CurrentUnitedHealthcarePolicy CS373ID.C

FDA Cleared or Approved Companion Diagnostic Testing (for Idaho Only)

State-specific UnitedHealthcare Community Plan medical policy applicable to Idaho (including Idaho Medicaid Plus) describing coverage criteria for FDA cleared/approved companion diagnostic (CDx) molecular oncology tests (tissue and liquid biopsy) and listing specific FDA-cleared CDx tests and their covered indication/drug pairings. Also includes documentation requirements, definitions, applicable procedure codes and test descriptions/clinical evidence summaries.

Policy Summary

PayerUnitedHealthcare

PolicyFDA Cleared or Approved Companion Diagnostic Testing (for Idaho Only)

Policy CodePolicy CS373ID.C

Change TypeRevised / Added / Clarified / Removed (see changes list)

Effective DateJun 1, 2026

Next Review Date

Key ActionEnsure the patient's medical record fully documents medical necessity (history, exam, relevant test results) and is legible and available upon request.

POLICY UPDATE CHANGES

Policy applies to tests granted approval as FDA cleared or approved Companion Diagnostic (CDx) tests and lists specific tests and indication/drug pairings for which FoundationOne CDx, FoundationOne Liquid CDx, oncoReveal CDx, TruSight Oncology Comprehensive, and xT CDx are proven and medically necessary.

Concurrent testing using an FDA cleared tissue-based CDx and a liquid biopsy-based CDx is considered proven and medically necessary for advanced or metastatic (stage IV) NSCLC.

Added requirement that subsequent use of an FDA cleared/approved CDx on a new specimen is proven and medically necessary when the individual has disease recurrence or cancer progression/non-response and initial criteria are met.

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

Updated Medical Records Documentation Used for Reviews to require legible, supportive documentation available upon request.

Removed definitions for Comprehensive Genomic Profiling (CGP) and Next Generation Sequencing (NGS) and removed a reference link.

>=5Minimum genes detected by CDx tests covered

2Cancer types with explicit concurrent testing allowance

9Examples of listed CDx tests in part 1

2New CPT codes added

MultipleNamed CDx tests with proven indications

Coverage Summary & Scope

This is an Idaho-specific UnitedHealthcare Community Plan medical policy (Policy CS373ID.C) for FDA-cleared or FDA-approved Companion Diagnostic (CDx) molecular oncology tests performed on tumor tissue or liquid biopsy. Coverage stance is covered_with_criteria; the policy applies only in Idaho (including Idaho Medicaid Plus). The policy limits coverage to FDA-cleared/approved CDx tests that detect alterations in five or more genes (>=5) and are listed in the FDA Cleared or Approved Companion Diagnostic Devices Table or have an FDA PMA approval order. Examples of named CDx tests included in the policy are FoundationOne CDx, FoundationOne Liquid CDx, Guardant360 CDx, MI Cancer Seek, Oncomine Dx Express Test, Oncomine Dx Target Test, oncoReveal CDx, TruSight Oncology Comprehensive, and xT CDx.

Operational thresholds and effective date

TMB threshold>= 10 mut/Mb

Concurrent testing windowwithin 30 days

JurisdictionIdaho (Idaho Medicaid)

Effective date2026-06-01

Medical‑Necessity Criteria (Proven / Covered Uses)

General coverage criterion for FDA cleared/approved CDx tests

CDx tests are proven and medically necessary when ALL of the following are met:

ALL of the following

ALL of the following
- The test has been granted approval as an FDA cleared or approved Companion Diagnostic (CDx) test.
- The test 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
  - The test appears in the FDA's Cleared or Approved Companion Diagnostic Devices Table for use with the intended targeted therapeutic product and clinical indication.

Not Medically Necessary / Unproven Uses

Not medically necessary / unproven uses

Uses considered unproven and not medically necessary:

ALL of the following

All other uses of the listed FDA cleared or approved CDx tests that are not specified above or do not meet the stated criteria are considered unproven and not medically necessary due to insufficient evidence of efficacy.

Unproven and Not Medically Necessary Uses

Not covered when:

ANY of the following

Uses of FDA cleared/approved CDx tests that are not listed in the policy and do not meet the above criteria.

Named CDx Tests and Covered Indication / Drug Pairings

The policy enumerates specific FDA-cleared/approved CDx tests and the exact clinical indication/drug pairings for which those tests are considered proven and medically necessary. For each listed test (for example, FoundationOne CDx, FoundationOne Liquid CDx, Guardant360 CDx, oncoReveal CDx, TruSight Oncology Comprehensive, xT CDx, and others), the policy provides multiple specific cancer indication and therapeutic drug pairings in the policy body that must be met for coverage.

CDx Test	Key cancer type examples / drug pairings (abbreviated)
FoundationOne CDx	Breast (trastuzumab, ado‑trastuzumab emtansine, pertuzumab, alpelisib, capivasertib+fulvestrant); Colorectal (cetuximab, panitumumab); NSCLC (alectinib, encorafenib+binimetinib, afatinib, gefitinib, lazertinib+amivantamab, capmatinib, dabrafenib+trametinib, osimertinib, erlotinib, dacomitinib, crizotinib, ceritinib); Ovarian (olaparib); Prostate mCRPC (niraparib+abiraterone, olaparib); Solid tumors (pembrolizumab, selpercatinib, entrectinib, larotrectinib)
FoundationOne Liquid CDx	Breast (Itovebi+palbociclib+fulvestrant, alpelisib); Metastatic colorectal (encorafenib+cetuximab); NSCLC (alectinib, encorafenib+binimetinib, gefitinib, lazertinib+amivantamab, capmatinib, osimertinib, erlotinib, tepotinib); Prostate mCRPC (niraparib+abiraterone, olaparib, rucaparib); Solid tumors (entrectinib)
Guardant360 CDx	Breast (elacestrant); NSCLC (fam‑trastuzumab deruxtecan, sotorasib, amivantamab, osimertinib) and additional listed pairings across tumor types (e.g., cholangiocarcinoma, thyroid, glioma)
MI Cancer Seek	Breast (alpelisib); Colorectal (encorafenib+cetuximab, panitumumab); Melanoma (encorafenib+binimetinib, cobimetinib+vemurafenib, trametinib, dabrafenib, vemurafenib); NSCLC (afatinib, gefitinib, lazertinib+amivantamab, osimertinib, erlotinib, dacomitinib); Solid tumors (dostarlimab, pembrolizumab)
Oncomine Dx Express Test	NSCLC (sunvozertinib / Zegfrovy)
oncoReveal CDx	Colorectal (cetuximab, panitumumab); NSCLC (afatinib, gefitinib, lazertinib+amivantamab, osimertinib, erlotinib, dacomitinib)
TruSight Oncology Comprehensive	NSCLC (selpercatinib); Solid tumors (larotrectinib)
xT CDx	Colorectal (cetuximab, panitumumab) and additional specified pairings listed in policy

Coding (Applicable / Added / Removed Codes)

Applicable CPT/PLA/Proprietary codes (reference only)mixed

0022U	Targeted genomic sequence analysis panel, non-small cell lung neoplasia, DNA and RNA analysis, 23 genes, interrogation for sequence variants and rearrangements, reported as presence or absence of variants and associated therapy(ies) to consider.
0037U	Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden.
0211U	Oncology (pan-tumor), DNA and RNA by next-generation sequencing, utilizing formalin-fixed paraffin-embedded tissue, interpretative report for single nucleotide variants, copy number alterations, tumor mutational burden, and microsatellite instability, with therapy association.
0239U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free DNA, analysis of 311 or more genes, interrogation for sequence variants, including substitutions, insertions, deletions, select rearrangements, and copy number variations.
0242U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 55-74 genes, interrogation for sequence variants, gene copy number amplifications, and gene rearrangements.
0473U	Oncology (solid tumor), next-generation sequencing (NGS) of DNA from formalin-fixed paraffin-embedded (FFPE) tissue with comparative sequence analysis from a matched normal specimen (blood or saliva), 648 genes, interrogation for sequence variants, insertion and deletion alterations, copy number variants, rearrangements, microsatellite instability, and tumor-mutation burden.
0523U	Oncology (solid tumor), DNA, qualitative, next-generation sequencing (NGS) of single-nucleotide variants (SNV) and insertion/deletions in 22 genes utilizing formalin-fixed paraffin-embedded tissue, reported as presence or absence of mutation(s), location of mutation(s), nucleotide change, and amino acid change.
0543U	Oncology (solid tumor), next-generation sequencing of DNA from formalin-fixed paraffin-embedded (FFPE) tissue of 517 genes, interrogation for single-nucleotide variants, multi-nucleotide variants, insertions and deletions from DNA, fusions in 24 genes and splice variants in 1 gene from RNA, and tumor mutation burden.
Unlisted molecular pathology procedure	Unlisted molecular pathology procedure (CPT unlisted code placeholder).

Added CPT codesCPT

0211U	Oncology (pan-tumor), DNA and RNA by next-generation sequencing, utilizing formalin-fixed paraffin-embedded tissue, interpretative report for single nucleotide variants, copy number alterations, tumor mutational burden, and microsatellite instability, with therapy association.
0523U	Oncology (solid tumor), DNA, qualitative, next-generation sequencing (NGS) of single-nucleotide variants (SNV) and insertion/deletions in 22 genes utilizing formalin-fixed paraffin-embedded tissue, reported as presence or absence of mutation(s), location of mutation(s), nucleotide change, and amino acid change.

Removed CPT/Coding entriesCPT

0179U	Removed from Applicable Codes
81445	Removed from Applicable Codes
81449	Removed from Applicable Codes
81450	Removed from Applicable Codes
81451	Removed from Applicable Codes
81455	Removed from Applicable Codes
81456	Removed from Applicable Codes
81599	Removed from Applicable Codes

Provider Actions & Documentation Requirements

Documentation Required

Medical record documentation required

The patient's medical record must fully support the medical necessity of the requested companion diagnostic testing. Documentation should be legible, maintained in the patient's medical record, and made available to UnitedHealthcare upon request.

Include medical history, relevant physical examination findings, and clinical indication for testing
Include prior and current diagnostic test results (imaging, pathology, prior molecular testing)
Document treatment history, prior systemic therapies, response to therapy, and reasons for testing
Maintain records in an accessible, legible format and provide upon request

Documentation Required

Medical record documentation requirement

Maintain documentation that fully supports the medical necessity for the use of an FDA-cleared or -approved companion diagnostic test. Records must be kept in the patient's medical file and be available to UnitedHealthcare upon request.

Background, Evidence Highlights, and Definitions

A Companion Diagnostic (CDx) is defined as an FDA-cleared or FDA-approved test that provides information essential for the safe and effective use of a corresponding therapeutic drug. This policy's scope is limited to FDA-cleared/approved molecular oncology CDx tests that detect alterations in five or more genes in tumor tissue or in circulating tumor DNA (liquid biopsy) and that are listed in the FDA CDx devices table or have an FDA Premarket Approval order designating them as CDx tests. The policy also details criteria for subsequent use on new specimens and conditions for concurrent tissue and liquid CDx testing in advanced/metastatic disease.

Key evidence summaries

KEYNOTE-158 ORR in TMB-high group29% (95% CI 21%-39%) with TMB-H defined as >=10 mut/Mb using FoundationOne CDx

FoundationOne Liquid CDx reproducibilityReproducibility of variant identification 99.59%; PPA 96.3%; NPA >99.9%

Guardant360 CDx sotorasib (KRAS p.G12C) ORRORR full analysis set 37.1% (46/124); Guardant360-positive cohort ORR 36.4% (28/77); disease control rate 80.6% (100/124)

Tempus xT CDx concordance (Iams et al.)

Revision History

06/01/2026revisedLatest

06/01/2026added

Concurrent testing using an FDA cleared tissue-based CDx and a liquid biopsy-based CDx is considered proven and medically necessary for advanced or metastatic (stage IV) NSCLC. Detail: Specifies concurrent tissue and liquid CDx testing criteria for stage IV NSCLC.

Policy Summary

PayerUnitedHealthcare

PolicyFDA Cleared or Approved Companion Diagnostic Testing (for Idaho Only)

Policy CodePolicy CS373ID.C

Change TypeRevised / Added / Clarified / Removed (see changes list)

Effective DateJun 1, 2026

Next Review Date

Key ActionEnsure the patient's medical record fully documents medical necessity (history, exam, relevant test results) and is legible and available upon request.

On This Page

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 FDA's Cleared or Approved Companion Diagnostic Devices Table.

Proven and Medically Necessary Criteria for FDA-cleared/approved CDx tests

Covered when ALL of the following are met:

ALL of the following

The test is an FDA cleared or approved Companion Diagnostic (CDx) test.
AND used to inform management of one of the listed indication/drug pairings OR meets alternate table criteria
- The test is used to inform management of a specified indication/drug pairing listed in the policy (e.g., FoundationOne CDx, FoundationOne Liquid CDx, oncoReveal CDx, TruSight Oncology Comprehensive, xT CDx and other listed tests).
- The test appears in the 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 even if not yet listed in the FDA table.

Subsequent use of an FDA cleared/approved CDx test on a new specimen

Subsequent use is proven and medically necessary when ALL of the following are met:

ALL of the following

The criteria above for the CDx test are met.
One of the following
- The individual is experiencing disease recurrence.
- The individual's cancer has progressed or did not respond to the most recent systemic therapy.

Subsequent use of an FDA cleared/approved CDx on a new specimen

Considered proven and medically necessary when ALL of the following are met:

ALL of the following

The criteria above for the CDx test are met.
AND one of
- The individual is experiencing disease recurrence.
- The individual's cancer has progressed or did not respond to the most recent systemic therapy.

Concurrent tissue and liquid CDx testing

Concurrent testing is considered proven and medically necessary when the CDx criteria above are met and for the following cancer types:

ALL of the following

Advanced or metastatic (stage IV) breast cancer
Advanced or metastatic (stage IV) non-small cell lung cancer (NSCLC)

Concurrent testing (tissue-based CDx and liquid biopsy-based CDx)

Considered proven and medically necessary when ALL of the following are met:

ALL of the following

The criteria above for the CDx test are met.
The clinical context is advanced or metastatic (stage IV) NSCLC.
Concurrent testing allowance explicit for stage IV NSCLC in policy.

Tests and indication/drug pairings listed as proven and medically necessary

The following specific FDA-cleared/approved CDx tests are listed as proven and medically necessary when used to inform management for the specified cancer indication/drug pairings:

ANY of the following

FoundationOne CDx — proven and medically necessary for multiple indication/drug pairings including but not limited to breast cancer, cholangiocarcinoma, colorectal cancer, low-grade glioma, melanoma, NSCLC, ovarian cancer, metastatic castration-resistant prostate cancer, and solid tumors as detailed in the policy.
FoundationOne Liquid CDx — proven and medically necessary for multiple indication/drug pairings including specified breast, colorectal, NSCLC, prostate, and solid tumor pairings as detailed in the policy.
Guardant360 CDx — proven and medically necessary for listed indication/drug pairings including breast cancer, NSCLC, and additional tumor-specific listings elsewhere in the policy.
MI Cancer Seek — proven and medically necessary for listed breast, colorectal, melanoma, NSCLC, and solid tumor pairings.
Oncomine Dx Express Test — proven and medically necessary when used to inform management of NSCLC with sunvozertinib (Zegfrovy).
Oncomine Dx Target Test — proven and medically necessary when used to inform management of specified indication/drug pairings (policy continues beyond part 1).
oncoReveal CDx — proven and medically necessary for colorectal cancer and NSCLC pairings listed in the policy.
TruSight Oncology Comprehensive — proven and medically necessary for NSCLC (selpercatinib) and solid tumors (larotrectinib).
xT CDx — listed as proven and medically necessary for specified pairings (document continues).

All other uses of the above FDA cleared or approved CDx tests for indications/drug pairings not specified and not meeting criteria.

Documentation should demonstrate how test results will inform use of the targeted therapeutic product or clinical management
Include specimen source, date of collection, and laboratory test report

Prior Authorization

Coverage requires CDx FDA status and indication match

Coverage requires that the companion diagnostic (CDx) test is FDA-cleared or FDA-approved as a CDx for the intended therapeutic product and clinical indication. Providers must ensure the test's FDA CDx status corresponds to the therapeutic drug and indication for which the test will inform treatment selection.

Acceptable FDA sources include: FDA Cleared or Approved Companion Diagnostic Devices Table
FDA Premarket Approval (PMA) Database approval orders designating the test as a CDx

Prior Authorization

State applicability and Idaho guidance

This policy applies to the state of Idaho, including Idaho Medicaid Plus plans. For additional clinical coverage criteria and state-specific molecular oncology testing policies, refer to the Idaho Medicaid Provider Handbook, Provider Guidelines, Laboratory Services: Genetic Testing.

Policy applies to Idaho only; consult Idaho-specific guidance for tests not FDA-cleared/approved as CDx
See Idaho Medicaid Provider Handbook for laboratory services and genetic testing policies

Overall concordance 66.4%; ctDNA-unique variants 9.3%; tissue-unique 24.2%; higher ctDNA burden correlated with ctDNA-unique detection

ASCO recommendation (2024)Routine testing recommended for activating PIK3CA, AKT1, or PTEN mutations in HR+ HER2- metastatic breast cancer

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 that provides information that is essential for the safe and effective use of a corresponding therapeutic drug; here, an FDA cleared or approved test for use with a specific drug or group of drugs (FDA, 2025).
Concurrent Testing	Tissue-based testing and Liquid Biopsy ordered for the same clinical indication within a 30-day period (Iams et al., 2024).
Liquid Biopsy	Testing performed on a sample of bodily fluid to identify cancer cells or tumor-derived DNA/RNA/molecules circulating in body fluids (National Cancer Institute, 2024).
Concurrent Testing (policy added definition)	Use of an FDA Cleared or Approved tissue-based CDx test and a Liquid Biopsy-based CDx test at the same time; added definition in policy.
Companion Diagnostic (CDx) (updated)	Updated in policy; implies an FDA-cleared or approved in vitro diagnostic linked to selecting patients for specific targeted therapies.

Subsequent use of an FDA cleared/approved CDx on a new specimen is proven and medically necessary when the individual has disease recurrence or cancer progression/non-response and initial criteria are met. Detail: Added requirement that subsequent use of an FDA cleared/approved CDx on a new specimen is proven and medically necessary when the individual has disease recurrence or cancer progression/non-response and initial criteria are met.

06/01/2026added

Applicable CPT coding updated: Added CPT codes 0211U and 0523U; removed several prior CPT codes including 0179U and multiple 814xx codes. Detail: Removed several prior CPT codes including 0179U and multiple 814xx codes.

06/01/2026clarified

Medical Records Documentation requirement updated to require legible, supportive documentation available upon request. Detail: Updated Medical Records Documentation Used for Reviews to require legible, supportive documentation available upon request.

06/01/2026removed/updated_definitions

Definitions updated: Added definition of 'Concurrent Testing' and updated definitions for Advanced Cancer, Companion Diagnostic, and Liquid Biopsy; removed definitions for Comprehensive Genomic Profiling (CGP) and Next Generation Sequencing (NGS). Detail: Added definition of 'Concurrent Testing' and updated other definitions (Advanced Cancer, Companion Diagnostic, Liquid Biopsy).

FDA Cleared or Approved Companion Diagnostic Testing (for Idaho Only)

Coverage Summary & Scope

Medical‑Necessity Criteria (Proven / Covered Uses)

Not Medically Necessary / Unproven Uses

Named CDx Tests and Covered Indication / Drug Pairings

Coding (Applicable / Added / Removed Codes)

Provider Actions & Documentation Requirements

Background, Evidence Highlights, and Definitions

Related Policies / Non‑CDx Tests

Revision History