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    v1.0.30
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0250u-pgdx-elio-tissue-complete-ngs-tumor-profiling
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    CPT 0250U: PGDx elio tissue complete NGS tumor profiling

    CPT code 0250U is a Proprietary Laboratory Analyses (PLA) code for the PGDx elioTM tissue complete test from Personal Genome Diagnostics Inc., a next-generation sequencing (NGS) assay performed on formalin–fixed paraffin–embedded (FFPE) solid tumor tissue to evaluate 505+ genes for somatic mutations including insertions and deletions, single nucleotide variants, and translocations to inform therapy selection across multiple solid tumor types; service type: comprehensive genomic profiling by NGS; typical site of service: specialty reference or molecular pathology laboratory processing FFPE tumor specimens.

    For related coverage guidance, see recent payer policy updates: Prenatal (Fetal) Diagnostic Testing, Oral Cancer Screening and Testing, RTM Testing for Alpha-1 Antitrypsin Deficiency.

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    Clinical & Coding Specifications

    Clinical Context

    A 62-year-old patient with a history of metastatic non-small cell lung cancer (NSCLC) presents after progression on first-line therapy. A recent tumor biopsy of a lung mass was formalin-fixed and paraffin-embedded (FFPE). The oncology team requests comprehensive genomic profiling to identify actionable somatic alterations across a broad panel of cancer genes to guide subsequent targeted therapy and immunotherapy decisions. Tissue is forwarded to the molecular pathology laboratory performing NGS-based testing.

    The laboratory performs the PGDx elioTM tissue complete assay (0250U), a Proprietary Laboratory Analysis that sequences >505 cancer-associated genes from FFPE tumor tissue to detect single nucleotide variants (SNVs), insertions and deletions (indels), copy-number alterations, and structural rearrangements (translocations). A pathology review confirms tumor content and suitability for testing, DNA/RNA extraction is completed, library preparation and sequencing are performed, bioinformatics pipelines analyze variants, and a clinical report is issued to the treating oncologist describing detected alterations and their potential therapeutic relevance. Typical sites of service include hospital outpatient laboratories, independent molecular pathology laboratories, and specialized commercial reference labs. The service type is high-complexity molecular diagnostic testing (next-generation sequencing), billed as a PLA test specific to Personal Genome Diagnostics Inc.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    88305Level IV surgical pathology, gross and microscopic examinationPathologist review and initial diagnosis of the FFPE tumor specimen before NGS testing

    88342 | Immunohistochemistry, per single antibody stain | May be used to assess protein expression (e.g., PD-L1) on the same specimen to complement genomic results

    81210 | EGFR gene analysis — sequence analysis of an oncogene (example single-gene test) | Single-gene or small-panel tests that may be ordered prior to or instead of broad NGS panel; related clinically when reflex testing strategy is used

    81445 | Oncology (solid organ) panel, 5-50 genes | Smaller targeted NGS panels that may be performed instead of or prior to a large-panel PLA like 0250U

    99000 | Handling and/or conveyance of a specimen for transport to another facility | Administrative/transport codes sometimes used when sending FFPE blocks or slides to an external reference laboratory for 0250U testing

    Related Modifiers

    7 rows

    ModifierDescriptionWhen to Use
    22Modifier –22 (Increased Procedural Services) is used when a reported procedure is substantially more extensive than normally required. The CPT Manual and CMS state it may be appended only when the…- When to use: Append modifier -22 to a procedural CPT code when the service performed is substantially more extensive than the usual service described by that code — i.e., the procedure required…
    26Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
    52Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
    53Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
    62Modifier 62 indicates that two surgeons function as co‑surgeons, each performing distinct parts of the same primary surgical procedure. It is appended to the primary procedure code (and any…- Use modifier -62 when two surgeons act as co‑surgeons (both primary surgeons) on a single definitive primary procedure, each performing distinct parts of the same surgical procedure (append -62 to…
    78CPT modifier -78 indicates an unplanned, related return to the operating or procedure room by the same provider during the global postoperative period. It is appended when treatment for a…- Use modifier -78 when an unplanned, related complication during the original procedure’s global postoperative period requires the patient to return to a formal operating or procedure room and the…
    80CPT® Modifier 80 (Assistant Surgeon) is appended to a surgical CPT code when a physician (MD or DO) provides full, continuous assistance throughout the operative procedure. It is intended only for…- Use CPT Modifier -80 when a physician (MD or DO) serves as an assistant surgeon and provides full, continuous assistance throughout the entire operative procedure; append -80 to the surgical CPT…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207RH0000X
    208000000X
    207L00000X
    2086S0102X
    363L00000X
    261QP3300X
    163WM1400X
    332B00000X

    Related ICD-10-CM Codes

    28 rows

    ICD-10-CM CodeDescription
    C16.9Malignant neoplasm of stomach, unspecified
    C18.9Malignant neoplasm of colon, unspecified
    C22.0Liver cell carcinoma
    C25.9Malignant neoplasm of pancreas, unspecified
    C34.90Malignant neoplasm of unspecified part of unspecified bronchus or lung
    C43.9Malignant melanoma of skin, unspecified
    C44.91Basal cell carcinoma of skin, unspecified
    C50.912Malignant neoplasm of unspecified site of left female breast
    C53.9Malignant neoplasm of cervix uteri, unspecified
    C56.9Malignant neoplasm of unspecified ovary

    Showing 1–10 of 28

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    10 rows

    PolicyPayerEffective Date
    Prenatal (Fetal) Diagnostic TestingBlue Cross Blue Shield - Rhode Island2027-01-01
    Oral Cancer Screening and TestingOscar Health2027-01-01
    RTM Testing for Alpha-1 Antitrypsin DeficiencyOscar Health2027-01-01
    Cytochrome P450 Genotype-Guided Treatment Strategy Corporate Medical Policybcbsvermont2027-01-01
    Polygenic Risk ScoreBlue Cross Blue Shield - Rhode Island2026-12-01
    Gene Expression Profiling for Cutaneous MelanomaBlue Cross Blue Shield - Rhode Island2026-12-01
    Genetic Testing for Diagnosis and Management of Mental Health ConditionsBlue Cross Blue Shield - Rhode Island2026-11-01
    Molecular Testing in the Management of Pulmonary NodulesBlue Cross Blue Shield - Rhode Island2026-11-01
    Genetic Testing for Hereditary Cancer (for North Carolina Only)Colorado Rocky Mountain Health Plans2026-10-01
    Expanded Molecular Testing of Cancers to Select Targeted TherapiesBlue Cross Blue Shield - North Dakota2026-10-01

    Related Codes

    CPT-0001U-PRECISETYPE-HEA-MULTIPLEX-RBC-ANTIGEN-GENOTYPING

    CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

    CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

    CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

    CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

    CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

    CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

    CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

    CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

    CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

    CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

    CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

    CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

    CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

    CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

    CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

    CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

    CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

    CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

    CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

    Showing 1–10 of 536

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    Frequently Asked Questions

    References

    1. 1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
    2. 2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
    3. 3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.
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