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IMPORTANT: THIS DOCUMENT CONTAINS OUTDATED INFORMATION.
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October 5, 2015 - Revised: 12.22.15

Afirma Assay by Veracyte Coding and Billing Guidelines (CM00014, V3)

The MolDX Team has completed the Afirma assessment and determined that the test meets criteria for analytical and clinical validity, and clinical utility as a reasonable and necessary Medicare benefit. Effective 01/01/12, MolDX will reimburse Afirma services for patients with the following conditions:

  • Patients with one or more thyroid nodules with a history or characteristics suggesting malignancy such as:
    • Nodule growth over time
    • Family history of thyroid cancer
    • Hoarseness, difficulty swallowing or breathing
    • History of exposure to ionizing radiation
    • Hard nodule compared with rest of gland consistency
    • Presence of cervical adenopathy
    • Have an indeterminate follicular pathology on fine needle aspiration

MolDX expects this test will be performed once per patient lifetime. Should the unlikely situation of a second, unrelated thyroid nodule with indeterminate pathology occur, coverage may be considered upon appeal with supporting documentation.

To report an Afirma service, please submit the following claim information:

  • Claims prior to 01/01/2016: CPT code 81479– unlisted molecular pathology procedure
  • DOS 01/01/2016 and forward: CPT code 81545 – Oncology (thyroid), gene expression analysis of 142 genes
  • Enter assigned Z-Code™ Identifier in the comment/narrative field for the following claim field/types:
    • Loop 2300 NTE 01 for Part A or Loop 2400 or SV101-7 field for Part B
    • Form locator 80 for Part A or Box 19 for part B for paper claim

Select the appropriate ICD-9-CM diagnosis from the following list:

  • 226 - Benign neoplasm of thyroid glands
  • 237.4 - Neoplasm of uncertain behavior; other and unspecified endocrine glands
  • 240.9 - Simple and unspecified goiter; Goiter, unspecified
  • 240.0 - Simple and unspecified goiter; Goiter, specified as simple
  • 241.0 - nontoxic uninodular goiter
  • 241.1 - nontoxic multinodular goiter
  • 241.9 - Nontoxic nodular goiter; unspecified nontoxic nodular goiter
  • 246.2 - Cyst of thyroid

ICD-10-CM codes:

  • D34 – Benign neoplasm of thyroid gland
  • D44.0 – Neoplasm of uncertain behavior of thyroid gland
  • D44.9 – Neoplasm of uncertain behavior of unspecified endocrine gland
  • E01.0 – Iodine-deficiency related diffuse (endemic) goiter
  • E01.1 – Iodine-deficiency related multinodular (endemic) goiter
  • E01.2 – Idodine-deficiency related (endemic) goiter, unspecified
  • E04.0 – Nontoxic diffuse goiter
  • E04.1 – Nontoxic single thyroid nodule
  • E04.2 – Nontoxic multinodular goiter
  • E04.8 – Other specified nontoxic goiter
  • E04.9 – Nontoxic goiter, unspecified

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