Currentblue cross blue shield - tennesseePolicy G2100

In Vitro Chemoresistance and Chemosensitivity Assays - G2100

Defines coverage position for in vitro chemotherapy sensitivity and resistance assays (including proprietary and non-proprietary tests) with indications, limitations, scientific background, and references. Applies to commercial, Medicare, and Medicaid members subject to benefit coverage and government determinations.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyIn Vitro Chemoresistance and Chemosensitivity Assays - G2100

Policy CodePolicy G2100

Change TypeNo material change

Effective Date

Next Review Date

Key ActionClaims for in vitro chemosensitivity and chemoresistance assays do not meet coverage criteria and will be denied; apply member benefits and applicable government (LCD/NCD) policies when determining payment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes identified in this update.

2Assay categories explicitly non-covered

0Covered indications listed

1Guideline references included

Coverage Summary

Policy subject: In vitro chemoresistance and chemosensitivity assays. This policy defines the coverage position for in vitro chemotherapy sensitivity and resistance assays, including both proprietary and non-proprietary tests, and provides indications, limitations, scientific background, and references.

Medical Necessity / Coverage Criteria

Not covered (do NOT meet coverage criteria)

The following does not meet coverage criteria due to lack of evidence that the tests are required and beneficial:

In vitro chemosensitivity assays, including, but not limited to, the histoculture drug response assay or a fluorescent cytoprint assay, DO NOT MEET COVERAGE CRITERIA.

In vitro chemoresistance assays, including, but not limited to, extreme drug resistance (EDR) assays, DO NOT MEET COVERAGE CRITERIA.

Not Covered / Experimental Tests

Multiple proprietary and non-proprietary assays exist (examples include ChemoFX, MiCK/ChemoINTEL, HDRA, ATP-TCA, MTT, and DISC), but published evidence is insufficient to support routine clinical use to guide individual patient chemotherapy selection.

Clinical guideline support for non-coverage: The American Society of Clinical Oncology (ASCO) 2011 guideline states that use of these assays to select chemotherapeutic agents for individual patients is not recommended outside of the clinical trial setting. The National Comprehensive Cancer Network (NCCN) (2021) indicates chemosensitivity/resistance assays are being used at some institutions but that the current level of evidence is not sufficient to supplant standard of care (category 3 recommendation).

Provider Actions

Denial Risk

Claims for in vitro chemosensitivity/chemoresistance assays will be denied

Claims for in vitro chemosensitivity assays (e.g., HDRA, fluorescent cytoprint) and in vitro chemoresistance assays (e.g., EDR) do not meet coverage criteria and are not covered; apply member's benefit coverage and any applicable government (LCD/NCD) policy when determining payment.

Documentation Required

Confirm applicable government coverage

If conflict exists between this policy and applicable government policy (e.g., LCDs or NCDs), government policy supersedes; verify Medicare/Medicaid determinations at CMS or state Medicaid websites prior to payment.

Verify LCD/NCD on the CMS Medicare Coverage Database: https://www.cms.gov/medicare-coverage-database/search.aspx
Verify state Medicaid coverage on the applicable state Medicaid website

Background and Evidence

In vitro chemosensitivity and chemoresistance assays evaluate tumor samples ex vivo to determine whether tumor growth is inhibited by specific chemotherapeutic agents or panels of agents. Typical steps include isolating tumor cells, incubating them with drugs, and assessing cell survival or response (e.g., cytotoxicity, apoptosis).

Although these assays can show concordance across methods and identify patterns of sensitivity or resistance in small studies, there are methodological challenges (timing of drug effects, variability in assays and interpretation) and insufficient large prospective evidence demonstrating that assay-directed therapy improves clinically meaningful outcomes; therefore routine clinical utilization is not supported.

Source	Summary
ASCO guideline (2011)	Does not recommend use of these assays to select chemotherapeutic agents outside of clinical trials.
NCCN (2021) ovarian cancer	Chemosensitivity/resistance assays used at some institutions but evidence insufficient to supplant standard of care; category 3 recommendation.

EDR (Extreme Drug Resistance): An assay category identifying tumors with extreme resistance to chemotherapeutic agents; cited in policy terminology and explicitly listed among non-covered chemoresistance assays.

HDRA (Histoculture Drug Response Assay): A histoculture-based chemosensitivity assay referenced in the policy and terminology table (HDRA) as an example of assays that do not meet coverage criteria.

LDT (Laboratory-Developed Test): Tests developed and validated in-house by laboratories; LDTs are regulated under CLIA as high-complexity tests and are not necessarily FDA-cleared or approved.

Revision History

coverage_decisionLatest

In vitro chemosensitivity assays (including histoculture drug response assay and fluorescent cytoprint) and in vitro chemoresistance assays (including extreme drug resistance assays) do not meet coverage criteria due to lack of published evidence that they are required and beneficial; claims will be denied and routine clinical use is not recommended outside clinical trials.

guideline_referenceLatest

ASCO (2011) does not recommend use of chemotherapy sensitivity and resistance assays to select chemotherapeutic agents outside clinical trials; participation in clinical trials remains a priority.