CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Needle Aspiration of the Thyroid — molecular and genomic testing adjuncts

Policy governing coverage and medical necessity criteria for molecular/genomic assays performed on thyroid fine needle aspiration (FNA) specimens to aid management and surgical planning; applies to Medicare Advantage and Commercial products of the payer.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNeedle Aspiration of the Thyroid — molecular and genomic testing adjuncts

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateSep 20, 2023

Key ActionObtain prior authorization for Medicare Advantage plans (recommended for commercial products) and ensure documentation links the ordered molecular test to a listed test/code and medical criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9+named molecular/genomic tests addressed

20-30%FNAs indeterminate

6-30%postop malignancy rate (indeterminate)

once/noduleThyroSeq/Xpression frequency

5 codes

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specific CPT/PLA codes listed

Coverage and Medical Necessity Criteria

Afirma GSC (CPT 81546)

Afirma Genomic Sequencing Classifier (GSC) may be considered medically necessary when ALL of the following are met:

Afirma GSC criteria: 1) Patient has one or more thyroid nodules with history or characteristics suggesting malignancy (eg, nodule growth over time; hoarseness, difficulty swallowing or breathing; family history of thyroid cancer; history of exposure to ionizing radiation; presence of cervical adenopathy; hard nodule compared with rest of gland consistency). 2) Indeterminate follicular pathology on fine needle aspiration.

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

ThyraMIR (CPT 0018U), ThyGeNEXT (CPT 0245U), RosettaGX Reveal (CPT 81479)

ThyraMIR, ThyGeNEXT, and RosettaGX Reveal may be considered reasonable and necessary when ALL of the following are met:

MicroRNA panel criteria: 1) Indeterminate pathology on fine needle aspiration. 2) Patient has one or more thyroid nodules with history or characteristics suggesting malignancy (eg, nodule growth over time; hoarseness, difficulty swallowing or breathing; family history of thyroid cancer; history of exposure to ionizing radiation; presence of cervical adenopathy; hard nodule compared with rest of gland consistency).

ThyroSeq (CPT 0026U) and Afirma Xpression Atlas (CPT 0204U)

ThyroSeq and Afirma Xpression Atlas testing may be considered medically necessary when ALL of the following criteria are met:

ThyroSeq / Xpression Atlas criteria: 1) Thyroid fine-needle aspiration performed for established indications based on ultrasound characteristics, size, and clinical findings. 2) Atypia of undetermined significance (AUS) or follicular lesion of undetermined significance. 3) Presence of indeterminate thyroid FNA cytopathology described as follicular neoplasm (FN) or suspicious for a follicular neoplasm (SFN; Bethesda category IV). 4) Local institutional malignancy rates are known and used for extrapolation of results to thyroid cancer risk. 5) The need for thyroidectomy is unclear after consideration of clinical, imaging, and cytologic features and the informed patient is willing to potentially undertake surveillance.Once per nodule workup for ThyroSeq and Xpression Atlas

Afirma Xpression Atlas CPT 0204U: code deleted effective 6/30/2024.

ThyroSeq CRC (CPT 0287U)

ThyroSeq Cancer Risk Classifier (CRC) may be considered medically necessary when used to guide surgical planning in patients with indeterminate/suspicious cytology:

ThyroSeq CRC criteria: Use in thyroid nodules meeting Bethesda diagnostic category III, IV, or V to help 'rule in' malignancy and guide planning for initial resection rather than a two‑stage surgical approach.

Applied to FNA specimens with indeterminate or suspicious cytologic findings; ThyroSeq CRC is an NGS analysis of 112 genes.

Indeterminate cytology and surgical planning

Covered when testing is used to clarify indeterminate FNA cytology or to inform surgical planning/recurrence risk

Indications for molecular testing: Molecular testing (NGS panels, gene expression classifiers, microRNA assays) is indicated for thyroid nodules with indeterminate cytology (eg, atypia of undetermined significance, follicular lesion of undetermined significance, follicular neoplasm, suspicious for follicular neoplasm, or suspicious for malignancy) and for using classifier results to inform extent of surgery or recurrence risk assessment.

Supported by descriptions of ThyroSeq, ThyGenX/ThyraMIR algorithmic testing, and Afirma malignancy classifiers to inform preoperative planning.

Commercial self-funded employer groups may have contract-specific exclusions for expanded biomarker or genetic testing. For those members, the plan’s benefit booklet and the member’s subscriber or employer agreement govern coverage. Providers should confirm plan-level benefits and exclusions before ordering molecular thyroid testing to determine whether the test is a covered benefit, requires prior authorization, or is expressly excluded from coverage.

Some gene expression profiling assays described in the literature remain investigational and have not been widely validated or adopted commercially. These investigational profiles (for example, reports cited in research settings) are not addressed in this policy and are not considered medically necessary for routine clinical use.

If a service is determined to be not medically necessary or is a non-covered benefit under the member’s plan, the service may be denied and the member could be financially responsible unless prior written agreement for member liability was obtained. Providers should verify member-specific benefits and obtain any required member agreements before proceeding.

Prior authorization is required for Medicare Advantage plans and is recommended for Commercial products. Unlisted genetic testing CPT codes and some molecular pathology procedures (eg, CPT 81479) require authorization to determine the specific service rendered and whether it meets coverage criteria. Laboratories are not permitted to obtain prior authorization on behalf of the ordering physician; only the ordering physician may initiate and participate in the authorization process.

Services provided without required prior authorization or that do not meet the policy’s medical necessity criteria may be determined to be not medically necessary and denied. Additionally, medically necessary services that are excluded by a member’s contract may not be covered. Providers must document clinical justification, follow authorization procedures, and confirm plan benefits to avoid denials and potential member liability.

Codes and Billing

Covered CPT Codes / Named assaysCPTCovered

81479	Afirma BRAF / Afirma MTC / RosettaGX Reveal (listed as CPT 81479 in policy)
81546	Afirma Genomic Sequencing Classifier (GSC)
0204U	Afirma Xpression Atlas (Code Deleted Effective 6/30/2024)
0245U	ThyGeNEXT
0026U	ThyroSeq
0018U	ThyraMIR
0287U	ThyroSeq Cancer Risk Classifier (CRC)

Unlisted genetic testing codesCPT

unlisted/genetic

Unlisted CPT codes for genetic testing when no specific CPT exists; authorization required to determine service rendered and coverage

Covered PLA/Codes (examples)mixedCovered

0245U	Oncology (thyroid), mutation analysis of 10 genes and 37 RNA fusions and expression of 4 mRNA markers, next-generation sequencing, fine needle aspirate (ThyGeNEXT)
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) (Afirma GSC)

Covered PLA/Codes (additional)mixedCovered

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 (ThyroSeq)
0287U	Oncology (thyroid), DNA and mRNA, next generation sequencing analysis of 112 genes, fine needle aspirate or FFPE tissue, algorithmic prediction of cancer recurrence reported as categorical risk (ThyroSeq CRC)
0204U	Oncology (thyroid), mRNA, gene expression analysis of 593 genes for sequence variants and rearrangements, utilizing fine needle aspirate, reported as detected or not detected (Afirma Xpression Atlas) (Code Deleted Effective 6/30/2024)

Unlisted molecular pathologyCPT

81479

Unlisted molecular pathology procedure — requires authorization for Medicare Advantage and Commercial Products when used for tests not having a specific CPT/PLA code

Thyroid nodule testing frequency — constraint

Frequency constraintThyroSeq (CPT 0026U) and Afirma Xpression Atlas (CPT 0204U) testing may be performed once per nodule workup

Applies toThyroSeq and Afirma Xpression Atlas as specified in policy language

Condition for repeat testingNot indicated more than once for the same nodule workup per policy statement

Provider Requirements, Authorization and Billing Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products. Authorization is required to determine if the ordered molecular test is a covered service and clinically appropriate. The ordering physician (not the laboratory or a laboratory representative) must request and obtain prior authorization. Services provided by a laboratory without required authorization will be denied and the financial liability will fall to the participating laboratory; such services may not be billed to the member.

Prior authorization required for Medicare Advantage; recommended for Commercial
Unlisted molecular pathology CPT 81479 requires authorization when no specific PLA/CPT exists
Ordering physician must submit authorization; laboratories may not obtain authorization or participate on behalf of the ordering physician
Unauthorized laboratory services will be denied and may not be billed to the member

Documentation Required

Authorization and Test-Code Match

Background and Scope

Thyroid nodules are common and most are benign. Fine needle aspiration (FNA) cytology is the primary diagnostic tool used to evaluate nodules, but roughly 20–30% of FNA results are indeterminate (eg, Bethesda III–V). Molecular and genomic assays — including next‑generation sequencing panels, gene expression classifiers, and microRNA‑based tests — have been developed to improve diagnostic accuracy for indeterminate cytology and to help guide the need and extent of surgery or recurrence risk assessment.

Terminology and Definitions

Bethesda III definition — AUS/FLUS

TermBethesda category III (AUS/FLUS): atypia/follicular lesion of undetermined significance

ContextIndeterminate cytologic finding used to select nodules for molecular testing

Policy useListed as an eligible indeterminate cytology category for Afirma, ThyraMIR/ThyGeNEXT, and ThyroSeq testing

Bethesda IV definition — follicular neoplasm / suspicious for follicular neoplasm

TermBethesda category IV: follicular neoplasm / suspicious for follicular neoplasm (FN/SFN)

Policy relevanceSpecified as an indeterminate cytology category indicating consideration for ThyroSeq or Xpression Atlas testing

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNeedle Aspiration of the Thyroid — molecular and genomic testing adjuncts

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateSep 20, 2023

SourceLink

On This Page

Authorization must document that the ordered molecular test matches a listed test/code and meets the policy's clinical criteria. When an ordered test corresponds to a specific PLA or CPT code listed in the Coding section, submit that code and supporting clinical documentation. For tests without a specific code, submit 81479 with documentation supporting the medical necessity and description of the service rendered.

Match ordered test to listed PLA/CPT code when available (see Coding section: 0245U, 81546, 0026U, 0287U, 0204U (deleted 6/30/2024), etc.)
Use 81479 Unlisted molecular pathology procedure only when no specific CPT/PLA exists — prior authorization required
Provide clinical documentation linking test to policy medical criteria (e.g., indeterminate FNA, Bethesda category, imaging and clinical findings)

Note

Algorithmic/Reflex Testing Sequences

Reflex or algorithmic testing sequences are permissible when consistent with the policy's clinical strategy (for example: ThyGenX followed by ThyraMIR as a reflex when ThyGenX is negative; Afirma GSC with reflex Afirma BRAF/MTC where applicable). Document the intended testing sequence and clinical rationale in the authorization request.

Example reflex strategies: ThyGenX -> ThyraMIR; Afirma GSC -> Afirma BRAF or Afirma MTC
Authorization should note planned reflex/algorithmic sequence and criteria that trigger reflex testing

Documentation Required

Authorization and Documentation Requirements

Authorization and documentation must be completed by the ordering clinician. Include relevant clinical information (FNA cytology result, Bethesda category, ultrasound and clinical features, local institutional malignancy rates if used, and whether surgery remains unclear) to support medical necessity. Institutional sample handling or chain-of-custody notes should be provided when relevant.

Ordering physician must supply clinical documentation to support medical necessity
Include FNA cytology (AUS, FN, SFN, Bethesda category), imaging findings, and rationale for testing
Document institutional malignancy rates if used to interpret results

Note

Member Benefits and Eligibility

Member-specific benefits and eligibility are determined by the subscriber certificate or employer agreement and may supersede policy provisions. Verify member benefits and prior authorization requirements by contacting the provider call center prior to testing.

Contact provider call center for member-specific benefits and eligibility
Benefits/coverage determined by member's subscriber agreement or employer agreement

Denial Risk

Unauthorized Laboratory Billing Risk

If a laboratory or any party supports or performs portions of the authorization process on behalf of the ordering physician, BCBSRI may consider this a policy violation and take severe action up to termination from the BCBSRI provider network.

Laboratories must not obtain or participate in authorization on behalf of ordering physicians
Violations may result in network termination or other severe actions

Billing Rule

Charge and Billing Limitations

Services determined not medically necessary or not covered may not be charged to the member unless the member was informed in advance and agreed in writing to pay out-of-pocket. Providers should refer to their participation agreements for applicable provisions.

Do not charge members for services determined not medically necessary unless there is documented prior written member agreement
Refer to provider participation agreements for billing rules

Example wording in policyPresence of indeterminate thyroid FNA cytopathology described as follicular neoplasm (FN) or suspicious for a follicular neoplasm (SFN; Bethesda category IV)

Bethesda V definition — suspicious for malignancy

TermBethesda category V: suspicious for malignancy

Policy relevanceIncluded among cytologic categories (III–V) for which molecular testing or ThyroSeq CRC may be applied to inform surgical planning

Clinical implicationHigher pretest probability of malignancy prompting consideration of molecular classifier use

SNV — single nucleotide variant definition and examples

DefinitionSingle nucleotide variant (SNV): a point mutation in a single nucleotide of DNA

Common examplesBRAF and RAS SNVs (frequently seen in papillary and follicular thyroid carcinomas)

Detection methodsCan be detected by Sanger sequencing, pyrosequencing, real-time PCR, or NGS panel testing

Gene expression profiling / GSC — definition and example (Afirma GEC -> GSC)

DefinitionGene expression profiling / Genomic Sequencing Classifier (GSC): analysis of mRNA expression levels across many genes to classify nodules as benign or suspicious

ExampleAfirma GEC migrated to Afirma GSC (now evaluates ~10,196 genes with core gene set) used to report categorical results (eg, benign or suspicious)

Use caseIntended for thyroid nodules with indeterminate cytology to help identify low-risk nodules

Algorithmic testing — definition and example of sequential testing strategies

DefinitionAlgorithmic testing: use of two or more tests in a prespecified sequence where subsequent testing depends on earlier results

ExampleThyGenX followed by ThyraMIR — a positive ThyGenX 'rules in' malignancy; a negative ThyGenX reflexes to ThyraMIR to 'rule out' disease

Clinical purposeSequential strategies allow initial 'rule in' testing and reflex 'rule out' testing to guide surgical decision-making and avoid unnecessary surgery

Molecular diagnostic tests for thyroid nodules — definition and examples (ThyroSeq, genomic classifiers, miRNA/mRNA/DNA assays)

DefinitionMolecular diagnostic tests for thyroid nodules: assays that analyze DNA, RNA (mRNA/miRNA), and gene panels or classifiers to detect variants, rearrangements, and expression patterns

ExamplesThyroSeq (NGS panel of 112 genes; CPT 0026U), multigene genomic classifiers (eg, Afirma GSC; CPT 81546), and miRNA/mRNA/DNA assays such as ThyraMIR and ThyGeNEXT

PurposeUsed for indeterminate FNA cytology to stratify cancer risk and guide extent of surgery or surveillance