CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

in_vitro_chemoresistance_and_chemosensitivity_assays_policy

Policy governs coverage determination for in vitro chemosensitivity and chemoresistance assays used to predict tumor response to chemotherapy for commercial and Medicare Advantage members. It states the assays are considered not medically necessary / not covered due to insufficient evidence.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policyin_vitro_chemoresistance_and_chemosensitivity_assays_policy

Policy CodePolicy N/A

Change TypeClarified coverage determination

Effective DateJan 1, 2022

Next Review Date

Key ActionRefer to the member's Benefit Booklet/Evidence of Coverage/Subscriber Agreement for applicable not medically necessary/not covered benefits as benefits may vary between groups/contracts.

SourceLink

POLICY UPDATE CHANGES

Policy statement declares in vitro chemosensitivity and chemoresistance assays are not covered / not medically necessary due to insufficient evidence.

3Explicit CPT/HCPCS codes listed as not covered

1Commercial Products: not medically necessary

1Medicare Advantage: not covered

Coverage Summary

Policy governs coverage determination for in vitro chemosensitivity and chemoresistance assays used to predict tumor response to chemotherapy for commercial and Medicare Advantage members. The policy declares these assays are not covered / not medically necessary because the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Effective date: 01/01/2022. Policy last review: 09/01/2021.

Policy metadata

Policy subjectIn vitro chemoresistance and chemosensitivity assays

Coverage stance summaryIn vitro chemosensitivity and chemoresistance assays are not covered / not medically necessary because the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Effective date01/01/2022

Last review09/01/2021

StatusCURRENT (Not covered / Not medically necessary)

Medical-Necessity / Coverage Determination

Policy Statement / Coverage Determination

In vitro chemosensitivity assays and chemoresistance assays are

Assays not covered: In vitro chemosensitivity assays and chemoresistance assays are not covered because the evidence is insufficient to determine that the technology results in an improvement in the net health outcome
Commercial Products: considered not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome
Medicare Advantage Plans codes: Medicare Advantage Plans: the following CPT/HCPCS codes are not covered and considered not medically necessary: 81535, 0564T, 81536; other assays without specific CPT codes should be filed with an unlisted code

Not Covered / Not Medically Necessary Codes

Not covered / Not medically necessary codesCPT|HCPCSNot Covered

81535	Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a response score; first single or drug combination
0564T	Oncology, chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs), from cultured CSCs and primary tumor cells, categorical response reported based on percent of cytotoxicity observed, minimum of 14 drugs or drug combinations
81536	Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as drug response score; each additional single or combination (list separately in addition to code for primary procedure)
unlisted	There are no CPT codes for other assays. Claims should be filed with an unlisted code.

Provider Actions / Billing Guidance

Documentation Required

Benefit verification

Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable not medically necessary/not covered benefits, since benefits may vary between groups/contracts.

Billing Rule

Claims filing for non-specified assays

When there is no specific CPT code for an assay, file the claim with an unlisted code per the policy guidance. The policy notes that there are no CPT codes for other assays and instructs that claims should be filed with an unlisted code.

Background and Evidence Summary

Multiple assay types (e.g., DiSC, EVA/PCD, FMCA, thymidine incorporation, HDRA, ATP bioluminescence, ChemoFX) quantify cell viability after exposure to chemotherapeutic agents, but methods, doses, and incubation times vary and are not standardized. Clinical studies show inconsistent associations between assay results and survival, and there is an absence of prospective evidence that assay-directed therapy improves overall survival.

Evidence source	Summary
Randomized controlled trials / prospective studies	Some trials show improved tumor response but no consistent survival benefit; prospective studies have not consistently demonstrated association with survival and no studies comparing assay-directed therapy to physician-directed therapy demonstrating improved overall survival; evidence insufficient to determine net health outcome improvement.
Systematic reviews / guidelines	Systematic reviews and an ASCO guideline update (2011) cited; overall evidence judged insufficient to support clinical use — assays considered not medically necessary / not covered due to insufficient evidence.

In vitro chemosensitivity/chemoresistance assays: laboratory tests using tumor specimens to measure cell viability or death after exposure to chemotherapeutic agents to predict tumor responsiveness or resistance.

Revision History

2022-01-01effective_date

Policy statement declares in vitro chemosensitivity and chemoresistance assays are not covered / not medically necessary due to insufficient evidence.

2021-09-01last_reviewLatest

Policy statement declares in vitro chemosensitivity and chemoresistance assays are not covered / not medically necessary due to insufficient evidence.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policyin_vitro_chemoresistance_and_chemosensitivity_assays_policy

Policy CodePolicy N/A

Change TypeClarified coverage determination

Effective DateJan 1, 2022

Next Review Date

Key ActionRefer to the member's Benefit Booklet/Evidence of Coverage/Subscriber Agreement for applicable not medically necessary/not covered benefits as benefits may vary between groups/contracts.

SourceLink

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