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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.
Merkel cell polyomavirus antibody testing — blood/serum sample for quantitative oncoprotein antibody titer or qualitative VP1 capsid antibody testing.
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
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)