ModifiedCommunity Health Plan WashingtonPolicy N/A

Genetic Testing: Gastroenterologic Disorders (Non‑Cancerous) — Coverage Criteria

Defines medical necessity and investigational indications for genetic and non-invasive serum tests used to diagnose or rule out common non-cancerous gastroenterologic conditions (e.g., celiac disease, hereditary hemochromatosis, hereditary pancreatitis, IBD, liver fibrosis) for members of Community Health Plan Washington/Centene-affiliated health plans.

Policy Summary

PayerCommunity Health Plan Washington

PolicyGenetic Testing: Gastroenterologic Disorders (Non‑Cancerous) — Coverage Criteria

Policy CodePolicy N/A

Change TypeCriteria added and revised across multiple test groups (new fibrosis criteriaHFE and IBD panel updatescode removals)

Effective DateN/A

Next Review DateN/A

Key ActionDocument required clinical justification (e.g., FIB-4 >1.3 for fibrosis tests or abnormal iron indices for HFE genotyping) and obtain prior authorization when indicated.

SourceLink

POLICY UPDATE CHANGES

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

HFE panel criteria retitled and focused to HFE C282Y and H63D genotyping with updates to when genotyping is indicated (e.g., confirm elevated TS prior to testing; family member screening recommendations).

Hereditary Inflammatory Bowel Disease/Crohn's Disease panel criteria updated to prioritize genomic testing in very-early-onset IBD (under age 6) and added detailed family/clinical testing criteria.

Algorithmic IBD diagnostic and prognostic tests (e.g., Prometheus IBD sgi Diagnostic and Prometheus Crohn's Prognostic) found to have insufficient evidence for improved health outcomes.

Updated Background and Rationale to reflect updated Evidence Review and updated evidence review dates in References.

Removed PLA code 0203U and CPT codes 81356 and 86671 from the Policy Reference Table and the criteria.

Non-invasive Liver Fibrosis Serum Tests criteria updated to add alternative name 'metabolic dysfunction-associated steatotic liver disease (MASLD)'.

Added criterion that HLA-DQA1 and HLA-DQB1 genotyping analysis has not been previously performed for Celiac Disease - HLA-DQ Genotyping Analysis.

Removed example tests (duplicates) from Policy Reference Table and removed CPT code 88342 from the Policy Reference Table and criteria.

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~10groups with coverage statements

>1.3FIB-4 threshold

insufficientPrometheus IBD evidence

newNew fibrosis criteria

0203U,81356,86671,88342Codes removed

Coverage Criteria and Medical Necessity Rules

HLA-DQ Genotyping Analysis

HLA-DQ Genotyping Analysis — medically necessary when ALL criteria are met (HLA-DQA1/DQB1 genotyping relevant).

ALL of the following

The member/enrollee is being evaluated for celiac disease (CD).
AND at least one of the following:
- Had an inconclusive serology (antibody) result.
- Had an inconclusive histology (biopsy) result.
- Started a gluten-free diet before evaluation for celiac disease.
HLA-DQA1 and HLA-DQB1 genotyping analysis has not been previously performed.
Relevant CPT examples: 81375, 81376, 81377, 81382, 81383.

HFE C282Y and H63D Genotyping

HFE C282Y and H63D Genotyping — criteria set (ANY/ALL logic) for when testing is medically necessary.

ANY of the following

I. Clinical or laboratory indications
- The member/enrollee has abnormal serum iron indices (e.g., elevated transferrin-iron saturation and/or elevated serum ferritin concentration, indicating iron overload).
- Testing is performed to establish a diagnosis of hereditary hemochromatosis.
The member/enrollee has a first-degree relative with a diagnosis of hereditary hemochromatosis.

Hereditary Pancreatitis Multigene Panel

Hereditary Pancreatitis Multigene Panel — ALL/ANY criteria for medical necessity; includes panel composition guidance.

ALL of the following

The member/enrollee has a personal history of pancreatitis.
AND at least one of the following:
- Unexplained episode of acute pancreatitis in childhood (18 years or younger).
- Recurrent (two or more separate, documented) acute attacks of pancreatitis of unknown cause (after excluding anatomical anomalies, obstructive lesions, trauma, viral infection, gallstones, alcohol, drugs, hyperlipidemia, etc.).
- Chronic pancreatitis of unknown cause, particularly with onset before age 35 years without a history of heavy alcohol use.

Hereditary Inflammatory Bowel Disease / Crohn's Disease Panel Tests

Hereditary IBD / Crohn's Disease Panels — medical necessity logic and prioritized indications (including VEO-IBD).

ALL of the following

I. Indications (one of the following must be present)
- Diagnosis of infantile-onset inflammatory bowel disease (IBD) before age 2 years.
- Diagnosis of very early onset inflammatory bowel disease (VEO-IBD) before age 6 years.
AND at least one of the following additional criteria:
- Congenital multiple intestinal atresias.
- Congenital diarrhea.

Non-Invasive Liver Fibrosis Serum Tests

Non-invasive Liver Fibrosis Serum Tests — ALL criteria including FIB-4 threshold and clinical risk factors for coverage.

ALL of the following

I. Clinical risk factors (one of the following must be present)
- Nonalcoholic fatty liver disease (NAFLD) / metabolic dysfunction-associated steatotic liver disease (MASLD).
- Nonalcoholic steatohepatitis (NASH).
- Type 2 diabetes mellitus (T2D).
- Obesity (BMI >25).
- Abnormal liver function tests.

Non-Invasive Liver Fibrosis Serum Tests — Covered Criteria

Non-invasive liver fibrosis serum tests — covered criteria.

ALL of the following

Member/enrollee has one or more clinical risk factors for liver fibrosis (see group: NAFLD/MASLD, NASH, T2D, obesity with BMI >25, abnormal liver enzymes, or history of alcohol use).
Prior FIB-4 score is greater than 1.3 (FIB-4 >1.3).>1.3
Testing is intended to rule out or stratify risk of liver fibrosis and inform the need for further imaging or specialist referral.

Coding and Billing References

HLA-DQ Genotyping CPT CodesCPTCovered

81375	HLA-DQA1/DQB1 genotyping (listed for HLA-DQ genotyping)
81376	HLA genotyping (listed)
81377	HLA genotyping (listed)
81382	HLA genotyping (listed)
81383	HLA genotyping (listed)

HFE Genotyping CPT CodesCPTCovered

81256

HFE C282Y and H63D genotyping

Hereditary Pancreatitis Panel CPT CodesCPTCovered

81222	Hereditary pancreatitis gene sequencing (listed)
81223	Hereditary pancreatitis gene sequencing (listed)
81404	Targeted gene panel (listed)
81405	Targeted gene panel (listed)
81479	Unlisted molecular pathology procedure (used for algorithmic/panel tests)

IBD Diagnostic/Algorithmic CPT CodesCPTExperimental

81479	Unlisted molecular pathology procedure (used for IBD algorithmic/diagnostic panels)
82397	Therapeutic drug monitoring (listed in IBD diagnostic algorithmic tests group)
83520	Serum iron-binding capacity (listed)
86140	Tissue-based assay (listed)
88346	Immunohistochemistry separate stain (listed)
88350	Microscopy (listed)

Hereditary IBD / Crohn's Disease Panel CPT CodesCPT

81479	Unlisted molecular pathology procedure (used for hereditary IBD/Crohn's panels)
81321	Sequencing (listed)
81406	Targeted multi-gene panel (listed)
81407	Targeted multi-gene panel (listed)

Non-invasive Liver Fibrosis CPT CodesCPTCovered

0002M	Non-invasive liver fibrosis serum test (example)
0003M	Non-invasive liver fibrosis serum test (example)
84450	Assay for bilirubin/related (listed)
84460	Assay for liver enzymes (listed)
85049	Blood count automation (listed)
81517	Enhanced Liver Fibrosis (ELF) test (listed in examples)

Policy Reference Table coding updatesCPT

81256

Example genetic test code referenced in Policy Reference Table (replaced 81479)

Removed/Deprecated codes in Policy Reference Tablemixed

0203U	Prometheus example PLA code removed from Policy Reference Table
81356	CPT code removed from Policy Reference Table
86671	CPT code removed from Policy Reference Table

Removed from Policy Reference TableCPT | PLANot Covered

0203U	PLA code (removed)
81356	CPT code (removed)
86671	CPT code (removed)
88342	CPT code (removed)

inv-30: FIB-4 index threshold

FIB-4 threshold> 1.3 (prior FIB-4 testing must show score greater than 1.3 before non-invasive liver fibrosis serum tests)

Indicated populationsPatients with NAFLD/MASLD, NASH, type 2 diabetes, obesity (BMI >25), abnormal LFTs, or history of alcohol use

Role in testing sequenceFIB-4 is recommended as the preferred first-line noninvasive risk stratification test; proprietary biomarkers/imaging used when FIB-4 >1.3 or as confirmatory testing

inv-31: Transferrin saturation threshold

Transferrin saturation (TS) threshold

Prior Authorization, Documentation, and Provider Guidance

Prior Authorization

HLA-DQ genotyping authorization — documentation and prior testing history requirements

HLA-DQ genotyping (HLA-DQA1/HLA-DQB1) for evaluation of celiac disease is subject to authorization and documentation requirements. Order only when the patient is being evaluated for celiac disease and at least one of the following applies: inconclusive serology, inconclusive histology, or the patient started a gluten-free diet prior to evaluation. Confirm that HLA-DQA1/DQB1 genotyping has not previously been performed; prior genotyping documented in the medical record will render repeat testing ineligible. Providers should include the clinical rationale for testing in the prior authorization request and the medical record (see items).

Affected codes: examples include CPT 81375, 81376, 81377, 81382, 81383 (HLA-DQ genotyping).
Required documentation: clinical indication for celiac evaluation; result(s) of prior serology and/or histology; documentation of gluten-free diet start date if applicable; explicit statement that HLA-DQA1/DQB1 testing has not been previously performed.

Denial Risk

Use of inflammatory bowel disease diagnostic or prognostic algorithmic tests — investigational / denial risk

Background and Rationale

Genetic and molecular testing in gastroenterology can confirm diagnoses in symptomatic patients, change clinical management, and avoid unnecessary further workup. Examples include HLA genotyping to exclude celiac disease when serology or histology are inconclusive, and targeted HFE genotyping to confirm hereditary hemochromatosis after biochemical evidence of iron overload. Policy updates reflect current evidence reviews and are intended to align testing coverage with guideline‑directed, high‑value clinical use.

This policy incorporates an updated evidence review and corresponding background revisions. Changes include addition of new criteria for non‑invasive liver fibrosis testing, clarification of HFE and HLA genotyping language, updated nomenclature (HLA‑DQA1/HLA‑DQB1), and removal of deprecated example tests and codes from the Policy Reference Table; evidence review dates and reference citations were updated accordingly.

Definitions and Key Terms

inv-51: Definition of 'Close relatives'

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

inv-52: Infantile-onset IBD

Age cut-offInfantile-onset IBD defined as clinical manifestations and/or diagnosis when younger than 2 years of age

SourceDefinition referenced to Ouahed, et al

Use in criteria

Policy Updates and Material Changes

2024-10-23added

Non-Invasive Liver Fibrosis Serum Tests criteria created to align coverage with guidelines and added MASLD as an alternate name.

2024-11-24revised

Updated Background and Rationale with evidence review dates; added HLA-DQA1 and HLA-DQB1 prior-testing prerequisite for Celiac HLA-DQ genotyping and updated allele nomenclature.

2025-01-11removed

Policy Summary

PayerCommunity Health Plan Washington

PolicyGenetic Testing: Gastroenterologic Disorders (Non‑Cancerous) — Coverage Criteria

Policy CodePolicy N/A

Change TypeCriteria added and revised across multiple test groups (new fibrosis criteriaHFE and IBD panel updatescode removals)

Effective DateN/A

Next Review DateN/A

Key ActionDocument required clinical justification (e.g., FIB-4 >1.3 for fibrosis tests or abnormal iron indices for HFE genotyping) and obtain prior authorization when indicated.

SourceLink

On This Page

At least one close relative with recurrent acute pancreatitis, chronic pancreatitis of unknown cause, or childhood pancreatitis of unknown cause.

The panel includes, at a minimum, PRSS1, SPINK1, CFTR, and CTRC genes.

CPT examples: 81222, 81223, 81404, 81405, 81479.

Diagnosis of malignancy under age 25 years.

Features of an inborn error of immunity such as susceptibility to infections.

Complex autoimmune features.

A close relative meeting any of the above criteria.

OR additional situations where panel testing is considered medically necessary:

The member/enrollee is undergoing hematopoietic stem cell transplant.
The member/enrollee has a history of multiple intestinal resections.

CPT examples: 81479, 81321, 81406, 81407.

A history of alcohol use.

Previous fibrosis-4 index (FIB-4) testing with a score greater than 1.3.>1.3

CPT/HCPCS examples: 0002M, 0003M, 84450, 84460, 85049.

TS >= 45% is an indication for HFE genotyping per ACG algorithm

Confirmatory recommendationGood practice to confirm elevated TS before HFE genetic testing (EMQN recommendation)

Complementary test noteLaboratories should test for p.C282Y; p.H63D may be offered as an optional complementary test per local practice

Algorithmic and prognostic IBD (inflammatory bowel disease/Crohn's disease) tests are investigational and carry a high denial risk. These include diagnostic or prognostic algorithmic panels and proprietary serologic algorithm tests. Prior authorization is expected to be denied in the absence of strong evidence of clinical utility; providers should not rely on these tests for routine diagnosis or management decisions.

Investigational examples: algorithmic diagnostic tests and prognostic algorithmic tests (policy examples include CPT 81479, 81401, 83520, 88346, 88350, 86140).
Guideline context: professional guidelines (ACG, ECCO) recommend against routine serologic antibody testing to establish or rule out IBD subtypes.

Documentation Required

Hereditary IBD documentation — age of onset and supporting clinical/family criteria required

Hereditary IBD / monogenic IBD panel testing: Authorization and documentation must reflect guideline-concordant indications. Genomic/panel testing is appropriate primarily for very-early-onset disease (typically onset <6 years, especially <2 years) or when additional clinical, family, or immunologic criteria suggest monogenic IBD. Include age of onset and supporting clinical or family criteria in the request.

Required documentation: age at symptom onset, family history of IBD or immunodeficiency, recurrent infections or unexplained fevers, very severe or treatment-refractory disease, associated autoimmune features, or other listed testing criteria.
Testing recommended: consider panel, exome, or genome sequencing for children <2 years and for children <6 years with supporting features; testing for onset after age 6 only in exceptional circumstances.

Billing Rule

Claims or coverage may be denied if testing includes removed codes or lacks required authorization

Claims or coverage may be denied when testing includes codes or tests removed from the Policy Reference Table or when required documentation or prior testing steps are absent. Providers should verify coding and prior authorization requirements before submission.

Examples of removed/denied codes: PLA 0203U, CPT 81356, CPT 86671, CPT 88342 (recently removed from the Policy Reference Table).
Action: confirm current acceptable CPT/PLA codes and whether prior authorization is required/allowed for the requested test.

Step Therapy

Step approach for celiac testing — documentation expectations

Documentation should demonstrate a stepwise, evidence-based evaluation for celiac disease prior to ordering HLA-DQ genotyping. HLA genotyping is intended as an adjunct when first-line testing is inconclusive or infeasible (e.g., patient already on a gluten-free diet). Include explicit evidence of prior testing and rationale in the medical record and prior authorization materials.

Step approach: 1) initial serologic testing (tTG IgA ± total IgA) and/or duodenal biopsy where indicated; 2) if results are inconclusive or if patient is on a gluten-free diet, consider HLA-DQA1/DQB1 genotyping; 3) document that genotyping has not already been performed.
Documentation elements: dates and results of serology and/or histology, dietary history (gluten exposure), and clinical symptoms prompting testing.

Documentation Required

Documentation must include personal history and panel composition; HFE testing requires abnormal iron indices or family history

When ordering hereditary pancreatitis or other gastroenterology-related multigene panels, prior authorization and documentation must include personal history and panel composition details. For HFE testing, document abnormal iron indices or relevant family history prior to ordering.

Hereditary pancreatitis panels: include documentation of personal history of pancreatitis and clinical criteria (e.g., age of onset, recurrent unexplained episodes) and confirm the panel includes minimum required genes (e.g., PRSS1, SPINK1, CFTR, CTRC).
HFE genotyping: required documentation includes abnormal serum transferrin saturation and/or elevated ferritin, or a first-degree relative with diagnosed hereditary hemochromatosis.

Documentation Required

Documentation should reflect updated evidence-based rationale and prior testing when applicable

Documentation should reflect updated evidence-based rationale and any required prior genotyping or testing steps. Ensure the clinical record justifies the requested test based on current guideline-directed indications.

Examples: for celiac HLA testing, note prior serology/histology results and prior genotyping status; for noninvasive liver fibrosis testing, include FIB-4 score (>1.3) and relevant risk factors.
Operational note: include citations or guideline references in the clinical rationale when available to expedite review.

Prior Authorization

Non-invasive liver fibrosis testing — sequence and documentation requirements

Noninvasive liver fibrosis serum tests require prior risk stratification. Use FIB-4 as first-line screening; proprietary or specialized serum fibrosis biomarkers are reserved for second-line evaluation and generally require a FIB-4 > 1.3 plus documented clinical risk factors.

Required documentation: FIB-4 score (>1.3) and presence of risk factors (NAFLD/NASH, type 2 diabetes, obesity, abnormal liver tests, history of alcohol use).
Billing/coding: confirm the appropriate CPT/PLA code for the specific proprietary test and prior authorization status before ordering.

Billing Rule

Verify coding and prior authorization after code removals

Providers should verify coding and prior authorization expectations following policy updates and code removals. Failure to update test orders and claims to current policy-acceptable codes may result in claim denials or delays.

Action: confirm that the ordered test code is listed in the current Policy Reference Table and that prior authorization requirements are met.
Reminder: codes removed in recent updates include PLA 0203U, CPT 81356, CPT 86671, and CPT 88342; do not submit claims using removed codes.

Triggers consideration for genomic testing per hereditary IBD panel criteria

inv-53: Very early onset IBD (VEO-IBD)

Age cut-offVery early onset IBD (VEO-IBD) defined as clinical manifestations and/or diagnosis when younger than 6 years of age

SourceDefinition referenced to Ouahed, et al

ImplicationVEO-IBD (especially <2 yrs) prioritized for genomic/panel testing under policy

inv-54: FIB-4 test description and components

Test componentsFIB-4 uses AST, ALT, platelet count, and age to estimate probability of advanced liver fibrosis

PurposeA blood-based index for noninvasive assessment and initial risk stratification of liver fibrosis

Clinical roleRecommended as a simple, low-cost first-line assessment before advanced biomarkers or imaging

inv-55: HFE genotyping (C282Y and H63D)

TargetsHFE genotyping refers specifically to C282Y (p.C282Y) and H63D (p.H63D) variants

Testing strategyRecommend testing for p.C282Y; p.H63D may be offered as an optional complementary test sequentially or simultaneously per local practice

Indication contextGenotyping performed to establish diagnosis of hereditary hemochromatosis when biochemical evidence exists or family history is present

inv-56: Fibrosis-4 index (FIB-4) as initial noninvasive test

Role in testing pathwayFIB-4 is the preferred initial noninvasive test for liver fibrosis risk stratification

ComponentsFIB-4 calculation uses AST, ALT, platelets, and age to estimate probability of advanced fibrosis

Next stepsWhen FIB-4 > 1.3, follow-up with imaging (TE, MRE) or proprietary serum biomarkers (eg, ELF) is recommended for confirmation

inv-57: MASLD (alternate name for NAFLD)

Alternate nameMASLD (metabolic dysfunction-associated steatotic liver disease) is recognized as an alternate name for NAFLD in the criteria

ContextMASLD included in Non-Invasive Liver Fibrosis Serum Tests eligibility (policy update)

ImplicationTerminology change ensures coverage criteria apply to NAFLD/MASLD populations for noninvasive fibrosis testing

Removed example tests from the Policy Reference Table and removed PLA 0203U and CPT codes 81356 and 86671 from the Policy Reference Table and criteria.

2025-11-01removedLatest

Removed duplicate example test and CPT code 88342 from the Policy Reference Table and criteria; updated evidence review dates and performed additional evidence review updates for IBD algorithmic/prognostic tests.

Certain test criteria and example entries have been retired or removed due to low volume or redundancy. For example, the MCM6 targeted variant analysis criteria were retired and several PLA/CPT codes and duplicate example tests were removed from the Policy Reference Table to streamline operational guidance and coding.