CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Molecular Markers in Fine Needle Aspiration of the Thyroid

Defines medical necessity criteria, prior authorization requirements, and CPT coding guidance for molecular diagnostic and gene expression tests (Afirma, RosettaGX Reveal, ThyGeNEXT, ThyraMIR, ThyroSeq, ThyroSeq CRC) performed on thyroid fine needle aspirate (FNA) samples for Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Molecular Markers in Fine Needle Aspiration of the Thyroid

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01/01/2023

Next Review DateN/A

Key ActionOrder prior authorization for Medicare Advantage plans (recommended for commercial) and ensure only the ordering physician handles authorization and appeals; unlisted genetic tests require prior authorization to determine medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material changes — has_material_change=false in brief.

6Tests addressed in policy

III-IV-VCovered Bethesda categories for ThyroSeq

Prior auth requiredPrior authorization status for MA

Coverage Summary

This policy defines medical necessity criteria, prior authorization requirements, and CPT coding guidance for molecular diagnostic and gene expression tests performed on thyroid fine needle aspirate (FNA) samples — specifically Afirma, RosettaGX Reveal, ThyGeNEXT, ThyraMIR, ThyroSeq, and ThyroSeq CRC — for Medicare Advantage and Commercial products.

Policy quick reference

Tests addressed in policy6

Covered Bethesda categories for ThyroSeqBethesda III-IV-V

Prior authorization status for MAPrior auth required

Policy effective date2023-01-01

Policy last review date2022-12-30

Medical Necessity Criteria

Afirma - CPT 81546

Covered when ALL of the following are met:

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 BRAF and Afirma MTC

Covered when ALL of the following are met:

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

ThyraMIR, ThyGeNEXT, RosettaGX Reveal

Covered when ANY of the following are met:

An indeterminate pathology on fine needle aspiration

ThyroSeq (CPT 0026U) and ThyroSeq CRC (CPT 0287U)

Covered when ALL of the following are met:

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.

Definitions: - Bethesda diagnostic category III: atypia/follicular lesion of undetermined significance - Bethesda diagnostic category IV: follicular neoplasm/suspicion for a follicular neoplasm - Bethesda diagnostic category V: suspicious for malignancy

Coding

Afirma codesCPTCovered

81546	Oncology (thyroid), mRNA, gene expression analysis of 10,196 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (eg, benign or suspicious) (New Code Effective 1/1/2021)
81545	Oncology (thyroid), gene expression analysis of 142 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (eg, benign or suspicious) (Deleted Effective 12/31/2020)

ThyGeNEXT codesCPTCovered

0245U	Oncology (thyroid), mutation analysis of 10 genes and 37 RNA fusions and expression of 4 mRNA markers using next-generation sequencing, fine needle aspirate, report includes associated risk of malignancy expressed as a percentage (New Code Effective 4/1/2021)
81445	Targeted genomic sequence analysis panel, solid organ neoplasm, 5-50 genes... (Code 81445 must be used for Dates of Service prior to 4/1/2021) (Text Revision Effective 1/1/2023)

ThyraMIR codeCPTCovered

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

ThyroSeq codesCPTCovered

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")
0287U	Oncology (thyroid), DNA and mRNA, next-generation sequencing analysis of 112 genes, fine needle aspirate or formalin-fixed paraffin-embedded (FFPE) tissue, algorithmic prediction of cancer recurrence, reported as a categorical risk result (low, intermediate, high) (New code effective 1/01/2022)

RosettaGX Reveal / Unlisted testsmixedCovered

81479

Unlisted molecular pathology procedure (requires prior authorization for Medicare Advantage and Commercial Products)

Prior authorization required codeCPT

81479

Unlisted molecular pathology procedure — requires prior authorization to determine service and medical necessity

Note: the Unlisted molecular pathology procedure (CPT 81479) must be used for tests without a specific CPT code and requires prior authorization for Medicare Advantage Plans (recommended for Commercial Products) to determine the service and medical necessity.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization requirement

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products; all Unlisted genetic testing CPT codes require prior authorization to determine the service and medical necessity.

Affected code: 81479
Prior authorization required for Medicare Advantage; recommended for Commercial

Documentation Required

Ordering physician must handle authorization

Only the ordering physician may be involved in authorization, appeal or other administrative processes related to prior authorization/medical necessity; laboratories or third parties cannot obtain authorization on behalf of the ordering physician and unauthorized lab-provided services will be denied and billed to the laboratory.

Laboratories/third parties cannot obtain authorization on behalf of the ordering physician
If a laboratory provides an unapproved service without authorization, the service will be denied and billed to the laboratory

Background

Molecular marker assays and gene expression classifiers (Afirma, RosettaGX Reveal, ThyGeNEXT, ThyraMIR, ThyroSeq, and ThyroSeq CRC) have been developed to improve the diagnostic accuracy of thyroid FNA samples and reduce unnecessary surgery for indeterminate nodules.

These tests include gene expression classifiers (eg, Afirma GEC/GSC analyzing mRNA expression) and mutation/NGS panels (eg, ThyGeNEXT, ThyroSeq v3 of 112 genes) as well as microRNA assays (eg, ThyraMIR and RosettaGX Reveal). Their intended use is to better stratify risk of malignancy from FNA cytology to guide management and potentially avoid diagnostic surgical biopsies or to inform extent of initial surgery.

Indeterminate cytologic findings: Bethesda category III (atypia/follicular lesion of undetermined significance) and category IV (follicular neoplasm/suspicion for a follicular neoplasm).

Suspicious findings: Bethesda category V (suspicious for malignancy).

Name	Number	Type	Effective Date
MolDX: Molecular Diagnostic Tests (MDT)	L35160	LCD
MolDX: AFIRMA™ Assay by Veracyte Billing and Coding	A54356	Article

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Molecular Markers in Fine Needle Aspiration of the Thyroid

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01/01/2023

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Medical Coverage Policy | Molecular Markers in Fine Needle Aspiration of the Thyroid

Coverage Summary

Medical Necessity Criteria

Coding

Provider Actions & Prior Authorization

Background

Medicare Determinations

Revision History