Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy)
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This policy governs coverage determinations for use of circulating tumor DNA and circulating tumor cells (liquid biopsy) in cancer management for Blue Cross Blue Shield - Rhode Island members, distinguishing Medicare Advantage and Commercial Products.
No material clinical or coverage changes in this revision.
Coverage Determination
General coverage determination
Covered when ALL of the following are met:
Medicare Advantage: not covered; Commercial products: not medically necessary.
The policy excludes the use of circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) for all indications. All indications for ctDNA and CTC testing are not covered / not medically necessary as described in the Medicare Advantage and Commercial sections because the available evidence is insufficient to determine effects on health outcomes.
For Commercial Products, ctDNA and/or CTC testing is considered not medically necessary for all indications. The rationale is that clinical validity and clinical utility have not been established across intended uses (selecting targeted therapy, monitoring treatment response, predicting relapse, and screening); published data demonstrating effects on health outcomes are lacking and available studies are insufficient to support replacing tissue-based analyses.
Coding and Reimbursement
| 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 |
Provider Actions and Billing Guidance
Prior Authorization
Prior authorization: Not applicable for this policy.
Verify Member Benefits and Eligibility
Benefit verification required — benefits and eligibility vary by contract. Providers must verify member-specific coverage in the member's Evidence of Coverage, Benefit Booklet, subscriber agreement, or employer agreement; those documents supersede this policy.
- Check the member's Evidence of Coverage/Benefit Booklet or subscriber agreement for coverage details.
- For member-specific benefits and eligibility, call the provider call center.
Denial Risk and Member Financial Responsibility
Denial risk — Medicare Advantage and Commercial plans: circulating tumor DNA and circulating tumor cells (liquid biopsy) are not covered or considered not medically necessary for all indications; claims may be denied and services may be non-covered.
- If a service is determined to be not medically necessary or a non-covered benefit, the claim may be denied.
- Providers may not bill the member for services determined to be not medically necessary or non-covered unless the member was informed and agreed in writing in advance.
Provider Action: Contact Provider Call Center
Provider action required — contact the provider call center for member-specific questions and before delivering services when coverage is uncertain.
- Verify coverage prior to testing to avoid claim denials and unexpected member liability.
- Obtain documented member consent in writing if a non-covered service will be provided at the member's expense.
Background
Liquid biopsy refers to analysis of tumor-derived material in peripheral blood, most commonly circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs). ctDNA consists of small fragments of tumor-derived cell-free DNA that are typically present at a low fraction of total cell-free DNA and therefore require highly sensitive detection methods. CTCs are intact tumor cells shed into the bloodstream from primary or metastatic sites; they are typically short-lived and are detected using epithelial surface markers (for example, EpCAM and cytokeratins). Both approaches aim to noninvasively characterize tumors and their genomes but have methodological heterogeneity and limited demonstrated clinical utility.
Definitions
Line of Therapy / Indication Details
Line-of-therapy related determinations
Use of ctDNA or CTC testing for line-of-therapy decisions is considered not supported when ANY of the following describe the intended clinical use:
Randomized trial of CTC‑guided therapy switch showed no overall survival benefit; observational data are insufficient and methods vary across tests.
Biomarker Examples and Requirements
References and Revision History
Reference list includes at least 26 citations related to circulating tumor cells and ctDNA (references numbered through 26).
Policy effective date: 12/01/2016. Policy last updated: 03/03/2021. Status: CURRENT.
Policy notice — verify benefits and do not bill members for non‑covered services without written consent
This medical policy is informational only and does not guarantee payment. Benefits and eligibility are determined by the member's subscriber agreement or employer agreement, which supersede this policy. Contact the provider call center for member-specific benefits and follow contractual terms before billing members.
- Policy is not a guarantee of payment and may be revised at any time.
- Do not charge members for non‑covered services unless they agreed in writing in advance.
- Prior authorization is listed as not applicable for this policy, but benefit verification is required.
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