CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Molecular Markers in Fine Needle Aspiration of the Thyroid

Defines medical necessity criteria and coding for molecular/genomic tests (Afirma, RosettaGX Reveal, ThyGeNEXT, ThyraMIR, ThyroSeq) used on fine needle aspirate (FNA) thyroid nodules to assist surgical decision-making for indeterminate or suspicious cytology. Also states prior authorization requirements and coding guidance for BlueCHiP for Medicare and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMolecular Markers in Fine Needle Aspiration of the Thyroid

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2017

Next Review Date

Key ActionOrdering physicians must obtain prior authorization for unlisted genetic testing CPT codes (81479) for BlueCHiP for Medicare and are required to handle authorization, appeals, and related administrative processes themselves.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

5Tests addressed

III-IV-VBethesda categories for ThyroSeq

81479Unlisted CPT requires prior auth

Coverage Summary

This policy addresses molecular/genomic tests performed on fine needle aspirate (FNA) thyroid nodules — including Afirma (gene expression classifier; CPT 81545), RosettaGX Reveal (microRNA test, unlisted CPT), ThyGeNEXT (targeted NGS panel; CPT 81445), ThyraMIR (microRNA profiling; CPT 0018U) and ThyroSeq (NGS panel; CPT 0026U) — to assist surgical decision-making for indeterminate or suspicious cytology. The policy's overall coverage stance is covered_with_criteria and includes coding guidance (specific CPT codes and use of 81479 for unlisted molecular pathology) and prior authorization requirements.

Medical Necessity Criteria

Afirma - Medically Necessary Criteria

The Afirma assay may be considered medically necessary for patients with the following conditions (patients must have 1 and 2):

ALL of the following

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.

Afirma - Related Tests

Afirma BRAF and Afirma MTC

Afirma BRAF and Afirma MTC are medically necessary after a positive Afirma Genomic Sequencing Classifier.

ThyraMIR, ThyGeNEXT, RosettaGX Reveal - Medically Necessary Criteria

These services may be considered reasonable and necessary for patients with any of the following conditions:

Any of

An indeterminate pathology on fine needle aspiration.
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.

ThyroSeq - Medically Necessary Criteria

The use of ThyroSeq in FNA of thyroid nodules with indeterminate or suspicious cytologic findings may be considered medically necessary in patients who meet the following:

Thyroid nodules meeting Bethesda diagnostic category III, IV or V to rule in malignancy to guide surgical planning for initial resection rather than a 2-stage surgical biopsy followed by definitive surgery.

Operational intent: guide surgical planning to choose initial definitive resection instead of staged procedures.

Coding

AfirmaCPTCovered

81545

Oncology (thyroid), gene expression analysis of 142 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (eg, benign or suspicious)

ThyGeNEXTCPTCovered

81445

Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5-50 genes

ThyraMIRCPTCovered

0018U

Oncology (thyroid), microRNA profiling by RT-PCR of 10 microRNA sequences, utilizing fine needle aspirate, algorithm reported as a positive or negative result for moderate to high risk of malignancy

ThyroSeqCPTCovered

0026U

Oncology (thyroid), DNA and mRNA of 112 genes, next-generation sequencing, fine needle aspirate of thyroid nodule, algorithmic analysis reported as a categorical result ("Positive, high probability of malignancy" or "Negative, low probability of malignancy")

Unlisted molecular pathologyCPT

81479

Unlisted molecular pathology procedure (requires prior authorization for any test without a specific CPT code)

Provider Actions & Billing Requirements

Prior Authorization

Prior authorization requirement

Prior authorization is required for BlueCHiP for Medicare and is recommended for Commercial Products. Unlisted molecular pathology/molecular genetic testing performed with an unlisted CPT requires prior authorization to determine what service is being rendered and whether it is medically necessary.

Affected CPT code: 81479 (Unlisted molecular pathology procedure)
All unlisted genetic testing CPT codes require prior authorization

Documentation Required

Ordering physician must obtain authorization

Only the ordering physician may be involved in obtaining prior authorization, appeals, or other administrative processes related to prior authorization and medical necessity. Laboratories, their representatives, or third parties are not allowed to obtain authorization on behalf of the ordering physician; if a laboratory provides a service that was not authorized, the service will be denied and the financial liability may be assigned to the laboratory.

Background

Molecular marker assays are intended to improve the accuracy of thyroid FNA cytology to reduce unnecessary surgery and to assist preoperative planning by better classifying nodules as benign or malignant.

Types of tests addressed include gene expression classifiers (eg, Afirma analyzing expression patterns), microRNA profiling (eg, ThyraMIR, RosettaGX Reveal), and next-generation sequencing (NGS) panels or targeted variant/rearrangement testing (eg, ThyGeNEXT, ThyroSeq) that detect single nucleotide variants and gene rearrangements associated with thyroid cancer.

The clinical intent is to "rule out" low-risk nodules to avoid surgical biopsy or to "rule in" malignancy and guide the extent of initial surgery (eg, planning initial resection versus a two-stage approach). Prior authorization is required for BlueCHiP for Medicare and recommended for Commercial products; unlisted molecular pathology CPT codes (eg, 81479) require prior authorization to determine the specific service and medical necessity.

Bethesda diagnostic category III: Atypia/follicular lesion of undetermined significance (AUS/FLUS).

Bethesda diagnostic category IV: Follicular neoplasm/suspicion for a follicular neoplasm.

Bethesda diagnostic category V: Suspicious for malignancy.

Name	Number	Type
MolDX: Molecular Diagnostic Tests (MDT)	L35160	LCD
Billing and Coding: MolDX: AFIRMA™ Assay by Veracyte	A54356	Article
Biomarkers for Oncology	L35396	LCD
Billing and Coding: Biomarkers for Oncology	A52986	Article