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    OpenPayerPolicy UpdatesClinical/Medical PolicyBlue Cross Blue Shield Nebraska gastro testing Pri…
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    CurrentBlue Cross Blue Shield - NebraskaPolicy M.80

    MA Specialty Testing: Gastroenterology (Preauthorization Required)

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    Medical policy governing preauthorization and medical necessity criteria for specialty laboratory and genetic tests used in non-malignant gastroenterologic conditions (e.g., hereditary hemochromatosis, pancreatitis, inflammatory bowel disease, and noninvasive liver disease). Affects providers requesting these tests for Blue Cross Blue Shield - Nebraska members.

    Policy Summary
    PayerBlue Cross Blue Shield - Nebraska
    PolicyMA Specialty Testing: Gastroenterology (Preauthorization Required)
    Policy CodePolicy M.80
    Change TypeMinor or no material changes
    Effective DateMay 1, 2026
    Next Review DateJan 1, 2027
    Key ActionObtain preauthorization for specialty gastroenterology genetic and molecular tests and document clinical history supporting the indication (e.g., abnormal iron indices, pancreatitis episodes, age of onset, or FIB-4/NFS scores).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    RequiredPreauthorization required
    Not coveredIBD algorithmic tests
    Under 6 yrsMonogenic IBD testing
    MultipleGuidelines cited
    CPT/molecularCodes listed

    Coverage Criteria for Specialty Gastroenterology Testing

    HFE C282Y and H63D genotyping

    HFE C282Y and H63D genotyping is reasonable and necessary when ONE of the following is present:

    HFE testing indications: Abnormal serum iron indices (e.g., elevated serum transferrin-iron saturation and/or elevated serum ferritin concentration, indicating iron overload)
    Family history indication: First-degree relative with a diagnosis of hereditary hemochromatosis

    Hereditary pancreatitis multigene panel

    Hereditary pancreatitis multigene panel analysis is reasonable and necessary when ALL of the following are met:

    Pancreatitis panel overall

    • Specific clinical/family criteria: Unexplained acute pancreatitis in childhood (<=18 yrs) OR recurrent (>=2) unexplained acute pancreatitis episodes OR chronic pancreatitis of unknown cause with onset before age 35 without heavy alcohol use OR at least one close relative with recurrent/chronic/childhood pancreatitis of unknown cause
    • Panel content requirement: Panel includes at a minimum PRSS1, SPINK1, CFTR, and CTRC

    IBD algorithmic diagnostic and prognostic tests

    Algorithmic diagnostic and prognostic IBD tests

    IBD algorithmic tests: Inflammatory bowel disease diagnostic algorithmic tests are considered not reasonable and necessary.
    IBD prognostic tests: Inflammatory bowel disease prognostic algorithmic tests are considered not reasonable and necessary.

    Evidence reviews (Concert) published 06/01/2025 concluded insufficient evidence to support coverage.

    Hereditary IBD / Crohn's disease multigene panels

    Genetic multigene panel testing for IBD may be reasonable and necessary when ONE of the following is met:

    Infantile IBD: Member was diagnosed with infantile-onset inflammatory bowel disease before age 2 yearsage <2 years
    VEO-IBD: Member was diagnosed with very early onset inflammatory bowel disease (VEO-IBD) before age 6 yearsage <6 years

    Testing recommended for children under 2 and for those under 6 with additional features suggesting monogenic disease

    Blood-based non-invasive liver fibrosis tests (FIB-4, NFS, APRI)

    Blood-based non-invasive liver fibrosis serum tests (e.g., FIB-4, NFS, APRI) may be considered reasonable and necessary when ALL of the following apply:

    Eligibility - at least one condition: Member has at least one of: signs/symptoms or a diagnosis of chronic liver disease; abnormal liver chemistries; hepatic steatosis on imaging; prediabetes/type 2 diabetes; features of metabolic syndrome (e.g., dyslipidemia, obesity); significant alcohol consumption; first-degree relative with MASH (NASH) cirrhosis.

    Use FIB-4 as first-line risk stratification per guidelines; not reasonable and necessary for other indications.

    Blood-based noninvasive liver disease algorithmic tests (rule-out fibrosis)

    Blood-based noninvasive liver disease algorithmic tests may be considered reasonable and necessary when ALL of the following are met:

    Algorithmic test overall requirements: Member does NOT have a confirmed diagnosis of liver fibrosis AND this test has NOT been performed within the last year AND the member meets BOTH condition groups 1 and 2 below.
    Condition group 1: One of: untreated chronic HCV infection OR suspected/confirmed MASLD (formerly NAFLD).

    Member must NOT have chronic cholestatic liver disease.

    Condition group 2 - risk score or metabolic features: Either an intermediate/high-risk FIB-4 score (>=1.3 if <65 yrs; >=2.0 if >=65 yrs) OR a low-risk FIB-4 score combined with prediabetes/diabetes OR two or more features of metabolic syndrome OR an indeterminate/high-risk NAFLD fibrosis score (NFS).FIB-4 and NFS thresholds referenced

    Inflammatory Bowel Disease / Crohn’s Diagnostic Algorithmic Tests

    Concert evidence review conclusions for algorithmic diagnostic tests

    Coverage conclusion: There is INSUFFICIENT EVIDENCE in peer-reviewed publications to support clinical validity and utility of IBD Crohn’s diagnostic algorithmic tests (e.g., Prometheus IBD sgi Diagnostic) to improve health outcomes compared to standard care; available evidence does not support health plan coverage.

    Concert Evidence Review published 06/01/2025

    Inflammatory Bowel Disease / Crohn’s Prognostic Algorithmic Tests

    Concert evidence review conclusions for prognostic tests

    Coverage conclusion: There is INSUFFICIENT EVIDENCE in peer-reviewed publications to support clinical validity and utility of Crohn’s prognostic algorithmic tests (e.g., PredictSURE-IBD) to improve health outcomes; current evidence does not support health plan coverage.

    Concert Evidence Review published 06/01/2025; randomized trial cited showing no significant clinical utility

    HFE (hereditary hemochromatosis) genetic testing

    Professional guidance for appropriate use

    Recommended testing conditions: Test for p.C282Y is recommended; p.H63D may be offered sequentially or simultaneously per local practice; population screening is not recommended. Confirm elevated transferrin saturation before HFE genetic testing is considered good practice.TS >=45% or elevated serum ferritin per ACG algorithm referenced

    EMQN and ACG guidance cited

    Hereditary pancreatitis genetic testing

    When to consider genetic testing

    Indications: Molecular genetic testing for hereditary pancreatitis is indicated in a proband with pancreatitis and at least one of: unexplained documented childhood acute pancreatitis; recurrent acute pancreatitis of unknown cause; chronic pancreatitis of unknown cause (onset <35 years without heavy alcohol use); or a family history of recurrent/chronic/childhood pancreatitis.

    ACG and GeneReviews recommendations

    Hereditary IBD / monogenic IBD genetic testing

    Population and phenotype-based recommendations

    Recommended populations: Genomic/panel testing is recommended for all children with infantile-onset IBD (onset <2 years) and for children with VEO-IBD (<6 years) especially when additional features suggesting monogenic disease are present; testing may be offered in exceptional circumstances after age 6.age <2 (strong recommendation); age <6 with features (strong recommendation)

    NASPGHAN and British Society guidance cited

    Coverage logic — diagnostic and staged testing

    Coverage aligned with clinical guidance when tests are used for diagnostic evaluation or risk stratification in at-risk populations

    Genetic panel testing for pediatric IBD: Targeted genetic panel testing is recommended for infantile-onset IBD or when phenotype is consistent with monogenic pediatric IBD, in presence of immunologic abnormalities, or with family consanguinity.

    NASPGHAN position paper recommendation

    Liver function panel testing: Liver chemistry panels are appropriate to confirm abnormal results or evaluate suspected liver disease or contributing conditions; not appropriate for routine screening without signs/symptoms.

    ACG guideline and CMS LCD support

    Blood-based NILDA initial staging: Use FIB-4 as first-line noninvasive blood-based test to stratify risk for advanced fibrosis in patients with hepatic steatosis or suspected MASLD and in high-risk groups (eg, type 2 diabetes).FIB-4 <1.3 exclusion; adjust threshold to <2.0 for age >65

    AGA and AASLD guidance

    The policy identifies specific indications where testing is considered reasonable and necessary and explicitly states that testing performed outside those indications is considered not reasonable and necessary. Examples in this excerpt include: HFE C282Y/H63D genotyping for members without abnormal serum iron indices or without a first-degree relative with hereditary hemochromatosis; hereditary pancreatitis multigene panels when the member does not meet the listed personal or family history criteria; algorithmic IBD diagnostic or prognostic tests when used for routine or unsupported indications; and blood-based liver algorithmic tests when the patient does not meet the multi-branch clinical and risk-score requirements. (See HFE genotyping criteria, hereditary pancreatitis panel criteria, IBD algorithmic test statements, and blood-based algorithmic test criteria.)

    The policy further clarifies that many tests are considered not reasonable and necessary "for all other indications" when the specific criteria are not met. Providers should document clinical findings that satisfy the stated entry conditions (for example, abnormal iron indices or qualifying pancreatitis history) before requesting testing to avoid coverage denials.

    Prometheus IBD sgi Diagnostic and similar algorithmic blood-based tests for inflammatory bowel disease are addressed directly by concert evidence reviews cited in the policy. The evidence reviews conclude there is insufficient evidence of clinical validity and utility for diagnostic tests (e.g., Prometheus IBD sgi Diagnostic) and for prognostic tests (e.g., PredictSURE-IBD), and therefore these algorithmic tests are not supported for health plan coverage.

    As a result, algorithmic IBD diagnostic and prognostic assays are categorized in the policy as not reasonable and necessary, and requests for these tests should be expected to face denial unless new, guideline-changing evidence is available.

    The policy references CMS local coverage guidance noting that hepatic panel testing performed as part of routine annual physicals or population-based screening without signs, symptoms, or illness indicating medical necessity is considered not medically reasonable or necessary. The policy therefore aligns with this guidance: liver function panels should be ordered to confirm abnormal prior results or to evaluate suspected liver disease or contributing conditions, not for routine screening of asymptomatic individuals.

    Providers should document the clinical signs, symptoms, abnormal results, or specific risk factors that justify ordering a hepatic panel to support medical necessity and coverage.

    This medical policy is used by Blue Cross Blue Shield of Nebraska to determine scientific validity and to administer plan benefits, but it does not itself define plan benefits. Coverage and payment for any service are determined by the member’s applicable benefit contract. The policy excerpt does not list explicit contractual exclusions; therefore, actual benefit determination should be confirmed against the terms and conditions of the member’s plan.

    Providers should verify member coverage and any plan-specific limitations or authorizations before ordering tests, and use the policy criteria to document medical necessity when requesting preauthorization.

    Illustrative examples of requests likely to be denied under the policy include: ordering HFE genotyping when the member does not have confirmatory abnormal serum iron indices (e.g., elevated transferrin saturation or ferritin) and there is no first-degree relative with diagnosed hereditary hemochromatosis; requesting Prometheus IBD sgi Diagnostic or other IBD algorithmic diagnostic/prognostic tests despite the policy’s evidence-based determination that these tests are not reasonable and necessary; and submitting a hereditary pancreatitis multigene panel when the member lacks the required personal history (e.g., unexplained childhood pancreatitis, recurrent unexplained pancreatitis, chronic pancreatitis with early onset) or relevant family history.

    These examples reflect the policy’s requirement that testing requests meet the specific, documented clinical criteria to be considered reasonable and necessary.

    The policy states that routine population-based liver chemistry screening or hepatic panel testing without clinical indications is not medically necessary, consistent with CMS LCD wording. For blood-based algorithmic liver tests, the policy requires specific clinical context and risk-score thresholds (for example, appropriate FIB-4 or NFS results and relevant risk factors) before testing is considered reasonable and necessary; absent those indications, testing to screen an asymptomatic population is not supported.

    Order hepatic panels and algorithmic liver tests only when documentation supports clinical indications (abnormal prior results, signs/symptoms of liver disease, imaging showing steatosis, metabolic risk factors, or qualifying FIB-4/NFS scores).

    Within the provided excerpt the policy clearly identifies many specific tests and scenarios that are considered not reasonable and necessary, but it does not present a separate general statement explicitly labeled as a universal "not medically necessary" clause beyond these itemized exclusions. The document does include CMS and evidence-review conclusions that certain routine or unsupported uses (e.g., routine hepatic panel screening; Prometheus/PredictSURE IBD assays) are not medically reasonable or necessary.

    For any coverage determination, absence of an explicit universal NMN statement in this excerpt does not alter the policy’s guidance that individual test requests must meet the listed clinical criteria and evidence-based conclusions to be considered for coverage.

    Relevant CPT and Molecular Pathology Codes

    Hereditary Hemochromatosis / example codesmixed
    81256HFE C282Y and H63D genotyping (HFE hematochromatosis gene analysis, common variants)
    E83.110Iron overload disorder
    E83.118Other hemochromatosis
    E83.119Hemochromatosis, unspecified
    R79.0Abnormal iron studies
    E83.19Other disorders of iron metabolism
    R16.0Hepatomegaly
    Hereditary Pancreatitis / example codesmixed
    81220Hereditary pancreatitis / related gene testing
    81222CFTR gene analysis - duplication/deletion variants
    81223CFTR gene analysis - full gene sequence
    81404Molecular pathology procedure, Level 5
    81405Molecular pathology procedure, Level 6
    81479Unlisted molecular pathology procedure
    Inflammatory Bowel Disease / Crohn's Disease codesmixed
    81479Unlisted molecular pathology procedure
    82397Assay code listed in IBD diagnostic table
    83520Assay code listed in IBD diagnostic/prognostic table
    86140Assay code listed in IBD diagnostic table
    88346Pathology code listed in IBD table
    88350Pathology code listed in IBD table
    0203UPredictSURE IBD / Autoimmune IBD mRNA profile (mRNA gene expression profiling, 17 genes, whole blood)
    81401Molecular pathology procedure, Level 2
    Blood-based noninvasive liver disease algorithmic test codesCPT
    81596FibroSURE / FibroTest (BioPredictive)
    81517Enhanced Liver Fibrosis (ELF) Test (analysis of 3 biomarkers: HA, PIIINP, TIMP-1)
    0002MLIVER DIS 10 ASSAYS SERUM ALGORITHM W/ASH
    0003MLIVER DIS 10 ASSAYS SERUM ALGORITHM W/NASH
    Codes (excerpt)CPT
    0002MLIVER DIS 10 ASSAYS SERUM ALGORITHM W/ASH
    0003MLIVER DIS 10 ASSAYS SERUM ALGORITHM W/NASH
    81222CFTR GENE ANALYSIS DUPLICATION/DELETION VARIANTS
    81223CFTR GENE ANALYSIS FULL GENE SEQUENCE
    81256HFE HEMOCHROMATOSIS GENE ANAL COMMON VARIANTS
    81321PTEN GENE ANALYSIS FULL SEQUENCE ANALYSIS
    81401MOLECULAR PATHOLOGY PROCEDURE LEVEL 2
    Molecular pathology CPT levels (examples and gene list excerpts)CPT
    81404MOLECULAR PATHOLOGY PROCEDURE LEVEL 5
    81405MOLECULAR PATHOLOGY PROCEDURE LEVEL 6
    Molecular pathology CPT groupingsCPT
    81405Molecular pathology procedure level 6
    81406Molecular pathology procedure level 7
    81407Molecular pathology procedure level 8
    81479Unlisted molecular pathology procedure
    Covered CPT Codes (biomarker panels listed)CPT
    81517Liver disease, analysis of 3 biomarkers (HA, PIIINP, TIMP-1), serum, prognostic algorithm reported as a risk score and risk of liver fibrosis and liver-related clinical events within 5 years
    Other test-specific codesCPT
    0203UAutoimmune (inflammatory bowel disease), mRNA, gene expression profiling by quantitative RT-PCR, 17 genes, whole blood, reported as a continuous risk score and classification of IBD aggressiveness
    FIB-4 index (FIB-4) risk thresholds
    FIB-4 intermediate/high-risk thresholds>= 1.3 for individuals younger than 65 years; >= 2.0 for individuals 65 years of age or older
    FIB-4 low-risk threshold< 1.3 for individuals younger than 65 years; < 2.0 for individuals 65 years of age or older
    Use contextIndicates need for secondary NIT or further evaluation when intermediate/high-risk
    NAFLD Fibrosis Score (NFS) threshold
    NFS indeterminate/high-risk threshold referenced

    Provider Actions, Authorization & Documentation Requirements

    Prior Authorization

    Prior authorization required

    Preauthorization is required for specialty gastroenterology testing; when national or local coverage determinations (NCD/LCD) exist they take precedence and should be applied first.

    Prior Authorization

    IBD algorithmic tests — PA not supported by evidence

    Concert evidence reviews concluded there is insufficient evidence to support clinical validity or utility of IBD Crohn’s diagnostic and prognostic algorithmic tests; these findings effectively discourage prior authorization for these algorithmic tests because coverage is not supported.

    • Examples cited include Prometheus IBD sgi Diagnostic and PredictSURE‑IBD.
    Prior Authorization

    PA required for listed molecular/specialty CPT codes

    Background and Scope

    Background: This policy addresses specialty laboratory testing used in non-malignant gastroenterologic conditions, including genetic testing for hereditary hemochromatosis (HFE C282Y/H63D), hereditary pancreatitis multigene panels, genetic testing for infantile and very early onset inflammatory bowel disease, and blood-based algorithmic and noninvasive tests for liver fibrosis risk stratification. It ties coverage to specific clinical criteria, family history, validated risk scores (such as FIB-4 and NFS), and evidence reviews for novel algorithmic assays.

    The policy emphasizes preauthorization requirements for specialty gastroenterology testing, recommends confirmatory laboratory evidence or relevant family history prior to genetic testing, and cites Concert evidence reviews and professional society guidance when concluding that certain algorithmic IBD tests lack sufficient evidence to support coverage.

    Definitions and Key Terms

    Close relatives — definition
    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
    Infantile-IBD and VEO-IBD — age-based definitions
    Infantile-onset IBDOnset or diagnosis younger than 2 years of age
    Very early onset IBD (VEO-IBD)Onset or diagnosis younger than 6 years of age
    Testing recommendation
    Policy Summary
    PayerBlue Cross Blue Shield - Nebraska
    PolicyMA Specialty Testing: Gastroenterology (Preauthorization Required)
    Policy CodePolicy M.80
    Change TypeMinor or no material changes
    Effective DateMay 1, 2026
    Next Review DateJan 1, 2027
    Key ActionObtain preauthorization for specialty gastroenterology genetic and molecular tests and document clinical history supporting the indication (e.g., abnormal iron indices, pancreatitis episodes, age of onset, or FIB-4/NFS scores).
    SourceLink
    On This Page
    Coverage Criteria for Specialty Gastroenterology TestingRelevant CPT and Molecular Pathology CodesProvider Actions, Authorization & Documentation RequirementsBackground and ScopeDefinitions and Key Terms
    Sequential testing for indeterminate/high risk: For FIB-4 >=1.3 (or >=2.0 if older than 65) or in patients with metabolic risk factors, perform a second NIT (ELF, FibroTest, or imaging elastography) for secondary risk assessment.

    AGA best practice advice and AASLD suggestion

    Use of proprietary tests: Proprietary tests (ELF, FibroTest, FibroMeter) may be used as secondary tests where available; they have higher specificity but higher cost and varied validation across etiologies.

    ACG/AASLD/Canivet review

    NAFLD Fibrosis Score (NFS) indeterminate or high-risk noted (threshold referenced as less than -1.455)
    NFS inputsCalculated from AST, ALT, albumin, age, BMI, platelet count, and presence of impaired fasting glucose or diabetes
    Action on indeterminate/high-riskConsider second NIT (ELF, FibroTest) or imaging-based assessment
    FIB-4 cutoff for exclusion of advanced fibrosis
    FIB-4 cutoff to exclude advanced fibrosisFIB-4 < 1.3 excludes advanced hepatic fibrosis for patients younger than 65 years; for patients older than 65 years use < 2.0
    Repeat testing guidanceFor FIB-4 below cutoff without diabetes/metabolic features, repeat every 1-2 years
    If diabetes or metabolic features presentPerform a second NIT even if FIB-4 is below the exclusion cutoff
    ALT abnormal threshold cited in AGA workup
    ALT abnormal threshold (AGA workup)> 20 U/L for women; > 30 U/L for men
    Context of useThese ALT cutoffs are part of suggested clinical workup for suspected NAFLD
    Follow-up implicationElevated ALT per these thresholds prompts further NIT-based risk assessment

    The molecular and specialty CPT codes listed in the policy (e.g., 0002M, 0003M, 81222, 81223, 81256, 81321, 81401) are subject to the plan's preauthorization requirements.

    • Submit prior authorization requests when ordering any listed molecular pathology or specialty gastroenterology CPT codes.
    Prior Authorization

    PA required for listed specialty gastroenterology tests

    Certain molecular pathology and biomarker panel CPT codes specifically listed in the policy (for example 81517, 0203U, 81405–81407, 81479) require preauthorization per the policy title.

    • Prior authorization should be obtained for listed biomarker panels and molecular pathology level codes before testing.
    Note

    General provider responsibilities

    Providers must follow the policy’s stated actions: obtain preauthorization when required, document clinical indications, and ensure testing meets the policy criteria to avoid denial.

    • Include evidence of meeting the specific clinical criteria described in the policy for the test ordered.
    • Ensure prior authorization is requested for CPTs listed in the policy before testing.
    Step Therapy

    Sequential HFE testing — p.C282Y first

    For HFE genotyping a stepwise approach is acceptable: test for p.C282Y first; p.H63D may be offered sequentially or simultaneously per local practice.

    • Confirm elevated transferrin saturation (TS) before genetic testing when possible, as good practice per EMQN/ACG guidance.
    Step Therapy

    No step therapy required (excerpt)

    The policy excerpt does not specify any step therapy requirements for ordering these tests.

    • No mandated step-therapy sequence is described in this document excerpt.
    Documentation Required

    Documentation — include clinical history and prior testing

    Documentation should include clinical history supporting the indication (for example serum iron indices, documented pancreatitis episodes, age of onset for IBD, and FIB‑4/NFS/APRI scores) and prior testing history (e.g., that the algorithmic test has not been performed within the last year when applicable).

    • For liver algorithmic tests document prior test dates and supporting risk scores (FIB‑4, NFS) per policy thresholds.
    • Provide clinical details ruling out alternate causes when ordering hereditary pancreatitis panels.
    Documentation Required

    HFE testing — documentation expectations

    For HFE (hereditary hemochromatosis) genotyping, documentation is expected to confirm elevated transferrin saturation (TS) and/or elevated serum ferritin prior to genetic testing when possible; family screening of first‑degree relatives is recommended.

    • ACG algorithm suggests HFE genotyping if TS ≥45% and/or serum ferritin is elevated.
    • Document family history details for first‑degree relatives when relevant.
    Documentation Required

    Genetic panel testing — documentation required

    When ordering hereditary pancreatitis or monogenic IBD genetic panels, document the clinical criteria that justify testing (e.g., unexplained childhood pancreatitis, recurrent idiopathic pancreatitis, chronic pancreatitis onset <35 without heavy alcohol use, infantile‑onset IBD <2 years, or VEO‑IBD <6 years with suggestive phenotype).

    • Confirm the panel includes required genes for pancreatitis (PRSS1, SPINK1, CFTR, CTRC) per policy.
    • For pediatric IBD panels document features suggesting monogenic disease (early onset, family history, immunologic abnormalities, consanguinity).
    Documentation Required

    Liver panel — document clinical indication

    Document the clinical indication when ordering liver function panels; these tests are appropriate to confirm prior abnormal results or evaluate suspected liver disease and contributing conditions, but are not appropriate for routine screening without signs/symptoms.

    • CMS LCD states hepatic panel testing performed during routine annual physicals without signs/symptoms is not medically necessary — document clinical signs or abnormal prior results.
    Note

    Policy disclaimer — not an authorization or contract

    The Medical Policy Disclaimer states these policies are used to administer plan benefits and do not constitute authorization, certification, or a contract for benefits; benefits are determined by the terms of the applicable benefit contract.

    • Obtaining prior authorization per this policy does not by itself guarantee coverage — confirm member benefits under the applicable contract.
    Denial Risk

    Denial risk — tests not meeting clinical criteria

    Requests for testing that do not meet the policy’s clinical criteria (for example HFE genotyping without abnormal iron indices or without a first‑degree relative with HH; hereditary pancreatitis panel when the required personal/family history criteria are not met; IBD algorithmic/prognostic tests which are deemed not reasonable and necessary) may be denied.

    • Ensure submitted clinical documentation clearly demonstrates the specific criteria in the policy are satisfied to reduce risk of denial.
    Denial Risk

    Denial risk — IBD algorithmic diagnostic/prognostic tests

    Algorithmic Crohn’s diagnostic and prognostic blood‑based tests (e.g., Prometheus IBD sgi Diagnostic, PredictSURE‑IBD) are not supported by sufficient peer‑reviewed evidence and therefore are not supported for health plan coverage; requests for these tests are at high risk of denial.

    • Prior authorization is discouraged because the Concert evidence reviews found insufficient evidence of clinical utility.
    Denial Risk

    Denial risk — routine screening without indications

    Hepatic panel testing performed as part of an annual physical or routine screening without signs, symptoms, or illness indicating medical necessity may be denied per CMS local coverage guidance.

    • Document any abnormal prior results or clinical signs that justify ordering a hepatic panel to avoid routine‑screening denials.
    Denial Risk

    No other explicit denial triggers listed

    The policy excerpt does not list additional explicit denial triggers beyond the described clinical‑criteria failures and the IBD algorithmic test exclusions.

    • Denial decisions remain subject to the member’s benefit contract and the reviewer’s assessment of documented clinical need.
    Targeted genetic panel testing recommended for all children <2 years and for children <6 years with suggestive features
    FIB-4 index — definition and inputs
    DefinitionFIB-4 is a blood test that estimates probability of advanced liver fibrosis using AST, ALT, platelet count, and age
    InputsAST (SGOT), ALT (SGPT), platelet count, and patient age
    Clinical roleRecommended as first-line noninvasive test (NILDA) for initial fibrosis risk stratification
    NAFLD Fibrosis Score (NFS) — definition and inputs
    DefinitionNAFLD Fibrosis Score (NFS) estimates probability of advanced liver fibrosis using AST, ALT, albumin, age, BMI, platelet count, and presence of impaired fasting glucose or diabetes
    InputsAST, ALT, albumin, age, BMI, platelet count, impaired fasting glucose or diabetes status
    Interpretation noteAn indeterminate or high-risk NFS (threshold example referenced) supports further noninvasive assessment
    Signs/symptoms of liver dysfunction — examples
    Examples of signs/symptomsJaundice; right upper quadrant abdominal pain/tenderness; fatigue; abdominal swelling; itching; anorexia; nausea/vomiting
    Hematologic/lab manifestationsAnemia; thrombocytopenia; unexplained bleeding or bruising
    Gastrointestinal manifestationsLoose/fatty stools
    Infantile-IBD and VEO-IBD (redundant) — age-based definitions
    Infantile-IBDOnset/diagnosis before 2 years of age
    VEO-IBDOnset/diagnosis before 6 years of age
    Clinical implicationConsider targeted genetic panel testing when infantile or VEO-IBD phenotypes present
    Infantile-onset IBD / Very Early-onset IBD — phenotypic guidance and genetic testing
    Phenotypic guidanceTargeted genetic panel testing is recommended for infantile-onset IBD and for patients whose phenotype is consistent with known monogenic pediatric IBD (eg, immunologic abnormalities, consanguinity)
    Recommended actionRefer infants/young children with suggestive features to immunology and consider panel, exome, or genome sequencing
    Age-based strong recommendationTesting recommended for all children <2 years and for children <6 years with concerning features
    NILDA / NIT / noninvasive tests — examples
    Examples of NILDA/NIT testsAPRI; FIB-4; Enhanced Liver Fibrosis (ELF); FibroTest/FibroSURE
    PurposeNoninvasive assessment of liver fibrosis without biopsy; used for initial risk stratification and sequential testing
    Role in pathwayFIB-4 recommended as first-line; ELF or FibroTest used as secondary assessment when FIB-4 is indeterminate or high
    Liver disease 3 biomarker panel (CPT 81517)
    Biomarkers includedHyaluronic acid (HA); Procollagen III amino-terminal peptide (PIIINP); Tissue inhibitor of metalloproteinase 1 (TIMP-1)
    MethodImmunoassays on serum reported as a prognostic algorithmic risk score
    CPT code81517
    0203U Autoimmune IBD mRNA profile — description
    Test descriptionmRNA gene expression profiling by qRT-PCR of 17 genes from whole blood, reported as a continuous risk score and classification of IBD aggressiveness
    Genes reported17 genes (15 target and 2 reference genes)
    CPT code0203U