Summary & Overview
CPT 0069U: miR–31–3p Expression Test for Colon Cancer
Headline: New CPT code 0069U designates the proprietary miR–31now™ molecular test for colon cancer tissue
Lead: CPT code 0069U identifies a manufacturer-specific molecular diagnostic assay — the miR–31now™ test from GoPath Laboratories — which measures miR–31–3p expression in formalin–fixed, paraffin–embedded colon cancer specimens and reports an algorithm-derived expression score intended to inform treatment decisions.
What the code represents and national importance: CPT code 0069U is a Proprietary Laboratory Analyses (PLA) code that codifies a single-company laboratory test used in the molecular characterization of colon cancer. As precision oncology testing expands, discrete PLA codes like 0069U enable clearer tracking of utilization, facilitate payer adjudication, and support data collection on adoption of tumor-directed biomarkers nationwide.
Key payers covered in the analysis: Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
What readers will learn: The publication provides benchmarks and context for CPT code 0069U, summarizes payer coverage landscapes, and outlines clinical context for use of the miR–31now™ assay. It addresses coding specifics, typical site-of-service considerations, and what information is available for payers and providers. Data not available in the input will be noted as such where applicable.
Billing Code Overview
CPT code 0069U is a Proprietary Laboratory Analyses (PLA) code for the miR–31now™ test performed by GoPath Laboratories. The test measures miR–31–3p expression in formalin–fixed, paraffin–embedded colon cancer tissue and uses an algorithm to assign an expression score to guide treatment therapy decisions.
Service type: Laboratory — molecular diagnostic test
Typical site of service: Clinical laboratory or reference pathology laboratory; specimen collected in an outpatient or inpatient setting and submitted to the laboratory
Clinical & Coding Specifications
Clinical Context
A typical patient is a 60-year-old individual with a histologically confirmed stage II–III colon adenocarcinoma who has undergone surgical resection of the primary tumor. Tumor tissue fixed in formalin and embedded in paraffin (FFPE) is submitted to GoPath Laboratories for the miR–31now™ test. The laboratory extracts RNA from the FFPE block, measures miR–31–3p expression, and applies the proprietary algorithm to generate an expression score. The report is used by the treating medical oncologist to inform selection of systemic therapy, particularly in the context of decisions about anti–EGFR therapy versus alternative regimens for metastatic or recurrent disease. Typical workflow steps include: specimen accessioning, histology review to confirm tumor content, RNA extraction and assay run, algorithmic scoring, and result reporting to the ordering oncologist. Typical site of service is a clinical molecular diagnostics laboratory supporting outpatient oncology care; specimen collection originates from hospital outpatient surgical pathology or an ambulatory surgical setting.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the professional interpretation component if separated from the technical laboratory component (rare for PLA codes but applicable when professional-only reporting occurs). |
52 | Reduced services | Use when the test was partially performed or limited relative to the full methodology (document reason for reduction). |
53 | Discontinued procedure | Use if the specimen or assay was started but discontinued for clinical or technical reasons. |
56 | Preoperative assessment | Use when the service is related to a preoperative clinical evaluation (limited relevance; include if applicable in facility billing). |
62 | Two surgeons | Use only when two surgeons are involved in a surgical service related to specimen procurement and relevant to billing rules (rare for lab PLA). |
78 | Unplanned return to the operating/procedure room | Use when an unplanned reoperation for specimen collection occurs related to the diagnostic pathway. |
80 | Assistant surgeon | Use when an assistant surgeon is billed for surgical specimen procurement when allowed. |
82 | Assistant surgeon (when qualified resident not available) | Use when an assistant surgeon role is required and a resident is not available. |
AD | Medical directions of one or more physicians by a single physician of a multi-physician group | Use when applicable to ordering/interpretive services management in specific payor arrangements. |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services | Use when advanced practice clinicians provide billable services related to specimen coordination or result counseling, per payor policy. |
QK | Medical direction of two, three, or four concurrent anesthesia procedures | Included for completeness when anesthesia services relate to specimen procurement; limited applicability. |
QX | CRNA service with medical direction | Same context as above for anesthesia support during specimen procurement. |
QY | Medical direction of one CRNA by an anesthesiologist | As above. |
TC | Technical component | Use when billing only the technical component of the laboratory test (typical for the performing lab when professional component is billed separately). |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207RH0000X | Hematology & Oncology | Medical oncologists order and interpret results to guide systemic therapy choices. |
| 2085P0200X | Pathology | Surgical pathologists perform tumor content assessment and coordinate FFPE specimen submission. |
| 363A00000X | Clinical Laboratory Director | Laboratory directors oversee molecular diagnostic testing and reporting. |
| 207L00000X | Radiation Oncology | Radiation oncologists may reference molecular results in multidisciplinary planning for recurrent disease. |
| 208000000X | Anatomic Pathology & Clinical Pathology | Providers performing diagnostic tissue review and communicating with the molecular lab. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C18.0 | Malignant neoplasm of cecum | Distal primary colon tumors tested when molecular profiling informs systemic therapy. |
C18.2 | Malignant neoplasm of ascending colon | Right-sided colon cancers commonly undergo molecular testing to guide therapy. |
C18.4 | Malignant neoplasm of transverse colon | Molecular markers, including miR–31 expression, may inform treatment choices. |
C18.6 | Malignant neoplasm of sigmoid colon | Common site of primary colon cancer with specimens submitted for PLA testing. |
C18.7 | Malignant neoplasm of other and unspecified parts of colon | Used for colon cancers not otherwise specified; relevant for molecular testing. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Used by pathology to evaluate the resected colon specimen and select tumor blocks for molecular testing. |
88342 | Immunohistochemistry, each antibody stain | May be performed on FFPE tissue to confirm tumor phenotype prior to molecular testing in the diagnostic workflow. |
81599 | Unlisted molecular pathology procedure | Historically used for proprietary molecular tests before PLA codes; related conceptually but replaced by unique PLA code 0069U. |
0001U | Example PLA molecular biomarker code (placeholder) | Laboratories often perform panels or other PLA assays in conjunction with single-marker PLA tests; included to represent companion molecular testing workflows. |
81275 | KRAS gene analysis, codons 12,13 | Common companion molecular test for colon cancer that informs anti–EGFR therapy decisions alongside miR–31 testing. |