In vitro chemosensitivity and chemoresistance assays — Coverage Criteria
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This policy governs coverage determinations for in vitro chemosensitivity and chemoresistance assays used to predict tumor responsiveness to chemotherapeutic agents for Blue Cross Blue Shield - Rhode Island members, including Commercial and BlueCHiP for Medicare products.
No material clinical or coverage changes in this revision.
Coverage Determination
Coverage stance
Coverage determination by product:
Benefits for in vitro chemosensitivity and chemoresistance assays may vary between groups or contracts. Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for the applicable coverage determination and any contract-specific provisions.
Services determined to be not medically necessary or to be non-covered benefits are exclusions from payment. Providers should verify member eligibility and benefit design before performing such services and must obtain written member agreement in advance if charging the member for services that are determined to be not medically necessary or non-covered.
For Commercial Products, in vitro chemosensitivity and chemoresistance assays are considered not medically necessary. The available evidence, including randomized and nonrandomized studies as well as correlational observational data, is insufficient to demonstrate that assay-directed therapy improves survival or other patient-important outcomes; therefore the tests are not supported for routine clinical use to guide chemotherapy selection.
When a service is determined to be not medically necessary, it may not be payable under the member's contract. Providers may not bill members for such services unless the member has been informed and has provided written agreement to pay in advance.
Coding and Billing
| 81535 | Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stand 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 stand 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) |
| No codes listed |
| No codes listed |
Provider Actions, Prior Authorization & Billing
Prior Authorization
Not applicable
Benefit Verification
Benefits may vary by contract. Verify member-specific benefits, eligibility, and coverage determinations by reviewing the member's Benefit Booklet, Evidence of Coverage or Subscriber Agreement or by contacting the provider call center.
Step therapy / Utilization
Step therapy / utilization requirements are not specified in this policy. Utilization management, step therapy, or quantity limits may vary by contract; refer to the member's benefit documents or contact the provider call center for any applicable requirements.
Coverage / Denial Risk
Claims for in vitro chemosensitivity and chemoresistance assays are not covered or are considered not medically necessary because evidence is insufficient to determine clinical utility. Providers should not bill members for services determined to be not medically necessary or non-covered unless the member has been informed and provided written agreement to pay.
- Not covered / not medically necessary: in vitro chemosensitivity and chemoresistance assays
- Providers must verify benefits and obtain any necessary authorizations per contract terms before rendering services
- Do not bill members for non-covered/not medically necessary services unless member has given written agreement
Coding / Billing
CPT codes 81535 and 81536 are explicitly listed as not covered/not medically necessary and claims billed with these codes will be denied. There are no specific CPT codes for other assays; file those claims with an appropriate unlisted code and ensure benefit verification prior to submission.
- 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 — NOT COVERED/NOT MEDICALLY NECESSARY
- 81536 — same, each additional drug or combination — NOT COVERED/NOT MEDICALLY NECESSARY
- Other assays — no specific CPT; submit as unlisted code
Background
In vitro chemosensitivity and chemoresistance assays are laboratory tests that expose a patient's tumor cells to chemotherapeutic agents in vitro and measure cell viability or death using a variety of methods (for example, differential staining/dye exclusion, radioactive precursor incorporation, colorimetric assays such as the HDRA, and ATP bioluminescence). The assays aim to infer likely clinical response by quantifying drug-induced cell death or apoptosis, but methods, drug concentrations, and incubation conditions vary across assays and commercial tests.
Key Definitions
Line of Therapy
any
Regimen Selection
| Regimen/Intervention | Coverage status | Rationale / policy text |
|---|---|---|
| Any regimen selection guided by in vitro chemosensitivity or chemoresistance assay results (assay-directed selection of chemotherapeutic agents) | ||
| Not covered / Not medically necessary | ||
| In vitro chemosensitivity and chemoresistance assays are not covered for BlueCHiP for Medicare and are considered not medically necessary for Commercial products because the evidence is insufficient to determine effects on health outcomes; assay-directed selection of chemotherapy has not consistently demonstrated improved survival or other patient-important outcomes. |
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