CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Germline and Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Breast Cancer

Policy governs medical necessity and coverage for PIK3CA biomarker testing (tissue and circulating tumor DNA/liquid biopsy) to guide targeted therapy (e.g., alpelisib) and immunotherapy decisions in advanced or high-risk breast cancer for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyGermline and Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Breast Cancer

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateJul 17, 2024

Key ActionObtain prior authorization (required for Medicare Advantage; recommended for Commercial) before PIK3CA testing when medical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ASCO/NCCN: strongGuideline recommendation

≈40%PIK3CA frequency

2PLA codes listed

RequiredPrior authorization

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Coverage Criteria for PIK3CA Testing

Medical necessity for PIK3CA testing to select targeted therapy

Covered when ALL of the following are met

PIK3CA testing for alpelisib eligibility: Individual has hormone receptor–positive, HER2–negative advanced or metastatic breast cancer; AND testing is being performed to evaluate eligibility for treatment with alpelisib (Piqray) after progression on or after an endocrine‑based regimen; AND testing modality may be tumor tissue or circulating tumor DNA (ctDNA)/liquid biopsy — tissue testing is preferred when available

Based on FDA‑approved therapeutics and guideline recommendations

PIK3CA testing to select targeted treatment with alpelisib

PIK3CA testing to identify eligibility for alpelisib in HR‑positive, HER2‑negative advanced/metastatic breast cancer.

Indication and sequencing: Testing is requested for a patient with hormone receptor–positive, HER2–negative locally recurrent unresectable or metastatic breast cancer who is a candidate for PI3K inhibitor therapy (alpelisib) following progression on or after an endocrine‑based regimen

Per guideline recommendation and FDA‑approved indication

Specimen types and reflex testing

Tumor tissue testing (preferred) — perform PIK3CA testing on tumor tissue when available
If ctDNA is negative, tumor tissue testing should be performed if available
Circulating tumor DNA (ctDNA)/liquid biopsy is acceptable when tissue is not available; a negative ctDNA result should prompt tumor tissue testing if tissue can be obtained
ctDNA may detect mutations but has lower sensitivity; follow with tissue testing if ctDNA is negative

Not covered indications

Not covered / not medically necessary

Other uses: PIK3CA testing (tissue or ctDNA) for individuals with breast cancer in indications other than selection of alpelisib for HR‑positive, HER2‑negative advanced or metastatic disease following progression on or after endocrine therapy

Considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products due to insufficient evidence; benefits/coverage may vary by contract

Some genetic testing services may be excluded for self-funded groups by contract per the state Biomarker Testing Mandate / Proprietary Laboratory Analysis (PLA). For members in self-funded groups that have excluded expanded biomarker coverage, the specific services that are covered with authorization, considered not medically necessary, or are contract exclusions will be determined by the member’s benefit booklet or employer agreement. Refer to the related Genetic Testing Services and Proprietary Laboratory Analyses policies and the member’s Benefit Booklet to confirm coverage for a given plan.

PIK3CA testing performed outside the specified indication (i.e., for uses other than selecting patients for alpelisib in HR-positive, HER2-negative advanced or metastatic breast cancer after progression on or after an endocrine-based regimen) is not covered for Medicare Advantage Plans and is considered not medically necessary for Commercial Products due to insufficient evidence. Contract exclusions for some self-funded groups may further restrict coverage; verify benefits in the member’s Benefit Booklet.

Provider Responsibilities and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage Plans and is recommended for Commercial Products. Providers should confirm member benefits and eligibility prior to ordering testing.

Applies to Medicare Advantage and Commercial products
Verify member benefits and eligibility before ordering

Documentation Required

Authorization and Documentation Responsibility

Ordering physician is responsible for obtaining authorization, submitting necessary documentation of medical necessity, and managing any appeals. Laboratories, laboratory representatives, or third parties may not obtain authorization or act on behalf of the ordering physician.

Only the ordering physician may be involved in the authorization, appeal, or other administrative processes related to authorization and medical necessity
Authorization documentation must support clinical appropriateness per policy criteria
Benefits and eligibility determinations are based on the member's subscriber agreement or employer plan documents

Denial Risk

Laboratory Authorization Prohibition and Denial Risk

Laboratories and third parties are prohibited from obtaining prior authorization or participating in the authorization process on behalf of the ordering physician. If a laboratory or third party is found to have supported any portion of the authorization process, BCBSRI may deem this a violation and take action up to termination from the provider network. Services provided without required authorization may be denied and the financial liability may rest with the participating laboratory; such charges may not be billed to the member.

Laboratories may not obtain authorization or facilitate appeals on behalf of ordering physicians
Unauthorized laboratory services may be denied and billed to the laboratory, not the member
Violations may result in disciplinary action, up to termination from the BCBSRI provider network

Note

Referenced Codes

The following CPT/PLA codes are referenced for clinical use when medical criteria are met. Providers should use applicable codes when submitting authorization requests or claims.

0155U – Oncology (breast cancer), DNA, PIK3CA (PLA code for the therascreen PIK3CA RGQ PCR Kit from QIAGEN)
0177U – Oncology (breast cancer), DNA, PIK3CA gene analysis of 11 gene variants utilizing plasma, reported as PIK3CA gene mutation status

Note

Provider Administrative Reminder

For questions about member-specific coverage, providers should contact the BCBSRI provider call center. This policy does not guarantee payment; benefits and eligibility are determined by the member's subscriber agreement or employer plan documents.

Contact the provider call center for member-specific benefits and eligibility
This policy is informational and not a guarantee of payment

Key Definitions

Definition — PIK3CA (clinical relevance)

GenePhosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA)

Clinical significanceSomatic alterations in PIK3CA are present in approximately 40% of HR-positive, HER2-negative breast cancers and can predict response to PI3K inhibitors.

Therapeutic implicationPIK3CA mutation status is used to determine eligibility for the PI3K inhibitor alpelisib (in combination with endocrine therapy) in advanced or metastatic HR-positive, HER2-negative breast cancer.

Testing modalitiesTumor tissue (preferred) or circulating tumor DNA (ctDNA)/liquid biopsy; if ctDNA is negative, tumor tissue testing should be performed if available.

Guideline supportASCO (2022) and NCCN recommend PIK3CA testing (tumor tissue or ctDNA) for patients who are candidates for PI3K inhibitor therapy; recommendation strength: strong.

Member Eligibility Requirements

Eligibility requirements for PIK3CA testing (top-level criteria nodes) are not specified in this policy text. Coverage decisions rely on the clinical criteria for the approved indication (selection of patients for alpelisib in HR-positive, HER2-negative advanced or metastatic breast cancer after progression on or after endocrine therapy), member-specific benefits, and any applicable contract exclusions. Refer to the COVERED INDICATIONS and the member’s Benefit Booklet or subscriber agreement for plan-specific eligibility determinations.

Additional eligibility details and any subgroup-specific requirements are not defined in this policy. For questions about individual member eligibility, prior authorization prerequisites, or documentation expectations, ordering providers should consult the member’s Benefit Booklet, the prior authorization requirements for the patient’s product (Medicare Advantage vs. Commercial), and related Blue Cross Blue Shield RI genetic testing policies.

OpenPayer

Germline and Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Breast Cancer

Coverage Criteria for PIK3CA Testing

Relevant Billing Codes

Provider Responsibilities and Authorization

Not Covered / Not Medically Necessary

Key Definitions

Background and Rationale

Member Eligibility Requirements

Policy Revision History

0155U	Oncology (breast cancer), DNA, PIK3CA (phosphatidylinositol-4,5-bisphosphate 3-kinase; catalytic subunit alpha) (PLA code for the therascreen PIK3CA RGQ PCR Kit from QIAGEN)
0177U	Oncology (breast cancer), DNA, PIK3CA gene analysis of 11 gene variants utilizing plasma, reported as PIK3CA gene mutation status