ModifiedCommunity Health Plan WashingtonPolicy N/A

Concert genetic testing: multisystem inherited disorders, intellectual disability, and developmental delay

Defines coding implications and examples of genetic tests used for diagnosing multisystem inherited disorders, intellectual disability, developmental delay, and related conditions; intended for providers submitting claims and coding genetic testing services.

Policy Summary

PayerCommunity Health Plan Washington

PolicyConcert genetic testing: multisystem inherited disorders, intellectual disability, and developmental delay

Policy CodePolicy N/A

Change TypeMultiple revised and added condition-specific criteriaconsolidation of familial-variant criteria to a general policy

Effective DateN/A

Next Review DateNov 1, 2025

Key ActionReference the most up-to-date professional coding guidance before submitting claims for reimbursement.

SourceLink

POLICY UPDATE CHANGES

NF1 sequencing/deletion-duplication criteria were expanded and renamed from Legius Syndrome SPRED1 to NF1 with added specific clinical features that meet testing criteria.

NF2 testing criteria were updated to add GeneReviews guidance and new adult and child-specific clinical criteria (e.g., bilateral vestibular schwannomas, unilateral vestibular plus other tumors, schwannoma at any location in children).

TSC genetic testing guidance emphasized that identification of a pathogenic variant in TSC1 or TSC2 is sufficient for diagnosis and recommended testing for suspected cases or for genetic counseling.

Multiple sections were reworded and criteria adjusted across the policy (e.g., Chromosomal Microarray, Angelman/Prader-Willi, Beckwith-Wiedemann/Russell-Silver, Noonan/RASopathies, PIK3CA, and others) including removal or relocation of some conditions to other policies.

Updated multiple condition-specific test criteria (e.g., CHD7, NF1, NF2, Noonan/RASopathies, Fanconi anemia, PIK3CA, CFTR) and removed/added specific items within those sections.

Added criteria to allow coverage of diagnostic CFTR testing not related to sweat testing based on CF consensus statement.

Removed minimum gene lists for Noonan Spectrum Disorders/RASopathies and Fanconi Anemia Multigene Panels due to limited rationale for inclusion.

Moved criteria for Known Familial Variant Analysis to a separate policy 'Genetic Testing: General Approach to Genetic and Molecular Testing'.

Removed deletion/duplication testing from PIK3CA criteria because such mutations are uncommon in the disorder.

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multipleexample CPT codes referenced

multiplesyndromes with dedicated criteria

investigationalpanel testing restricted

familial-variant movedconsolidated to separate policy

Semi-annualreview cadence

Medical Necessity and Coverage Criteria

Medical Necessity and Coverage Criteria for selected genetic and genomic tests. Codes shown are illustrative and not exhaustive.

Chromosomal Microarray Analysis (CMA) for Developmental Delay/Intellectual Disability/Autism/Multiple Congenital Anomalies/Short Stature

ANY of the following
- Developmental delay and/or intellectual disability (excluding isolated speech/language delay).
- Autism spectrum disorder (ASD).
- Multiple congenital anomalies not specific to a well-delineated genetic syndrome.
- Short stature (including idiopathic short stature or small for gestational age with persistent short stature).
Chromosomal microarray analysis is considered investigational for all other indications, including isolated speech/language delay, due to low diagnostic yield.
See Background and Rationale and professional society guidance (AAP, ACMG) supporting CMA as a first-tier test for GDD/ID, ASD, multiple congenital anomalies, and certain short stature evaluations.

Beckwith-Wiedemann Syndrome (BWS) / Russell-Silver Syndrome (RSS) testing (11p15 methylation / del/dup, UPD7, CDKN1C)

H19 and KCNQ1OT1 methylation analysis (e.g., 81401), deletion/duplication analysis of 11p15 (e.g., 81479), chromosome 7 uniparental disomy analysis (e.g., 81402), or CDKN1C sequencing and/or deletion/duplication analysis (e.g., 81479) to confirm or establish a diagnosis is considered medically necessary when clinical criteria are met.
Clinical features for BWS include one or more of: macroglossia; abdominal wall defects requiring surgical correction (e.g., omphalocele); embryonal tumors (e.g., Wilms tumor, hepatoblastoma); hemihyperplasia; macrosomia (>90th/97th centile); hyperinsulinemic hypoglycemia; characteristic pathology or visceromegaly; family history suggestive of BWS; ear creases/ear pits; characteristic facies; kidney anomalies; transient hypoglycemia requiring intervention.
Testing for Russell-Silver syndrome (RSS) is considered medically necessary when the member meets at least three Netchine-Harbison Clinical Scoring System (NH-CSS) features such as small for gestational age, postnatal growth failure, relative macrocephaly at birth, frontal bossing, body asymmetry, and feeding difficulties or BMI ≤ -2 SD or requirement for feeding support.
These assays are investigational for other indications.

Diagnostic CFTR Sequencing and Deletion/Duplication Analysis

ANY of the following
- A positive (≥60 mmol/L) or inconclusive (30–59 mmol/L) sweat chloride test.
- A positive newborn screen for cystic fibrosis (e.g., elevated immunoreactive trypsinogen).
- Symptoms suggestive of cystic fibrosis from at least two different organ systems (examples include: chronic sinusitis or nasal polyps; lower respiratory disease such as bronchiectasis or recurrent lower airway infections; gastrointestinal/lumen findings such as meconium ileus or distal intestinal obstruction; pancreatic insufficiency or recurrent pancreatitis; reproductive findings such as male obstructive azoospermia; other findings including hyponatremic dehydration, failure to thrive, digital clubbing).
CFTR sequencing and/or del/dup analysis is considered investigational for all other indications. This diagnostic testing is distinct from carrier screening and should be applied when confirming a suspected clinical diagnosis or following abnormal diagnostic testing per CF guidance.
See policy Background and Rationale for additions permitting coverage not solely reliant on sweat testing per CF consensus statements.

CHD7 Sequencing and/or Deletion/Duplication Analysis for CHARGE Syndrome

ANY of the following
- Coloboma of the iris, retina, choroid, and/or disc.
- Anophthalmos or microphthalmos.
- Choanal atresia or stenosis.
- Cleft palate with or without cleft lip.
- Cranial nerve dysfunction or anomaly (e.g., hyposmia/anosmia, facial palsy, sensorineural hearing loss, difficulty with sucking/swallowing, aspiration, gut motility problems).
- Ear malformations including auricular abnormalities, middle ear/ossicular malformations, or temporal bone abnormalities.

General Coding and Notes

Codes and examples provided in this policy are illustrative and not all-inclusive. Inclusion or exclusion of codes does not guarantee coverage; providers should use current coding guidance when submitting claims.
Refer to Concert Platform for the comprehensive list of registered tests.

Coding Examples and Code Tables

Chromosomal microarray example CPTsCPT

81228	Chromosomal microarray analysis (example listed)
81229	Chromosomal microarray analysis (example listed)
S3870	Microarray related code (example listed)

Autism/ID panel example CPTsCPT

81470	Exome/genomic sequencing - panel/exome example
81471	Exome/genomic sequencing - panel/exome example
81479	Unlisted molecular pathology procedure (used for some panels)

Fragile X example CPTsCPT

81243	FMR1 repeat analysis (Fragile X diagnostic example)
81244	FMR1 methylation testing (Fragile X diagnostic example)

CHARGE syndrome / CHD7 example CPTsCPT

81407	CHD7 sequencing (CHARGE syndrome example)
81479	Unlisted molecular pathology procedure (panel components)

Examples of molecular codes referencedCPT

81408	NF1 sequencing and/or deletion/duplication analysis
81405	Multigene panel sequencing (example codes used for NF2, HHT)
81406	Multigene panel sequencing (paired with 81405)
81479	Unlisted molecular pathology procedure (used in multiple single-gene/panel contexts)

Diagnostic / syndrome-specific codes (covered examples)CPTCovered

81228	Chromosomal microarray analysis, constitutional
81229	Chromosomal microarray analysis, follow-up or related
81222	CFTR sequencing
81223	CFTR deletion/duplication analysis
81224	CFTR intron 9 polyT/TG analysis
81243	FMR1 repeat analysis
81244	FMR1 methylation analysis

Codes referenced for HHT and other panelsCPT

81405	Targeted multigene or exome sequencing panel (used here for some panels)
81406	Another panel sequencing code referenced for multiple tests
81479	Unlisted molecular pathology procedure (used for some sequencing analyses)

NF1 code referenceCPT

81408

NF1 sequencing and/or deletion/duplication analysis

Noonan / RASopathy panel code referenceCPT

81442

Noonan spectrum/RASopathy multigene panel

TSC codesCPT

81407	TSC1/TSC2 sequence and/or deletion/duplication analysis (specific use)
81405	Panel sequencing code referenced for TSC
81406	Panel sequencing code referenced for TSC

Example sequencing code mentionedCPT

81408

Targeted sequencing/analysis code referenced for NF1-related testing

Example exome test codes updated in Policy Reference Table (replacements)CPT

81415	Genomic Unity Exome Analysis - Proband (example test added to PRT)
81416	Genomic Unity Exome Analysis - Comparator (Duo or Trio) (example test added to PRT)

Coding verification reminder

Coding verification reminderProviders must reference the most up-to-date sources of professional coding guidance prior to submission of claims for reimbursement.

Codes informational onlyCPT codes and descriptions included are for informational purposes and inclusion or exclusion does not guarantee coverage.

Claims supportTests, labs, CPT and ICD examples in the document are examples to help navigate claims and are not comprehensive; consult the Concert Platform for registered tests.

CMA indications summarized as key points

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required: HHT Multigene Panel

Providers should obtain prior authorization for HHT multigene panel testing when pursuing testing to establish or confirm a diagnosis of hereditary hemorrhagic telangiectasia (HHT). Medical necessity is expected when the member/enrollee has spontaneous and recurrent epistaxis, or mucocutaneous telangiectases at characteristic sites (lips, oral cavity, fingers, nose), or visceral arteriovenous malformations (pulmonary, cerebral, spinal, gastrointestinal, or pancreatic). The panel must include, at minimum, ACVRL1 and ENG. HHT multigene panels submitted without documentation of these clinical features are likely to be denied as not medically necessary.

Affected codes: 81405, 81406, 81479
Minimum genes expected: ACVRL1, ENG
Required clinical documentation: epistaxis, characteristic mucocutaneous telangiectases, or visceral AVM
Panels without supporting clinical features may be denied

Prior Authorization

Prior Authorization Required: PIK3CA and TSC Testing

Prior authorization is required for PIK3CA and TSC testing when used to establish or confirm the respective diagnoses and when clinical criteria are met. For PIK3CA sequencing (81479), medical necessity is expected for suspected PIK3CA‑Related Segmental Overgrowth when the member exhibits relevant brain imaging findings (e.g., hemimegalencephaly, focal cortical dysplasia, dysplastic megalencephaly) or characteristic early‑onset overgrowth/vascular/cutaneous features; note that mosaic variants are common and testing of multiple tissue types (blood, skin, saliva, affected tissue) may be necessary. For TSC1/TSC2 sequencing and/or deletion/duplication (81405, 81406, 81407), prior authorization should accompany documentation of at least one major feature of tuberous sclerosis complex (e.g., three or more angiofibromas or fibrous cephalic plaque, lymphatic or vascular malformations, characteristic cutaneous findings, kidney malformations, or benign tumors as described in the policy). Tests submitted without supporting clinical findings or without consideration of mosaicism (for PIK3CA) may be denied as not medically necessary.

Definitions and Terminology

Genetic testing — general definition for rare diseases

Purpose of genetic testingGenetic testing may be used to establish or confirm a diagnosis in patients with signs/symptoms of a genetic disorder when clinical evaluation and standard tests are non-diagnostic.

Clinical utilityEstablishing a genetic diagnosis may inform management of medical and behavioral problems and reduce further diagnostic workup.

ScopeDocument addresses genetic testing for common, well-described conditions affecting multiple body systems.

Coding implications — CPT codes informational only

CPT codes informationalCurrent Procedural Terminology (CPT) codes referenced in this policy are provided for informational purposes only and do not guarantee coverage.

Provider action

Background, References, and Related Policies

This policy includes multiple editorial and operational updates. Notably, criteria for Known Familial Variant Analysis have been consolidated and moved to the separate policy Genetic Testing: General Approach to Genetic and Molecular Testing to standardize familial‑variant decision‑making across genetic test policies. Several disorder sections were revised or reworded for clarity, and minimum gene lists were removed from some panels where rationale was limited. Examples of these changes include updates to NF1, NF2, Noonan/RASopathies, Fanconi anemia, CFTR, PIK3CA, and other sections. (See policy change notes for specifics.)

Operational edits also updated coding and the Policy Reference Table: two erroneously listed example exome tests (0214U/0215U) were replaced with 81415/81416, and the diagnostic CFTR section was revised to permit coverage for diagnostic CFTR sequencing/deletion‑duplication analysis independent of sweat testing per the CF consensus statement. These changes reflect both consolidation of familial‑variant criteria and clarifications to test naming and coding guidance.

General and syndrome‑specific guidance in the policy aligns with current professional recommendations: chromosomal microarray analysis (CMA) is recommended as a first‑tier diagnostic test for children with global developmental delay/intellectual disability, autism spectrum disorder, or multiple congenital anomalies per the American Academy of Pediatrics and ACMG guidance. CMA is considered investigational for isolated speech/language delay due to low diagnostic yield.

For many named syndromes the policy defers to GeneReviews and relevant society guidance for test selection and diagnostic algorithms. For example, Angelman and Prader‑Willi testing recommendations follow GeneReviews‑described workflows (methylation testing first, followed by deletion/UPD/imprinting center testing or UBE3A sequencing as indicated). The policy also references the AAP/ACMG guidance that supports use of CMA, fragile X testing, and consideration of exome testing in appropriate ASD/ID evaluations, while noting that evidence is insufficient to support routine use of ASD/ID multigene panels.

Document Changes and Review Dates

2024-11-24revised

Diagnostic CFTR criteria were added/renamed to allow coverage not related to sweat testing per Cystic Fibrosis consensus guidance and to distinguish diagnostic testing from carrier screening; supporting background and references were updated.

2024-04-24revised

Multiple sections were edited in a semi-annual review (V2.2024): CHARGE/CHD7, HHT, NF1, NF2, Rett/MECP2 removal, consolidation of Known Familial Variant Analysis into a general genetics policy, and updates to coding/reference tables.

2024-04-24revised

Policy Summary

PayerCommunity Health Plan Washington

PolicyConcert genetic testing: multisystem inherited disorders, intellectual disability, and developmental delay

Policy CodePolicy N/A

Change TypeMultiple revised and added condition-specific criteriaconsolidation of familial-variant criteria to a general policy

Effective DateN/A

Next Review DateNov 1, 2025

Key ActionReference the most up-to-date professional coding guidance before submitting claims for reimbursement.

SourceLink

On This Page

CHD7 sequencing and/or deletion/duplication analysis is considered investigational for all other indications.

Policy stance on ASD/ID panelsAutism spectrum disorder / intellectual disability multigene panels (e.g., 81470, 81471, 81479, 81185, 81236, 81302, 81321, 0156U) are considered investigational.

Examples of panel codesExample CPT codes referenced for ASD/ID panels include 81470, 81471, and 81479.

Implication for claimsUse of these panels for ASD/ID is investigational and may be denied; alternative diagnostic pathways (e.g., CMA) should be considered when indicated.

Diagnostic feature counts examples

NF1 diagnostic count exampleSix or more café-au-lait macules (greater than 5 mm prepubertal; >15 mm postpubertal) is a listed diagnostic feature for NF1.

NF1 clinical feature setOther NF1 features include axillary/inguinal freckling; two or more neurofibromas or one plexiform neurofibroma; optic pathway glioma; two or more Lisch nodules; distinctive osseous lesion; OR a parent meeting diagnostic criteria.

TSC diagnostic thresholdDefinite TSC: 2 major features OR 1 major feature plus 2 minor features; Possible TSC: 1 major OR 2 minor features.

Exome test listing corrections in Policy Reference Table

Exome PRT code correctionReplaced erroneously listed example test codes 0214U and 0215U with 81415 (Genomic Unity Exome Analysis - Proband) and 81416 (Genomic Unity Exome Analysis - Comparator Duo/Trio) in the Policy Reference Table.

Operational noteExample test entries in the PRT were updated to correct coding references for exome analyses.

Claims impactProviders should use updated PRT entries/codes when referencing example exome tests to avoid mismatched billing codes.

PIK3CA code: 81479 — recommend testing affected tissue when mosaicism suspected
TSC codes: 81405, 81406, 81407 — include documentation of ≥1 major TSC feature
Failure to test appropriate tissue for mosaic PIK3CA may yield false‑negative results and affect coverage determination

Documentation Required

Documentation and Coverage Decision Reminder

This clinical policy is a guide to medical necessity and coverage determinations; it is not a guarantee of payment. Coverage decisions are made in accordance with the member's plan documents, applicable laws, and Health Plan administrative policies. Providers must submit sufficient clinical documentation to demonstrate that testing meets the medical necessity criteria outlined in this policy. Codes listed in the policy are informational only and do not ensure coverage. Providers should reference up‑to‑date professional coding resources before claim submission.

Submit clinical documentation that supports the specific medical necessity criteria for the requested test
Codes in this policy are informational — prior authorization and coverage require review of documentation and member benefits
Reference the member's evidence of coverage and applicable Health Plan administrative policies when assessing potential coverage

Providers should reference current CPT manuals and professional coding guidance when preparing claims.

Examples not exhaustiveTests, associated labs, CPT and ICD examples in the document are illustrative and not comprehensive for billing decisions.

Chromosomal microarray analysis (CMA) definition and common codes

CMA definitionChromosomal microarray analysis (CMA) is genomic microarray testing (example CPTs: 81228, 81229, S3870) used to evaluate developmental delay, intellectual disability, autism spectrum disorder, or congenital anomalies.

When medically necessaryCMA is considered medically necessary for DD/ID (excluding isolated speech delay), ASD, multiple congenital anomalies not specific to a defined genetic syndrome, or short stature.

Example CPTsExample CMA CPT codes listed include 81228, 81229, and S3870.

Autism spectrum disorder / intellectual disability panel definition and investigational stance

Policy stanceAutism spectrum disorder / intellectual disability multigene panels (e.g., 81470, 81471, 81479) are considered investigational.

Panel examplesExample panel CPT codes referenced include 81470, 81471, 81479, 81185, 81236, 81302, 81321, and 0156U.

ImplicationClaims for ASD/ID multigene panels may be denied based on investigational designation; consider alternative testing per policy criteria.

Close relatives — degree definitions

First-degree relativesParents, siblings, and children.

Second-degree relativesGrandparents, aunts/uncles, nieces/nephews, grandchildren, and half-siblings.

Third-degree relativesGreat grandparents, great aunts/uncles, great grandchildren, and first cousins.

Autism spectrum disorders (ASD) — DSM-5 based definition

Core DSM-5 definitionAutism spectrum disorders are defined by persistent deficits in social communication and interaction across contexts, including deficits in social-emotional reciprocity, nonverbal communicative behaviors, and developing/maintaining relationships.

Functional domainsManifestations include impairments in social-emotional reciprocity, nonverbal communication, and relationships; deficits may be current or by history.

Contextual noteDefinition aligns with DSM-5 diagnostic criteria as described in the policy Definitions section.

Multiple congenital anomalies — definition

Definition summaryMultiple congenital anomalies are structural or functional abnormalities usually evident at birth or shortly after and are not specific to a well-delineated genetic syndrome.

Clinical impactSuch anomalies can affect life expectancy, health status, physical or social functioning, and typically require medical intervention.

ReferenceDefinition aligned with ACMG guidance as cited in the policy.

Developmental delay (DD) — definition and domains

DD definitionDevelopmental delay: slow-to-meet or not reaching milestones in one or more developmental domains (communication, motor, cognition, social-emotional, or adaptive skills) relative to age expectations.

Domains listedCommunication, motor, cognition, social-emotional, and adaptive skills.

Clinical useDD as defined is a trigger for consideration of diagnostic testing such as CMA when other criteria are met.

Intellectual disability (ID) — DSM-5 based definition

DSM-5 criteria summaryIntellectual disability requires deficits in intellectual functions confirmed by testing, deficits in adaptive functioning limiting independence, and onset during the developmental period.

Assessment requirementDeficits in intellectual functions must be confirmed by clinical assessment and standardized intelligence testing.

Functional impactAdaptive deficits limit functioning across multiple environments without ongoing support.

NF1 testing definition — molecular confirmation may be unnecessary with clinical criteria

NF1 testing roleMolecular genetic confirmation for NF1 may be unnecessary when clinical diagnostic criteria are met, but genetic testing can confirm diagnosis in young children with only café-au-lait macules and assist family testing.

UtilityTesting can differentiate NF1 from Legius syndrome and may be helpful in atypical presentations; negative testing does not detect all cases (approx. 95% sensitivity).

Guidance sourceRecommendations referenced from the American Academy of Pediatrics and GeneReviews.

TSC1/TSC2 testing definition — pathogenic variant sufficient for diagnosis

TSC genetic diagnostic ruleIdentification of a pathogenic variant in TSC1 or TSC2 is sufficient for diagnosis of tuberous sclerosis complex regardless of clinical findings.

Testing recommendationGenetic testing is recommended for suspected cases and for genetic counseling; obtain a three-generation family history.

Clinical diagnostic thresholdsDefinite TSC: 2 major features OR 1 major + 2 minor; Possible TSC: 1 major OR 2 minor features.

Diagnostic CFTR sequencing/deletion-duplication analysis definition (distinct from carrier screening)

Diagnostic (not carrier) CFTR testingDiagnostic CFTR sequencing and deletion/duplication analysis (e.g., 81222, 81223) are intended to establish or confirm a diagnosis and are distinct from carrier screening.

When indicatedDiagnostic CFTR testing added criteria to allow coverage not related to sweat testing per cystic fibrosis consensus guidance.

Claims notePolicy renamed diagnostic CFTR criteria to differentiate from carrier screening to guide coverage determinations.

PIK3CA testing scope narrowed to sequencing only

Scope narrowed to sequencingPIK3CA testing criteria were updated to specify PIK3CA sequencing only; deletion/duplication testing was removed because such mutations are uncommon in this disorder.

Clinical contextBecause many PIK3CA variants are mosaic, multiple tissue types may need testing; failure to detect a variant does not exclude diagnosis.

Code contextPIK3CA sequencing examples referenced (policy uses sequencing code examples such as 81479 for analysis).

Disorder‑specific references and updates were added or clarified for multiple conditions. For NF1, the policy now references AAP/ GeneReviews diagnostic guidance and explicitly lists diagnostic features (e.g., six or more café‑au‑lait macules, axillary/inguinal freckling, two or more neurofibromas or one plexiform neurofibroma, optic pathway glioma, two or more Lisch nodules, or a distinctive osseous lesion), and notes when molecular testing is helpful (eg, in young children with only café‑au‑lait macules).

For NF2, GeneReviews guidance and new adult/child‑specific clinical criteria were incorporated (for adults: bilateral vestibular schwannomas or unilateral vestibular schwannoma plus additional tumor types; for children: schwannoma at any site, early skin plaques, meningioma, cortical wedge cataract, retinal hamartoma, or mononeuropathy).

Tuberous sclerosis complex (TSC1/TSC2) guidance now reflects the International TSC Clinical Consensus Group recommendation that identification of a pathogenic variant in TSC1 or TSC2 is sufficient for diagnosis; the policy lists the major/minor clinical features used to determine when genetic testing is indicated (eg, definite TSC = 2 major features or 1 major + 2 minor).

Regarding PIK3CA, the policy narrows testing scope to sequencing only (removing deletion/duplication testing) because copy‑number events are uncommon in PIK3CA‑related overgrowth; it also emphasizes mosaicism and the potential need to test multiple tissue types when clinical or imaging findings (such as hemimegalencephaly or focal cortical dysplasia) suggest PIK3CA‑related segmental overgrowth.

NF1 sequencing/deletion-duplication criteria were expanded/renamed (removed Legius SPRED1 content) and an additional diagnostic criterion was added to align with guidelines.

2024-11-20revisedLatest

Semi-annual review resulted in title and version updates (V1.2025) and numerous editorial changes including removal of minimum gene lists for Noonan/RASopathies and Fanconi anemia panels and removal of two conditions from 'Other Covered Multisystem Inherited Disorders'.