Lung Liquid Biopsy (InVisionFirst) Coverage Criteria
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Defines medical necessity, prior authorization, and coding for the InVisionFirst plasma-based circulating tumor DNA (ctDNA) assay for advanced (stage IIIB/IV) non–small cell lung cancer (NSCLC) in BCBSRI Medicare Advantage and Commercial products.
No material clinical or coverage changes in this revision.
Coverage Criteria for InVisionFirst (ctDNA) in Advanced NSCLC
Medically necessary indications for InVisionFirst
Covered when ALL of the following are met
Use of InVisionFirst is limited to the clinical situations described above. Specifically, the assay is intended for patients with advanced (Stage IIIB/IV) nonsmall cell lung cancer (NSCLC) at diagnosis when standard tissue-based comprehensive genomic profiling (CGP) is infeasible (for example, quantity not sufficient for tissue CGP or invasive biopsy is medically contraindicated), or at disease progression for patients who meet the criteria outlined for progression (including patients progressing on or after chemotherapy or immunotherapy who have not had the listed tissue-based tests and for whom tissue CGP is infeasible, or patients progressing on EGFR tyrosine kinase inhibitors). The policy does not state coverage for early-stage NSCLC or for situations where tissue-based CGP is feasible.
Benefits and coverage for InVisionFirst may vary by group or contract. Refer to the member’s Benefit Booklet, Evidence of Coverage, or Subscriber Agreement to determine applicable laboratory benefits. No coverage will be provided beyond the medical criteria specified in this policy.
Coding and Test Identifiers
| 0388U | Oncology (non-small cell lung cancer), next-generation sequencing with identification of single nucleotide variants, copy number variants, insertions and deletions, and structural variants in 37 cancer-related genes, plasma, with report for alteration detection |
| 81479 | Unlisted molecular pathology procedure (may have been used for dates of service prior to 07/01/2023) |
Provider Responsibilities and Authorization
Prior authorization required for Medicare Advantage; recommended for Commercial
Prior authorization must be obtained for InVisionFirst when the member is covered under a Medicare Advantage plan; prior authorization is recommended (but not required) for Commercial products.
- Applies to InVisionFirst (ctDNA NGS assay) per this policy.
Ordering physician must handle authorization and appeals (no lab representation)
Laboratories are not permitted to obtain prior authorization on behalf of the ordering physician; the ordering physician must be the party involved in authorization, appeals, or other administrative processes related to prior authorization/medical necessity.
- Do not use laboratory representatives or third parties to obtain authorization or prepare documentation for authorization or appeals.
Authorization ownership — ordering physician only
Only the ordering physician shall be involved in the authorization, appeal, or other administrative processes related to prior authorization/medical necessity; laboratories and their representatives may not obtain authorization or participate in the process on the physician's behalf.
- Use of a laboratory representative or third party to obtain authorization or facilitate appeals is a violation and may result in severe action, including network termination.
Unauthorized laboratory services will be denied and not billable to member
Services provided by a laboratory that were not authorized will be denied and the financial liability will rest with the participating laboratory; such services may not be billed to the member.
- If a laboratory is found to have supported any portion of the authorization process improperly, BCBSRI may take severe action up to termination from the provider network.
Definitions and Test Description
Background and Clinical Context
Many patients with nonsmall cell lung cancer present with advanced disease. Identification of actionable genomic driver alterations such as EGFR, ALK, ROS1, BRAF, MET, and ERBB2 can direct use of targeted therapies. When tissue-based comprehensive genomic profiling is not feasible due to insufficient tissue or contraindications to invasive biopsy, a plasma-based circulating tumor DNA (ctDNA) next-generation sequencing assay (InVisionFirst/InVision®) can detect these alterations and is intended for use at diagnosis in those circumstances or at progression, including after EGFR tyrosine kinase inhibitor therapy.
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