Summary & Overview
CPT 0026U: ThyroSeq® v3 Thyroid Molecular Test
CPT code 0026U is a Proprietary Laboratory Analyses (PLA) code that identifies ThyroSeq® version 3, a laboratory-specific molecular diagnostic assay for evaluation of thyroid nodules. As a PLA code, 0026U is tied to a unique test made by a specific developer and is used to distinguish this proprietary genomic assay in billing and coverage discussions. Nationally, PLA codes matter because they allow payers, providers, and labs to track and manage utilization and reimbursement for novel laboratory-developed tests.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code’s clinical context, typical sites of service, and the payers commonly engaged in coverage and reimbursement for laboratory molecular diagnostics. The analysis also highlights common modifiers used with laboratory billing and identifies where data was not available in the input.
This publication provides benchmarks and policy-relevant information useful for billing staff, laboratory managers, and policy analysts: recognition of the PLA designation and its implications for tracking test use, the expected clinical application for thyroid nodule evaluation, and payer coverage landscape at a national level. Data not available in the input includes specific associated taxonomies, ICD-10 diagnoses, related codes, and service line detail beyond the laboratory context.
Billing Code Overview
CPT code 0026U is a Proprietary Laboratory Analyses (PLA) code that describes ThyroSeq® version 3, a targeted molecular test developed at the University of Pittsburgh Medical Center for CBLPath, Inc. The code denotes a single, manufacturer- or laboratory-specific genomic assay used for analysis of thyroid nodules and related specimens.
Service Type: Proprietary laboratory molecular diagnostic test
Typical Site of Service: Clinical laboratory or reference laboratory
Clinical & Coding Specifications
Clinical Context
A 45-year-old patient presents to an endocrinology clinic after a thyroid nodule is identified on neck ultrasound. Fine-needle aspiration (FNA) cytology returns an indeterminate result (e.g., Bethesda III or IV). The endocrinologist orders molecular testing using the ThyroSeq® v3 assay to better stratify malignancy risk and inform surgical decision-making. A clinic staff member collects the FNA sample or reserves previously collected cytology material, prepares and ships the specimen to the performing laboratory (CBLPath, Inc.), and documents specimen type, collection date, and relevant clinical history in the requisition. The laboratory performs the proprietary genomic panel analysis described by PLA code 0026U, generates a report with mutation and gene-fusion findings, and returns actionable risk assessment to the ordering clinician. Typical sites of service include hospital outpatient departments, freestanding ambulatory surgery centers, outpatient clinics (endocrinology or otolaryngology), and reference laboratories that perform PLA testing.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unmodified claim | Use when no specific modifier is applicable for the service. |
11 | Primary service | Use when 0026U is the primary service billed during the encounter. |
22 | Increased procedural services | Use if unusually extensive additional laboratory work or interpretation beyond typical test complexity is documented and supported. |
26 | Professional component | Use when billing only the professional/interpretive portion of the test separate from the technical component. |
52 | Reduced services | Use if the test is partially performed or a reduced service is rendered and documented. |
59 | Distinct procedural service | Use when 0026U is a distinct service from another billed procedure on the same day and documentation supports a separate service. |
62 | Two surgeons | Use when physician participation by two surgeons is required and documented (rarely applicable; surgical context only). |
80 | Assistant surgeon | Use when an assistant surgeon performs a portion of a related surgical procedure; not typically appended to lab PLA but may appear on associated surgical claims. |
90 | Reference (outside) laboratory | Use when the performing laboratory is an outside/reference lab and only reporting/administrative component is billed by another entity. |
AD | Advanced beneficiary notice | Use to indicate ABN applies when patient may be liable for payment if payer denies coverage. |
QK | Medical direction of two or more assistants | Use in surgical contexts when medical direction for assistants is billed; not typical for lab PLA but may appear with related surgeries. |
QX | Modifier for assistant-at-surgery (when requirements met) | See QK note; rarely used with 0026U itself. |
QY | Surgical assistant certified nurse first assistant | Similar context as other assistant modifiers; included for completeness when associated surgical procedures occur. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207R00000X | Anatomic Pathology | Pathologists oversee laboratory testing, interpretation, and reporting of molecular assays. |
207L00000X | Clinical Molecular Genetics | Laboratory specialists who perform and validate molecular genomic assays such as ThyroSeq v3. |
207K00000X | Clinical Pathology | Clinical pathologists responsible for laboratory operations and test result sign-out. |
207P00000X | Endocrinology, Diabetes & Metabolism | Ordering clinicians who evaluate thyroid nodules and interpret molecular test results in clinical context. |
208D00000X | Otolaryngology | Surgeons who manage thyroid nodules and utilize molecular results for surgical planning. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
E04.1 | Nontoxic single thyroid nodule | Common indication for cytology and molecular testing when nodule evaluation is needed. |
E04.2 | Nontoxic multinodular goiter | Molecular testing may be used for dominant nodules with indeterminate cytology. |
E07.9 | Disorder of thyroid, unspecified | Used when specific thyroid disorder is not yet classified and further molecular testing may guide diagnosis. |
E05.90 | Thyrotoxicosis, unspecified without thyrotoxic crisis | Occasionally recorded when nodules produce thyroid hormone; molecular testing may be relevant for management planning. |
R09.89 | Other specified symptoms and signs involving the circulatory and respiratory systems | Symptoms prompting imaging and incidental thyroid nodule discovery; may lead to molecular testing. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
10021 | Fine needle aspiration without imaging guidance | Percutaneous FNA used to obtain cytology material that may be submitted for molecular testing like 0026U. |
10022 | Fine needle aspiration with imaging guidance | Image-guided FNA to obtain sample for cytology and subsequent molecular analysis. |
88172 | Cytopathology, immediate evaluation (ROSE) | Rapid on-site evaluation of adequacy during FNA; may reduce need for repeat procedures prior to sending material for 0026U. |
88377 | Consultation and review of slides with additional intraoperative consultation | Pathology consults that can accompany cytologic interpretation before molecular testing decisions. |
36415 | Collection of venous blood by venipuncture | If ThyroSeq or associated assays require peripheral blood for matched normal DNA or quality controls, blood collection is billed separately. |
82948 | Drug assay, qualitative perform (example) | Ancillary laboratory tests that might be ordered in parallel; included as an example of common lab codes performed in laboratory workflows (note: not specific to ThyroSeq). |