BCBSRI genomic profiling Coverage & Prior Auth

Coverage Criteria

Somatic (Acquired) cancer medical necessity

Covered when ALL of the following are met:

Somatic testing clinical criteria: 1. Patient has: A. either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and B. not been previously tested with the same test using NGS for the same cancer genetic content; and C. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

Somatic test requirements: 2. The diagnostic laboratory test using next generation sequencing (NGS) must have: A. Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and B. an FDA-approved or cleared indication for use in that patient's cancer; and C. results provided to the treating physician for management of the patient using a report template to specify treatment options.

Germline (Inherited) cancer medical necessity

Covered when ALL of the following are met:

Germline testing patient criteria: 1. Patient has: A. ovarian or breast cancer; and B. a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and C. a risk factor for germline (inherited) breast or ovarian cancer; and D. not been previously tested with the same germline test using NGS for the same germline genetic content.

Germline test requirements: 2. The diagnostic laboratory test using NGS must have all of the following: A. FDA-approval or clearance; and B. results provided to the treating physician for management of the patient using a report template to specify treatment options.

Not proven clinical utility for expanded panels

Evidence stance for expanded panels:

Evidence summary: Evidence is insufficient to determine that expanded molecular panels (comprehensive genomic profiling) improve net health outcomes; a randomized controlled trial (SHIVA) showed no difference in progression-free survival and clinical utility has not been demonstrated for expanded panels as a whole.

The policy lists HeproDx, OncoTarget/OncoTreat, EXaCT-1 Whole Exome Testing, and LC-MS/MS Targeted Proteomic Assay as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. These specific assays are identified because current evidence is insufficient to demonstrate improved net health outcomes for their use in directing targeted cancer treatment. (HeproDx; OncoTarget/OncoTreat; EXaCT-1; LC-MS/MS Targeted Proteomic Assay)

Benefits and eligibility for any member are determined by the member's subscriber agreement, member certificate, or employer agreement, which supersede this medical policy. For member-specific benefits, providers should contact the provider call center. Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online authorization tool for participating providers for specified tests; laboratories are not permitted to obtain authorization on behalf of the ordering physician.

The policy states that expanded molecular panels (comprehensive genomic profiling) have not demonstrated clinical utility as a whole to direct targeted cancer treatment. Evidence includes one randomized controlled trial (SHIVA) and other nonrandomized studies and systematic reviews; the SHIVA trial showed no difference in progression-free survival. Because panels include many variants across diverse tumor types, the clinical validity and net health benefit of broad profiling versus more limited, tumor-specific testing have not been established. Consequently, many expanded panels are considered not medically necessary unless specific FDA-approved/cleared indications and the policy criteria are met.

Services determined to be not medically necessary or non-covered may be denied, and providers may not charge the member for such services unless the member has been informed in advance and agreed in writing to accept financial responsibility. Additionally, if a laboratory performs a service that was not authorized, the service may be denied as the financial liability of the participating laboratory and may not be billed to the member.

Covered Indications

Somatic testing for advanced/recurrent/metastatic (stage III/IV) cancer and germline testing for breast/ovarian cancer when criteria met

Covered indications (somatic and selected germline testing):

Somatic testing for advanced/recurrent/metastatic cancer: Patient with recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer who is seeking further cancer treatment and has not been previously tested with the same NGS test for the same cancer genetic content.

Germline testing for breast/ovarian cancer: Patient with breast or ovarian cancer who has a clinical indication and risk factor for hereditary breast or ovarian cancer and has not been previously tested with the same germline NGS test for the same genetic content.

Proprietary/PLA assays noted: Certain exome or proteomic PLA/PLA-like assays (eg, codes 0036U, 0174U) are identified in the policy text; coverage and medical necessity depend on meeting the policy clinical criteria and any applicable authorization requirements.

Coding

Covered CPT Codes (may be considered medically necessary when criteria met)CPTCovered

0022U	Oncomine ™ Dx Target Test
0037U	FoundationOne CDx ™ (F1CDx)
0111U	Praxis( ™ ) Extended RAS Panel
0172U	myChoice® CDx
0211U	MI Cancer Seek ™ NGS Analysis
0239U	FoundationOne® Liquid CDx
0242U	Guardant360® CDx
0473U	xT CDx

Codes related to oncoReveal — neutral status / code noted as deletedCPT

0448U

oncoReveal ™ DX Lung and Colon Cancer Assay - Oncology (lung and colon cancer), DNA, qualitative, next-generation sequencing detection of single-nucleotide variants and deletions in EGFR and KRAS genes, formalin-fixed paraffin-embedded (FFPE) solid tumor samples, reported as presence or absence of targeted mutation(s), with recommended therapeutic options (Deleted Code Effective 12/31/2024)

Not covered / Not medically necessary codesCPTNot Covered

0006M	Hepro Dx — Oncology (hepatic), mRNA expression levels of 161 genes, utilizing fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein level, algorithm reported as a risk classifier
0019U	OncoTarget/OncoTreat — Oncology, RNA, gene expression by whole transcriptome sequencing, formalin-fixed paraffin embedded tissue or fresh frozen tissue, predictive algorithm reported as potential targets for therapeutic agents
0036U	EXaCT-1 Whole Exome Testing — Exome (ie, somatic mutations), paired formalin-fixed paraffin-embedded tumor tissue and normal specimen, sequence analyses
0174U	LC-MS/MS Targeted Proteomic Assay — Oncology (solid tumor), mass spectrometric 30 protein targets, formalin-fixed paraffin-embedded tissue, prognostic and predictive algorithm reported as likely, unlikely, or uncertain benefit of 39 chemotherapy and targeted therapeutic oncology agents

Proprietary/PLA/PLA-like codes mentionedCPT

0036U	Exome (ie, somatic mutations), paired formalin-fixed paraffin-embedded tumor tissue and normal specimen, sequence analyses
0174U	Oncology (solid tumor), mass spectrometric 30 protein targets, formalin-fixed paraffin-embedded tissue, prognostic and predictive algorithm reported as likely, unlikely, or uncertain benefit of 39 chemotherapy and targeted therapeutic oncology agents

Clinical stage for somatic testing — required elements

Clinical stage (somatic testing)Recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer.

Prior NGS testing restrictionPatient must not have been previously tested with the same test using NGS for the same cancer genetic content.

Intent for testingPatient has decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required / Recommended

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online authorization tool for participating providers. Laboratories are not permitted to obtain authorization or participate in the authorization process on behalf of the ordering physician; only the ordering/treating physician may initiate or manage prior authorization, appeals, or other administrative steps.

Prior authorization required for Medicare Advantage Plans
Recommended for Commercial Products via online tool
Labs or lab representatives may not obtain or facilitate authorization

Note

PLA / Proprietary Assay Codes Noted

The policy lists specific PLA/Proprietary assay (CPT PLA) codes and tests that are addressed by the authorization process and medical necessity criteria. Examples include Oncomine Dx Target Test (CPT 0022U), FoundationOne CDx (CPT 0037U), Praxis Extended RAS Panel (CPT 0111U), myChoice CDx (CPT 0172U), MI Cancer Seek NGS Analysis (CPT 0211U), FoundationOne Liquid CDx (CPT 0239U), Guardant360 CDx (CPT 0242U), xT CDx (CPT 0473U), oncoReveal DX Lung and Colon Cancer Assay (PLA-like test) and others; some PLA/PLA-like codes such as 0036U and 0174U are noted elsewhere in the policy.

Eligibility Requirements

Eligibility for coverage is limited to patients who meet the policy's clinical and test-specific requirements. For somatic (acquired) testing, coverage applies when the patient has recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer, has not previously undergone the same NGS test for the same cancer genetic content, and is seeking further cancer treatment. For germline (inherited) testing, coverage applies for patients with breast or ovarian cancer who have a clinical indication and a risk factor for hereditary disease and who have not previously received the same NGS germline test for the same genetic content. In all cases the diagnostic NGS test must meet regulatory and reporting requirements (see policy test requirements).

Additional eligibility details include that tests must be ordered by the treating physician (laboratories may not obtain authorization on behalf of the ordering physician) and that the diagnostic laboratory test using NGS must have appropriate regulatory standing, including FDA approval or clearance when required, with results provided to the treating physician using a report template that specifies treatment options. Patients must not have been previously tested with the same test using NGS for the same genetic content to be eligible under the policy criteria.

Not Covered

The policy identifies specific CPT codes that are listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. Examples include codes for HeproDx (CPT 0006M), OncoTarget/OncoTreat (CPT 0019U), EXaCT-1 Whole Exome Testing (CPT 0036U), and the LC-MS/MS Targeted Proteomic Assay (CPT 0174U). These codes are explicitly noted in the policy's not-covered section.

The provided excerpt does not enumerate other explicit tests or clinical indications as universally not covered beyond those named; instead it emphasizes that coverage decisions depend on meeting the policy's medical criteria, applicable FDA/CLIA requirements, and member-specific benefits as determined by subscriber or employer agreements. Where evidence is insufficient for expanded panels, such services are treated as not medically necessary absent meeting stated criteria.

Definitions

Expanded panels — definition and evidence

DefinitionMolecular panels that test a wide variety of genetic markers in cancers without regard for whether specific targeted treatment has demonstrated benefit.

Evidence stanceExpanded panels (comprehensive genomic profiling) as a whole have not demonstrated consistent clinical utility; evidence is insufficient to show improved net health outcomes compared with tumor‑specific testing.

ScopeIncludes broad gene panels and tests that evaluate many potential variants rather than limited cancer‑specific marker panels.

NGS as a diagnostic laboratory test

DefinitionNext Generation Sequencing performed in a CLIA‑certified laboratory, ordered by a treating physician, and reported to guide management.

Regulatory requirement

Background

Comprehensive genomic profiling, often performed as an expanded NGS panel, assesses many genetic variants across tumor types to identify potential targeted therapies. The policy notes that while targeted therapy directed at specific gene variants can improve response and survival in some trials, the overall clinical utility of broad panels has not been demonstrated because panels test a large number of variants across many cancers. NGS-based testing can be clinically appropriate when it meets the policy's criteria — for example, somatic profiling in advanced or metastatic disease or germline testing in breast/ovarian cancer with appropriate clinical indication and risk factors — and when performed in a CLIA-certified laboratory with required FDA approval/clearance where applicable and results reported to guide management.

OpenPayer

Comprehensive Genomic Profiling for Selecting Targeted Cancer Therapies