Anthem Blue Cross ConnecticutCommercial Clinical Policy

CG-GENE-04 Molecular Marker Evaluation of Thyroid Nodules Form


Molecular Marker Evaluation of Thyroid Nodules

Indications

(844831) Was the initial cytopathology indeterminate, showing atypia of undetermined significance (AUS), follicular lesion of undetermined significance (FLUS), suspicious for follicular neoplasm (SFN), follicular neoplasm (FN), or suspicious for malignancy (SUS)? 
(844832) Will one of the following gene expression classifiers be used: Afirma Genomic Sequencing Classifier, Afirma Medullary Thyroid Carcinoma (MTC) Classifier for indeterminate GSC results, ThyGeNEXT/ThyraMIR, or ThyroSeq Genomic Classifier? 

Repeat Molecular Marker Evaluation of the same Thyroid Nodule

Notes: All other indications not listed as medically necessary are considered not medically necessary.

Indications

(844833) Is this molecular marker evaluation a repeat test on the same thyroid nodule? 

Other Molecular Marker Evaluations (e.g., Afirma Xpression Atlas)

Notes: Use of other molecular marker evaluations such as Afirma Xpression Atlas is considered not medically necessary.

Indications

(844834) Is the molecular marker evaluation being performed with a method other than Afirma Genomic Sequencing Classifier, Afirma MTC Classifier, ThyGeNEXT/ThyraMIR, or ThyroSeq Genomic Classifier, such as Afirma Xpression Atlas? 

Effective Date

06/28/2023

Last Reviewed

05/11/2023

Original Document

  Reference



This document addresses the use of molecular markers for the evaluation of thyroid nodules to identify genetic mutations (mutation analysis) and to identify benign thyroid nodules preoperatively. Examples of these tests include, but are not limited to:

  • Afirma® Thyroid FNA Analysis (i.e., Genomic Sequencing Classifier, Medullary Thyroid Carcinoma Classifier, and Xpression Atlas) (Veracyte, South San Francisco, CA)
  • ThyGeNEXT® and ThyraMIR® (Interpace Diagnostics, Parsippany, NJ)
  • ThyroSeq® (CBLPath, Rye Brook, NY)

Note: Please see the following related document for additional information:

  • CG-GENE-14 Gene Mutation Testing for Cancer Susceptibility and Management

Clinical Indications

Medically Necessary:

Molecular marker evaluation of a thyroid nodule is considered medically necessary for use with fine needle aspirates when the following criteria are met:

  1. Initial cytopathology is indeterminate (that is, atypia of undetermined significance [AUS], follicular lesion of undetermined significance [FLUS], suspicious for follicular neoplasm [SFN], follicular neoplasm [FN], or suspicious for malignancy [SUS]); and
  2. One of the following gene expression classifiers will be used:
    1. Afirma Genomic Sequencing Classifier; or
    2. Afirma Medullary Thyroid Carcinoma (MTC) Classifier when results from the Genomic Sequencing Classifier are indeterminate; or
    3. ThyGeNEXT/ThyraMIR; or
    4. ThyroSeq Genomic Classifier.

Not Medically Necessary:

The use of molecular marker evaluation of thyroid nodules is considered not medically necessary for repeat testing of the same nodule and all other indications not listed above as medically necessary.

The use of other molecular marker evaluations of thyroid nodules (for example, Afirma Xpression Atlas) is considered not medically necessary.