In vitro Chemosensitivity and Chemoresistance Assays — Coverage Criteria
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This policy addresses coverage and medical necessity determinations for in vitro chemosensitivity and chemoresistance assays used to predict tumor responsiveness to chemotherapy for members of the payer's Medicare Advantage and Commercial products.
No material clinical or coverage changes in this revision.
Coverage Determinations
Coverage Stance
Coverage determination statements in this policy:
See methods and evidence summaries for details on study types and outcomes (randomized trials, nonrandomized studies, and correlational observational studies) that informed this determination.
For Medicare Advantage Plans, in vitro chemosensitivity and chemoresistance assays are not covered because the available evidence is insufficient to demonstrate an improvement in net health outcome. For Commercial Products, these assays are considered not medically necessary for the same reason.
This medical policy is provided for informational purposes and is not a guarantee of payment. Benefits and eligibility are determined by the member's subscriber agreement or employer agreement and those documents supersede this policy; for member-specific benefit information, contact the provider call center. If services are determined to be not medically necessary (or are non-covered benefits), the provider may not charge the member for those services unless the member has been informed and has agreed in writing in advance.
Rationale for Commercial Products coverage: In vitro chemosensitivity and chemoresistance assays are considered not medically necessary because the evidence is insufficient to determine that use of these assays results in improved net health outcomes. Consequently, assay-directed therapy has not been shown consistently to improve survival or other patient-centered outcomes.
Coding and Billing
| 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 |
| 81536 | Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug response score; each additional single drug or drug combination (List separately in addition to code for primary procedure) |
| 0564T | Oncology, chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs), from cultured CSCs and primary tumor cells, categorical drug response reported based on percent of cytotoxicity observed, a minimum of 14 drugs or drug combinations |
| Unlisted | File claims using the appropriate unlisted procedure code per payer rules; include detailed clinical documentation and test description |
Billing for other assays
File other assay claims with an unlisted procedure code and include complete clinical documentation and a clear description of the test method and reported result. Lack of adequate documentation or failure to use the payer’s required unlisted-code submission process may result in claim denial or processing delays.
- Include detailed test name, methodology, and clinical rationale with the claim.
- If required by the payer, submit supporting records and result reports with the claim or via the prior authorization process.
- Use the payer’s guidance for mapping unlisted procedures to existing codes when available.
Provider Responsibilities and Billing Impact
Prior authorization not required
Prior authorization is not applicable for these assays under this policy.
Verify coverage and prior authorization with payer
This medical policy is informational and not a guarantee of payment; providers should verify coverage and prior authorization requirements with the payer based on the member's benefit documents.
- Check the member's subscriber certificate or employer agreement for benefit-specific requirements.
- Contact the provider call center for member-specific benefits and prior authorization confirmation.
No specified step-therapy or additional actions
No additional provider-action requirements are specified in the policy for step therapy or other authorization processes.
No further provider actions detailed
No additional provider-action requirements are specified in the policy beyond verification of benefits and the nonapplicability of prior authorization.
Coverage exclusion may lead to claim denial
Claims for in vitro chemosensitivity and chemoresistance assays are not covered for Medicare Advantage and are considered not medically necessary for Commercial products; billing such services may result in claim denial.
- Do not expect payment for these assays for Medicare Advantage members.
- For Commercial members, these assays are considered not medically necessary and may be denied.
Member financial liability requires prior written agreement
If services are determined to be not medically necessary (or medically necessary services that are non-covered benefits), the provider may not charge the member unless the member agreed in writing in advance to continue at their own expense.
- Obtain written member agreement before providing services expected to be non-covered to avoid billing disputes.
- Refer to participation agreement(s) for applicable provisions about member billing.
Verify member benefits and eligibility
Benefits and eligibility are determined by the member's subscriber agreement or employer agreement and those documents supersede this medical policy; for member-specific benefits call the provider call center.
- Verify the member's benefit documents before providing or billing for assays.
- Contact the provider call center for benefit confirmation.
Background and Scope
In vitro chemosensitivity and chemoresistance assays isolate tumor cells or microaggregates from a patient specimen and expose them to one or more chemotherapeutic agents in a laboratory setting to measure cell viability, death, or other markers of drug effect. Methods include differential staining, incorporation of radioactive precursors, colorimetric assays, and chemoluminescence (for example, ATP bioluminescence assays). The goal of these assays is to predict tumor responsiveness to specific chemotherapeutic agents and to inform selection of therapy, although methodologies and drug concentrations used vary across assays.
Definitions
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