CurrentBlue KCPolicy POL-PP-291

In Vitro Chemoresistance and Chemosensitivity Assays

This Blue KC reimbursement policy governs coverage and payment stance for in vitro chemotherapy sensitivity and resistance assays for applicable lines of business and provider types.

Policy Summary

PayerBlue KC

PolicyIn Vitro Chemoresistance and Chemosensitivity Assays

Policy CodePolicy POL-PP-291

Change TypeNo material changes

Effective DateOct 1, 2025

Next Review DateOct 1, 2026

Key ActionDo not expect reimbursement for in vitro chemosensitivity or chemoresistance assays due to insufficient published evidence of benefit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ActivePolicy status

002Version number

10/1/2025Version effective

Professional, Facility, LabProvider entities

Commercial, MA, ACA, FEPLines of business

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Determination

Coverage determination

Coverage is determined by member benefits. The following tests do not meet coverage criteria:

ALL of the following

Not covered tests
- In vitro chemosensitivity assays (e.g., histoculture drug response assay, fluorescent cytoprint assay) may not be reimbursed.
- In vitro chemoresistance assays (e.g., extreme drug resistance [EDR] assays) may not be reimbursed.
Application of coverage criteria is dependent upon an individual's benefit coverage at the time of the request.
These tests do not meet coverage criteria due to a lack of available published scientific literature confirming that the test(s) are required and beneficial for the diagnosis and treatment of an individual's illness.

Status: Not covered / Not medically necessary for reimbursement under this policy.

Relevant Codes and Billing

Not covered HCPCS/CPT and Proprietary Test CodesmixedNot Covered

81535	Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology; predictive algorithm reported as a drug response score, first single drug or drug combination (ChemoFX®)
81536	Oncology (gynecologic), each additional single drug or drug combination (ChemoFX®)
0083U	Oncology, response to chemotherapy drugs using motility contrast tomography (Onco4D™)
0248U	Oncology spheroid cell culture in 3D microenvironment, 12 drug panel, brain or brain metastasis response prediction (3D Predict Glioma)
0249U	Oncology (breast), semiquantitative analysis of 32 phosphoproteins with algorithmic analysis (Theralink® RPPA)
0285U	Oncology, disease progression and response monitoring to cancer treatments, cfDNA quantitative assay (RadTox™)
0435U	Oncology, chemotherapeutic drug cytotoxicity assay of cancer stem cells, categorical drug response (ChemoID®)
0525U	Oncology, spheroid cell culture, 11 drug panel ovarian/fallopian/peritoneal response prediction (3D Predict™ Ovarian)
0564T	Oncology, chemotherapeutic drug cytotoxicity assay of cancer stem cells, categorical drug response (reported percent cytotoxicity)
88104	Cytopathology smears with interpretation (non-cervical/vaginal)

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Prior Authorization and Reimbursement Stance

Denial Risk

Prior authorization / reimbursement stance — assays not routinely reimbursed

The policy states that in vitro chemosensitivity and chemoresistance assays may not be reimbursed because there is a lack of published scientific literature confirming that these tests are required and beneficial for diagnosis and treatment. Providers should expect claims for these assays to be denied when submitted for reimbursement unless member benefits explicitly allow them.

In vitro chemosensitivity assays (e.g., histoculture drug response assay, fluorescent cytoprint assay) may not be reimbursed.
In vitro chemoresistance assays (e.g., extreme drug resistance [EDR] assays) may not be reimbursed.
Denial rationale: lack of available published scientific literature confirming that the tests are required and beneficial.

Definitions

inv-04: In vitro chemosensitivity assays

TermIn vitro chemosensitivity assays

DefinitionLaboratory analyses performed to evaluate whether tumor growth is inhibited by chemotherapy drugs (examples: histoculture drug response assay, fluorescent cytoprint assay).

PurposeAssess tumor response to one or more chemotherapeutic agents to inform potential drug effectiveness in vitro.

Coverage stanceMay not be reimbursed — does not meet coverage criteria due to lack of published scientific literature confirming benefit.

inv-05: In vitro chemoresistance assays

TermIn vitro chemoresistance assays

DefinitionTests that evaluate tumor resistance to chemotherapy (example: extreme drug resistance [EDR] assays).

PurposeIdentify tumor resistance to specific chemotherapeutic agents to predict lack of benefit from those drugs in vitro.