BCBS RI ctDNA/CTC Coverage Update

Coverage Determinations

Overall coverage determination

Coverage stance summarized by product:

Medicare Advantage: 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.

Commercial Products: The use of circulating tumor DNA and/or circulating tumor cells is considered not medically necessary for all indications as the evidence is insufficient to determine the effects of the technology on health outcomes.

Topics not addressed by this policy

Explicit exclusions within scope:

Excluded topics in this policy document: This policy does not address use of liquid biopsy to select targeted treatment for breast cancer, metastatic colorectal cancer, non-small cell lung cancer, melanoma/glioma, ovarian cancer, pancreatic cancer, and prostate cancer; the use of liquid biopsy to select immune checkpoint inhibitor therapy; tumor-informed ctDNA testing for cancer management; comprehensive genomic profiling for selecting targeted cancer therapies; blood-based testing for detection or risk assessment of prostate cancer; or AR-V7 circulating tumor cells for metastatic prostate cancer.

This policy does not address the use of liquid biopsy to select targeted therapy for specific tumor types or other specialized indications. Specifically, it excludes use of blood-based testing to select targeted treatment for breast, metastatic colorectal, non-small cell lung, melanoma/glioma, ovarian, pancreatic, and prostate cancer. It also does not address use of liquid biopsy to select immune checkpoint inhibitor therapy, tumor‑informed ctDNA testing for cancer management, comprehensive genomic profiling to select targeted cancer therapies, blood‑based testing for prostate cancer detection or risk assessment, or AR‑V7 circulating tumor cells for metastatic prostate cancer.

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 the effects of these technologies on health outcomes. Providers should refer to member benefit booklets and related policy documents for group‑specific coverage exceptions and prior authorization requirements.

None — policy indicates ctDNA/CTC testing is not covered or not medically necessary for all indications

Not covered / Not medically necessary (summary):

Commercial Products (general): For Commercial products, ctDNA and/or CTC testing is considered not medically necessary for all indications due to insufficient evidence of clinical utility.

Medicare Advantage (general): For Medicare Advantage Plans, the use of ctDNA and/or CTC testing is not covered for all indications because the evidence is insufficient to determine effects on health outcomes.

Specific codes noted as not covered / not medically necessary: The following tests/codes are listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial products: CPT 86152, CPT 86153 (CTC enumeration) and PLA/HCPCS 0091U.

Services determined to be not medically necessary or otherwise non‑covered are excluded from payment under the member's benefit plan. If a service is found to be non‑covered, providers may not bill the member unless the member has been informed and has provided written agreement in advance to accept financial responsibility. Contact the provider call center or review the member's subscriber or employer agreement for plan‑specific details.

A determination that a service is not medically necessary may result in denial of coverage. This document excerpt does not provide an exhaustive list of all conditions or test scenarios that may be deemed not medically necessary; individual coverage decisions depend on the member's contract, benefit design, and the clinical circumstances of the request.

Indications and Evidence Notes

Use of ctDNA to guide adjuvant therapy decisions in colon cancer

Clinical trial evidence discussed in the policy (context only):

DYNAMIC randomized trial (stage II colon cancer): The policy references the DYNAMIC randomized trial (Tie J et al., N Engl J Med. 2022) and subsequent 5-year outcomes (Nat Med. 2025) assessing ctDNA-guided adjuvant therapy decisions in stage II colon cancer.

References: Tie J et al., NEJM 2022; Tie J et al., Nat Med 2025.

Related ctDNA-guided adjuvant studies: Additional ctDNA-guided adjuvant chemotherapy analyses and trials (including ctDNA-positive cohort analyses and other randomized studies) are cited; these are referenced as emerging evidence but do not change the overall not-covered / not medically necessary stance.

CPT / Coding Guidance

Not covered / Not medically necessary (CTC enumeration)CPTNot 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

Specific CPT-Addendum (PLA/ Proprietary) code notedHCPCSNot Covered

0091U

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

Cited coverage resourcesmixed

No codes listed

Ordering, Authorization, and Billing Guidance

Note

Prior Authorization

Not applicable

Prior Authorization

Provider authorization responsibilities

Only the ordering physician shall be involved in the prior authorization, appeal, or other administrative processes related to prior authorization/medical necessity. Laboratories, laboratory representatives, third parties, or anyone with a relationship to a laboratory are not permitted to obtain authorizations or participate in the authorization process on behalf of the ordering physician.

Laboratories and lab representatives must not obtain prior authorization.
If a lab or third party supports any portion of the authorization process, BCBSRI will treat that as a violation and may take actions up to termination from the provider network.

Key Terms

inv-19: ctDNA — definition

TermCirculating tumor DNA (ctDNA)

DefinitionTumor-derived fragments of cell-free DNA present in peripheral blood (most ctDNA derives from apoptotic and/or necrotic tumor cells).

Primary usesGenomic characterization of tumors (tumor genotyping) and noninvasive assessment of tumor-derived mutations.

Biologic notectDNA fragment size and integrity may reflect apoptotic vs necrotic origin and can derive from primary tumor, metastases, or CTCs.

inv-20: CTCs — definition

TermCirculating tumor cells (CTCs)

Definition

Background and Rationale

Liquid biopsy encompasses blood‑based analysis of tumor‑derived material, most commonly circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs). ctDNA consists of cell‑free tumor DNA fragments in plasma that can be used for genotyping, monitoring for minimal residual disease, and assessing response or recurrence, while CTCs are intact tumor cells shed into the bloodstream that can be enriched and enumerated for prognostic and investigational purposes. These methods are noninvasive alternatives to tissue biopsy but are technically challenging because ctDNA can be a small fraction of total cell‑free DNA and CTCs are rare and transient in circulation.

The policy references multiple clinical and guideline sources addressing the clinical validity and utility of ctDNA and CTC testing, including CMS coverage guidance, joint ASCO/CAP reviews, ESMO recommendations, and randomized trials (for example, studies evaluating ctDNA‑guided adjuvant therapy in colon cancer). These references support the policy rationale about evidence limitations and ongoing evaluation of clinical applications.

Explicit Non-Coverage Notices

The following procedure codes are explicitly listed as not covered / not medically necessary for the applicable products: CPT 86152 and CPT 86153 for CTC enumeration, and HCPCS 0091U (Oncology [colorectal] screening, cell enumeration of circulating tumor cells) as noted in the coding section of the policy.

This excerpt does not present an exhaustive list of specific tests or clinical indications that may be excluded from coverage; non‑coverage or not‑medically‑necessary determinations depend on the member's specific benefits and medical necessity review. Providers should verify member eligibility and coverage details and consult the full policy and benefit documents for complete information.

References and Revision Notes

2024-01-01effective_date

Policy effective date set for coverage determinations for ctDNA and CTC testing.

2026-07-01last_reviewLatest

Most recent policy review completed (last_review).

2026-07-01next_review

Next scheduled policy review date (planned).

OpenPayer

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