Summary & Overview
CPT 81351: TP53 Full-Gene Sequencing for Li–Fraumeni Syndrome
CPT code 81351 covers laboratory sequencing of the entire TP53 gene to detect variants linked to Li–Fraumeni syndrome. Nationally, full-gene TP53 sequencing is an important diagnostic and hereditary risk-assessment tool because TP53 mutations confer high lifetime cancer risk and have implications for surveillance and family testing. Payers commonly reviewed in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
Readers will find a concise overview of clinical context, typical sites of service, and service type for CPT code 81351, plus the payer landscape and common billing modifiers. The publication outlines standard benchmarking topics relevant to molecular diagnostics reimbursement and coverage policy, highlights clinical indications tied to hereditary cancer evaluation, and summarizes practical billing considerations for laboratories submitting claims for TP53 full-gene sequencing. Data not available in the input are noted where applicable.
Billing Code Overview
CPT code 81351 describes comprehensive sequencing of the entire TP53 gene performed by a laboratory analyst on a patient specimen (for example, blood). The test analyzes the full gene sequence of tumor protein 53 (TP53) to identify pathogenic or likely pathogenic variants associated with Li–Fraumeni syndrome, a hereditary cancer predisposition disorder. Results can inform diagnosis and the potential need for cascade testing of family members.
Service Type: Clinical molecular diagnostic sequencing
Typical Site of Service: Clinical laboratory or molecular diagnostics laboratory
Clinical & Coding Specifications
Clinical Context
A 34-year-old patient with a personal history of early-onset breast cancer and a strong family history of diverse malignancies is referred to clinical genetics for hereditary cancer evaluation. After genetic counseling, the clinician orders germline sequencing of the tumor protein p53 (TP53) gene to evaluate for Li–Fraumeni syndrome. A specimen (peripheral blood) is collected in the outpatient laboratory or phlebotomy clinic. The specimen is sent to a molecular diagnostic laboratory where a laboratory analyst performs full gene sequencing of TP53 to detect pathogenic variants, likely pathogenic variants, or variants of uncertain significance.
The typical clinical workflow: a genetics or oncology provider documents indication and orders testing; informed consent and genetic counseling occur; blood draw at an ambulatory lab or hospital outpatient phlebotomy; sample accessioning and DNA extraction in the molecular lab; sequencing and bioinformatic analysis; laboratory scientist documents results and prepares a definitive report for the ordering provider. Typical sites of service include outpatient phlebotomy clinics, hospital outpatient departments, or reference molecular diagnostic laboratories. The service type is laboratory molecular diagnostic testing (germline full gene sequencing).
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component |