Currentblue cross blue shield - tennesseePolicy N/A

In Vitro Chemoresistance and Chemosensitivity Assays Coverage Policy

This policy governs coverage of in vitro laboratory assays that test tumor sensitivity or resistance to chemotherapy drugs for BlueCross BlueShield of Tennessee members.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyIn Vitro Chemoresistance and Chemosensitivity Assays Coverage Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDo not submit claims for in vitro chemosensitivity or chemoresistance assays without prior authorization; these assays do not meet coverage criteria and are at risk of denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Not-covered assay categories

~20Procedure codes referenced

NumerousEvidence citations

Coverage Criteria — In Vitro Chemosensitivity and Chemoresistance Assays

Not covered assays

The following assays do not meet coverage criteria due to lack of sufficient published evidence of benefit:

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Proprietary assay (example)	Description / intended use	Coverage status
ChemoFX®	Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology; predictive algorithm reported as a drug response score (codes 81535, 81536). Lab/manufacturer: Helomics, Corp.	Not covered
ChemoID®	Chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs) and primary tumor cells; categorical drug response reported based on percent cytotoxicity observed; minimum of 14 drugs or drug combinations (proprietary ChemoID®; codes 0435U, 0564T).	Not covered
Onco4D™	Response to chemotherapy drugs using motility contrast tomography on fresh or frozen tissue; reported as likelihood of sensitivity or resistance to drugs or drug combinations (proprietary Onco4D™; code 0083U).	Not covered
3D Predict Glioma	Oncology spheroid cell culture in 3D microenvironment, 12‑drug panel for brain or brain metastasis response prediction for each drug (proprietary 3D Predict Glioma; code 0248U).	Not covered

Coding — Procedure and Proprietary Codes Referenced

Referenced CPT/HCPCS/Proprietary codes (group 1)mixed

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	Each additional single drug or drug combination for ChemoFX®
86849	Unlisted immunology procedure
88104	Cytopathology, fluids, washings or brushings, except cervical or vaginal; smears with interpretation
88199	Unlisted cytopathology procedure
88305	Level IV - Surgical pathology, gross and microscopic examination
88313	Special stain including interpretation and report; Group II, all other
88358	Morphometric analysis; tumor (eg, DNA ploidy)
89050	Cell count, miscellaneous body fluids
89240	Unlisted miscellaneous pathology test

1–10 of 12

1/2

Referenced CPT/HCPCS/Proprietary codes (group 2)mixed

0249U	Oncology (breast), semiquantitative analysis of 32 phosphoproteins and protein analytes with algorithmic analysis (Theralink® RPPA)
0285U	Oncology, response to radiation, cell-free DNA, quantitative branched chain DNA amplification (RadTox™)
0435U	Oncology, chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs), categorical drug response, minimum of 14 drugs (ChemoID®)
0564T	Oncology, chemotherapeutic drug cytotoxicity assay of CSCs, percent cytotoxicity observed, minimum of 14 drugs (ChemoID®) — reported for ChemoID®

Provider Actions and Billing Considerations

Denial Risk

Coverage stance for referenced procedures

Assays described by the cited codes (in vitro chemosensitivity and chemoresistance assays) are identified in this policy as not meeting coverage criteria and are not covered. Requests for these assays should be denied unless an applicable government policy (LCD/NCD/state Medicaid) specifies otherwise.

In vitro chemosensitivity assays (e.g., histoculture drug response assay, fluorescent cytoprint assay) — Not covered
In vitro chemoresistance assays (e.g., extreme drug resistance [EDR] assays) — Not covered

Documentation Required

Provider actions

Providers should submit requests consistent with member benefits and check for any applicable government coverage guidance before proceeding. If a Medicare LCD/NCD or state Medicaid policy covers a specific assay, follow that guidance. Documentation should clearly show the applicable government policy when overriding this payer policy.

Verify member benefits and eligibility prior to ordering.
Check Medicare (LCD/NCD) and state Medicaid policies for coverage exceptions: https://www.cms.gov/medicare-coverage-database/search.aspx
When government policy applies, include citations or documentation of the LCD/NCD/state Medicaid policy in the prior authorization or claim submission.

Denial Risk

Coverage denials for specific assays

If the requested assay is one of the specific examples listed as not meeting coverage criteria (e.g., histoculture drug response assay, fluorescent cytoprint assay, extreme drug resistance [EDR] assays), the request does not meet criteria and should be denied unless an overriding government policy applies.

Examples of assays denied: histoculture drug response assay; fluorescent cytoprint assay; extreme drug resistance (EDR) assays.
Denial rationale: Lack of sufficient published scientific literature demonstrating clinical benefit.

Note

Government policy precedence

When there is a conflict between this policy and any applicable government policy (LCD/NCD or state Medicaid), the government policy governs the coverage determination.

Follow Medicare LCDs/NCDs and state Medicaid coverage rules where they differ from this payer policy.
Document the government policy reference when it is used to approve an otherwise non-covered assay.

Background

In vitro chemotherapy sensitivity and resistance assays are laboratory analyses performed to evaluate whether tumor growth is inhibited by a known chemotherapy drug or a panel of drugs. Proprietary and non‑proprietary platforms exist (for example, assays such as histoculture drug response, fluorescent cytoprint, and extreme drug resistance [EDR] assays) that test tumor response to chemotherapeutic agents ex vivo to inform potential treatment choices.

Definitions

In vitro chemosensitivity/chemoresistance assays — definition entry

TermIn vitro chemosensitivity/chemoresistance assays

DefinitionLaboratory analyses performed specifically to evaluate whether tumor growth is inhibited by a known chemotherapy drug or a panel of drugs.

PurposeAssess tumor cell response to chemotherapeutic agents in vitro to inform potential drug sensitivity or resistance.

Examples of proprietary platforms (referenced in policy brief)ChemoFX®, ChemoID®, Onco4D™, 3D Predict Glioma.

Typical specimen typeFresh or cultured tumor tissue/cells tested ex vivo.