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    v1.0.28
    OpenPayerPolicy UpdatesGastroenterologyCommunity Health Plan Washington Genetic Testing C…
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    ModifiedCommunity Health Plan WashingtonPolicy N/A

    Concert Genetic Testing: Gastroenterology

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    Defines medical necessity criteria, coding implications, and related guidance for genetic and algorithmic laboratory tests used in non‑cancer gastroenterologic conditions (e.g., hereditary hemochromatosis, hereditary pancreatitis, inflammatory bowel disease, noninvasive liver disease). Applies to members of the payer's health plans.

    Policy Summary
    PayerCommunity Health Plan Washington
    PolicyConcert Genetic Testing: Gastroenterology
    Policy CodePolicy N/A
    Change TypeMaterial revisions to criteria, panel names, and coding
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization with supporting clinical documentation (age/onset, family history, and relevant test thresholds) when requesting genetic or algorithmic test coverage.
    SourceLink
    POLICY UPDATE CHANGES

    Updated language throughout to replace terms (e.g., 'mutation' to 'variant'), adjust panel titles (HFE genotyping), and add expanded criteria for hereditary IBD/VEO-IBD testing.

    Added specific testing criteria for hereditary/very early-onset inflammatory bowel disease including detailed family and clinical features.

    Changed HFE-related panel title to 'HFE C282Y and H63D Genotyping' and altered testing approach language.

    Added multiple new definition items and specific criteria elements for hereditary inflammatory bowel disease/Crohn's disease panel tests including family and immune-related features.

    Changed references to testing and panels: replaced 'inheritance patterns' with 'genetic testing' and updated several test names and code updates (e.g., replaced CPT 81479 with 81256 and updated HFE genotyping language).

    Created new Non-Invasive Liver Fibrosis Serum Tests (blood-based noninvasive liver disease algorithmic tests) and moved FibroSure tests into it.

    Removed certain CPT/PLA codes and example tests from policy reference tables for IBD prognostic/diagnostic algorithmic tests (examples: removed PLA 0203U and CPTs 81356, 86671; CPT 88342 removed from table and criteria in places).

    Updated Celiac Disease HLA-DQ genotyping criterion to require that HLA-DQA1 and HLA-DQB1 genotyping has not previously been performed and corrected allele naming.

    multipletest types referenced
    age thresholdsage-based criteria
    insufficientPrometheus tests
    Non-invasive liver testsNew criteria sets
    codes changedcodes updated
    V1.2025versioning

    Coverage and Medical Necessity Criteria

    HFE C282Y and H63D Genotyping — Medical Necessity

    Covered when ANY of the following are met:

    Abnormal iron indices: The member/enrollee has abnormal serum iron indices (e.g., elevated transferrin-iron saturation and/or elevated serum ferritin concentration) indicating iron overload.see TS threshold (e.g., TS >=45% per ACG guidance)

    Supported by EMQN and ACG guidance recommending confirmation of elevated TS before genetic testing.

    Family history: The member/enrollee has a first-degree relative with a diagnosis of hereditary hemochromatosis.n/a

    Selective screening of first-degree relatives is recommended by guidelines.

    Hereditary Pancreatitis Multigene Panel — Medical Necessity

    Covered when ALL of the following are met:

    Core requirements

    • Qualifying clinical features: 1. Unexplained episode of acute pancreatitis in childhood (18 years or younger) OR 2. Recurrent (>=2) documented acute attacks of pancreatitis of unknown cause OR 3. Chronic pancreatitis of unknown cause, particularly onset before age 35 without heavy alcohol use OR 4. At least one close relative with recurrent acute pancreatitis, chronic pancreatitis of unknown cause, or childhood pancreatitis of unknown cause.age cutoffs: childhood <=18; onset <35

      GeneReviews and ACG support testing in these scenarios.

    Panel content requirement: C. The multigene panel must include at minimum PRSS1, SPINK1, CFTR, and CTRC.gene list required

    Ensures coverage only for panels including core genes.

    Hereditary IBD / Crohn's Disease Panel — Medical Necessity

    Covered when ALL of the following are met:

    Age of onset requirement: A. Diagnosis of infantile-onset IBD before age 2 OR B. Diagnosis of very early onset IBD (VEO-IBD) before age 6.age <2 or <6

    Testing recommended for all children <2 and for children <6 when additional features present.

    Additional qualifying features: At least one of the following: congenital multiple intestinal atresias; congenital diarrhea; malignancy under age 25; features of an inborn error of immunity (e.g., recurrent infections); complex autoimmune features; a close relative meeting any of the above; undergoing stem cell transplant; history of multiple intestinal resections; consanguinity or multiple affected family members.n/a

    Panel testing indicated only when age criterion PLUS one or more high‑risk clinical or family features are present.

    Blood-based Noninvasive Liver Disease Algorithmic Tests — Medical Necessity

    Covered when ALL of the following are met:

    Noninvasive liver algorithmic test requirements: A. No confirmed diagnosis of liver fibrosis; AND B. The test has not been performed within the last year; AND C. The member/enrollee meets both clinical disease and risk stratification requirements below.timeframe: >1 year since prior test

    Applies to FibroSURE, NASH FibroSURE, ELF and similar proprietary tests.

    Clinical disease requirement: 1. One of: untreated chronic hepatitis C virus (HCV) infection OR suspected/confirmed metabolic dysfunction-associated steatotic liver disease (MASLD, formerly NAFLD); member does NOT have chronic cholestatic liver disease.exclude chronic cholestatic liver disease

    AASLD/AGA guidance referenced for appropriate disease contexts.

    Risk stratification requirement: 2. One of: (a) An intermediate or high-risk FIB-4 score (>=1.3 if <65 years; >=2.0 if >=65 years), OR (b) A low-risk FIB-4 AND either prediabetes/type 2 diabetes OR two or more features of metabolic syndrome (e.g., abdominal obesity, hypertension, high triglycerides).

    IBD Algorithmic Tests — Not Supported

    Not covered / not supported for routine use:

    IBD diagnostic algorithmic tests: Current evidence does not support inflammatory bowel disease / Crohn's disease diagnostic algorithmic tests (e.g., Prometheus IBD sgi Diagnostic) for all indications.n/a

    Evidence review found insufficient peer-reviewed data to demonstrate improved health outcomes compared to standard care.

    IBD prognostic algorithmic tests: Current evidence does not support inflammatory bowel disease / Crohn's disease prognostic algorithmic tests (e.g., Prometheus Crohn's Prognostic) for all indications.n/a

    Guidelines regard prognostic algorithmic tests as research tools with insufficient demonstrated clinical utility.

    Genetic testing — hereditary pancreatitis and monogenic IBD

    Genetic/molecular testing is indicated in selected gastroenterology conditions when specific clinical and family criteria are met.

    Hereditary pancreatitis testing (per GeneReviews): Molecular genetic testing for hereditary pancreatitis is indicated in a proband with pancreatitis and at least one of: an unexplained documented episode of acute pancreatitis in childhood; recurrent acute attacks of pancreatitis of unknown cause; chronic pancreatitis of unknown cause with onset before age 35 without heavy alcohol use; a relative with recurrent acute or chronic pancreatitis or childhood pancreatitis.at least one

    Sourced from GeneReviews and ACG guidance; common causes should be excluded prior to testing.

    Monogenic IBD / VEO-IBD testing indications: Genomic/panel testing is recommended for all children <2 years and for those <6 years with one or more additional features (family history, consanguinity, recurrent infections, hemophagocytic features, autoimmune features, dermatologic manifestations, early malignancy, multiple intestinal atresias, severe or refractory disease).one or more additional features required for <6 years

    Sourced from UpToDate, European pediatric society guidance, and policy additions enumerating I.B.1.a–i.

    Algorithmic tests and noninvasive liver disease testing

    Algorithmic diagnostic/prognostic tests and proprietary blood-based liver fibrosis tests are addressed separately.

    Prometheus IBD algorithmic tests: Prometheus IBD sgi Diagnostic and Prometheus Crohn's Prognostic test have insufficient evidence in peer-reviewed publications to demonstrate improved health outcomes compared to standard care.n/a

    Concert evidence review concluded insufficient evidence; these tests are not supported for routine coverage.

    Noninvasive liver fibrosis testing approach: Use FIB-4 as a first-line screen; if FIB-4 is above age-specific thresholds (>=1.3 if <65; >=2.0 if >=65) or in presence of diabetes/metabolic syndrome, perform a second noninvasive test (ELF, FibroTest, or elastography). Sequential testing is preferred over single proprietary tests for fibrosis staging.FIB-4 cutoffs and sequential testing rules

    Supported by AGA and AASLD guidance recommending sequential testing for staging.

    Hereditary Inflammatory Bowel Disease / Crohn's Disease Panel Tests

    Key updated coverage criteria/groups referenced in this section

    Hereditary IBD/Crohn's Panel updates: Panel testing is considered when the patient had IBD symptoms before age 18 years OR has additional family or clinical features; policy added detailed subcriteria I.B.1.a–i (affected family members, multiple family members, consanguinity, recurrent infections, hemophagocytic features, autoimmune features, dermatologic features, malignancy, multiple intestinal atresias).N/A

    Document revision added and clarified multiple family and clinical feature items to refine testing indications.

    HFE C282Y and H63D Genotyping

    HFE C282Y and H63D Genotyping

    HFE genotyping approach: Genotyping for common HFE variants (C282Y and H63D) is specified; prior sequencing/deletion language was replaced with targeted genotyping for these variants.N/A

    Policy text revised to rename panel and focus on targeted genotyping for common HFE variants.

    Non-Invasive Liver Fibrosis Serum Tests — Medical Necessity

    Non-Invasive Liver Fibrosis Serum Tests (blood-based noninvasive liver disease algorithmic tests)

    Blood-based noninvasive liver disease assessment: New criteria created to align coverage with AASLD/EASL and other guideline recommendations; FibroSure and similar proprietary tests were moved into this criteria set for evaluation under specified clinical and risk-based conditions.N/A

    Policy adds MASLD terminology and emphasizes sequential testing beginning with FIB-4.

    This policy does not support broad, nonspecific use of genetic or algorithmic laboratory tests for population screening or routine application outside defined clinical scenarios. Specifically, HFE C282Y and H63D genotyping is not indicated for general population screening; testing is limited to patients meeting the targeted clinical or family criteria described in the HFE section (for example, abnormal iron studies or a first‑degree relative with hereditary hemochromatosis). Similarly, algorithmic diagnostic or prognostic tests for inflammatory bowel disease and proprietary blood‑based fibrosis algorithms should not be used routinely for all indications; coverage is restricted to the clinical pathways and risk thresholds specified in the policy (for example, FIB‑4–guided pathways for noninvasive liver testing).

    Prometheus tests are explicitly addressed in the evidence reviews informing this policy. The Concert evidence reviews concluded that Prometheus IBD sgi Diagnostic and Prometheus Crohn's Prognostic tests have insufficient peer‑reviewed evidence to demonstrate improved health outcomes compared to standard care; therefore these specific Prometheus algorithmic diagnostic and prognostic assays are not supported under this policy.

    Several tests previously listed under Other Not Covered Gastroenterologic Disorders Tests have been reorganized. Example: FibroSure tests were moved into the new Non‑Invasive Liver Fibrosis Serum Tests criteria; remaining tests from that section were consolidated into the General Genetic and Molecular Testing policy for coverage routing and administrative consistency.

    Restating unsupported uses: the policy does not support use of IBD diagnostic or prognostic algorithmic tests for all indications, nor does it support HFE genotyping as a population screening test. In addition, blood‑based algorithmic tests should be used only per the specific noninvasive liver disease criteria (for example, when FIB‑4 and clinical risk features meet the policy thresholds) and are not intended for broad algorithmic application outside those scenarios.

    Rationale for not supporting Prometheus algorithmic tests centers on a lack of demonstrated clinical validity and utility in peer‑reviewed literature. The policy evidence reviews found insufficient evidence that Prometheus IBD sgi Diagnostic or Prometheus Crohn's Prognostic testing improves clinical outcomes compared with current standard diagnostic and management approaches; therefore algorithmic results do not reliably change care decisions in a way that benefits patients.

    Investigational policy language was updated to reflect the current evidence‑review phrasing. Where tests lack adequate supporting data, statements now indicate that current evidence does not support coverage. The document edits also included minor wording and formatting refinements (for example, updated test lists and reference table edits) to clarify investigational determinations.

    Coding, Tests, and Clinical Thresholds

    Hereditary Hemochromatosis — example billing codesmixed
    81256HFE C282Y and H63D genotyping (as listed)
    E83.110Disorder of iron metabolism - as listed
    E83.118Other hemochromatosis codes listed
    E83.119Other hemochromatosis codes listed
    R79.0Abnormal levels of other serum enzymes and proteins - listed
    E83.19Other disorders of iron metabolism - listed
    R16.0Hepatomegaly - listed
    Hereditary Pancreatitis — example billing codesmixed
    81222Hereditary pancreatitis panel (gene-specific sequencing) — listed
    81223Hereditary pancreatitis panel (additional gene) — listed
    81404CPT multigene sequencing panel — listed
    81405CPT multigene sequencing panel — listed
    81479Unlisted molecular pathology procedure — listed
    K85.0-K85.9Acute pancreatitis diagnosis range — listed
    K86.1Chronic pancreatitis — listed
    Z83.79Family history of other diseases of digestive system — listed
    Inflammatory Bowel Disease & Noninvasive Liver Disease — example codesmixed
    81479Unlisted molecular pathology — used for algorithmic/diagnostic tests
    82397C-reactive protein (example in diagnostic algorithm listing)
    83520Serum protein electrophoresis (listed)
    86140Immunoassay, analyte-specific reagent (listed)
    88346Morphometric analysis (listed)
    88350Tissue examination by molecular techniques (listed)
    81401Targeted genomic sequence panel (listed for prognostic tests)
    0203UProprietary predictive/prognostic test (PredictSURE IBD) — listed
    81596FibroTest/HCV FibroSURE — listed
    81517Enhanced Liver Fibrosis (ELF) Test — listed
    1–10 of 11
    1/2
    Edited/Referenced codesmixed
    81256Replaced 81479 with 81256 in sequencing/genotyping code list (documented replacement)
    81479Previously listed miscellaneous molecular pathology code (noted as replaced)
    86140Code edited in inflammatory bowel disease section (document notes editing of this code)
    88342Removed from Policy Reference Table and the criteria (noted removal)
    Policy reference coding changesCPT | PLA | mixed
    81256Replaces prior use of 81479 in policy reference table (specifics: referenced replacement of 81479 with 81256)
    81479Previously listed code replaced in policy (now removed/replaced)
    88342Removed from Policy Reference Table and the criteria in IBD algorithmic tests
    81356Removed from Policy Reference Table (IBD prognostic algorithmic tests)
    86671Removed from Policy Reference Table (IBD prognostic algorithmic tests)
    0203UPLA code removed from Policy Reference Table
    inv-22: Fibrosis-4 index (FIB-4) thresholds and age-specific cutoffs
    FIB-4 intermediate/high risk thresholds>= 1.3 for individuals younger than 65 years; >= 2.0 for individuals 65 years or older
    FIB-4 low‑risk cutoff (age <65)< 1.3 indicates low risk of advanced fibrosis and strong NPV for exclusion
    FIB-4 low‑risk cutoff (age >=65)< 2.0 indicates low risk of advanced fibrosis in individuals 65 years or older
    Use in sequential testingFIB-4 is recommended as first-line NIT; elevated or indeterminate FIB-4 should prompt a second NIT (ELF, FibroTest/FibroSure, or elastography)
    Repeat testing interval for low-riskFor low FIB-4 without diabetes or metabolic syndrome, repeat FIB-4 every 1–2 years; shorter intervals if risk factors present

    Provider Responsibilities, Prior Authorization, and Documentation

    Billing Rule

    Coding and authorization

    Coding and authorization: This policy references CPT and other billing codes for informational purposes only. Inclusion or exclusion of a code does not guarantee coverage. Providers must verify current procedural coding and billing guidance prior to claim submission. Prior authorization may be required for certain tests; check payer-specific prior authorization requirements before ordering.

    • Codes referenced are informational only; inclusion/exclusion does not guarantee coverage.
    • Providers should reference up-to-date coding guidance before submitting claims.
    • Prior authorization may be required for some tests — verify with Community Health Plan Washington prior auth rules.
    Prior Authorization

    Coding and prior authorization note

    Background and Scope

    Scope: This policy addresses targeted genetic and algorithmic laboratory testing for non‑cancer gastroenterologic disorders, including hereditary hemochromatosis (HFE C282Y and H63D genotyping), hereditary pancreatitis multigene panels, hereditary/very‑early‑onset inflammatory bowel disease gene panels, and blood‑based noninvasive liver disease algorithmic tests. It defines clinical eligibility criteria, threshold values (for example, FIB‑4 cutoffs), and exclusions to limit testing to situations with evidence of clinical utility rather than general population or routine algorithmic screening.

    Definitions and Test Panel Names

    inv-40: HFE testing strategy definition and context
    Definition of HFE testing strategyTargeted genotyping for common HFE variants (p.C282Y with optional p.H63D) is the recommended approach; confirm elevated transferrin saturation before genetic testing
    Panel renaming/contextPolicy renamed HFE panel to 'HFE C282Y and H63D Genotyping', replacing prior sequencing/deletion language and emphasizing genotyping
    Guideline supportEMQN and ACG guidance referenced for testing strategy and sequencing of tests
    inv-41: Close relatives — definition (first-, second-, third-degree) for family history criteria
    First‑degree relativesParents, siblings, and children
    Second‑degree relativesGrandparents, aunts, uncles, nieces, nephews, grandchildren, and half-siblings
    Policy Summary
    PayerCommunity Health Plan Washington
    PolicyConcert Genetic Testing: Gastroenterology
    Policy CodePolicy N/A
    Change TypeMaterial revisions to criteria, panel names, and coding
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization with supporting clinical documentation (age/onset, family history, and relevant test thresholds) when requesting genetic or algorithmic test coverage.
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaCoding, Tests, and Clinical ThresholdsProvider Responsibilities, Prior Authorization, and DocumentationBackground and ScopeDefinitions and Test Panel Names
    FIB-4 thresholds specified

    Guidelines recommend FIB-4 as first-line and sequential testing (FIB-4 then ELF/FibroTest or elastography) for staging.

    inv-23: Transferrin saturation (TS) threshold for HFE testing (ACG algorithm reference)
    TS threshold for HFE genotyping (ACG/EMQN guidance)Confirm elevated transferrin saturation (TS) before HFE genetic testing; consider TS >= 45% per ACG algorithm guidance
    EMQN practice pointEMQN advises confirming elevated TS prior to HFE genetic diagnosis testing (good practice, 1B)
    Role of p.C282Y/p.H63D testingEMQN recommends testing for p.C282Y and optionally p.H63D as complementary; elevated TS should prompt genotyping
    inv-24: FIB-4 cutoff for low risk of advanced fibrosis
    FIB-4 cutoff to exclude advanced fibrosisFIB-4 < 1.3 (or < 2.0 if age >= 65) is associated with strong negative predictive value and may be used to rule out advanced fibrosis
    Clinical action when FIB-4 lowIf low FIB-4 AND no diabetes/metabolic syndrome, monitor with periodic FIB-4 (e.g., every 1–2 years); if diabetes or metabolic features present, obtain a second NIT
    Sequential testing rationaleCombination of two or more NITs improves staging and reduces need for biopsy when FIB-4 is indeterminate or elevated
    inv-25: Cyst fluid amylase diagnostic threshold
    Cyst fluid amylase diagnostic thresholdCyst fluid amylase < 250 IU/L essentially excludes a pseudocyst (reported exclusion in 98% of cases)
    Clinical implicationLow cyst fluid amylase suggests no pseudocyst; pseudocysts typically do not require surveillance or treatment when asymptomatic
    Source contextThreshold cited in ACG pancreatic cyst guidance as reported in GeneReviews
    inv-26: Age at IBD symptom onset used in criteria (updated to capture symptoms before age 18 for certain criteria)
    Age cutoff update for IBD criteriaPolicy updated to capture patients who had IBD symptoms before age 18 years for specific hereditary IBD panel considerations
    Infantile/VEO-IBD contextInfantile-onset IBD defined <2 years and VEO-IBD defined <6 years for earlier-onset testing pathways
    Requirement linkageEarlier age of symptom onset (including <18 years in some criteria) is combined with additional clinical or family features to indicate panel testing

    Coding and PA note: Some specific code updates have been made in the policy (e.g., replacement of CPT 81479 with 81256 in relevant panels). Prior authorization and coverage decisions will follow the updated criteria and coding sets reflected in this policy and associated payer prior authorization rules.

    • 81479 replaced with 81256 in affected references where applicable.
    • Policy coding changes may affect which tests require prior authorization.
    • Providers should follow the updated criteria when determining PA needs.
    Prior Authorization

    Prior authorization follows updated criteria

    Prior authorization follows updated criteria: Tests that have been moved between policy sections or consolidated (for example, some tests moved to the General Genetic and Molecular Testing policy or to the Non-Invasive Liver Fibrosis Serum Tests criteria) will be subject to the PA requirements of their new policy location. When criteria were consolidated or revised, PA determinations will be made against the new criteria sets.

    • Tests moved between policies will follow PA criteria in the destination policy (e.g., FibroSure moved to Non-invasive Liver Fibrosis Serum Tests).
    • Known familial variant testing criteria were consolidated to 'Genetic Testing: General Approach to Genetic and Molecular Testing' — PA will follow that policy.
    • Updated HLA-DQA1/DQB1 criterion (not previously performed) applies when assessing PA for Celiac HLA testing.
    Denial Risk

    Algorithmic IBD tests — denial risk

    Algorithmic IBD tests — denial risk: Algorithmic/Proprietary IBD diagnostic tests (for example, Prometheus IBD sgi Diagnostic) have insufficient evidence of clinical utility in peer‑reviewed publications to show improved health outcomes versus standard care. These tests carry a heightened risk of denial when submitted for coverage without documentation meeting the policy's clinical criteria.

    • Prometheus IBD sgi Diagnostic and similar algorithmic diagnostic tests currently have insufficient evidence — expect higher denial risk.
    • Provide strong clinical justification and documentation if ordering these tests; consider standard diagnostic pathways first.
    Note

    Routing and policy consolidation may affect coverage

    Routing and policy consolidation may affect coverage: Several tests were moved between policy sections or consolidated (for example, FibroSure moved into the Non‑Invasive Liver Fibrosis Serum Tests criteria; remaining tests moved into the General Genetic and Molecular Testing policy). These routing changes can alter applicable coverage criteria and PA requirements.

    • FibroSure tests moved to Non‑Invasive Liver Fibrosis Serum Tests criteria.
    • Remaining tests consolidated under General Genetic and Molecular Testing policy — review destination policy for coverage and PA rules.
    • Check the policy location of a test to determine applicable criteria and prior auth procedures.
    Documentation Required

    Required clinical documentation

    Required clinical documentation: To support medical necessity for genetic and molecular testing, include relevant clinical documentation in the PA/claim record per policy. Documentation should demonstrate the diagnostic question being addressed and that the member meets the policy criteria.

    • Relevant clinical history (symptoms, age at onset) and physical findings.
    • Family history when indicated (affected relatives, degree of relation).
    • Previous test results (e.g., prior genotyping, FIB‑4 scores, imaging) and dates.
    • Documentation of prior steps where stepwise testing is required (e.g., FIB‑4 result followed by ELF or imaging).
    • Results of standard diagnostic evaluations that rule out common causes when required (e.g., gallstones for pancreatitis).
    Note

    Not applicable/None stated

    Not applicable/None stated: No additional provider actions specific to this subsection beyond those outlined in other callouts.

    Step Therapy

    Sequential noninvasive test (NIT) guidance

    Sequential NIT testing: For noninvasive liver fibrosis assessment, sequential testing is recommended—begin with simple, widely available tests such as FIB‑4 (and repeat per thresholds) and, when indicated, follow with a second noninvasive test (ELF or imaging-based elastography) before ordering more complex proprietary tests. This stepwise approach aligns with AASLD and ACG guidance and may be required for coverage.

    • FIB‑4 is the recommended initial test; repeat intervals and thresholds are in policy.
    • If FIB‑4 is intermediate or high (>=1.3 for <65 y or >=2.0 for >=65 y), perform a second NIT (ELF or imaging) where accessible.
    • For low FIB‑4 with diabetes or metabolic syndrome features, perform a second NIT as feasible before advanced testing.
    Third‑degree relativesGreat-grandparents, great-aunts, great-uncles, great-grandchildren, and first cousins
    inv-42: FIB-4 definition — description of the test components and purpose
    FIB-4 componentsCalculated from AST, ALT, platelet count, and age to estimate probability of advanced liver fibrosis
    PurposeUsed as a first-line noninvasive test to stratify risk for advanced hepatic fibrosis (guides need for second NIT)
    Interpretation linkageSpecific age-based cutoffs inform next-step testing: <1.3 (or <2.0 if >=65) to exclude advanced fibrosis; >=1.3 (or >=2.0 if >=65) prompts additional testing
    inv-43: Infantile-IBD / VEO-IBD age cutoffs definitions (<2 years, <6 years)
    Infantile‑IBD definitionClinical manifestations and/or diagnosis before age 2 years
    VEO‑IBD definitionClinical manifestations and/or diagnosis before age 6 years
    Testing implicationChildren <2 years (and select <6 years with additional features) are prioritized for genomic/panel testing for monogenic IBD
    inv-44: Hereditary Inflammatory Bowel Disease/Crohn's Disease Panel Tests — definition of updated panel criteria elements
    Updated panel scopeHereditary IBD/Crohn's Disease panels now include earlier age of onset, specified family history elements, and additional clinical features (e.g., recurrent infections, hemophagocytic features, autoimmune/dermatologic findings, early malignancy, multiple intestinal atresias)
    Additional qualifying featuresPolicy added enumerated subitems I.B.1.a–I.B.1.i detailing affected family members, multiple family members, consanguinity, recurrent infections, hemophagocytic features, autoimmune features, dermatologic findings, malignancy, and multiple intestinal atresias
    Testing trigger logicPanel testing indicated when early onset (infantile/VEO or symptoms before age 18 in some criteria) is present plus one or more listed high‑risk clinical or family features
    inv-45: HFE C282Y and H63D Genotyping — renamed panel definition replacing prior sequencing language
    Panel renaming and definitionHFE C282Y and H63D Genotyping: renamed panel specifying targeted genotyping for the common HFE variants (C282Y and H63D), replacing prior sequencing language
    Scope of testingFocuses on genotyping for p.C282Y (recommended) with p.H63D optional as complementary testing (sequential or simultaneous)
    Policy change noteSequencing/deletion criteria were removed and replaced with targeted genotyping language; coding references updated accordingly