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ModifiedCommunity Health Plan WashingtonPolicy N/A

Concert Genetic Oncology: Circulating Tumor DNA and Circulating Tumor Cells (Liquid Biopsy)

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Defines medical necessity and investigational indications for ctDNA (liquid biopsy) molecular profiling panels, focused lung panels, and specific variant analyses (EGFR, BRAF, KRAS, PIK3CA) for oncology care; applies to providers ordering these tests for members of the plan.

Policy Summary

PayerCommunity Health Plan Washington

PolicyCirculating Tumor DNA and Circulating Tumor Cells (Liquid Biopsy)

Policy CodePolicy N/A

Change TypeCoverage criteria revisedcodes and wording standardized

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document clinical indication and, where applicable, that the member is considering specified therapy and has progressed on ≥1 prior line of therapy.

SourceLink

POLICY UPDATE CHANGES

PIK3CA ctDNA criteria were revised to require the member to be considering treatment with alpelisib plus fulvestrant or capivasertib plus fulvestrant and to have had progression on at least one line of therapy.

Terminology in multiple sections was standardized from 'Comprehensive' to 'Broad' for molecular profiling panel tests via ctDNA.

AR-V7 CTC testing criteria aligned with CMS LCD language limiting testing to once per diagnosis encounter unless a second test is reasonable and necessary and requiring tissue testing infeasibility documentation.

Replaced term 'Comprehensive' with 'Broad' throughout Broad Molecular Profiling Panel Tests via ctDNA criteria and added CPT codes 81462, 81463, and 81464 to those criteria.

Removed requirement that tissue testing be unavailable (minor expansion) for several variant analyses (BRAF, KRAS, EGFR) and broad profiling to align with current guidelines.

Added new CTC test entries (CELLSEARCH melanoma 0490U, ER 0491U, PD-L1 0492U) and added CELLSEARCH CTC test with CPT 86152 to policy reference table while removing several other tests/codes.

Developed a new AR-V7 CTC analysis criteria set based on CMS LCD guidance (but AR-V7 specific criteria later removed from the specific criteria set due to low volume and NCCN changes).

Updated multiple tumor-type coverage listings and clarified lung cancer language to 'advanced' rather than stage IV to match NCCN.

3Broad panel CPTs added

9Broad panels listed

7Lung-focused codes

Not coveredCTC enumeration

1AR-V7 criteria developed

11/2024Last revision

Coverage Criteria for ctDNA and CTC Testing

Broad Molecular Profiling Panel Tests via Circulating Tumor DNA (ctDNA) - Medically Necessary

Covered when ALL of the following are met:

Clinical requirement: Member has a diagnosis, progression, or recurrence of one of the listed tumor types (see list).see list

See chunks 12-13 for full tumor type list.

Simultaneous tissue testing: If a broad molecular profiling panel via ctDNA is performed simultaneously with solid tumor tissue testing, the member must have one of: lung adenocarcinoma, large cell lung carcinoma, squamous cell lung carcinoma, or NSCLC not otherwise specified (NOS).N/A

Applies only to simultaneous testing; exception limited to lung cancers.

Broad Molecular Profiling Panel Tests via ctDNA - Investigational

Policy Summary

PayerCommunity Health Plan Washington

PolicyCirculating Tumor DNA and Circulating Tumor Cells (Liquid Biopsy)

Policy CodePolicy N/A

Change TypeCoverage criteria revisedcodes and wording standardized

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document clinical indication and, where applicable, that the member is considering specified therapy and has progressed on ≥1 prior line of therapy.

SourceLink

On This Page

Considered investigational when:

Other indications: All other indications not listed as medically necessary, including simultaneous use with tissue testing for tumor types other than the specified lung cancers.N/A

Investigational = not covered.

Lung Cancer Focused Panel Tests via ctDNA - Medically Necessary

Covered when ALL of the following are met:

Tumor types: Member has diagnosis or progression of advanced or metastatic lung adenocarcinoma, large cell lung carcinoma, squamous cell lung carcinoma, or non-small cell lung cancer (NSCLC) not otherwise specified (NOS).N/A

See chunk 14.

Lung Cancer Focused Panel Tests via ctDNA - Investigational

Considered investigational when:

Other indications: All other indications not listed for lung cancer focused ctDNA panels.N/A

See chunk 14.

EGFR Variant Analysis via ctDNA - Medically Necessary

Covered when ALL of the following are met:

Tumor type: Member has advanced or metastatic lung adenocarcinoma, large cell lung carcinoma, squamous cell lung carcinoma, or NSCLC not otherwise specified (NOS).N/A

Chunk 15.

Therapy consideration: Treatment with an EGFR tyrosine kinase inhibitor (e.g., erlotinib, gefitinib, afatinib, osimertinib) is being considered.N/A

Chunk 15.

BRAF Variant Analysis via ctDNA - Medically Necessary

Covered when ANY of the following sets of conditions are met:

Metastatic colorectal cancer: Member has metastatic colorectal cancer AND testing for NRAS and KRAS is also being performed (separately or as part of a panel).N/A

Chunk 16.

Cutaneous melanoma: Member has stage III or higher cutaneous melanoma AND is being considered for adjuvant or other systemic therapy.N/A

Chunk 16.

Pancreatic adenocarcinoma: Member has locally advanced or metastatic pancreatic adenocarcinoma AND is being considered for anticancer therapy.N/A

Chunk 16.

PIK3CA Variant Analysis via ctDNA - Medically Necessary

Covered when ALL of the following are met:

Tumor type: Member has recurrent, unresectable, or stage IV hormone receptor–positive / HER2–negative breast cancer.N/A

Chunk 18.

Therapy consideration: Member is considering treatment with alpelisib plus fulvestrant, or capivasertib plus fulvestrant.N/A

Chunk 18.

Prior therapy: Member has had progression on at least one line of therapy.>=1 line

Chunk 18.

KRAS Variant Analysis via ctDNA - Medically Necessary

Covered when ANY of the following are met:

Colorectal cancer: Member has metastatic colorectal cancer AND testing for NRAS and BRAF is also being performed (separately or as part of an NGS panel).N/A

Chunks 17,19.

Pancreatic adenocarcinoma: Member has locally advanced or metastatic pancreatic adenocarcinoma AND is being considered for anticancer therapy.N/A

Chunks 17,19.

PIK3CA Variant Analysis via ctDNA — Considered medically necessary when ALL of the following are met

Considered medically necessary when ALL of the following are met:

PIK3CA ctDNA medical necessity: A. Member has recurrent, unresectable, or stage IV hormone receptor–positive/HER2–negative breast cancer; B. Member is considering treatment with alpelisib plus fulvestrant, or capivasertib plus fulvestrant; C. Member has had progression on at least one line of therapy.

Codes: 0177U, 81309; see chunk 18 and NCCN guidance in chunk 31.

PIK3CA Variant Analysis via ctDNA - investigational

PIK3CA ctDNA testing is considered investigational when the above criteria are not met.

PIK3CA investigational: PIK3CA variant analysis via ctDNA is investigational for all other indications.

KRAS/BRAF Variant Analysis via ctDNA

KRAS and BRAF ctDNA testing coverage statements:

KRAS via ctDNA medical necessity: I. Member has metastatic colorectal cancer AND testing for NRAS and BRAF is also being performed (separately or as part of an NGS panel).

Codes: 81275, 81276. See chunk 19 and NCCN support in chunks 30 and 29.

KRAS via ctDNA for pancreatic adenocarcinoma: II. Member has locally advanced or metastatic pancreatic adenocarcinoma AND is being considered for anticancer therapy.

Tissue preferred but ctDNA acceptable when tissue infeasible.

KRAS/BRAF investigational: KRAS and BRAF variant analysis via ctDNA are investigational for all other indications.

AR-V7 Circulating Tumor Cells Analysis (81479) — Considered medically necessary when ALL of the following are met

Considered medically necessary when ALL of the following are met:

AR-V7 CTC necessity: A. Diagnosis of metastatic castration-resistant prostate cancer; B. Tissue-based testing is not feasible; C. The test is ordered only once during the current cancer diagnosis (additional testing allowed only if reasonable and necessary); D. Member has at least one of: newly metastatic cancer OR signs of clinical, radiological or pathologic disease progression.

Per policy: code 81479 and CMS LCD requirements (chunks 32-33).

AR-V7 CTC Analysis - investigational

AR-V7 testing is investigational for indications not meeting the above criteria.

AR-V7 investigational: AR-V7 CTC analysis is considered investigational for all other indications.

See chunks 20 and 33.

Circulating Tumor Cell (CTC) Enumeration

CTC enumeration coverage stance:

CTC enumeration investigational: Circulating tumor cell (CTC) enumeration (86152) is considered investigational and not medically necessary.

NCCN and CMS note limited clinical utility to change management (chunks 34-35).

Broad Molecular Profiling Panel Tests via ctDNA

Covered when criteria in policy for Broad Molecular Profiling Panel Tests via ctDNA are met (policy updated to align with NCCN and to allow concurrent testing in advanced/metastatic NSCLC).

Broad panel coverage: Member meets tumor-type specific coverage criteria as listed in policy and testing is ordered consistent with NCCN-based indications; CPT codes 81462, 81463, 81464 apply as listed in policy.

Concurrent ctDNA and tissue testing allowed for advanced/metastatic non-small cell lung cancer.

Focused Panel and Single-Gene Variant Analyses via ctDNA

Covered when tumor-specific clinical criteria are met as updated to align with NCCN guidance (language updated to 'advanced' for lung cancer; tissue-unavailable requirement removed).

Focused panel and single-gene coverage: Testing for specific variants (EGFR, BRAF, KRAS, PIK3CA, etc.) is covered when the member meets the policy's tumor-specific clinical indications (e.g., advanced/metastatic disease, consideration of targeted therapy or progression), updated to match guideline recommendations.

Tissue testing availability is no longer an absolute exclusion in several criteria sets.

CTC Enumeration and AR-V7 Analysis

CTC tests and AR-V7 CTC analysis addressed in policy with reference table updates and alignment to CMS LCD guidance.

CTC test entries and AR-V7: Specific CTC tests (CELLSEARCH entries and others) are included in the policy reference table and may be considered per the policy; AR-V7 CTC analysis criteria were developed based on the LCD but AR-V7 specific criteria were later adjusted and would fall under the general policy when applicable.

CMS LCD L38566 referenced regarding clinical utility and testing frequency limits.

Use of circulating tumor DNA (ctDNA) panels or single-gene ctDNA tests for indications other than those explicitly listed in this policy is considered investigational and therefore not covered. The policy specifies tumor-type and clinical-context criteria for covered broad molecular profiling panels and focused/single-gene tests (see lists for covered tumor types and specific variant analyses); any other clinical uses fall under investigational/non‑covered determinations. (Examples of covered panel CPT codes are listed in the Broad Molecular Profiling Panel criteria.)

Simultaneous performance of ctDNA and tissue testing is permitted only in the limited lung cancer scenarios described in the policy; simultaneous tissue/ctDNA testing for other tumor types is considered investigational. Requests that do not meet the listed medically necessary indications may be denied.

Each individual single‑gene ctDNA assay (for example, PIK3CA, KRAS, BRAF, EGFR) is considered investigational when used outside the specific covered clinical scenarios defined in this policy. Coverage for these single‑gene tests is limited to the tumor types and therapy‑linked clinical circumstances identified in the policy (for example, PIK3CA testing in HR+/HER2‑ breast cancer when considering alpelisib or capivasertib plus fulvestrant after progression).

When a single‑gene ctDNA test is requested, prior authorization documentation must demonstrate that the clinical criteria for that specific variant analysis are met; otherwise the request may be denied as investigational.

Certain focused panel clinical criteria were removed from the policy because clinically appropriate, validated tests for those indications are not currently available. The policy editorial changes aligned criteria with guideline and availability considerations and specifically removed clinical criteria for some colorectal and melanoma focused panels where tests are not available.

As a result, coverage for these withdrawn focused panels is no longer provided and related indications should be considered investigational unless otherwise captured by other covered criteria.

Any ctDNA or circulating tumor cell (CTC) testing performed for indications not specified as medically necessary in this policy is considered investigational / not medically necessary. This includes performing ctDNA or CTC assays simultaneously with tissue testing outside the limited lung cancer exception described in the policy.

Requests for testing outside the policy‑listed indications may be subject to denial and require documentation demonstrating why the member meets a medically necessary criterion or why tissue testing is infeasible per CMS LCD guidance.

Circulating tumor cell (CTC) enumeration (CPT 86152) is explicitly considered investigational and therefore not medically necessary. The policy cites available guideline and CMS LCD rationale indicating that enumeration has not demonstrated sufficient clinical utility to change management in a way that improves outcomes.

Because CTC enumeration lacks demonstrated effect on clinical outcomes and guideline endorsement for routine therapeutic decision‑making, requests for 86152 should be considered not covered under this policy.

CTC enumeration analysis has not shown conclusive evidence that results lead to changes in management that improve patient outcomes. The policy references CMS LCD language noting that while enumeration may be prognostic for certain cancers, studies do not conclusively show a clear effect on outcomes resulting from changes in management based on enumeration.

NCCN guidance does not currently include broad recommendations for using CTC enumeration to guide therapy in metastatic breast cancer, and thus enumeration remains investigational in this policy.

Covered Indications and Tumor Types

Billing Codes and Coding Guidance

Broad Molecular Profiling Panel Tests via ctDNACPTCovered

0239U	Broad molecular profiling panel via ctDNA (example)
0242U	Broad molecular profiling panel via ctDNA (example)
0326U	Broad molecular profiling panel via ctDNA (example)
0409U	Broad molecular profiling panel via ctDNA (example)
81445	NGS panel - broad molecular profiling via ctDNA
81455	NGS panel - broad molecular profiling via ctDNA
81462	NGS panel - broad molecular profiling via ctDNA
81463	NGS panel - broad molecular profiling via ctDNA
81464	NGS panel - broad molecular profiling via ctDNA

Lung Cancer Focused Panel Tests via ctDNACPTCovered

0179U	Lung cancer focused ctDNA panel
0388U	Lung cancer focused ctDNA test (example)
81210	BRAF variant analysis
81235	EGFR variant analysis
81275	KRAS variant analysis
81462	CPT code applicable to lung-focused panels (also listed for broad panels)

Single-Gene / Variant Analyses via ctDNACPTCovered

81235	EGFR variant analysis via ctDNA
81210	BRAF variant analysis via ctDNA
81275	KRAS variant analysis via ctDNA
81276	KRAS variant analysis via ctDNA (additional)
0177U	PIK3CA variant analysis via ctDNA
81309	PIK3CA variant analysis via ctDNA

Referenced procedure codesCPT | HCPCS | mixed

0177U	PIK3CA variant analysis via ctDNA (listed)
81309	PIK3CA single gene analysis (listed)
81275	KRAS variant analysis (listed)
81276	KRAS variant analysis (alternate/related)
81479	AR-V7 CTC analysis
86152	Circulating Tumor Cell (CTC) enumeration

Broad panel CPT codesCPTCovered

81462	CPT code added to criteria for Broad Molecular Profiling Panel Tests via Circulating Tumor DNA (ctDNA)
81463	CPT code added to criteria for Broad Molecular Profiling Panel Tests via Circulating Tumor DNA (ctDNA)
81464	CPT code added to criteria for Broad Molecular Profiling Panel Tests via Circulating Tumor DNA (ctDNA)

CTC tests and CPT/HCPCS entriesmixedCovered

0490U	CELLSEARCH Circulating Melanoma Cell (new policy reference table entry)
0491U	CELLSEARCH ER Circulating Tumor Cell (new policy reference table entry)
0492U	CELLSEARCH PD-L1 Circulating Tumor Cell (new policy reference table entry)
86152	CELLSEARCH Circulating Tumor Cell (CTC) Test added to policy reference table

Staging language

Preferred staging terminologyUse the term 'advanced' for lung cancer (rather than 'stage IV') to align with NCCN guidance.

Concurrent testing allowanceConcurrent ctDNA and solid tumor tissue testing is permitted for advanced or metastatic non-small cell lung cancer only.

Scope of rewording'Advanced' replaces 'stage IV' across lung-related criteria including lung-focused panels and EGFR variant analyses.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required for Listed ctDNA/CTC CPT Codes

Prior authorization is required when ordering the listed ctDNA and CTC tests. Ensure the request documents the specific clinical indication and that the member meets the policy’s medical necessity criteria for the ordered test.

Affected CPT/Codes include listed ctDNA/CTC panel and variant codes (e.g., 0177U, 0239U, 0242U, 0326U, 0409U, 0485U, 0487U, 0499U, 81445, 81455, 81462–81464, 81479, 81235, 81210, 81309).
Prior authorization review must reference the applicable policy criteria section (broad panels, tumor-specific focused panels, or single-variant assays) and include relevant clinical documentation.

Prior Authorization

Prior Authorization for Broad Molecular Profiling Panels

Prior authorization is required for broad molecular profiling panels via ctDNA. Requests must demonstrate the member meets the policy’s tumor-type and clinical criteria and align with guideline-based indications (e.g., NCCN).

Broad panel codes include 0239U, 0242U, 0326U, 0409U, 0485U, 0487U, 0499U, 81445, 81455, 81462, 81463, 81464.
For advanced or metastatic NSCLC, concurrent ctDNA and tissue testing is allowed; however the PA request must state the clinical rationale and indicate why ctDNA panel is being used (e.g., to guide targeted therapy, tumor heterogeneity, or when tissue is limited).

Documentation Required

PIK3CA Clinical Documentation Required for ctDNA Testing

For PIK3CA ctDNA testing, prior authorization documentation must clearly state the breast cancer clinical context and treatment intent.

Applicable codes: 0177U, 81309.
Medical record must document: recurrent, unresectable, or stage IV hormone receptor–positive/HER2–negative breast cancer; consideration of alpelisib plus fulvestrant or capivasertib plus fulvestrant; and progression on at least one prior line of therapy.
If a liquid biopsy (ctDNA) is negative, note that tissue testing is recommended and may be required if clinical management depends on mutation status.

Prior Authorization

Therapy‑Linked Testing Requirements

Some variant tests are therapy-linked and require evidence of intended treatment decisions or prior progression on therapy to meet medical necessity.

EGFR variant testing (81235) — PA should document that EGFR TKI therapy is being considered for advanced/metastatic NSCLC.
PIK3CA testing (0177U, 81309) — PA must document consideration of alpelisib or capivasertib plus fulvestrant and prior progression on ≥1 line of therapy.
AR‑V7 CTC testing (81479) — PA must document metastatic castration‑resistant prostate cancer, that tissue testing is not feasible, the test is a one-time order for the current diagnosis, and evidence of newly metastatic disease or progression.

Documentation Required

Provider Actions and Documentation Expectations

Order tests in accordance with policy clinical criteria and guideline-based indications; include all supporting clinical notes, prior treatment history, and justification for liquid biopsy versus tissue testing (or concurrent testing when allowed). Incomplete documentation may result in denial.

Medical record must document one of the LCD-allowed reasons when required (e.g., tissue unavailable or infeasible) or otherwise meet the policy’s listed clinical indications.
Requests for tests outside the listed medically necessary indications (including broad panels for tumor types not listed) are subject to denial.
If ctDNA is negative and the result will impact treatment, document plans for follow-up tissue testing as appropriate.

Not Covered / Investigational

Any ctDNA or CTC testing for indications not specifically listed as medically necessary in this document is considered investigational / not covered. Covered uses are restricted to the tumor types and clinical contexts enumerated in the policy’s medically necessary criteria sections (broad panels, lung‑focused panels, and specific variant analyses).

Providers should obtain prior authorization and supply documentation demonstrating the member meets the policy criteria; testing outside those indications may be denied.

CTC enumeration testing (CPT 86152) is considered investigational / not covered. The policy specifically calls out 86152 as investigational and removed or limited other related test entries based on the evidence and CMS LCD findings.

Requests to perform CTC enumeration should be denied as not medically necessary unless future guidance or evidence changes the policy stance.

Clinical criteria for certain focused panels related to colorectal cancer and melanoma were removed from the policy because appropriate clinical‑grade tests for those indications are not currently available. As noted in the policy update, some focused panel entries were withdrawn due to lack of available tests.

When criteria were removed, those indications were no longer eligible for coverage under the focused panel provisions and should be treated as investigational or not covered unless captured by another covered criterion.

Definitions

ctDNA

DefinitionCell-free circulating tumor DNA (ctDNA) is tumor-derived DNA originating from primary or metastatic tumor tissue, released into the bloodstream as tumor cells die.

Clinical roleUsed as a noninvasive 'liquid biopsy' to detect driver or acquired mutations that may guide targeted therapy or track disease progression.

Testing caveatctDNA analysis should not replace histologic tissue diagnosis; if ctDNA is negative, follow-up tissue testing is recommended.

CTC

DefinitionCirculating tumor cells (CTCs) are intact tumor cells shed into the bloodstream or lymphatic system and detectable via surface epithelial markers (e.g., EpCAM, cytokeratins).

Primary useMost assays quantify CTCs for prognostic purposes rather than to directly guide therapeutic selection.

Detection methodsAssays typically detect CTCs using epithelial surface markers; performance and intended use vary by assay (see policy reference table).

ctDNA (fragmented, tumor-derived DNA)

Core conceptctDNA is fragmented, tumor-derived DNA circulating in the bloodstream that is not contained within cells and derives from tumor tissue or from circulating tumor cells.

SourceFragments originate either directly from the primary/metastatic tumor or secondarily from lysed circulating tumor cells.

Analytic implicationBecause ctDNA is cell-free and fragmented, assays target circulating DNA fragments rather than intact cellular material.

CTCs

Basic definitionCTCs are intact tumor cells that have shed into the bloodstream or lymphatic system from a primary tumor or metastatic site.

Clinical significanceCTCs are primarily measured for prognostic information (circulating level quantification) and may be used for specific biomarker analyses (e.g., AR-V7).

Assay characteristicsCTC assays detect intact cells and differ from ctDNA assays which analyze fragmented, cell-free DNA.

Advanced lung cancer

Terminology updateThe policy uses the term 'Advanced lung cancer' in criteria instead of specifying 'stage IV' to align with NCCN guidance.

Applied sections'Advanced' replaces 'stage IV' wording across lung-focused panel criteria and EGFR variant analysis sections.

RationaleChange made for consistency with NCCN lung cancer guideline language referenced in the policy revisions.

Broad molecular profiling

Terminology standardizationThe policy standardizes panel test terminology from 'Comprehensive' to 'Broad' when referring to molecular profiling panels via ctDNA.

Coding impactCPT codes for Broad molecular profiling panels (e.g., 81462–81464) were added to the criteria when terminology was updated.

Scope'Broad molecular profiling' refers to multi-gene ctDNA NGS panels used for tumor types listed in the Broad panel criteria.

Eligibility Requirements

Eligibility for ctDNA or CTC testing is determined by the specific clinical criteria listed in the policy. Top‑level eligibility conditions include a documented diagnosis of one of the covered tumor types with progression, recurrence, or advanced/metastatic disease as defined in the applicable criteria sets (for example, members with tumor types listed under the Broad Molecular Profiling Panel criteria).

For broad molecular profiling panels, eligibility requires that the member has one of the listed advanced/metastatic tumor types and that the test is ordered for clinical decision‑making consistent with guideline‑based indications.

Additional eligibility nodes specify clinical context for single‑gene or focused tests: for example, PIK3CA ctDNA testing is eligible when the member has recurrent/unresectable or stage IV HR+/HER2‑ breast cancer, is being considered for alpelisib or capivasertib plus fulvestrant, and has progressed on at least one line of therapy; AR‑V7 CTC analysis is eligible for metastatic castration‑resistant prostate cancer when tissue testing is infeasible and testing frequency limits are observed; and EGFR ctDNA testing is eligible when an EGFR TKI is being considered in advanced/metastatic NSCLC.

KRAS and BRAF ctDNA testing have defined eligibility tied to colorectal, pancreatic, melanoma, and other specific clinical scenarios as detailed in the policy.

Operational eligibility notes: the policy was revised to align with current guidelines by removing a prior absolute requirement that tissue testing be unavailable for several variant analyses and panels; tissue testing may now be performed or available in some situations and ctDNA testing remains acceptable when clinically appropriate.

State‑specific and operational application: prior authorization is required for listed ctDNA/CTC CPT codes and documentation must demonstrate that the member meets the specific clinical criteria; if ctDNA is negative, follow‑up tissue testing is recommended per NCCN guidance.

Background

Cell‑free circulating tumor DNA (ctDNA) is tumor‑derived, fragmented DNA released into the bloodstream as tumor cells die and can be detected via a peripheral blood (liquid) biopsy. ctDNA testing can identify driver or acquired mutations that may guide targeted therapy or help track disease progression, but it should not replace a histologic tissue diagnosis.

Circulating tumor cells (CTCs) are intact tumor cells shed into the circulation; assays detecting CTCs are primarily used for prognostic purposes (quantification/ enumeration) rather than routinely guiding therapy. The policy notes specific clinical contexts where ctDNA or CTC molecular assays may be useful and highlights that ctDNA should generally not be performed concurrently with tissue testing except in specified lung cancer scenarios.