CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Circulating Tumor DNA (ctDNA) and Circulating Tumor Cells (CTCs) for Cancer Management (Liquid Biopsy)

Defines coverage and medical necessity stance for blood-based ctDNA and CTC testing for cancer management for Blue Cross Blue Shield - Rhode Island members; applies to commercial and Medicare Advantage products covered by the payer.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyCirculating Tumor DNA (ctDNA) and Circulating Tumor Cells (CTCs) for Cancer Management (Liquid Biopsy)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionVerify member-specific benefits and eligibility with the provider call center before ordering testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

NMNCommercial coverage stance

86152/86153Medicare Advantage CPTs

InsufficientEvidence conclusion

Not requiredPrior auth

27References

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Coverage and Medical Necessity Determinations

General coverage determination

Covered only when supported by specific contract or referenced policies; otherwise considered not medically necessary:

General policy statement: The use of circulating tumor DNA and/or circulating tumor cells is not covered for all indications as the evidence is insufficient to determine the effects of the technology on health outcomes.

applies to commercial products; see Medicare CPT not covered list

Indication-specific evidence conclusions

Summarized conclusions by clinical use (evidence insufficient):

Select targeted treatment in advanced cancer: For advanced cancer, ctDNA testing to select targeted treatments: clinical validity and utility data are lacking for most commercially available tests; evidence insufficient to conclude replacement of tissue testing.

observational studies; heterogenous methodologies

CTCs to select targeted treatment in advanced cancer: For CTC testing to select targeted treatments: clinical validity and utility data are lacking for commercially available tests; evidence insufficient to determine effect on outcomes.

observational studies; heterogeneous methods

ctDNA or CTCs to monitor treatment response: Evidence (observational studies and one randomized controlled trial for CTCs) does not establish clinical utility for monitoring treatment response; randomized trial found no survival benefit when changing therapy based on persistent elevated CTCs after first-line chemotherapy.

evidence insufficient

Post-curative treatment risk of relapse: Use of ctDNA or CTCs to predict relapse after curative therapy: observational data exist but clinical validity and utility are insufficient to determine effects on health outcomes.

evidence insufficient

Screening asymptomatic high-risk individuals: No evidence identified for ctDNA screening in asymptomatic high-risk individuals; CTC screening data lack clinical validity and utility—evidence insufficient.

no supportive data

This policy specifically does not address blood-based testing to identify driver mutations for therapy selection in certain tumor types. Exclusions include blood-based testing for driver mutations to select therapy in non–small-cell lung cancer and metastatic colorectal cancer, as well as liquid biopsy to select treatment for several individual cancers (including breast, ovarian, prostate, pancreatic, and lung) and AR‑V7 testing for metastatic prostate cancer.

Some genetic testing services may be excluded by contract or addressed under separate policies for Genetic Services or Proprietary Laboratory Analyses (PLA). Providers should consult the member’s Benefit Booklet and the related Genetic Services/PLA policies to determine group‑specific coverage, authorization requirements, or contract exclusions.

Coverage is governed by the member’s subscriber agreement or employer agreement, which supersede this medical policy. Services that are determined to be not medically necessary or are non‑covered benefits under the member’s plan are excluded from coverage unless the member has been informed and provided written agreement to self‑pay.

For commercial products, the use of circulating tumor DNA (ctDNA) and/or circulating tumor cells (CTCs) is considered not medically necessary for all indications because the evidence is insufficient to determine effects on health outcomes. Coverage may be available only when explicitly supported by a specific contract or referenced policy.

The CPT codes 86152 and 86153 (cell enumeration using immunologic selection and identification in a fluid specimen, e.g., CTCs in blood) are listed as not covered for Medicare Advantage plans and are considered not medically necessary for commercial products.

Some services may be determined to be not medically necessary or to be non‑covered benefits for a given member; this policy does not enumerate every possible not‑medically‑necessary condition. Providers must verify member‑specific benefits and eligibility, and should not bill members for services determined to be not medically necessary unless the member has been informed and agreed in writing to self‑pay.

Billing Codes and Proprietary Test Codes

Not covered CPT CodesCPTNot Covered

86152	Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood)
86153	Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood); physician interpretation and report; when required

PLA / Proprietary Testmixed

OO91U

Oncology (colorectal) screening, cell enumeration of circulating tumor cells, utilizing whole blood, algorithm, for the presence of adenoma or cancer, reported as a positive or negative result (FirstSightCRCTM - CellMax Life)

Provider Responsibilities and Billing Guidance

Note

Prior Authorization Verification

Not applicable. Benefits and eligibility are determined by the member's subscriber agreement, member certificate, and/or employer agreement; those documents supersede this medical policy. For member-specific benefit and eligibility information, contact the provider call center.

Provider call center for member-specific benefits and eligibility

Billing Rule

Verify Member Benefits

Benefits vary by contract. Providers must verify member-specific benefits and coverage for genetic and biomarker testing (including circulating tumor DNA / circulating tumor cells) by referring to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement and by calling the provider call center as needed.

Refer to member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement
Call provider call center to confirm eligibility and benefit details

Clinical Background and Scope

Liquid biopsy refers to analysis of tumor‑derived material in peripheral blood, most commonly circulating tumor DNA (ctDNA) — fragments of cell‑free DNA shed by tumor cells — and intact circulating tumor cells (CTCs). These analytes are investigated for several potential uses including genomic characterization to guide targeted therapy selection, prognostic assessment, monitoring treatment response, and detecting minimal residual disease or relapse, but detection can be technically challenging and clinical utility varies by indication.

Key Terms

Circulating tumor DNA (ctDNA) — definition and brief characteristics

DefinitionFragments of tumor-derived cell-free DNA in the blood (cell-free DNA) originating mainly from apoptotic or necrotic tumor cells; can be used for genomic characterization of the tumor.

Typical source and abundanceDerived from primary tumor, metastases, or CTCs and often represents a small fraction of total cfDNA, requiring highly sensitive detection methods.

Biological noteNecrotic release generates larger DNA fragments while apoptotic release yields shorter fragments; length/integrity may help distinguish origins.

Primary clinical use describedGenomic characterization of the tumor (e.g., detection of tumor-derived mutations).

Circulating tumor cells (CTCs) — definition and brief characteristics

Definition

Use in Advanced Cancer Settings

Advanced cancer

ctDNA/CTC testing to select targeted therapy in advanced cancer: Evidence is insufficient to support routine use to guide therapy selection; clinical validity must be established separately for each commercially available test.

Specific Biomarker Notes

AR-V7 — biomarker notes

MarkerAR-V7 (androgen receptor splice variant 7)

Context noted in policyAR-V7 circulating tumor cell testing for metastatic prostate cancer is explicitly not addressed by this policy.

Implication for coverageUse of AR-V7 testing is outside the scope of this policy and may be subject to separate evaluation or policies.