CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

in_vitro_chemosensitivity_assays_and_chemoresistance_assays_policy

Policy governing coverage and prior authorization requirements for in vitro chemosensitivity and chemoresistance assays for members of Blue Cross Blue Shield - Rhode Island, describing clinical background, coding guidance, and coverage stance for commercial and Medicare Advantage products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policyin_vitro_chemosensitivity_assays_and_chemoresistance_assays_policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review Date

Key ActionAll unlisted genetic testing CPT codes require authorization to determine the specific service rendered and coverage/medical necessity prior to claim submission.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes were made to this policy.

Not coveredOverall coverage stance

Authorization requiredAuthorization requirement

Commercial & MAApplicability

Coverage Summary

Subject: In vitro chemosensitivity and chemoresistance assays. Coverage stance: Not covered / not medically necessary for Commercial and Medicare Advantage products. Applicability: Policy governs coverage and prior authorization requirements for these assays for members of Blue Cross Blue Shield - Rhode Island, including coding guidance and product-specific notes. Evidence conclusion: Insufficient to determine improvement in net health outcome; no consistent survival benefit demonstrated (mixed results from trials and correlational studies).

Medical Necessity / Policy Statements

Policy Statement / Medical Necessity

Coverage determination:

Policy Statement / Medical Necessity: 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

Commercial product stance:

Commercial Products: In vitro chemosensitivity assays and chemoresistance assays are considered not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Commercial Products - Benefits: Benefit coverage may vary between groups/contracts; refer to the group's Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable not medically necessary / not covered benefits.

Commercial Products - Genetic testing exclusions: Some genetic testing services related to biomarker testing may be subject to contract exclusions for self-funded groups; see Genetic Services or Proprietary Laboratory Analyses policies and the Biomarker Mandate policy for coding and coverage specifics.

Prior Authorization / Authorization Process

Authorization requirements and procedural rules:

Authorization / Coding: All Unlisted genetic testing CPT codes require authorization to determine what service is rendered and if the service is covered or not medically necessary.

Authorization / Coding - Unlisted CPT: There is no specific CPT coding for some services referenced; an Unlisted CPT code should be used for those assays.

Authorization Process - Prohibited third-party authorization: Only the ordering physician may be involved in the authorization, appeal, or other administrative processes related to authorization/medical necessity; laboratories or third parties are prohibited from obtaining authorization on behalf of the ordering physician.

If a laboratory or third party supports any portion of the authorization process, BCBSRI will deem it a violation and may take severe action up to termination from the provider network.

Authorization Process - Denial for unauthorized services:

Coding Guidance

Specific CPT codes described (not covered / not medically necessary for Commercial and Medicare Advantage)CPTNot Covered

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, a minimum of 14 drugs or combinations
81535	Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as response score; first single drug or combination
81536	Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a response score; each additional single drug or drug combination (list separately in addition to code for primary procedure)

Unlisted CPT / other assaysCPT

Unlisted CPT

Other assays without specific CPT codes should be filed with an unlisted code; authorization required for unlisted genetic testing CPT codes to determine service and coverage.

Authorization and coding guidance: All Unlisted genetic testing CPT codes require authorization prior to claim submission to determine the specific service rendered and whether it is covered or not medically necessary. For assays that lack a specific CPT code, claims should be filed with an Unlisted CPT code. The policy also lists specific codes (e.g., 0564T, 81535, 81536) and notes these codes are not covered / not medically necessary as specified.

Provider Actions & Authorization

Prior Authorization

Authorization required for unlisted genetic testing CPT codes

All Unlisted genetic testing CPT codes require authorization to determine the specific service rendered and whether the service is covered or not medically necessary. Authorization must be obtained prior to claim submission.

Affected codes: Unlisted CPT, 81535, 81536, 0564T
Authorization required prior to claim submission

Documentation Required

Ordering physician must perform authorization and appeals

Only the ordering physician may be involved in the authorization, appeal, or other administrative processes related to authorization/medical necessity. Laboratories and third parties are prohibited from obtaining authorization on behalf of the ordering physician.

Only the ordering physician may obtain authorization or file appeals
Laboratories and third parties are prohibited from obtaining authorization on behalf of the ordering physician

Denial Risk

Denial if service not authorized or authorization procured improperly

Services provided without required authorization will be denied. If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability rests with the participating laboratory and may not be billed to the member. Improper support of the authorization process by a laboratory or third party is a violation and may result in severe actions up to termination from the provider network.

Denial risk: services without required authorization will be denied
Financial liability: participating laboratory bears liability for unauthorized services and may not bill the member
Network actions: violations (labs/third parties supporting authorization) may result in severe actions up to termination from the BCBSRI provider network

Background & Evidence Summary

Background: In vitro chemosensitivity and chemoresistance assays test tumor cell viability after exposure to chemotherapeutic agents using multiple methodologies (differential staining/dye exclusion, ATP bioluminescence, colorimetric assays, thymidine incorporation, etc.). Assays vary in specimen processing, drug dosing (often ranging from below to above physiologic relevance), incubation/exposure times, and endpoints (cell viability, apoptosis, ATP levels), and only a few are commercially available. The overall evidence base includes correlational observational studies, randomized and nonrandomized trials, and prospective and retrospective studies; results are mixed, with some tumor response correlations but no consistent survival benefit demonstrated.

Evidence summary

Evidence conclusionInsufficient to determine improvement in net health outcome; no consistent survival benefit demonstrated.

Key study types citedRandomized trials, nonrandomized studies, and retrospective/prospective correlational studies; results mixed with some tumor response but no consistent survival improvement.

Definitions / Glossary: ChemoFx — an ATP-based chemoresponse assay (Helomics/Precision Therapeutics) that quantifies viability via ATP/chemoluminescence. EVA/PCD — Ex vivo Analysis of Programmed Cell Death assay (Rational Therapeutics) that measures differential staining after apoptotic and nonapoptotic cell death markers to assess drug-induced cell death.