Does S3854 require prior authorization?

No, S3854 does not require prior authorization (high confidence). Code is covered without prior authorization.

What is the Medicare reimbursement rate for S3854?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

Verity

`S3854`, Gene expression profiling panel for use in the management of breast cancer

HCPCS/CPT

Prior Authorization

No Prior Auth Required

Code is covered without prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Clinical context documentation implied or recommended in studies/guidelines:
No explicit documentation requirements are specified in this document chunk.
For use of ProMark (post-biopsy prostate prognostic testing), documentation should include patient biopsy-based risk classification (NCCN very-low or low risk), life expectancy (>10 years), and candidacy for active surveillance or definitive therapy.
For use of integrated proteomic classifiers for pulmonary nodules (e.g., Nodify XL2), documentation should include nodule size (8–30 mm), clinician-assessed pre-test probability of malignancy (pCA ≤ 50% for intended-use population), and rationale for test-directed management decisions.

Key Coverage Criteria

uPA and PAI-1 (urokinase plasminogen activator and plasminogen activator inhibitor-1): risk assessment and prediction of therapeutic response in primary breast cancer; high tissue levels associated with aggressive disease and poor prognosis. (ASCO 2016: may be used to guide adjuvant systemic therapy decisions in ER/PgR-positive, HER2-negative, node-negative breast cancer.)
IgVH mutation status: prognostic marker in CLL (mutational status divides CLL into prognostic groups; mutation associated with longer survival).
1p19q codeletion molecular cytogenetic analysis for astrocytomas and gliomas
5-hydroxyindoleacetic acid (5-HIAA) for neuroendocrine tumors
Afirma Thyroid FNA analysis for assessing fine needle aspiration samples from thyroid nodules that are indeterminate (experimental for other indications; repeat testing is considered experimental and investigational)
E04.9 Other nontoxic goiter (thyroid nodules/indeterminate thyroid nodules)

5 Active Policies

AMBETTER-CG-Onc-Algo-2025.1, Concert Genetic Oncology: Algorithmic Testing

AETNA-CPB-0352, Tumor Markers

CARELON-somatic-tumor-testing-2024-11-17-updated-2025-01-01, Somatic Tumor Testing

REGENCE-GT42, Assays of Genetic Expression in Tumore Tissue as a Technique to Determine Breast Cancer Prognosis

CARELON-somatic-tumor-testing-2025-11-15-updated-2026-04-01

Have a follow-up question?

Ask Verity about documentation requirements, denial risks, or coverage in your state.

For multigene breast tests (Oncotype Dx Breast, EndoPredict, Mammaprint, Breast Cancer Index, PAM50, uPA/PAI-1): documentation that breast cancer is nonmetastatic (node negative) or 1-3 ipsilateral axillary lymph nodes involved (with footnote definition of node negative: either standard node dissection negative by H&E or sentinel node negative by H&E; isolated tumor cells/micrometastases considered node negative), tumor ER/PR status, HER2 receptor status (HER2 negative for most tests; special rationale noted for small HER2-positive lesions), that adjuvant therapy is not precluded by other factors, and documentation that member and physician discussed potential results and agree to use results to guide therapy

S3854, Gene expression profiling panel for use in the management of breast cancer