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ModifiedAmbetter NevadaPolicy N/A

Concert Genetic Testing: Gastroenterology — Genetic and Blood‑Based Algorithmic Tests for Non‑Cancer Gastroenterologic Disorders

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Criteria and coding guidance for genetic and blood‑based algorithmic tests used in non‑cancer gastroenterologic conditions (e.g., hereditary hemochromatosis, hereditary pancreatitis, inflammatory bowel disease, noninvasive liver disease). Applies to Ambetter Nevada health plans and providers ordering/testing these services.

Policy Summary

PayerAmbetter Nevada

PolicyConcert Genetic Testing: Gastroenterology

Policy CodePolicy N/A

Change TypeCriteria and coding revisionsnew liver fibrosis criteriaupdated genotyping focus

Effective DateN/A

Next Review DateN/A

Key ActionVerify prior authorization and use the updated test codes (e.g., 81256 replacing 81479) when submitting genetic or liver test requests.

SourceLink

POLICY UPDATE CHANGES

Updated Hereditary Inflammatory Bowel Disease/Crohn's Disease panel criteria to emphasize testing for infantile-onset and very early-onset IBD and added multiple specific clinical features that prompt genomic testing.

Changed Hereditary Hemochromatosis testing approach to prefer HFE C282Y and H63D genotyping and removed routine sequencing.

Clarified wording in Hereditary Pancreatitis criteria (e.g., replaced 'The member/enrollee has an unexplained' with 'Unexplained').

Adjusted coding entries (replaced CPT 81479 with 81256 and modified other code mentions).

Non-Invasive Liver Fibrosis Serum Tests criteria is new, created criteria to align coverage with guidelines.

HFE panel guidance changed to HFE C282Y and H63D Genotyping and replaced sequencing pathway.

Hereditary Inflammatory Bowel Disease/Crohn's Disease Panel criteria updated: added multiple new family/clinical features and changed age-related wording.

HFE C282Y/H63DHFE genotyping specified

Multigene panelsMultigene panels required

FIB-4 thresholdsFIB-4 guidance

Insufficient evidencePrometheus tests

Infantile <2y; VEO <6yAge thresholds for monogenic IBD

CPT examplesCoding examples listed

Coverage Criteria and Medical Necessity

HFE C282Y and H63D Genotyping — Medically Necessary Indications

HFE C282Y and H63D genotyping is considered medically necessary when ANY of the following are met:

HFE genotyping indications: A. Abnormal serum iron indices indicating iron overload (e.g., elevated transferrin-iron saturation and/or elevated serum ferritin), OR B. First-degree relative with a diagnosis of hereditary hemochromatosis.TS >=45% referenced in ACG guidance

Population screening not supported; confirm elevated TS before genetic testing per EMQN/ACG guidance

Hereditary Pancreatitis Multigene Panel — Medically Necessary Indications

Hereditary pancreatitis multigene panel analysis is considered medically necessary when ALL of the following are met:

Hereditary pancreatitis panel required elements: I. Personal history of pancreatitis, AND II. At least one of: (1) unexplained episode of acute pancreatitis in childhood (<=18 years), (2) recurrent (>=2) unexplained acute pancreatitis attacks, (3) chronic pancreatitis of unknown cause especially onset <35 years without heavy alcohol use, (4) at least one close relative with recurrent acute or chronic pancreatitis or childhood pancreatitis.

Policy Summary

PayerAmbetter Nevada

PolicyConcert Genetic Testing: Gastroenterology

Policy CodePolicy N/A

Change TypeCriteria and coding revisionsnew liver fibrosis criteriaupdated genotyping focus

Effective DateN/A

Next Review DateN/A

Key ActionVerify prior authorization and use the updated test codes (e.g., 81256 replacing 81479) when submitting genetic or liver test requests.

SourceLink

On This Page

Panel must include at minimum PRSS1, SPINK1, CFTR, and CTRC

Hereditary Inflammatory Bowel Disease / Crohn's Disease Panel — Medically Necessary Indications

Genetic testing for inflammatory bowel disease via multigene panel is considered medically necessary when ALL of the following are met:

Hereditary IBD panel indications: A. Diagnosis of infantile-onset IBD before age 2 OR very early onset IBD before age 6, AND B. At least one qualifying feature such as congenital multiple intestinal atresias, congenital diarrhea, malignancy <25 years, features of inborn error of immunity (eg, recurrent infections with abnormal labs), complex autoimmune features, a close relative meeting these criteria, undergoing stem cell transplant, or history of multiple intestinal resections.

Testing recommended for all children under age 2 and for children under age 6 with these additional features per UpToDate and pediatric society guidance

IBD / Crohn's Disease Algorithmic Tests — Not Supported Generally

Inflammatory bowel disease algorithmic tests (diagnostic and prognostic) coverage stance:

IBD algorithmic tests: Current evidence does not support IBD/Crohn's disease diagnostic algorithmic tests for all indications.

Prometheus diagnostic and Prometheus Crohn's prognostic tests have been judged to have insufficient evidence to improve health outcomes compared to standard of care

Blood-based Noninvasive Liver Disease Algorithmic Tests — Medically Necessary Indications

Blood-based noninvasive liver disease algorithmic tests are considered medically necessary when ALL of the following are met:

Blood-based liver algorithmic test criteria: A. No confirmed diagnosis of liver fibrosis, AND B. Test has not been performed within the last year, AND C. Clinical context: 1) Untreated chronic HCV OR suspected/confirmed MASLD (not chronic cholestatic liver disease), AND 2) One of: (a) intermediate/high-risk FIB-4 (>=1.3 for <65; >=2.0 for >=65), OR (b) low-risk FIB-4 plus prediabetes/type 2 diabetes or >=2 metabolic syndrome features.FIB-4 thresholds as defined (>=1.3 <65; >=2.0 >=65)

Proprietary tests referenced include FibroSURE/FibroTest, ELF; sequential testing (FIB-4 first, then ELF or imaging) is recommended by guidance

Hereditary IBD / Monogenic IBD panel — medical necessity

Covered when criteria for monogenic IBD testing are met as described by professional society guidance

Monogenic IBD testing eligibility: Genomic/panel testing is indicated when ALL of the following apply: (1) Age of IBD onset younger than 2 years (infantile) OR younger than 6 years (VEO) particularly when additional criteria are present; (2) At least one additional feature is present such as affected family member(s) or family history consistent with monogenic IBD, multiple affected relatives, consanguinity, infection susceptibility with abnormal labs meeting criteria for inborn error of immunity, hemophagocytic lymphohistiocytosis features, significant autoimmune features, autoimmune/dermatologic manifestations, early-onset malignancy (<25 years), or congenital multiple intestinal atresias; (3) Testing prioritized in children <2 years and recommended in children <6 years with these features; genomic testing only in exceptional circumstances after age 6.

Reflects UpToDate, British/European pediatric society recommendations; documentation of age of onset and specified features advised

Hereditary pancreatitis — indications

Covered when ALL of the following are met

Hereditary pancreatitis testing — proband indications: Molecular genetic testing for hereditary pancreatitis is indicated in a proband with pancreatitis and at least one of: unexplained documented acute pancreatitis in childhood; recurrent acute pancreatitis of unknown cause (>=2 episodes); chronic pancreatitis of unknown cause particularly with onset before age 35 without heavy alcohol use (>5 drinks/day); or at least one relative with recurrent acute or chronic pancreatitis or childhood pancreatitis.

Based on GeneReviews and professional society guidance; panel should include key genes (eg, PRSS1, SPINK1, CFTR, CTRC)

Noninvasive liver fibrosis testing — staged approach

Covered when used as part of a staged evaluation consistent with professional guidance

NAFLD/ALD fibrosis assessment: Initial assessment should begin with simple blood-based tests such as FIB-4 or NAFLD fibrosis score. If FIB-4 is >=1.3 (or >=2.0 for patients >65) or if clinical risk factors exist (eg, diabetes, metabolic syndrome), perform a second NIT (ELF, FibroTest/FibroMeter, or imaging elastography). Serial monitoring with NITs may inform management but is not strongly recommended solely for tracking fibrosis progression.FIB-4 <1.3 rule-out (or <2.0 if age >65)

AGA, AASLD, ACG guidance support sequential testing (FIB-4 first, then secondary serum or imaging-based NIT)

Prometheus IBD/Prognostic tests — insufficient evidence

Coverage stance for Prometheus algorithmic tests

Prometheus IBD sgi Diagnostic and Crohn's Prognostic: Prometheus IBD sgi Diagnostic and Prometheus Crohn's Prognostic tests have insufficient peer-reviewed evidence to demonstrate improved clinical outcomes compared to standard of care and are considered not clinically supported for routine use.

Concert evidence review concluded insufficient evidence through May 2024

Updated coverage criteria groups

Coverage criteria have been updated or added for the following test groups

Non-Invasive Liver Fibrosis Serum Tests: New criteria created to align coverage with guidelines for blood-based noninvasive assessment of liver fibrosis and MASLD; proprietary tests (eg, FibroSure) moved into this group.

See Noninvasive liver fibrosis testing — staged approach

Hereditary Inflammatory Bowel Disease / Crohn's Disease Panel Tests: Criteria updated to add specific family history and clinical features (affected family members, multiple family members, consanguinity, recurrent infections, hemophagocytic features, autoimmune features, dermatologic features, malignancy, multiple intestinal atresias) and changed age-at-onset wording to emphasize infantile/VEO definitions.

See Monogenic IBD testing eligibility

HFE C282Y and H63D Genotyping: Panel renamed to focus on targeted genotyping for common HFE variants C282Y and H63D; sequencing criteria removed or replaced.

Investigational language and coding updated (81479 replaced by 81256)

HLA-DQ Genotyping Analysis: Criterion added that HLA-DQA1 and HLA-DQB1 genotyping analysis has not been previously performed.

Allele names updated to HLA-DQA1 and HLA-DQB1

HFE C282Y and H63D genotyping is considered medically necessary to establish a diagnosis of hereditary hemochromatosis when either of the following apply: the patient has abnormal serum iron indices (for example, elevated transferrin‑iron saturation and/or elevated serum ferritin consistent with iron overload) or the patient has a first‑degree relative with a diagnosis of hereditary hemochromatosis. The policy explicitly does not support genotyping for indications beyond those listed, including routine population screening.

The Prometheus IBD sgi Diagnostic and Prometheus Crohn’s Prognostic tests were evaluated in the Concert evidence review and found to have insufficient peer‑reviewed evidence demonstrating improved health outcomes versus standard of care. As a result, routine use of these Prometheus algorithmic diagnostic or prognostic IBD tests is not supported by the current evidence base.

Several tests previously listed under 'Other Not Covered Gastroenterologic Disorders Tests', including FibroSure, were migrated: FibroSure tests were moved into the new Non‑Invasive Liver Fibrosis Serum Tests criteria, while remaining tests were consolidated into the General Genetic and Molecular Testing policy for consolidation and updated management of low‑volume or otherwise out‑of‑scope items.

Tests not meeting the specific criteria in this policy are considered not medically necessary. This includes HFE genotyping and multigene panels when ordered for indications outside the listed criteria (for example, population screening), and inflammatory bowel disease diagnostic or prognostic algorithmic tests for which current evidence does not demonstrate clinical benefit.

Routine use of Prometheus algorithmic diagnostic or prognostic IBD tests is designated not medically necessary because the Concert evidence review concluded there is insufficient evidence that these tests improve clinical outcomes compared with standard diagnostic and prognostic approaches.

Investigational policy language was updated to more clearly reflect the evidence assessment: statements that previously used the term 'investigational' were revised to state that current evidence does not support certain tests for routine clinical use. The policy text and coding references were also revised to align with these evidence‑based determinations and recent editorial updates.

Example Codes, Index Thresholds, and Coding Updates

HFE genotyping — example/common billing codesmixed

81256	HFE C282Y and H63D genotyping (listed as common billing code)
E83.110	Iron metabolism disorder code listed
E83.118	Iron metabolism disorder code listed
E83.119	Iron metabolism disorder code listed
R79.0	Abnormal level of other serum enzymes and proteins
E83.19	Other specified disorders of iron metabolism
R16.0	Hepatomegaly

Hereditary pancreatitis and hereditary IBD panels — example/common billing codesmixed

81222	CFTR analysis (example for hereditary pancreatitis panels)
81223	Another CFTR-related code listed
81404	Targeted multigene panel code
81405	Comprehensive multigene panel code
81479	Unlisted molecular pathology procedure
K85.0-K85.9	Acute pancreatitis diagnosis range
K86.1	Other chronic pancreatitis
Z83.79	Family history of other specified conditions
81321	Hereditary IBD panel example
81406	Another multigene panel code

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Algorithmic and laboratory test codes (IBD prognostic, liver algorithmic tests)mixed

81401	Algorithmic prognostic test (listed for IBD prognostic tests)
83520	Iron or ferritin test code (listed)
88346	Immunohistochemistry; non-billing context listed
88350	Surgical pathology consultation; example listed
0203U	Prognostic Crohn's test (PredictSURE IBD) listed
82397	Serum iron test listed
86140	Antibody test listed
0003M	NASH FibroSURE (LabCorp) algorithmic test code
81517	ELF test code (algorithmic blood-based)
81596	FibroTest/FibroSURE code

Updated coding mentionsCPT

81256	Replacement for 81479 in sequencing/related entries (as noted in policy edits)
86140	Protein/antibody test code (mentioned in IBD section edits)
88342	Pathology/microscopic examination code (mentioned in IBD section edits)

HFE genotyping coding updatesCPTCovered

81256	HFE C282Y and H63D Genotyping (mentioned as replacement for 81479)
81479	Previously listed code replaced by 81256 (sequencing unspecified)

Removed CPT codesCPTNot Covered

88342

Removed from Policy Reference Table and criteria (historical)

FIB-4 index thresholds summary

FIB-4 cutoffs (age <65)>=1.3 indicates intermediate/high risk; <1.3 indicates low risk

FIB-4 cutoffs (age >=65)>=2.0 indicates intermediate/high risk; <2.0 indicates low risk

Use in staged approachFIB-4 used as initial test; if >=1.3 (<65) or >=2.0 (>=65), perform a second noninvasive test (ELF, FibroTest/FibroMeter, or imaging elastography)

Repeat testing restrictionDo not repeat blood-based noninvasive liver algorithmic tests if performed within the last year

Transferrin saturation (TS) threshold for HFE genotyping per ACG

Transferrin saturation (TS) thresholdACG/EMQN guidance: confirm elevated TS before HFE testing; ACG algorithm indicates HFE genotyping when TS is 45% or greater

Confirm TS before genotypingEMQN good practice: confirm elevated TS prior to HFE genetic diagnosis testing

Population screeningPopulation screening for p.C282Y is not recommended

FIB-4 rule-out threshold

FIB-4 rule-out threshold (general)FIB-4 <1.3 has strong negative predictive value for advanced fibrosis (useful to exclude advanced fibrosis)

Age-adjusted rule-outFor patients >=65 years, a higher rule-out threshold (<2.0) is used

Follow-up recommendationsFor low FIB-4 with diabetes or metabolic features, perform a second NIT (ELF or imaging); repeat FIB-4 every 1–2 years if low risk without metabolic features

Cyst fluid amylase key value

Cyst fluid amylase cutoffCyst fluid amylase <250 IU/L excludes pseudocyst in 98% of cases

Clinical relevanceLow cyst fluid amylase helps distinguish pseudocyst (no malignant potential) from cysts requiring surveillance

Source guidelineReferenced in ACG Clinical Guideline: Diagnosis and Management of Pancreatic Cysts (2018) via GeneReviews summary

Age at diagnosis for Crohn's disease (note on revised wording)

Infantile-onset definitionInfantile-IBD: diagnosis or clinical manifestations before age 2 years; testing prioritized for children under age 2

Very early-onset definitionVEO-IBD: diagnosis or clinical manifestations before age 6 years; testing recommended for children under age 6 with qualifying features

Revised age-at-diagnosis wordingAge at diagnosis for Crohn's disease wording was changed to align with updated guideline criteria (emphasis on <2 and <6 thresholds for infantile/VEO IBD)

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Verify prior authorization and coverage for referenced CPT codes

Certain CPT codes are listed in the policy as examples for the tests discussed; verify coverage and whether prior authorization is required with the plan before ordering or billing these services.

Example CPT/code references include 81256, 81222, 81223, 81404, 81405, 81479, 81321, 81406, 81407, 81401, 0203U, 0003M, 81517, 81596 (informational only).

Prior Authorization

Use updated codes when requesting prior authorization

Updated coding replaces certain legacy/unlisted CPT entries (e.g., replacement of 81479 with 81256); when requesting prior authorization, reference the policy's updated codes and criteria rather than older code listings.

Policy edits explicitly state 'replaced 81479 with 81256' and note updated coding mentions.
Prior authorization requests should cite the updated code 81256 where applicable.

Prior Authorization

Prior authorization may be required for updated genetic and liver tests

Because new or revised coverage criteria and coding (for genetic panels and noninvasive liver tests) are included in this policy, prior authorization may be required per plan procedures; confirm PA requirements for tests such as HFE genotyping (81256) and blood-based liver algorithmic tests.

The policy notes that Non-Invasive Liver Fibrosis Serum Tests criteria are new and that 81256 replaces prior unlisted codes.
Providers must follow plan-specific prior authorization processes for these updated tests.

Step Therapy

Avoid repeat noninvasive liver algorithmic testing within 1 year

Do not repeat blood-based noninvasive liver disease algorithmic tests if the same test was performed within the prior year; ordering within one year may not meet medical necessity criteria.

Policy criterion B: 'This test has NOT been performed within the last year.'

Step Therapy

Use stepwise testing (FIB-4 then second NIT/imaging) for fibrosis assessment

Follow a sequential (stepwise) testing approach for noninvasive liver fibrosis: start with a simple blood-based test (FIB-4) and perform a second NIT (ELF, FibroTest/FibroMeter, or imaging elastography) only when FIB-4 or clinical risk indicates need for further assessment.

Use FIB-4 first; if FIB-4 is >=1.3 (<65 years) or >=2.0 (>=65 years), obtain a second NIT (ELF, FibroTest) or imaging elastography.
When imaging is unavailable, consider a second serum test (e.g., ELF) to improve sensitivity.

Note

Documentation Required

Provide pre‑ and post‑test genetic counseling

Pre-test and post-test genetic counseling that addresses potential secondary/incidental findings and outlines a plan for returning results is strongly advised prior to genetic testing.

Counseling should facilitate informed decision-making and discuss return-of-results plans.

Documentation Required

Document age of onset and qualifying clinical features for monogenic IBD testing

For monogenic/heritage IBD panel testing, document the patient's age of IBD onset and the presence of qualifying clinical features (e.g., infantile onset <2 years or VEO <6 years and family history, recurrent infections, autoimmune features, consanguinity, hemophagocytic signs, early malignancy, or multiple intestinal atresias).

Policy recommends genomic testing for all children under age 2 and for children under age 6 with the listed clinical features.
Documentation must justify testing based on these age and feature criteria.

Documentation Required

Document prior HLA‑DQ testing status

Before ordering HLA-DQ genotyping, document that HLA-DQA1 and HLA-DQB1 genotyping analysis has not been previously performed for the member.

Policy added the criterion: 'HLA-DQA1 and HLA-DQB1 genotyping analysis has not been previously performed.'

Denial Risk

Coding inclusion does not guarantee coverage

Inclusion of a CPT code in the policy’s coding tables is informational only and does not guarantee coverage; verify coding guidance and coverage before submitting claims.

Policy language: 'Inclusion or exclusion of any codes does not guarantee coverage.'
Providers should reference current professional coding guidance prior to claim submission.

Denial Risk

Denial risk for Prometheus algorithmic IBD tests

Algorithmic IBD tests from Prometheus (Prometheus IBD sgi Diagnostic and Prometheus Crohn's Prognostic) have been judged to have insufficient peer‑reviewed evidence to improve health outcomes and may be denied for lack of clinical utility.

Policy states Prometheus Diagnostic and Prometheus Prognostic tests have 'INSUFFICIENT EVIDENCE' to demonstrate improved outcomes compared to standard care.
Coverage may be denied based on this evidence conclusion.

Billing Rule

Tests moved between policies — billing and denial implications

Tests moved between policies (for example, FibroSure moved into the new Non‑Invasive Liver Fibrosis Serum Tests group and several other tests moved to the consolidated General Genetic and Molecular Testing policy) may trigger denials if billed under previous criteria or policy references; verify current policy grouping and billing expectations before submission.

Policy notes FibroSure tests were moved to the new Non-invasive Liver Fibrosis Serum Tests criteria.
Remaining tests were moved to the General Genetic and Molecular Testing policy for consolidation; billing under old policy references may affect coverage.

Background and Scope

Scope: This policy addresses genetic and blood‑based algorithmic testing for non‑cancer gastroenterologic conditions including hereditary hemochromatosis, hereditary pancreatitis, hereditary/monogenic inflammatory bowel disease (infantile and very early‑onset IBD), and blood‑based noninvasive liver fibrosis assessments (also referenced as MASLD). It provides coverage criteria, documentation expectations, and coding/authorization guidance for Ambetter Nevada plans and providers ordering these services.

Definitions and Key Terms

Genetic counseling (definition / recommended action)

DefinitionPre-test and post-test genetic counseling that facilitates informed decision-making, addresses secondary/incidental findings, and includes a plan for returning results is strongly advised

Recommended timingCounseling should occur before testing and after results are available

PurposeAddresses informed consent, implications of findings, and result disclosure plan

FIB-4 (definition / thresholds)

DefinitionFIB-4 (Fibrosis-4 index) is a blood-based score estimating probability of advanced liver fibrosis using AST, ALT, platelet count, and age

Primary thresholds>=1.3 for individuals <65 years and >=2.0 for individuals >=65 years indicate intermediate/high risk; <1.3 (<65) or <2.0 (>=65) indicate low risk

Role in testing pathwayFIB-4 is recommended as the initial noninvasive test; abnormal/indeterminate results prompt a second NIT (ELF, FibroTest, or imaging elastography)

VEO-IBD / Infantile-IBD definitions

Infantile-IBDClinical manifestations and/or diagnosis before age 2 years

VEO-IBDClinical manifestations and/or diagnosis before age 6 years

Clinical features prompting testingFeatures include family history, recurrent infections, autoimmune features, hemophagocytic signs, malignancy <25 years, multiple intestinal atresias, and severe/refractory IBD

FIB-4 test description

Test descriptionFIB-4 is calculated from AST, ALT, platelet count, and age to estimate likelihood of advanced hepatic fibrosis

Negative predictive valueA FIB-4 <1.3 (or <2.0 for patients >=65) is associated with strong NPV to exclude advanced fibrosis

Intended useUsed as an initial, simple blood-based noninvasive test within a staged assessment for NAFLD/MASLD and other chronic liver diseases

Known Familial Variant Analysis (terminology and criteria)

Terminology changeReplaced wording 'mutation' with 'variant' and clarified 'close relative' language in known familial variant analysis criteria

DefinitionKnown Familial Variant Analysis refers to targeted testing for a specific pathogenic variant previously identified in a close relative

Scope/criteriaThese analyses follow consolidated criteria moved to the General Genetic and Molecular Testing policy for consistency

HLA-DQ Genotyping Analysis definition

DefinitionHLA-DQ genotyping analysis refers to genotyping of HLA-DQA1 and HLA-DQB1 alleles used to assess celiac disease susceptibility

Prior testing requirementCriterion added that HLA-DQA1 and HLA-DQB1 genotyping analysis must not have been previously performed

Allele namingAlleles updated to their proper names: HLA-DQA1 and HLA-DQB1