CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

InVisionFirst (Inivata, Inc.) circulating tumor DNA (ctDNA) test coverage and prior authorization

Know when Blue Cross Blue Shield - Rhode Island releases new policies or updates existing guidance.

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.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyInVisionFirst (Inivata, Inc.) circulating tumor DNA (ctDNA) test coverage and prior authorization

Policy CodePolicy N/A

Change TypeMaterial update — adds CPT 0388U and effective date 8/1/2026

Effective Date8/1/2026

Next Review DateN/A

Key ActionOrdering physician must complete the online prior authorization; laboratories may not obtain authorization on the physician's behalf.

SourceLink

POLICY UPDATE CHANGES

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.

0388UCPT code specified for InVisionFirst

8/1/2026Effective date

InVisionFirstTest named

Required (MA)

Related Billing Codes

CPT-0388U-INVISIONFIRST-LUNG-LIQUID-BIOPSY-CTDNA-PROFILING

CPT 0388U: InVisionFirst–Lung Liquid Biopsy for NSCLC ctDNA Profiling

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Coverage and Medical Necessity Criteria

Medical necessity tied to online authorization criteria

Covered when ALL of the following are met

Medical necessity via authorization tool: InVisionFirst (CPT 0388U) is considered medically necessary when the medical criteria in the online authorization tool for participating providers 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

Indication: Testing is for detection of targetable oncogenic driver mutations in patients with non-small-cell lung cancer (NSCLC) to inform targeted therapy or immunotherapy decisions.

Coverage is contingent on meeting the medical criteria in the online authorization tool.

Test and code: InVisionFirst (Inivata, Inc.) — CPT 0388U.

Effective 8/1/2026; test is medically necessary only when authorization tool criteria are met for participating providers.

Authorization requirement: Prior authorization must be obtained via the online authorization tool as specified by the plan; the ordering physician must complete the authorization process.

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

Covered CPT Codes (when authorization criteria met)CPTCovered

0388U

InVisionFirst (Inivata, Inc.)

Provider Responsibilities and Authorization

Prior 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

Note

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.

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

InVisionFirst — key facts

Test nameInVisionFirst (Inivata, Inc.)

Test typeCirculating tumor DNA (ctDNA) tumor profiling assay

PurposeDetects targetable oncogenic driver variants in non-small-cell lung cancer (NSCLC) to inform targeted therapy or immunotherapy decisions.

CPT code0388U

Medical necessity / authorizationConsidered medically necessary effective 8/1/2026 when medical criteria in the online authorization tool are met (applies to Medicare Advantage and Commercial Products).

Ordering / authorization rolePrior authorization is required for Medicare Advantage Plans (recommended for Commercial) via the online authorization tool; ordering physician must complete the authorization.

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