0177U PIK3CA PCR CPT Reimbursement & Policy | OpenPayer

Summary & Overview

CPT 0177U: PIK3CA PCR Assay for Plasma (Liquid Biopsy)

CPT code 0177U identifies a proprietary molecular diagnostic assay — the therascreen® PIK3CA RGQ PCR Kit from QIAGEN — used to detect 11 specific PIK3CA mutations in blood plasma via quantitative PCR. As a PLA code, 0177U applies only to this unique manufacturer test and is used to distinguish the assay for reporting, coverage, and reimbursement considerations. Nationally, codes like 0177U matter for precision oncology pathways, claims adjudication, and lab reporting transparency.

Key payers in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code's clinical purpose and service settings, payer coverage considerations and common modifiers used in claims, and context on how PLA codes function within molecular diagnostic billing. The publication also summarizes relevant benchmarking and policy implications for proprietary lab tests, including coding precision and the role of PLA codes in tracking manufacturer‑specific assays.

This summary is intended to provide clinicians, laboratory billing staff, and policy analysts with a clear, national‑level reference for CPT code 0177U, its clinical application, and the payer landscape relevant to molecular oncology testing.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0177UCPTProprietary Laboratory AnalysesMolecular DiagnosticsPIK3CAPCRLiquid BiopsyOncology Testing

Billing Code Overview

CPT code 0177U is a Proprietary Laboratory Analyses (PLA) code for the therascreen® PIK3CA RGQ PCR Kit from QIAGEN. The code is reported for a real‑time (quantitative) polymerase chain reaction (PCR) assay that detects 11 mutations in the phosphatidylinositol 3‑kinase catalytic subunit alpha (PIK3CA) gene in blood plasma. This represents a manufacturer‑specific liquid biopsy test targeting PIK3CA variants.

Service type: Molecular diagnostic testing using quantitative PCR to detect specific PIK3CA mutations in circulating cell‑free DNA.

Typical site of service: Clinical or reference laboratory processing with specimens collected in outpatient phlebotomy or clinic settings and analyzed in a laboratory equipped for molecular diagnostics.

Clinical & Coding Specifications

Clinical Context

A 62-year-old woman with hormone receptor–positive, HER2-negative metastatic breast cancer on endocrine therapy develops progressive disease with new visceral metastases. Her oncologist orders a plasma-based circulating tumor DNA (ctDNA) assay using the therascreen® PIK3CA RGQ PCR Kit to detect activating PIK3CA mutations that may predict benefit from PI3K inhibitor therapy. A peripheral blood draw is performed in the outpatient oncology clinic; the specimen is labeled and shipped to the performing laboratory under chain-of-custody and temperature-controlled conditions. The laboratory performs real-time quantitative PCR to evaluate 11 predefined PIK3CA hotspot mutations and reports a qualitative result (mutation detected / not detected) with analytic comments and assay limitations. The result is returned to the oncologist and entered into the electronic medical record to inform systemic therapy selection and clinical trial eligibility decisions.

Coding Specifications

Modifier	Description	When to Use
`00`	Default - No modifier	Use when no specific modifier applies to the service.
`11`	Office or outpatient service furnished personally by the reporting physician

CPT 0179U: cfDNA Molecular Profiling for Non–Small Cell Lung Cancer

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CPT-0587U-SAFEDRUGS-LC-MSMS-DRUG-PANEL-RISK-SCORE

CPT 0587U: SafeDrugs LC MS/MS Drug Panel with Algorithm Risk Score

CPT-0239U-FOUNDATIONONE-LIQUID-CDX-NGS-LIQUID-BIOPSY

CPT 0239U: FoundationOne Liquid CDx NGS Liquid Biopsy Panel

CPT-0389U-KAWASAKI-RNA-EXPRESSION-RISK-SCORE

CPT 0389U: Kawasaki Disease RNA Expression Risk Score Test

CPT-0273U-VERSITI-FIBRINOLYTIC-DISORDER-PANEL-NGS-ACGH

CPT 0273U: Versiti Fibrinolytic Disorder Panel, NGS + aCGH

CPT-0604U-BRADYKININ-QUANTITATIVE-LC-MSMS

CPT 0604U: Bradykinin Quantitative Assay by LC–MS/MS

CPT-0265U-PRAXIS-WHOLE-GENOME-SEQUENCING-NGS-MITOCHONDRIAL-DNA

CPT 0265U: Praxis Whole Genome Sequencing with Mitochondrial DNA

CPT-0600U-MOLECULAR-WOUND-INFECTION-PCR-TEST

CPT 0600U: Molecular Wound Infection PCR Test

CPT-0452U-EARLYTECT-BLADDER-CANCER-DETECTION-PENK-METHYLATION

CPT 0452U: EarlyTect® Bladder Cancer Detection, PENK Methylation Urine Assay

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Taxonomy Code	Specialty	Notes
`207RC0000X`	Medical Oncology	Order and interpretation of tumor mutation testing to guide systemic therapy.
`207L00000X`	Hematology/Oncology	Management of patients with metastatic solid tumors and coordination of molecular testing.
`208000000X`	Pathology	Oversight of laboratory testing, result validation, and reporting of molecular assay findings.
`1744P0800X`	Interventional Radiology	Image-guided specimen procurement when tissue-based testing is required; may coordinate with plasma testing.
`363A00000X`	Phlebotomy/Laboratory Technician	Specimen collection and processing for plasma ctDNA assays.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C50.911`	Malignant neoplasm of unspecified site of right female breast	Common primary diagnosis for ordering PIK3CA testing to guide targeted therapy in metastatic breast cancer.
`C50.912`	Malignant neoplasm of unspecified site of left female breast	Same clinical relevance for left-sided breast primary.
`C79.51`	Secondary malignant neoplasm of bone	Indicates metastatic disease where ctDNA testing may be used to identify actionable mutations.
`C78.7`	Secondary malignant neoplasm of liver and intrahepatic bile duct	Visceral metastases often prompt molecular testing to guide systemic therapy.
`Z85.3`	Personal history of malignant neoplasm of breast	May be present in patients with recurrent or metastatic disease undergoing mutation testing.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Frequently performed immediately prior to `0177U` to obtain plasma for the ctDNA PCR assay.
`99000`	Handling and/or conveyance of specimen for transfer from the office to a laboratory (this is illustrative; specific local codes may vary)	Often used for specimen shipping/handling when sending plasma to a reference lab performing `0177U`.
`88360`	Immunohistochemistry or special stains, per specimen; technical and professional components combined (example ancillary pathology testing)	May be performed on tissue specimens in parallel with plasma testing when tumor tissue is available to confirm mutation status.
`81479`	Unlisted molecular pathology procedure	Used when a molecular test lacks a specific CPT code; historically used prior to availability of a PLA code like `0177U`.
`99070`	Supplies and materials (e.g., clinical laboratory supplies) provided by the physician over and above those usually included with the office visit	May apply when special collection kits or shipping materials are supplied for the plasma assay.

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