Summary & Overview
CPT 0562U: Targeted cfDNA Genomic Sequencing (33 Genes)
CPT code 0562U denotes a Proprietary Laboratory Analyses (PLA) test: the PGDx elio™ plasma focus Dx assay from Personal Genome Diagnostics Inc. This laboratory-developed targeted genomic sequencing assay analyzes circulating cell–free DNA (cfDNA) in plasma to identify actionable genetic variants across 33 cancer-relevant genes. Nationally, such assays are increasingly important for precision oncology because they offer minimally invasive genomic profiling that can inform targeted therapy decisions and clinical trial eligibility.
Key payers in the coverage landscape considered here include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the clinical context for cfDNA targeted sequencing, typical sites of service and specimen workflow, and the implications of PLA designation for coding and reporting. The publication also summarizes payer coverage patterns, coding guidance and common billing modifiers, and benchmarking considerations for laboratory and oncology stakeholders.
This analysis is intended to help health system billing staff, molecular laboratories, and policy teams understand what CPT code 0562U represents, where it is performed, and how it is positioned within contemporary precision oncology testing strategies. Data not available in the input are noted where applicable.
Billing Code Overview
CPT code 0562U is a Proprietary Laboratory Analyses (PLA) code that applies specifically to the PGDx elio™ plasma focus Dx assay from Personal Genome Diagnostics Inc. The test performs targeted genomic sequence analysis of circulating cell–free DNA (cfDNA) in plasma to detect genetic changes across 33 genes. Results are reported as the presence of actionable variants that could influence treatment choices.
Service type: Targeted genomic sequencing of circulating cell–free DNA (cfDNA)
Typical site of service: Clinical reference laboratory or specialty molecular diagnostics laboratory; specimen collected in an outpatient or ambulatory setting and processed at the performing laboratory
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult with advanced or recurrent solid tumor (for example, non–small cell lung cancer, colorectal cancer, or breast cancer) who is being evaluated for targeted therapy or clinical trial eligibility. The oncologist orders a plasma-based circulating tumor DNA (ctDNA) genomic profile when tissue biopsy is unavailable, insufficient, or when a rapid, minimally invasive assessment of tumor genomic alterations is preferred. Blood is drawn in an outpatient infusion center, oncology clinic, or hospital phlebotomy service and sent to the performing laboratory (Personal Genome Diagnostics Inc.) for PGDx elio™ plasma focus Dx testing. The lab performs targeted sequencing of circulating cell–free DNA (cfDNA) across 33 genes, analyzes for actionable single-nucleotide variants, insertions/deletions, copy-number alterations, and selected fusions, and returns a report indicating detected actionable variants that could influence systemic therapy selection or trial matching. Results are reviewed at a follow-up oncology visit or tumor board to inform treatment decisions or to confirm need for additional tissue testing.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Procedure has both professional and technical components (global) | Use when the single PLA test is reported by a laboratory that provides the full service under a global billing arrangement (rare for PLA codes; include if system requires a global indicator). |
| 22 | Increased procedural services | Use when the lab documents and bills additional, separately reportable work beyond the standard assay (for example, extensive custom bioinformatics analysis documented as medically necessary and significantly beyond usual service).
| 52 | Reduced services | Use when the test is partially performed or limited compared with the full validated assay (documented reduction in analyte assessment or fail of portions of the panel).
| 53 | Discontinued procedure | Use when specimen processing was started but testing was stopped for documented clinical or technical reasons and the lab policy allows reporting of a discontinued service.
| 26 | Professional component | Use when splitting components and the ordering provider bills only the professional interpretation portion of the test (applicable in split-billing arrangements).
| TC | Technical component | Use when the laboratory bills only the technical processing and instrumentation portion of the assay.
| 59 | Distinct procedural service | Use when this assay is billed on the same day as another lab service and documentation supports that it is distinct from other services.
| XE | Separate encounter | Use when testing is performed during a separate encounter from other billed services and payer-specific rules require this modifier.
| XP | Separate practitioner | Use when another practitioner performs a separate, distinct part of care (rare for a single-vendor PLA but may apply in multi-site collaborations).
| KX | Requirements specified in policy are met | Use when documentation confirms coverage criteria required by the payer are met (often used for molecular tests with policy prerequisites).
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207RH0000X | Hematology & Oncology | Medical oncologists commonly order and interpret cfDNA results for systemic therapy selection and trial enrollment. |
| 207L00000X | Pathology | Molecular pathologists oversee test selection, validation, and interpretation of genomic sequencing assays.
| 208000000X | Medical Genetics | Clinical geneticists and molecular geneticists contribute to variant interpretation and germline considerations.
| 364SP0800X | Clinical Laboratory | Clinical laboratory directors and molecular diagnostic laboratory specialists perform and bill the assay.
| 207K00000X | Surgical Oncology | Surgical oncologists may order cfDNA testing when tissue biopsies are limited or to guide neoadjuvant/adjuvant decisions.
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Advanced or recurrent non–small cell lung cancer often undergoes cfDNA testing when tissue is limited or to detect resistance mutations. |
| C18.9 | Malignant neoplasm of colon, unspecified | Colorectal cancer may be evaluated by plasma NGS for actionable RAS, BRAF, and other alterations to guide targeted therapy.
| C50.919 | Malignant neoplasm of unspecified site of unspecified female breast | Metastatic breast cancer patients may have ctDNA testing to detect ESR1 mutations or other actionable alterations.
| C77.9 | Secondary malignant neoplasm of lymph node, unspecified | cfDNA testing can be used when biopsy of metastatic sites is impractical and systemic profiling is needed.
| D37.9 | Neoplasm of uncertain behavior of digestive system, unspecified | When malignant potential is uncertain and noninvasive genomic profiling is requested as part of diagnostic evaluation.
| Z85.118 | Personal history of other malignant neoplasm of bronchus and lung | Surveillance or recurrence evaluation may prompt plasma genomic testing to detect actionable relapse mutations.
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
81479 | Unlisted molecular pathology procedure | Used when elements of molecular testing performed are not covered by a specific CPT and for billing additional nonproprietary supplemental services related to genomic analysis. |
| 80500 | Drug assay, qualitative/quantitative, single drug | Performed when concurrent pharmacogenomic or drug monitoring assays are ordered alongside cfDNA profiling (not specific to PLA but may accompany oncology workup).
| 88184 | Flow cytometry, cell marker identification (per component) | May be performed in parallel in hematologic malignancy evaluation when liquid biopsies are part of a broader hematopathology assessment.
| 36415 | Collection of venous blood by venipuncture | The routine specimen collection CPT for obtaining the plasma sample sent to the laboratory prior to performing the PLA test.
| 88342 | Immunohistochemistry, each additional single antibody stain | Performed on tissue when tissue-based confirmatory testing or complementary biomarker analysis is required after cfDNA results.