Summary & Overview
CPT 0295U: DCISionRT® (PreludeDX™) DCIS Recurrence Risk Assay
CPT code 0295U represents a Proprietary Laboratory Analyses (PLA) test — DCISionRT® (PreludeDX™) — designed to assess recurrence risk for ductal carcinoma in situ (DCIS) of the breast. The assay uses immunohistochemistry on FFPE tumor tissue for seven protein biomarkers and integrates four clinical/pathologic inputs in a proprietary algorithm to produce a risk score that informs consideration of adjuvant radiation therapy. As a PLA code, 0295U identifies a single manufacturer-specific diagnostic service rather than a generalizable test.
Nationally, PLA codes like CPT 0295U are significant because they codify commercial biomarker assays that influence treatment planning and utilization of adjuvant therapies. The payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose of the test, the typical laboratory-based service setting, coverage and reimbursement context for major payers, and benchmarking elements relevant to utilization and policy updates. The publication provides clinical context for DCIS management, explains the technical approach of IHC plus algorithmic scoring, and summarizes payer patterns and policy considerations affecting access to this PLA test. Data not available in the input for specific coverage determinations, benchmark values, and associated taxonomies is noted where applicable.
Billing Code Overview
CPT code 0295U is a Proprietary Laboratory Analyses (PLA) code that describes the DCISionRT® test (PreludeDX™ from Prelude Corporation). The assay uses immunohistochemistry (IHC) staining of formalin–fixed paraffin–embedded (FFPE) ductal carcinoma in situ (DCIS) breast tissue for seven protein biomarkers and combines those results with four clinical and pathologic factors through an algorithm to generate a risk score for breast cancer recurrence and to guide radiation therapy decisions.
Service type: Proprietary laboratory diagnostic test using IHC and algorithmic analysis
Typical site of service: Clinical laboratory performing specialized pathology testing; specimen collection occurs in surgical pathology or outpatient biopsy settings
Clinical & Coding Specifications
Clinical Context
A typical patient is a woman diagnosed with ductal carcinoma in situ (DCIS) on core needle biopsy or surgical excision who and her treating team are considering adjuvant radiation therapy after breast-conserving surgery. The patient is generally early-stage, hormone receptor–positive or negative DCIS without invasive carcinoma identified. The clinical workflow: after surgical pathology confirms DCIS, the surgeon or breast oncology team orders the DCISionRT® (PreludeDX™) test to refine individual risk of ipsilateral breast recurrence and estimated benefit from whole-breast radiation. A formalin–fixed paraffin–embedded (FFPE) tissue block or unstained slides are sent to the performing laboratory. The lab performs immunohistochemistry for the seven protein biomarkers specified in the PLA descriptor, combines those results with four clinicopathologic factors in a validated algorithm, and returns a numeric risk score and categorical risk group. The treating clinician (breast surgeon, medical oncologist, or radiation oncologist) uses the test report to inform multidisciplinary discussion and shared decision-making about recommending or omitting adjuvant radiation therapy and follow-up intensity.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Standard use when no special circumstances apply |
22 | Increased procedural services | Rarely applicable; use when documentation supports substantially greater work for associated specimen handling or reporting beyond typical laboratory processes |
26 | Professional component | Use when billing only the professional interpretation/reporting component separate from the technical processing (if applicable and payer allows separate billing) |
52 | Reduced services | Use when testing is partially performed or a reduced service is rendered (e.g., limited panel due to inadequate tissue) |
53 | Discontinued procedure | Use if testing was started but discontinued before completion for valid clinical or technical reasons |
62 | Two surgeons | Not typical for this lab test; used when two surgeons are involved in the surgical specimen collection workflow |
78 | Unplanned return to the operating room | Not typically used for this lab assay; included for completeness when operative events affect specimen status |
80 | Assistant surgeon | Rarely applicable; may be used when assistant involvement relates to specimen procurement billing in certain settings |
82 | Assistant surgeon (when qualified resident not available) | As above, related to operative billing tied to specimen collection |
TC | Technical component | Use when billing only the technical processing and assay components performed by the laboratory (common for PLA codes when professional and technical components are split) |
QK | Medical direction of two, three, or four concurrent anesthesia procedures | Not applicable to the assay; excluded from primary consideration but present in the modifier list |
QX | Services performed by a CRNA under direction of a physician | Not applicable to this laboratory test |
QY | Medical direction of one CRNA by an anesthesiologist | Not applicable to this laboratory test |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207RC0000X | General Surgery | Breast surgeons order and submit surgical specimens and may request the assay |
| 207RH0000X | Surgical Oncology | Surgical oncologists managing DCIS commonly coordinate testing decisions |
| 207Y00000X | Medical Oncology | Medical oncologists review recurrence risk and adjuvant therapy planning |
| 2084P0800X | Radiation Oncology | Radiation oncologists use the assay result to counsel about radiation benefit |
| 363LF0000X | Pathology | Anatomic pathologists handle tissue selection, block preparation, and communication with the testing lab |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
D05.10 | Lobular carcinoma in situ of breast, unspecified breast | LCIS is a noninvasive lesion; while DCISionRT targets DCIS, distinguishing in situ subtypes is relevant to pathology reporting |
D05.11 | Lobular carcinoma in situ of right breast | Side-specific in situ diagnoses are recorded in surgical pathology and may be present in differential coding |
D05.12 | Lobular carcinoma in situ of left breast | As above for left-sided lesions |
D05.9 | Unspecified carcinoma in situ of breast | Used when in situ carcinoma is diagnosed but further specification is not documented; relevant to reporting context for PLA use |
D05.0 | Lobular carcinoma in situ | General in situ carcinoma coding included for completeness in in situ registries |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88342 | Immunohistochemistry or immunocytochemistry, per single antibody stain; initial single antibody stain procedure | May be performed in-house by sending lab for one or more IHC stains that are part of the PLA testing workflow; individual stains can be billed when not included in a PLA bundled payment and when payer policy allows |
88348 | Morphometric analysis, quantitative; immunohistochemistry or immunocytochemistry, image analysis, per specimen | May be used when image analysis software quantifies biomarker expression as part of the algorithmic assessment supporting the DCISionRT report |
88360 | Special stains, each; in situ hybridization (e.g., chromogenic ISH) | Occasionally used in ancillary testing if additional molecular or ISH studies are needed for case workup unrelated to the PLA algorithm |
88172 | Cytopathology, cell block preparation | Relevant if a cytology specimen with cell block is the source material submitted for the assay (less common than surgical FFPE tissue) |
99000 | Handling and/or conveyance of specimen for transfer from physician to lab | Used in some institutional billing arrangements to account for specimen handling logistics when permitted by payer policy |