Summary & Overview
CPT 0306U: Invitae PCM Tissue Profiling and MRD Baseline Assay
CPT code 0306U designates the Invitae PCM Tissue Profiling and MRD Baseline Assay, a Proprietary Laboratory Analyses (PLA) test that sequences tumor DNA to create a baseline profile for later minimal residual disease (MRD) monitoring. As a PLA code, 0306U applies exclusively to a single manufacturer’s assay and is important for payers and providers because it identifies a specific, proprietary molecular diagnostic service used in cancer care and longitudinal MRD surveillance.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise clinical and billing context for the assay, how the code is used to capture the baseline tumor profiling service, and which national payers are relevant to coverage discussions. The publication summarizes reimbursement and policy considerations, common billing modifiers, typical site-of-service practices, and where stakeholders can expect PLA-specific coding implications to arise.
This resource is intended to clarify the clinical purpose of 0306U, its role in MRD workflows, and the payer landscape nationally. Data not available in the input for detailed payer-specific coverage policies, associated taxonomies, and ICD-10 pairings are noted as unavailable.
Billing Code Overview
CPT code 0306U is a Proprietary Laboratory Analyses (PLA) code reported only for the Invitae PCM Tissue Profiling and MRD Baseline Assay from Invitae Corporation. The test sequences the DNA of a tumor specimen to generate a tumor profile that serves as a baseline for subsequent testing to determine minimal residual disease (MRD) levels after treatment.
Service Type: Tumor DNA sequencing for MRD baseline profiling
Typical Site of Service: Clinical laboratory / specialized molecular pathology laboratory
Data not available in the input for Associated Taxonomies, ICD-10 Diagnoses, Related Codes, and Service Line.
Clinical & Coding Specifications
Clinical Context
A patient with a recently resected or biopsied solid tumor (for example, stage II–III colorectal adenocarcinoma or non‑small cell lung carcinoma) presents for baseline molecular profiling. The treating oncologist orders the Invitae PCM Tissue Profiling and MRD Baseline Assay to sequence the tumor specimen and generate a tumor profile that will serve as the baseline comparator for later plasma-based minimal residual disease (MRD) testing. The workflow: tumor tissue is obtained at surgery or diagnostic biopsy, sent to the pathology laboratory for formalin fixation and paraffin embedding, then a specimen or extracted nucleic acid is submitted to Invitae. Invitae performs targeted DNA sequencing, reports somatic variants and a personalized tumor profile, and provides the baseline signature for serial peripheral blood MRD monitoring. Results inform baseline tumor mutation profile, eligibility for targeted therapies, and the specific markers tracked on follow-up MRD assays.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unmodified service | Use when no modifier is required and the PLA test is reported in standard fashion. |
26 | Professional component | Use when billing only for the professional (interpretive) component, where applicable and separated. |
TC | Technical component | Use when billing only for the technical component (laboratory processing and sequencing). |
52 | Reduced services | Use when the test is performed but in a reduced or limited manner relative to the full assay. |
53 | Discontinued procedure | Use if specimen processing is started but discontinued due to specimen unsuitability or other valid reason. |
62 | Two surgeons | Not typical for the assay itself; used when two surgeons are involved in the operative specimen procurement that affects billing context. |
78 | Return to operating room for related procedure | Not applicable to the lab test directly but may be relevant to associated surgical billing if reoperation occurs. |
80 | Assistant surgeon | Similar to 62, applies to operative services related to specimen collection when an assistant surgeon is involved. |
QK | Medical direction of two, three, or four assistants | Applies to surgical team billing context when medical direction exists; not for the lab test itself. |
QX | CRNA service performed with medical direction by a physician | Applies to anesthesia billing in the procedural context of specimen procurement. |
QY | Medical direction of one CRNA by a physician | Applies to anesthesia billing when relevant to specimen collection. |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services furnished under a physician's supervision | Use when these providers are involved in specimen collection or care related to the testing episode. |
SH | Diagnostic services furnished under an outpatient psychiatric facility | Rarely used; included for completeness where facility billing rules require. |
SJ | Services provided by a student | Use when a qualified trainee provides part of the specimen collection under supervision. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207RH0000X | Hematology & Oncology | Medical oncologists ordering baseline tumor profiling and MRD monitoring. |
| 207V00000X | Pathology | Pathologists responsible for specimen handling, diagnosis confirmation, and submission to the performing lab. |
| 208000000X | General Surgery | Surgeons obtaining tumor specimens via resection or biopsy. |
| 207L00000X | Medical Genetics & Genomics | Molecular pathologists or genomicists consulting on test interpretation and variant relevance. |
| 208800000X | Surgical Oncology | Surgical oncologists involved in tumor procurement and longitudinal management. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal cancer specimens are commonly profiled to define baseline tumor mutations for MRD monitoring. |
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Lung cancers often undergo tissue profiling to identify actionable somatic variants and establish MRD baseline. |
C50.919 | Malignant neoplasm of unspecified site of unspecified female breast | Breast cancer tissue profiling supports targeted therapy selection and MRD tracking strategies. |
C61 | Malignant neoplasm of prostate | Prostate tumors may be sequenced when tissue is available to guide precision oncology and MRD planning. |
C80.1 | Malignant (primary) neoplasm, unspecified | Used when a malignant tumor is present but primary site details are pending; profiling aids diagnosis and monitoring. |
D37.9 | Neoplasm of uncertain or unknown behavior of unspecified site | Indeterminate tumors undergoing molecular profiling to clarify malignant potential and inform follow-up. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Performed by pathology to evaluate tumor tissue and provide diagnosis prior to molecular profiling; specimen preparation may be required before sending to Invitae. |
88104 | Cytopathology, smears and interpretation by physician; per specimen | Used when cytology specimens (e.g., fine needle aspiration) are the source material for molecular testing. |
81445 | Oncology (somatic) gene analysis; multiple genes by targeted sequencing, DNA, >50 genes (if applicable) | Represents comparable genomic sequencing panels; used in workflow when broader somatic panels are ordered in addition to or instead of the PLA test. |
81225 | EGFR (epidermal growth factor receptor) gene analysis | Example single‑gene molecular tests that may be ordered concurrently or historically for targeted therapy decisions. |
0000U | (Placeholder PLA example) Proprietary Laboratory Analyses code | Other PLA codes may be reported for different vendor-specific assays in the tumor profiling and MRD space and could appear in the same patient workflow. |
89500 | Collection of blood specimen | Performed when obtaining plasma for subsequent MRD monitoring; baseline assay uses tumor tissue but MRD follow-up requires blood collection. |