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Medicare Pricing
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Non-Facility
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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.
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)
Ask Verity about documentation requirements, denial risks, or coverage in your state.
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