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Genomic Profiling for Selecting Targeted Cancer Therapies
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This draft policy governs coverage and medical necessity determinations for expanded comprehensive genomic profiling tests used to select targeted cancer therapies for members of Blue Cross Blue Shield - Rhode Island, applicable to Medicare Advantage and Commercial products.
No material clinical or coverage changes in this revision.
Coverage stance and Indications
Coverage stance
Coverage stance for Medicare Advantage and Commercial products; benefits may vary by contract.
ALL of the following
Coverage summary
- Medicare Advantage Plans: certain comprehensive genomic profiling tests listed in this policy are not covered when evidence is insufficient to demonstrate improved health outcomes; refer to specific not-covered tests.
- Commercial Products: some genetic testing services are not medically necessary and may be subject to contract exclusions for self-funded groups; refer to member benefit booklet or subscriber agreement for plan-specific coverage.
- Benefits and eligibility may vary between groups and contracts; refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable laboratory and not medically necessary benefits/coverage.
- Laboratories are prohibited from obtaining clinical authorization or participating in the authorization process on behalf of the ordering physician; only the ordering physician may be involved in authorization, appeals, or other prior authorization/medical necessity processes.
Identification of germline mutations in inherited breast and ovarian cancers
Covered when ALL of the following are met for Medicare beneficiaries:
ALL of the following
- Test is performed in a CLIA-certified laboratory.
Clinical indication
- Individual has an inherited cancer of the breast or ovary and identification of a germline mutation via NGS will inform a targeted treatment regimen tailored to that germline mutation.
- Treating physician orders the test and is responsible for authorization; laboratories may not obtain authorization on behalf of the ordering physician.
- There is expectation that identification of the germline mutation will change clinical management and improve health outcomes for the Medicare beneficiary (eg, enable use of approved targeted therapy or influence surgical/medical management).
NGS / comprehensive genomic profiling to guide treatment in advanced, relapsed, metastatic cancer or cancer of unknown primary
Covered when ALL of the following are met for consideration of targeted therapy in advanced or metastatic disease:
ALL of the following
- Patient has advanced, relapsed, or metastatic cancer, or cancer of unknown primary, and targeted therapy is being considered.
- Comprehensive genomic profiling (NGS) is ordered by the treating physician and performed in a CLIA-certified laboratory.
Evidence and intended use
- There is peer-reviewed evidence, systematic review, or registry data supporting that actionable genomic alterations identified by the test will guide targeted treatment decisions for the patient’s tumor type or the identified alteration (references include clinical studies and meta-analyses).
- Testing is intended to identify actionable genomic alterations for which an approved or guideline-recommended targeted therapy is available, or to identify eligibility for clinical trials of targeted agents.
- Ordering and authorization responsibilities remain with the treating physician (laboratories may not obtain authorization on behalf of the ordering physician).
- Use of broad expanded molecular panels to direct targeted cancer treatment is not covered when clinical utility has not been demonstrated for the panel as a whole; consider tumor-specific or limited panels when appropriate.
Coding and National Coverage References
| 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 |
| 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 |
| 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 |
| NCD 90.2 | CMS National Covered Determination (NCD) for Next Generation Sequencing (NGS) |
Provider responsibilities and benefit determination
Laboratories must not obtain or participate in clinical authorization
Laboratories are prohibited from obtaining clinical authorization or participating in the authorization process on behalf of the ordering physician; only the ordering physician may be involved in authorization, appeals, or other prior authorization/medical necessity processes. If a laboratory or third party supports any portion of the authorization process, BCBSRI will deem that a policy violation and may take severe action up to termination from the BCBSRI provider network. Services provided by a laboratory that have not been authorized will be denied as the financial liability of the participating laboratory and may not be billed to the member.
- Only the ordering physician may be involved in authorization, appeals, or other administrative prior authorization/medical necessity processes.
- BCBSRI may take severe action, up to and including termination from the provider network, if a laboratory or third party supports any portion of the authorization process.
- Unauthorized laboratory services will be denied and the laboratory is financially liable; such services may not be billed to the member.
Verify member benefits and contact provider call center for eligibility
Benefits and eligibility are determined by the member's subscriber agreement, member certificate, and/or employer agreement; those documents supersede this medical policy. For member-specific benefits and eligibility information, contact the provider call center. Providers may not charge members for services determined to be not medically necessary (or non-covered) unless the member was informed and agreed in writing in advance to pay at their own expense.
- Member subscriber agreement, member certificate, or employer agreement governs benefits and eligibility and supersedes this policy.
- Call the provider call center for member-specific benefits and eligibility.
- Do not charge members for non-covered or not medically necessary services unless they provided written, informed consent to pay in advance.
Ordering physician must order tests and handle authorization (labs may not obtain authorization)
Tests must be ordered by the treating physician; laboratories may not obtain authorization or otherwise facilitate the authorization process on behalf of the ordering physician. Any use of a laboratory representative or third party to obtain authorization or prepare documentation for authorization or appeals is prohibited and may result in denial of the service and provider network sanctions.
- Ensure the treating physician places the order and handles authorization/appeal activities.
- Do not use laboratory representatives or third parties to obtain authorizations, facilitate the authorization process, or prepare documentation for appeals.
Key definitions
Services and tests not covered
The following proprietary/brand tests are not covered for Medicare Advantage Plans and are considered not medically necessary for Commercial Products because the evidence is insufficient to demonstrate improved health outcomes: HeproDx (HeproDX), OncoTarget/OncoTreat, EXaCT-1 Whole Exome Testing, and LC-MS/MS Targeted Proteomic Assay. Corresponding CPT/PLA codes associated with these tests are 0006M (HeproDx), 0019U (OncoTarget/OncoTreat), 0036U (EXaCT-1 Whole Exome Testing), and 0174U (LC-MS/MS Targeted Proteomic Assay).
The policy does not support routine use of broad, expanded molecular panels to direct targeted cancer treatment because current evidence is insufficient to demonstrate clinical utility for these wide-ranging panels. Although some individual genetic markers and limited, tumor-specific panels with established utility may guide therapy, comprehensive expanded panels that test many variants across cancer types have not been shown to improve net health outcomes as a class. Notably, the single published randomized trial (SHIVA) using an expanded panel showed no progression-free survival benefit, and the heterogeneity of variants and tumor types precludes determination of clinical validity and utility for expanded panels overall.
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