CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

Defines medical necessity criteria, coverage decisions, prior authorization and CPT coding for specific molecular/genetic assays used on thyroid fine needle aspiration (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 Date02/01/2023

Next Review Date

Key ActionPrior authorization is required for Medicare Advantage Plans and recommended for Commercial Products; ordering physicians must obtain authorization and unlisted genetic testing CPT codes require prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes were made in this update.

8Tests addressed in policy

6Covered/conditionally covered

1Not covered

Coverage Summary

Scope: Defines medical necessity criteria, coverage decisions, prior authorization and CPT coding for molecular/genetic assays performed on thyroid fine needle aspiration (FNA) samples to evaluate nodules, particularly in indeterminate cytology, for Medicare Advantage and Commercial Products.

Medical-Necessity Criteria

Afirma Genomic Sequencing Classifier (GSC) - Medical necessity

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

ALL of the following

ALL of the following
- ONE OR MORE OF
  - 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

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Afirma BRAF and Afirma MTC

Coverage linked to Afirma GSC result

ALL of the following

Afirma BRAF (CPT 81479) and Afirma MTC (CPT 81479) are medically necessary after a positive Afirma GSC.

ThyraMIR, ThyGeNEXT, RosettaGX Reveal - Medical necessity

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

ANY of the following

An indeterminate pathology on fine needle aspiration
ALL of the following
- Nodule growth over time
- Family history of thyroid cancer
- Hoarseness, difficulty swallowing or breathing
- History of exposure to ionizing radiation

ThyroSeq (CPT 0026U) - Medical necessity (Once per nodule)

The use of ThyroSeq testing to assess thyroid nodules may be considered medically necessary ONCE per nodule workup when ALL of the following criteria are met:

ALL of the following

Thyroid fine-needle aspiration(s) performed secondary to established indications based on ultrasound characteristics, size and clinical findings
ANY of the following
- Atypia of undetermined significance (AUS) or follicular lesion of undetermined significance (FLUS) (Bethesda category III)
- Follicular neoplasm (FN) or suspicious for a follicular neoplasm (SFN) (Bethesda category IV)
The need for thyroidectomy is unclear after consideration of clinical, imaging, and cytologic features

ThyroSeq CRC (CPT 0287U) - Medical necessity

Use of ThyroSeq CRC in FNA of thyroid nodules may be medically necessary when to rule in malignancy for surgical planning:

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.

Afirma Xpression Atlas (CPT 0204U) - Not covered / Not medically necessary

Coverage decision for Afirma Xpression Atlas

Afirma Xpression Atlas is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products due to insufficient evidence.

Coding

Covered / may be considered medically necessary when criteria metCPTCovered

81546	Afirma GSC: Oncology (thyroid), mRNA, gene expression analysis of 10,196 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (eg, benign or suspicious)
81479	Unlisted molecular pathology procedure (also used for Afirma BRAF, Afirma MTC, RosettaGX Reveal when applicable)
0245U	ThyGeNEXT: Oncology (thyroid), mutation analysis of 10 genes and 37 RNA fusions and expression of 4 mRNA markers using NGS, FNA
0018U	ThyraMIR: Oncology (thyroid), microRNA profiling by RT-PCR of 10 microRNA sequences, utilizing FNA
0026U	ThyroSeq: Oncology (thyroid), DNA and mRNA of 112 genes, NGS, FNA of thyroid nodule
0287U	ThyroSeq CRC: Oncology (thyroid), DNA and mRNA, NGS analysis of 112 genes, FNA or FFPE tissue, algorithmic prediction of cancer recurrence

Not covered / not medically necessaryCPTNot Covered

0204U

Afirma Xpression Atlas: Oncology (thyroid), mRNA, gene expression analysis of 593 genes; not covered for Medicare Advantage and not medically necessary for Commercial Products

Unlisted code for tests without specific CPTCPT

81479

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

Provider Actions

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 what service is being rendered and if the service is covered or not medically necessary. CPT 81479 (Unlisted molecular pathology procedure) is used for services without a specific CPT code and requires prior authorization.

Billing Rule

Use unlisted CPT (81479) when no specific code

When no specific CPT exists for a referenced service, use the unlisted molecular pathology CPT 81479 and obtain prior authorization to determine the service and medical necessity.

Documentation Required

Ordering physician must obtain authorization

Only the ordering physician shall be involved in the authorization, appeal, or other administrative processes related to prior authorization/medical necessity. Laboratories or third parties are prohibited from obtaining authorization on behalf of the ordering physician; use of a laboratory representative or third party to obtain authorization is a violation of policy.

Denial Risk

Unauthorized lab services denied

If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability will be the responsibility of the participating laboratory and may not be billed to the member.

Background & Evidence

Molecular assays described include gene expression classifiers (eg, Afirma GSC), NGS gene panels (eg, ThyGenX/ThyGeNEXT, ThyroSeq and ThyroSeq CRC), microRNA tests (eg, ThyraMIR, RosettaGX Reveal), and variant/rearrangement detection (eg, BRAF, RET, RAS testing).

These tests are used in the clinical context of thyroid FNA when cytology is indeterminate (Bethesda categories III or IV) and in some cases category V (suspicious for malignancy), to improve diagnostic accuracy, inform whether surgery is required, and guide the extent of initial surgical management (eg, rule-in to plan definitive resection vs rule-out to pursue surveillance).

Rationale: indeterminate FNA results occur in ~20–30% of nodules and often lead to diagnostic surgery; molecular testing can stratify malignancy risk to potentially avoid unnecessary lobectomy or to plan initial definitive surgery and lymph node management.

Intended use: to inform preoperative decision-making — for example, Afirma GSC and microRNA/algorithmic strategies are intended as "rule-out" classifiers to identify low-risk nodules that may avoid surgery, while mutation/NGS panels (ThyGenX/ThyGeNEXT, ThyroSeq, ThyroSeq CRC) and Afirma malignancy classifiers (BRAF, MTC) can "rule-in" malignancy and help plan the extent of surgery. Afirma Xpression Atlas is noted but not covered / not medically necessary due to insufficient evidence.

label	value
Afirma GSC validation
Referenced studies including JAMA Surg 2018 and systematic reviews/meta-analyses; evidence considered supportive for use in specified indeterminate nodules

Definitions (glossary)

Indeterminate cytologic findingsBethesda diagnostic category III (AUS/FLUS) and category IV (follicular neoplasm/suspicion for follicular neoplasm).

Suspicious FindingsBethesda diagnostic category V: suspicious for malignancy.

type	name	number	effective
LCD
MolDX: Molecular Diagnostic Tests (MDT)
L35160

OpenPayer

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

Coverage Summary

Medical-Necessity Criteria

Coding

Provider Actions

Background & Evidence

Medicare Determinations

Revision History