DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Comprehensive Genomic Profiling for Selecting Targeted Cancer Therapies

Defines BCBSRI coverage stance for expanded comprehensive genomic profiling tests used to select targeted cancer therapies for members, and lists specific proprietary tests addressed; applies to Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyComprehensive Genomic Profiling for Selecting Targeted Cancer Therapies

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2026

Next Review DateJun 5, 2026

Key ActionOrdering physicians must order tests and laboratories are not permitted to obtain authorization on behalf of the ordering physician.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4specific proprietary tests addressed

4codes listed not covered

96%patients with ≥1 alteration

SHIVAtrial with no PFS benefit

90.2CMS NCD cited

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Provider Updatesprovider communications

Coverage Determinations

Not covered / Not medically necessary — Expanded molecular panels

Primary coverage position: Expanded comprehensive genomic profiling panels (the proprietary tests listed) are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products due to insufficient evidence of improved net health outcomes.

Named tests include HeproDx, OncoTarget/OncoTreat, EXaCT-1 Whole Exome Testing, LC-MS/MS Targeted Proteomic Assay

Some genetic testing services may be a contract exclusion for self‑funded groups that have excluded expanded biomarker testing per the state mandate (see the Biomarker Testing Mandate policy). Determine group‑specific coverage by reviewing the member's Benefit Booklet and employer agreement; consult the provider call center for member‑specific benefit and eligibility information.

NGS for identifying germline mutations in inherited breast and ovarian cancer

Covered when ALL of the following are met:

Next-generation sequencing (NGS) is performed in a CLIA-certified laboratory and ordered by the treating/ordering physician.

Per CMS determination and policy ordering requirements

The test is used to identify germline mutations in individuals with breast or ovarian cancer for whom identification of such mutations will inform selection of targeted treatment and is expected to improve health outcomes.

CMS evidence supports utility of NGS to identify germline mutations that guide treatment in breast and ovarian cancers

Clinical use is limited to situations where targeted therapy selection is directly informed by the identified germline mutation and where such management is expected to improve outcomes for the patient.

Identification must lead to a tailored treatment regimen as described in CMS evidence

Exclusion: Use of expanded/comprehensive somatic profiling panels intended to broadly guide targeted therapy across multiple tumor types (ie, expanded panels without demonstrated clinical utility) is NOT covered for directing targeted cancer treatment.

Evidence is insufficient for clinical utility of expanded panels (eg, SHIVA trial showed no PFS benefit)

Coding and Specific Proprietary Tests

Not covered / Not medically necessary (proprietary tests) - HeproDxCPTNot Covered

0006M

Oncology (hepatic), mRNA expression levels of 161 genes, utilizing fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein level, algorithm reported as a risk classifier

Not covered / Not medically necessary (proprietary tests) - OncoTarget/OncoTreat, EXaCT-1CPTNot Covered

0019U	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	Exome (ie, somatic mutations), paired formalin-fixed paraffin-embedded tumor tissue and normal specimen, sequence analyses

Not covered / Not medically necessary (proprietary test) - LC-MS/MS Targeted Proteomic AssayCPTNot Covered

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

The policy specifically names the proprietary tests and associated CPT/PLA codes that are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. Examples cited in the Coding section include: HeproDx (e.g., CPT 0006M), OncoTarget/OncoTreat (e.g., CPT 0019U), EXaCT‑1 Whole Exome Testing (e.g., CPT 0036U), and the LC‑MS/MS Targeted Proteomic Assay (e.g., CPT 0174U). Refer to the Coding section for the full list of affected codes and descriptions when determining billing and authorization requirements.

Provider Responsibilities and Administrative Rules

Prior Authorization

Prior Authorization Administrative Rules

Prior authorization: Not applicable for this policy header. Laboratories may not obtain prior authorization on behalf of the ordering/treating physician — only the ordering physician may participate in authorization, appeals, or other administrative processes.

Prior authorization: Not applicable (policy header)
Laboratory staff or representatives may NOT obtain authorization on behalf of the ordering physician
Only the ordering physician may engage in authorization, appeal, or related administrative actions

Note

Confirm Member Benefits Prior to Testing

Verify member-specific benefits and eligibility before ordering/testing. Benefits and eligibility are determined by the member's subscriber agreement, member certificate, or employer agreement and supersede this policy.

Confirm eligibility and benefits via provider call center prior to testing

Specific Tests and Services Not Covered

The following proprietary tests are listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: HeproDx, OncoTarget/OncoTreat, EXaCT‑1 Whole Exome Testing, and the LC‑MS/MS Targeted Proteomic Assay. These named tests are specifically identified in the policy because the evidence is insufficient to show improved net health outcomes with comprehensive genomic profiling panels.

If services are determined to be not medically necessary or are non‑covered benefits under the member's plan, providers generally may not charge the member for those services unless the member has been informed and has agreed in writing in advance to accept financial responsibility. Additionally, laboratories are prohibited from obtaining clinical authorization on behalf of the ordering physician; unauthorized laboratory services may be denied and the financial liability may fall to the participating laboratory.

Background and Rationale

Comprehensive genomic profiling, often described as expanded panels, evaluates a large number of genetic markers across many tumor types without limiting analysis to variants with established clinical actionability. While these panels frequently identify multiple variants per patient, the evidence does not currently demonstrate that broad profiling across diverse tumor types improves net health outcomes. The policy cites randomized and nonrandomized studies (including the SHIVA randomized trial) and systematic reviews which found limited or no progression‑free survival benefit when patients were assigned to treatment solely on the basis of expanded panel findings rather than tumor‑specific, evidence‑based targets.

Definitions and Guiding Documents

Definition — expanded molecular panels

TermExpanded molecular panels

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

ScopeEvaluates large numbers of genetic markers concurrently to identify potential targeted therapies across tumor types, often including variants of uncertain actionability.

Policy stanceExpanded comprehensive genomic profiling panels (named proprietary tests) are not covered for Medicare Advantage and are not medically necessary for Commercial Products due to insufficient evidence of improved net health outcomes.

Examples (named in policy)HeproDX (CPT 0006M); OncoTarget/OncoTreat (CPT 0019U); EXaCT-1 Whole Exome (CPT 0036U); LC-MS/MS Targeted Proteomic Assay (CPT 0174U).

Eligibility and Required Conditions

There are no top‑level, additional eligibility criteria specified in this policy for expanded comprehensive genomic profiling beyond standard plan benefit and coverage rules. Coverage is subject to the member's subscriber agreement, employer agreement, and any contract exclusions; verify member benefits and eligibility with the provider call center before ordering testing. Tests must be ordered by the treating/ordering physician, and laboratories may not obtain authorization on the physician's behalf.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyComprehensive Genomic Profiling for Selecting Targeted Cancer Therapies

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2026

Next Review DateJun 5, 2026

Key ActionOrdering physicians must order tests and laboratories are not permitted to obtain authorization on behalf of the ordering physician.

SourceLink

On This Page

Refer to the member's Benefit Booklet or subscriber/employer agreement for coverage specifics

Documentation Required

Authorization Process Participation

Only the ordering/treating physician may participate in prior authorization, appeals, or other administrative processes. Laboratories, laboratory representatives, or third parties must not support or facilitate authorization or appeals on behalf of the ordering physician; doing so may be deemed a policy violation with sanctions up to termination from the BCBSRI provider network.

Authorization/appeal participation limited to ordering physician
Support from laboratories or third parties in the authorization/appeal process is prohibited and may result in provider network sanctions

Note

Benefits & Eligibility Verification

Verify benefits and eligibility with the provider call center. Benefits in the member's subscriber agreement, member certificate, or employer agreement take precedence over this policy. If services are determined not medically necessary or are non-covered benefits, providers may not bill the member unless the member was informed and provided written agreement to pay.

Verify member-specific benefits and eligibility with the provider call center
Do not bill members for non-covered or not medically necessary services unless informed and written agreement obtained

Denial Risk

Unauthorized Laboratory Actions and Financial Liability

Laboratories that provide services without required authorization or that attempt to obtain authorization on behalf of an ordering physician risk denial of the service and financial liability — such services may not be billed to the member and may constitute a policy violation subject to sanctions.

Unauthorized lab-obtained authorizations or unauthenticated services will be denied and the laboratory held financially liable
Providers must not bill members for denied non-covered services except with prior written member agreement

Definition — Next Generation Sequencing (NGS) and CLIA context

TermNext Generation Sequencing (NGS)

DefinitionA laboratory technique that can measure one or more genetic variations and be used as a diagnostic test or companion in vitro diagnostic when performed in a CLIA-certified laboratory.

Clinical applicationNGS reports of genetic variation can contribute to predicting a patient’s response to targeted therapies and inform treatment selection prior to therapy initiation.

Coverage contextCMS has determined NGS is reasonable and necessary and covered nationally when performed in a CLIA-certified lab and ordered by a treating physician, when criteria are met.

Use casesApplied for somatic (acquired) and germline (inherited) cancer testing to identify variants relevant to therapy selection.

NGS NCD / NCA

ReferenceCMS National Coverage Determination (NCD) for Next Generation Sequencing (NGS) (90.2).

ReferenceCMS National Coverage Analysis (NCA) decision memo: Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N), 2018.

ApplicabilityThese CMS determinations establish that NGS is nationally covered for Medicare when performed in CLIA-certified labs and ordered by a treating physician under specified criteria.

Policy useDocument cites the NCD/NCA as governing CMS policy and as supporting coverage of NGS in specified circumstances (e.g., advanced cancer).

NCCN guidelines — referenced guideline documents

SourceNational Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology — multiple tumor-specific guideline documents cited (examples include NSCLC, Breast, Colon, Ovarian, Melanoma).

ScopeNCCN guidelines across ≥30 tumor types are referenced in the policy as supportive sources for molecular testing recommendations.

Examples citedNon–Small Cell Lung Cancer; Cutaneous Melanoma; Uveal Melanoma; Breast Cancer; Colon Cancer; Rectal Cancer; Ovarian Cancer; Biliary Tract Cancers; Hepatocellular Carcinoma; Prostate Cancer; Pancreatic; Esophageal; Gastric; Testicular (versions 2025–2026 referenced).

Purpose in policyNCCN guideline documents are used as supportive references for clinical recommendations regarding molecular testing across tumor types.