ActionVerify the test is FDA-cleared/approved for the intended therapeutic product and document medical necessity in the medical record before coverage determination.

SourceLink

On This Page

The test appears in the U.S. Food and Drug Administration (FDA)'s Cleared or Approved Companion Diagnostic Devices Table for use with the intended targeted therapeutic product and clinical indication
The test has an approval order designating it as an FDA cleared or approved CDx test for use with the intended targeted therapeutic product and clinical indication in the FDA Premarket Approval Database, but the approval does not yet appear in the U.S. Food and Drug Administration (FDA)'s Cleared or Approved Companion Diagnostic Devices Table

Documentation Required

Medical record documentation requirement

Medical records may be required to support medical necessity for the requested CDx testing. Records should include relevant medical history, physical exam findings, and results of diagnostic tests or procedures. Documentation must be legible, maintained in the patient's medical record, and available upon request. Presence of documentation does not guarantee coverage.

Prior Authorization

FDA CDx status verification prior to coverage

Before coverage determination or authorization, verify that the test is designated as an FDA cleared or approved Companion Diagnostic for the intended therapeutic product and clinical indication. Acceptable evidence includes the test appearing in the FDA's List of Cleared or Approved Companion Diagnostic Devices table or an approval order in the FDA Premarket Approval (PMA) database when the CDx approval is not yet listed in the FDA table.

Documentation or verification of FDA CDx status and medical-record support may be requested to assess whether the member meets clinical criteria, but such documentation does not guarantee coverage. Coverage determinations must be made in the context of applicable federal, state, or contractual benefit requirements; in the event of a conflict, those federal, state, or contractual requirements govern.