InVisionFirst (Inivata, Inc.) circulating tumor DNA (ctDNA) test coverage and prior authorization
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Policy governs coverage and prior authorization requirements for the InVisionFirst (Inivata, Inc.) ctDNA test (CPT 0388U) for Medicare Advantage and Commercial members of Blue Cross & Blue Shield of Rhode Island.
Effective 8/1/2026, InVisionFirst (CPT 0388U) is considered medically necessary when medical criteria in the online authorization tool are met for Medicare Advantage and Commercial Products.
Coverage and Medical Necessity Criteria
Medical necessity tied to online authorization criteria
Covered when ALL of the following are met
Applies to Medicare Advantage Plans and Commercial Products effective 8/1/2026.
For self-funded groups that have exercised a contract exclusion and excluded the expanded coverage of biomarker testing associated with the state Biomarker Testing Mandate (R.I.G.L. §27-19-81), certain genetic testing services referenced in this policy may not be covered. Benefit booklets should be reviewed to determine whether a member’s plan includes such a contract exclusion and any customized coverage provisions.
When a self-funded group has excluded expanded biomarker testing under the state mandate, coverage determinations for genetic testing are modified: some tests may be covered only with prior authorization, others may be deemed not medically necessary, and some may be expressly not covered due to the contract exclusion. The Coding sections of the Genetic Testing Services and Proprietary Laboratory Analyses policies list which services fall into each category; consult the member’s Benefit Booklet for plan-specific guidance.
Indications for Coverage
Detection of targetable oncogenic driver mutations in NSCLC to inform targeted therapy or immunotherapy decisions
Covered when ALL of the following are met
Coverage is contingent on meeting the medical criteria in the online authorization tool.
Effective 8/1/2026; test is medically necessary only when authorization tool criteria are met for participating providers.
Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products. Laboratories or their representatives may not obtain authorization on the physician's behalf; unauthorized laboratory billing will be denied.
Billing Codes and Code Status
| 0388U | InVisionFirst (Inivata, Inc.) |
Provider Responsibilities and Authorization
Prior Authorization Required
Prior authorization is required for Medicare Advantage Plans and is recommended for Commercial Products. Authorization must be completed via the online authorization tool for participating providers.
- Affected test: InVisionFirst (Inivata, Inc.) — CPT 0388U
- Effective Date: 2026-08-01
Provider Action Required
Only the ordering physician may complete authorizations, appeals, or other administrative processes related to prior authorization and medical necessity.
- Labs or laboratory representatives may not obtain or participate in clinical authorization on behalf of the ordering physician.
- Use the online authorization tool for participating providers.
Authorization Must Be Completed by Ordering Physician
Authorization must be obtained by the ordering physician. Laboratories, their representatives, or third parties may not obtain authorization, facilitate the authorization process, or participate in appeals on behalf of the ordering physician.
- Ordering physicians only — no lab reps, vendors, or third parties may act on the physician's behalf.
- Authorization is tied to the online tool for participating providers.
Unauthorized Laboratory Billing Denied
Services provided by a laboratory that were not authorized will be denied and the financial liability will be the responsibility of the laboratory. BCBSRI may take severe action, up to termination from the provider network, if a laboratory or third party is found to have participated in obtaining authorization.
- Unauthorized laboratory billing will be denied and may not be billed to the member.
- Violations may result in termination from the BCBSRI provider network.
Exclusions and Not Covered Services
For self-funded groups that have a contract exclusion excluding the expanded biomarker testing required by the state Biomarker Testing Mandate, certain genetic testing services are not covered. Specifics—whether a service is covered with prior authorization, not medically necessary, or excluded—are detailed in the Coding sections of the related Genetic Testing Services and Proprietary Laboratory Analyses policies and in the member’s Benefit Booklet.
Clinical Background
A subset of non-small-cell lung cancers (NSCLC) harbor targetable driver mutations that guide selection of targeted therapies or immunotherapies. InVisionFirst is a circulating tumor DNA (ctDNA) tumor profiling test intended to detect such oncogenic variants in advanced NSCLC and support treatment decisions. Coverage for InVisionFirst (CPT 0388U) is contingent on meeting the medical criteria in the online authorization tool and prior authorization requirements effective 8/1/2026.
Key Definitions
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