CurrentHealth-New-EnglandPolicy N/A

Genetic and molecular testing codes requiring management

List of laboratory genetic and molecular CPT codes under management by Health New England (administered by eviCore) and how each code is managed for different benefit types; primarily indicates prior authorization requirements for many genetic tests.

Policy Summary

PayerHealth-New-England

PolicyGenetic and molecular testing codes requiring management

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateLab Program Effective 10/13/2017

Next Review DateN/A

Key ActionObtain prior authorization before performing or billing any listed genetic or molecular test code.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~200+genetic/molecular CPT codes listed or referenced

~60+codes requiring prior authorization (CPT/PLA/U)

BRCA, Lynch, CFTR, CYPtypes of genes/panels included

2012–2025AMA effective date range shown

Coverage and Management Overview

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Coverage conditioned on prior authorization

Covered when prior authorization is obtained for the listed test codes

Authorization requirement: Prior authorization is required for the listed PLA/HCPCS codes before the test is performed or billed.

No patient-specific clinical criteria included in these chunks.

Prior authorization required

Coverage stance for listed codes

Prior authorization requirement: All listed PLA/T codes require prior authorization as indicated in the lab program entries.

Each code entry states 'Requires Prior Authorization.'

This excerpt is an administrative code-management listing for Health New England (administered by eviCore). It enumerates genetic and molecular test codes and how each code is managed, but it does not contain patient-level clinical coverage rules or explicit medical necessity criteria. The listing indicates management actions (for example, statements that codes "Requires Prior Authorization") at the code line level rather than describing clinical eligibility or detailed indications for coverage.

Within the provided excerpt there are no explicit medical necessity criteria or exclusions described; code entries are presented with test descriptions and administrative management statuses (such as "Requires Prior Authorization") rather than clinical rules or patient eligibility requirements.

Entries in this section are primarily code descriptions (CPT/PLA/U/S/G codes) with short clinical descriptors or named gene lists and an administrative management designation. The document shows test purpose or example indications as part of the code description (for example, hereditary panels, oncology panels, or named gene analyses) while simultaneously indicating management status for each code.

No explicit clinical coverage criteria, medical necessity logic, or patient-specific rules are stated in this excerpt; the code entries and molecular pathology procedure levels are listed with management annotations rather than conditions for coverage.

This excerpt does not explicitly state exclusions for specific tests or indications. Instead, the listed PLA/HCPCS codes in this section are annotated with an administrative status of Requires Prior Authorization without accompanying not-covered statements.

The document maps specific tests and proprietary laboratory (PLA/U) codes to administrative management actions. These mappings show which tests require prior authorization for various payer settings, but they do not provide clinical rules or stepwise decision criteria for ordering or approving tests.

Many entries in the excerpt explicitly show the management status as Requires Prior Authorization, and where termination or additional notes are provided they are shown as "None". The listing therefore indicates administrative prerequisites (authorization) but not termination-based exclusions or clinical discontinuation rules.

Across the CPT and PLA/U listings in these chunks the pervasive management stance is that the codes listed are subject to utilization management. For the codes shown the document uniformly indicates Requires Prior Authorization prior to testing or billing.

In the code-level listings provided, the only management status recorded for the codes shown is Requires Prior Authorization. The excerpt does not include alternative management statuses (for example, explicit allowance without authorization) for those lines.

There are no statements in these chunks designating any tests as Not Medically Necessary. The content focuses on code descriptions and the administrative requirement that many codes Require Prior Authorization.

This section does not include explicit "not medically necessary" determinations for codes or indications. Instead, entries are presented with administrative management notes such as Requires Prior Authorization and without 'not medically necessary' language in the provided excerpt.

What Providers Must Do

Prior Authorization

Codes Requiring Prior Authorization

The codes listed in the payer's lab program are managed and require prior authorization before performing or billing the test. Providers must obtain and document prior authorization for each specific CPT, PLA, HCPCS, S-, U-, and other proprietary code listed below to avoid claim denial.

Many single-gene and multi-gene CPT codes (examples: 81162–81167, 81201–81203, 81304, 81306–81308) are managed as "Requires Prior Authorization" across Commercial, Hospital, Independent Lab Medicaid, and Medicare benefit types.
Multi-gene panel CPT codes specify required panel composition or minimum gene counts (examples: 81410, 81411, 81412, 81442–81451, 81455–81456, 81445, 81448–81450). Panel descriptions include required genes or minimum gene counts that must be documented when requesting authorization.
PLA/U/HCPCS/proprietary codes (examples: 0006M, 0135U–0158U, 0268U–0271U, 0388U–0395U, 0478U–0489U, 0543U–0569U, 0582U–0597U, 0794T, G0327, G9143, S3800–S3870, and many others listed in the Lab Program) explicitly require prior authorization across payer settings.
All listed U-codes and PLA codes (for example 0135U through 0586U and beyond as shown) are managed as "Requires Prior Authorization"; obtain PA prior to test performance or submission.
Failure to obtain prior authorization for any managed code may result in claim denial or recoupment.

Documentation Required

Documentation and Coding Details

When requesting prior authorization, providers must submit documentation that ties the requested code to the clinical indication and to any code-level panel composition requirements. Authorization approval should be documented in the patient's record and retained with the claim.

Include the exact CPT/PLA/U/HCPCS code(s) and code descriptions when requesting PA (example: CPT 81445 — "Solid organ neoplasm, genomic sequence analysis panel, 5-50 genes").
For multi-gene panels, document the specific genes tested or that the panel meets the minimum gene count and includes the required genes listed in the policy (e.g., 81410 must include at least the named 9 genes; 81443 requires sequencing of at least 15 genes).
Provide clinical indication, relevant family history or prior test results, specimen type (when specified in the program), and any pertinent laboratory/pathology reports.
Record AMA effective dates or other test-specific dates when provided in the lab program entry to ensure correct code/version is authorized.
Where PLA or proprietary codes are used, include the laboratory's test name and cross-reference to the PLA/U code being requested.

Documentation Required

Authorization Documentation Requirements

Authorization requests for PLA/HCPCS/U codes should include the same level of documentation as CPT requests; when a code entry lists specimen types, effective dates, or algorithm/reporting details, include those details in the request to avoid processing delays.

Supply specimen type if listed (examples in lab program: blood, plasma, buccal swab, urine, FFPE tissue, amniotic fluid, chorionic villus sample).
If the code description references algorithmic reporting or specific analytic techniques (e.g., NGS, qPCR, digital PCR, methylation analysis), document that the ordered test matches the described method.
For tests listed as "List separately in addition to code for primary procedure" (many PLA/U entries), indicate whether the code is adjunctive and include the primary procedure code as applicable.
When a code entry includes age, clinical subgroup, or disease-specific language (eg, oncology, rare disease, transplant monitoring), document how the member meets those clinical criteria.

Documentation Required

Documentation Expectations and Provider Actions

Providers must preserve prior authorization approvals and include them with claims and in the patient record. The payer may request supporting documentation during review; include gene lists, test method, clinical rationale, and any prior related testing.

Document and retain PA approval number and date in the medical record and on claim submissions when allowed.
Attach supporting clinical notes, pathology/laboratory reports, family history, and prior genetic test results that justify the requested test.
If a panel is being used to evaluate a specific suspected syndrome, document how the panel composition aligns with the syndrome (e.g., panels listing required genes such as FBN1, TGFBR1, TGFBR2 for aortic dysfunction panels).
For assays reported with algorithmic risk scores or multi-analyte signatures, include indication for testing and how results will influence patient management.

Example Clinical Indications Present in Code Descriptions

Examples (CPT descriptions)

Examples from CPT code descriptions; no indication-specific coverage rules are provided in this document segment

EXAMPLES: Hereditary breast and ovarian cancer (BRCA1, BRCA2).

Taken from single-gene BRCA CPT code descriptions.

EXAMPLES: Familial adenomatous polyposis (APC).

Listed in APC gene CPT code descriptions.

EXAMPLES: Cystic fibrosis (CFTR).

Included among example genes in multi-gene listings.

EXAMPLES: Lynch syndrome (MLH1, MSH2, MSH6, PMS2).

Referenced in MMR/Lynch CPT code entries.

EXAMPLES: Pharmacogenomic testing (CYP genes such as CYP2C19, CYP2D6).

Referenced in pharmacogenomics CPT code descriptions.

Hereditary and specialty panels (examples)

Panel examples tied to hereditary or specialty conditions (examples from panel CPT descriptions)

EXAMPLES: Aortic dysfunction/dilation panels (eg, FBN1, TGFBR1, TGFBR2, COL3A1, MYH11, ACTA2).>= 9 genes for 81410

Panel composition and minimum gene count specified in CPT descriptor.

EXAMPLES: Ashkenazi Jewish–associated disorders (eg, ASPA, BLM, CFTR, FANCC, GBA, HEXA).>= 9 genes for 81412

Listed as example for the Ashkenazi panel.

EXAMPLES: Cardiac ion channelopathies panels (eg, KCNH2, KCNQ1).>= 10 genes for 81413

CPT entries include minimum gene counts and duplication/deletion requirements.

Severe inherited conditions (examples)

Examples of severe inherited conditions associated with certain panel codes

EXAMPLES: Severe inherited conditions such as cystic fibrosis, beta hemoglobinopathies, phenylketonuria, galactosemia, and Ashkenazi-associated disorders.Panel 81443 requires >= 15 genes

81443 descriptor lists example conditions and minimum gene count.

Oncology and tumor profiling (examples)

Oncology and tumor-profiling examples drawn from multi-gene and cfDNA CPT descriptions

EXAMPLES: Solid organ neoplasm panels for somatic variant, copy number, rearrangement, MSI and TMB analysis (eg, 81445, 81455 family, PLA U-codes for large oncology panels).varies by code (eg, 5-50 genes for 81445; 51+ for 81455)

CPT descriptors specify gene-count ranges and analytes.

EXAMPLES: Hematolymphoid neoplasm panels (eg, 81450/81451; large U-code hematolymphoid panels like 0592U).5-50 genes for 81450; 417 genes for 0592U

CPT and U-code descriptors include panel sizes and intended tumor types.

EXAMPLES: Cell-free DNA (cfDNA) assays for tumor profiling and MRD (eg, 81462, 81463, 0326U, 0585U).varies by code (example: 521 genes for 0585U)

Mitochondrial disorders

Mitochondrial disorder testing examples

EXAMPLES: Whole mitochondrial genome sequencing with heteroplasmy detection and large-deletion analysis (eg, 81460, 81465).Whole mitochondrial genome sequencing required per code descriptors

CPT descriptors explicitly require full mitochondrial genome sequencing and heteroplasmy detection.

Hereditary cancer syndromes

Hereditary cancer syndrome panel examples (gene content noted in descriptors)

EXAMPLES: Hereditary colon cancer panels (eg, Lynch and related panels such as 0101U, 0138U).gene counts vary (eg, 15 genes for some U-codes)

U-code and CPT descriptors list gene content and deletion/duplication where applicable.

EXAMPLES: Hereditary breast/ovarian/pan-cancer panels (eg, BRCA1/2, ATM, PALB2, 0129U, 0131U).varies by code (eg, 5+ genes for some CPT panels; 17 genes for 0102U)

Code entries enumerate included genes.

Oncology tumor profiling purposes

Oncology tumor profiling purposes indicated in code descriptors

EXAMPLES: Diagnostic, prognostic, and predictive tumor assays including expression assays, methylation arrays, cfDNA panels, and lymphoma classification assays.

Multiple CPT and PLA/U-code entries describe these assay types for oncology indications.

Specialty-specific indications (examples)

Specialty-specific indications noted in code descriptions; these are examples and not prescriptive coverage rules

EXAMPLES: Neurology panels (inherited ataxias, muscular dystrophy), hematology panels (aHUS, coagulation disorders), transplant monitoring (dd-cfDNA), prenatal/fetal assays, pharmacogenomics, reproductive medicine panels.

Each U-code/CPT descriptor includes short specialty indication text.

Multiple indications across codes

Multiple clinical indications listed across U-code and PLA entries (examples by specialty)

EXAMPLES: Hematology disorders (eg, inherited thrombocytopenia, aHUS), oncology across tumor types, neurology, psychiatry, pain management, transplant monitoring, fetal testing, pharmacogenomics.

U-code listings enumerate these clinical contexts but do not define per-indication coverage criteria.

Clinical indications per U-code (examples)

U-code entries provide concise clinical indications per test; these are examples only

EXAMPLES: Oncology (solid tumor), cardiology (congenital heart disease testing), obstetrics (expanded carrier screening), psychiatry (pharmacogenomics), rare disease rapid WGS, carrier screening.

Each U-code line includes a short indication field; no per-indication medical necessity rules are provided.

Clinical indications tied to PLA codes

PLA code examples tied to varied clinical contexts (examples from PLA descriptors)

EXAMPLES: PLA entries describe uses such as transplant donor-derived cfDNA monitoring, noninvasive fetal antigen testing, preimplantation genetic assessment, rare disease rapid WGS, and pan-solid tumor profiling.

PLA descriptors list intended clinical uses but do not include patient eligibility criteria.

Disease- or condition-specific testing (examples)

Disease- or condition-specific testing examples drawn from S-/PLA- code descriptions

EXAMPLES: Examples include oncology panels, ALS testing, retinoblastoma, Von Hippel-Lindau (VHL), hypertrophic cardiomyopathy (HCM), developmental delay/ASD/ID microarray or WGS-based testing.

S- and PLA-code descriptors include these disease-specific examples.

Not Covered Tests and Exclusions

The excerpt does not explicitly list tests or clinical indications as 'not covered.' Instead, the majority of codes shown—including single-gene, multi-gene, and proprietary laboratory codes—are annotated with Requires Prior Authorization, indicating that prior authorization is required before the test will be approved for coverage.

No explicit 'not covered' tests are listed in these chunks. The entries consistently mark codes as administrative-managed, with the common action being Requires Prior Authorization rather than an explicit noncoverage statement.

The provided excerpts do not identify specific tests as non-covered. Instead, PLA/HCPCS and CPT code entries are shown with management annotations indicating that providers should obtain prior authorization before proceeding.

There are no explicit non-coverage determinations in this excerpt. The U-code and PLA listings are shown with administrative directives; many U-codes in these sections list Requires Prior Authorization rather than being labeled 'not covered.'

The U-code and proprietary code segments in these chunks do not include 'not covered' labels. For the codes shown the document specifies administrative management—chiefly that the tests Require Prior Authorization—and does not list explicit non-covered items in the excerpt.

No explicit 'not covered' tests are present in these chunks; instead the code entries describe test purposes and specify that the codes listed Require Prior Authorization. The excerpt therefore does not provide a list of tests denied as not medically necessary.

This segment does not present tests as 'not covered.' The PLA/CPT-PLA and U-code entries included are managed under the Lab Program and are annotated as Requires Prior Authorization, indicating an administrative requirement prior to coverage rather than explicit denial.

Terminology and Code Definitions

Requires Prior Authorization — definition

Prior authorization definitionRequires Prior Authorization indicates an authorization must be obtained before the test will be approved for coverage for the listed benefit types

Action when missing authorizationFailure to obtain prior authorization may trigger claim denial or management per the lab program entries

Applies across benefit typesThis requirement is applied to Commercial, Hospital, Independent Lab Medicaid, and Medicare as indicated per code lines

Molecular pathology procedure Levels

Molecular pathology procedure levels (81400–81408)Codes 81400–81408 correspond to molecular pathology procedure Levels describing scope/complexity (examples: Level 6 = analysis of 6–10 exons; Level 8 = analysis of 26–50 exons; Level 9 = analysis of >50 exons)

Usage contextThese levels are used for single-gene or multi-exon analyses and reflect complexity of testing

ManagementEntries for 81400–81408 in the listing are managed and marked as 'Requires Prior Authorization'

Genomic sequence analysis panel — codes and expectations

Genomic sequence analysis panel codes (81410–81450)CPT codes 81410–81450 designate disease-specific genomic sequence analysis panels and often include minimum gene-count requirements and named genes to be included (examples: 81410, 81430, 81440)

Panel composition expectationListings specify which genes or minimum gene counts must be present for the code (document panel composition when requesting authorization)

Management statusThese panel codes are managed and listed as 'Requires Prior Authorization' in the lab program

Genomic sequence analysis panel — concise

Genomic sequence analysis panel (short)Genomic sequence analysis panel: a multi-gene sequencing assay targeting genes associated with a specific inherited condition or phenotype

Includes DNA/RNA modalitiesPanels may interrogate DNA, RNA, or combined DNA/RNA depending on the code description

Authorization requirementMost genomic panel codes in this range require prior authorization per the lab program

PLA/U-code — definition

PLA / U-code definitionPLA/U-codes are proprietary laboratory analysis HCPCS codes (eg, 00XXU/00XXM) representing specific molecular/genetic tests with descriptions of methodology, genes/panels, specimen, and reported algorithmic results

Common contentPLA entries typically include gene/panel size, specimen type (FFPE, plasma, blood, urine), analytic method (NGS, RT-PCR, methylation), and algorithmic outputs

ManagementListed PLA/U-codes in the document require prior authorization as indicated per code line

mRNA sequence analysis / gene expression profiling

mRNA/gene expression profiling definitionAssays that sequence or quantify mRNA transcripts or gene expression, often reported with algorithmic subtype or risk scores (examples in listing: 0153U, 0586U, 0011M)

Typical outputsReported outputs include risk scores, recurrence scores, subtype classification, or categorical probabilities based on algorithmic interpretation

Specimen typesCommon specimen types include FFPE tissue, urine, blood, or fine-needle aspirate depending on the test code

Whole exome/genome and mitochondrial sequencing

Whole exome/genome & mitochondrial sequencingComprehensive sequencing (WES/WGS) and mitochondrial genome sequencing detect small sequence changes, deletions/duplications, STR expansions, and heteroplasmy; codes include 0212U, 0214U, 81460/81465

Clinical contextsUsed for rare constitutional/heritable disorders, rapid diagnostic sequencing, and mitochondrial disease evaluation

ManagementThese comprehensive sequencing codes require prior authorization per the lab program entries

Algorithmic / interpretive report — tests

Algorithmic/interpretive reportsMany assays include algorithmic interpretation reported as scores, probabilities, or categorical risk results (examples: 0153U triple negative subtype, 0245U thyroid recurrence risk, 0565U cancer signal detection)

Examples of algorithmsAlgorithms quantify immunotherapy response, recurrence risk, tumor fraction, or tissue subtype depending on the code

DocumentationAlgorithmic outputs are listed in code descriptions and should be included in authorization documentation where applicable

NGS — definition and context

NGS definitionNext-generation sequencing (NGS) is the primary method for many listed panels and U-codes for detecting sequence variants, copy number alterations, rearrangements, and fusions

NGS application examplesNGS is used for tumor panels (e.g., 0037U 324 genes, 0391U 437 genes, 0538U 600 genes) and cfDNA assays (e.g., 0326U, 0585U)

Reporting outputsNGS-based tests report SNVs, indels, CNAs, fusions, TMB, and MSI as specified by code descriptions

cfDNA / ctDNA — definition

cfDNA / ctDNA definitionCell-free DNA assays analyze circulating tumor DNA (ctDNA) from plasma for sequence variants, copy number changes, rearrangements, and MSI — examples include 0585U (521-gene cfDNA) and 0326U (≥83-gene cfDNA)

Use casesUsed for tumor profiling, MRD detection, and noninvasive testing depending on code (e.g., MRD codes 0306U/0307U, cfDNA tumor panels 0326U/0585U)

ManagementcfDNA/ctDNA assays listed require prior authorization in the lab program entries

Actionable variant — definition

Actionable variant definitionAn actionable variant is a reported genomic alteration identified as having potential clinical therapy or management implications (as referenced in multiple oncology panel descriptions, e.g., 0391U, 0538U)

Reported contextActionability is used in test reports to guide therapy selection, immunotherapy response scoring, or clinical trial consideration

Panel examplesMany tumor panels explicitly report actionable variants (examples: 0391U 437 genes; 0538U 600 genes)

Donor-derived cell-free DNA (dd-cfDNA)

Donor-derived cfDNA (dd-cfDNA)dd-cfDNA is the percentage of cell-free DNA in plasma attributed to donor organ and is reported to assess graft rejection (example code: 0540U quantifies dd-cfDNA)

Specimen and useAssays use plasma and report percent dd-cfDNA to inform transplant rejection probability

Managementdd-cfDNA assays are listed as 'Requires Prior Authorization' in the lab program

cfDNA and mRNA gene expression profiling examples

cfDNA panel example (0585U)0585U is a plasma cfDNA targeted genomic sequence panel of 521 genes reporting sequence variants, CNAs, rearrangements, and MSI (Requires Prior Authorization)

mRNA profiling example (0586U)0586U is an mRNA gene expression profiling assay of 216 genes (204 targeted + 12 housekeeping) from FFPE tissue (Requires Prior Authorization)

Hematolymphoid panel example (0592U)0592U lists a 417‑gene hematolymphoid targeted DNA panel including fusions/translocations (Requires Prior Authorization)

0094U	(listed laboratory specific PLA/U-code)
0111U	(listed laboratory specific PLA/U-code)
0113U	(listed laboratory specific PLA/U-code)
0114U	(listed laboratory specific PLA/U-code)
0118U	(listed laboratory specific PLA/U-code)
0120U	(listed laboratory specific PLA/U-code)
0133U	(listed laboratory specific PLA/U-code)
0134U	(listed laboratory specific PLA/U-code)
0228U	(listed laboratory specific PLA/U-code)
0229U	(listed laboratory specific PLA/U-code)

OpenPayer

Genetic and molecular testing codes requiring management

Coverage and Management Overview

CPT, PLA, and U-code Listings

What Providers Must Do

Example Clinical Indications Present in Code Descriptions

Patient and Test Eligibility Notes

Not Covered Tests and Exclusions

Background and Scope

Terminology and Code Definitions

Policy Dates and Revisions