ModifiedCentenePolicy N/A

Genetic Testing: Gastroenterologic (Non‑Cancerous) Disorders

Defines medical necessity and investigational indications for genetic and algorithmic tests used to diagnose or rule out non-cancerous gastrointestinal conditions (e.g., celiac disease, hereditary hemochromatosis, hereditary pancreatitis, IBD, non-invasive liver fibrosis). Applies to Centene-affiliated health plans and providers ordering/testing members.

Policy Summary

PayerCentene

PolicyGenetic Testing: Gastroenterologic (Non‑Cancerous) Disorders

Policy CodePolicy N/A

Change TypeCriteria additions, code removals, and new non-invasive fibrosis criteria

Effective DateN/A

Next Review DateN/A

Key ActionObtain and document prior clinical findings (e.g., FIB-4 >1.3, abnormal iron indices, inconclusive celiac serology/histology, or relevant family history) before requesting genetic or noninvasive fibrosis testing.

SourceLink

POLICY UPDATE CHANGES

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

HFE panel title changed to 'HFE C282Y and H63D Genotyping' and criteria adjusted to reference C282Y/H63D testing and first-degree relatives.

Hereditary Inflammatory Bowel Disease/Crohn's Disease Panel Tests: age at diagnosis and pediatric/monogenic testing criteria updated to align with guidelines.

Test examples and several CPT/PLA codes removed or updated in the Policy Reference Table (e.g., removed PLA 0203U, CPTs 81356, 86671, and CPT 88342 removed).

Added 'also known as metabolic dysfunction-associated steatotic liver disease (MASLD)' to noninvasive liver fibrosis serum test criteria.

Celiac disease HLA criterion: HLA-DQA1 and HLA-DQB1 genotyping analysis has not been previously performed.

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<6VEO‑IBD recommendation

Coverage Criteria for Gastroenterology Genetic and Algorithmic Tests

HLA-DQ Genotyping Analysis

HLA-DQ genotyping analysis is medically necessary when ALL of the following are met:

HLA-DQ Genotyping Analysis (to rule out celiac disease): Member is being evaluated for celiac disease; AND HLA-DQA1 and HLA-DQB1 genotyping has not been previously performed; AND one of: had an inconclusive serology (antibody) result, OR had an inconclusive histology (biopsy) result, OR started a gluten-free diet before evaluation for celiac disease.

HLA-DQ other indications: Any other indication for HLA-DQA1 and HLA-DQB1 genotyping is considered investigational.

HFE C282Y and H63D Genotyping

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

HFE testing clinical triggers: Member has abnormal serum iron indices (e.g., elevated transferrin saturation and/or elevated serum ferritin concentration indicating iron overload), OR member has a first-degree relative with a diagnosis of hereditary hemochromatosis.

Population screening and other indications are investigational.

HFE testing guidance note: Laboratory and guideline guidance supports targeted testing for p.C282Y with optional p.H63D; confirm elevated transferrin saturation prior to genetic testing.TS >=45% and/or elevated serum ferritin

Hereditary Pancreatitis Multigene Panel

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

Hereditary pancreatitis panel - core criteria: A) Personal history of pancreatitis; AND B) At least one of: unexplained acute pancreatitis in childhood (≤18 years), OR recurrent (two or more separate, documented) unexplained acute attacks of pancreatitis, OR chronic pancreatitis of unknown cause particularly with onset before age 35 without heavy alcohol use, OR at least one close relative with recurrent acute pancreatitis, chronic pancreatitis of unknown cause, or childhood pancreatitis of unknown cause; AND C) Panel includes at minimum PRSS1, SPINK1, CFTR, and CTRC.

Hereditary pancreatitis other indications: Hereditary pancreatitis multigene panel analysis is considered investigational for all other indications.

Inflammatory Bowel Disease Algorithmic Tests

Inflammatory bowel disease algorithmic/prognostic tests stance:

IBD diagnostic algorithmic tests: Inflammatory bowel disease diagnostic algorithmic tests (listed CPTs such as 81479, 82397, 83520, 86140, 88346, 88350) are considered investigational.

IBD prognostic algorithmic tests: Inflammatory bowel disease prognostic algorithmic tests (listed CPTs such as 81401, 83520, 88346, 88350) are considered investigational.

Hereditary Inflammatory Bowel Disease / Crohn's Disease Panel Tests

Hereditary IBD/Crohn's disease multigene panel testing is medically necessary when ALL of the following are met:

Eligible diagnoses by age: Member diagnosed with infantile-onset IBD (diagnosis before age 2 years) OR very early onset IBD (diagnosis before age 6 years) AND at least one of: congenital multiple intestinal atresias, congenital diarrhea, diagnosis of malignancy under age 25, features of an inborn error of immunity (eg, susceptibility to infections), complex autoimmune features, OR a close relative meeting any of the above criteria; OR the member is undergoing stem cell transplant; OR the member has a history of multiple intestinal resections.

Other indications: Genetic testing for IBD/Crohn's disease panels is considered investigational for all other indications.

Non-Invasive Liver Fibrosis Serum Tests

Non-invasive liver fibrosis serum tests are medically necessary when BOTH of the following are met:

Risk factor presence: Member has one of: nonalcoholic fatty liver disease (NAFLD, also known as MASLD), nonalcoholic steatohepatitis (NASH), type 2 diabetes, obesity (BMI >25), abnormal liver function tests, OR a history of alcohol use.

Prior testing threshold: Member had previous FIB-4 testing with a score greater than 1.3.> 1.3

Other indications: Non-invasive liver fibrosis serum tests are considered investigational for all other indications.

Updated coverage criteria overview

Policy criteria were updated in multiple panels — notable logical changes summarized below.

HFE C282Y and H63D Genotyping: Coverage oriented toward targeted testing for p.C282Y with optional p.H63D; confirm elevated transferrin saturation prior to testing; consider testing in first-degree relatives of diagnosed hereditary hemochromatosis patients.TS >=45% and/or elevated serum ferritin

Per EMQN and ACG guidance

Hereditary Pancreatitis Multigene Panel Indications: Consider genetic testing in younger patients (eg, <30) with unexplained acute pancreatitis when family history of pancreatic disease is present; for chronic/idiopathic pancreatitis evaluate at minimum PRSS1, SPINK1, CFTR, CTRC.age <30 for consideration; onset before 35 for chronic pancreatitis without heavy alcohol use

Per ACG and GeneReviews

Hereditary Inflammatory Bowel Disease / Crohn's Disease Panel Tests:

Criteria additions/edits

Documented changes to coverage criteria and enumerated test-specific requirements

Celiac HLA genotyping: HLA-DQA1 and HLA-DQB1 genotyping analysis has not been previously performed.

Added as an explicit criterion for celiac disease HLA-DQ genotyping analysis

Use of tests or panels for indications explicitly identified in this policy as investigational is excluded from coverage. Examples include algorithmic diagnostic or prognostic inflammatory bowel disease (IBD) tests and multigene panels when the patient does not meet the specific age, clinical, or family-feature criteria enumerated in this policy. Providers should not order these tests for routine population screening or for indications outside the specified medical necessity criteria, as such uses are designated investigational and may be denied.

Examples of test groups commonly considered investigational under this policy include: IBD diagnostic algorithmic tests and IBD prognostic algorithmic tests (listed CPTs), and multigene panel testing for hereditary pancreatitis or hereditary IBD when the detailed entry criteria are not met. Non‑invasive liver fibrosis serum tests are investigational when used without prior FIB‑4 > 1.3 and when the patient does not have the listed risk factors.

This policy also reflects updates to the Policy Reference Table that removed certain example tests and codes; when a test or billing code was removed from the reference table, sections of testing represented by those removed codes may no longer meet criteria and billing may be denied. Providers should confirm that the requested test and code align with the updated policy and the Health Plan’s coverage terms prior to ordering.

Prometheus IBD sgi Diagnostic and Prometheus Crohn's Prognostic tests currently have insufficient peer‑reviewed evidence demonstrating improved health outcomes compared with standard care and are therefore considered investigational for routine diagnostic or prognostic use in IBD.

Routine serologic or algorithmic serology testing for IBD is not recommended by major society guidance cited in the evidence review, and the current evidence reviews found no new literature supporting clinical utility for these Prometheus tests. As a result, these specific algorithmic IBD diagnostic and prognostic tests are listed as investigational and are excluded from coverage.

For patients with suspected IBD, follow guideline‑recommended diagnostic pathways rather than algorithmic/proprietary prognostic tests; if new, peer‑reviewed evidence emerges demonstrating clinical benefit, the policy may be reassessed.

The Policy Reference Table was updated to remove several example tests and associated billing codes. Specific removed codes called out in the update include CPT code 88342 and PLA code 0203U, and CPT codes 81356 and 86671.

Because those examples were removed from the reference table and associated criteria, providers should be aware that tests represented by the removed codes may no longer meet policy criteria and claims billed with those codes may be denied. Verify current acceptable codes against the Health Plan’s Policy Reference Table prior to ordering or submission.

Tests designated as investigational in this policy must not be ordered or performed for the investigational indications. Any performance of tests for indications the policy identifies as investigational (for example, IBD algorithmic diagnostic/prognostic tests or panels performed when panel criteria are not met) is considered not medically necessary and may be denied.

Providers are responsible for documenting that the requested test meets the specific medical necessity criteria in the policy (e.g., age thresholds and additional clinical features for hereditary IBD panels; FIB‑4 > 1.3 and listed risk factors for non‑invasive fibrosis serum tests; abnormal iron indices or affected first‑degree relative for HFE genotyping). Lack of supporting documentation for medically necessary criteria is a denial risk for investigational indications.

The following algorithmic inflammatory bowel disease tests are considered investigational and not supported for routine clinical use: diagnostic algorithmic tests (examples listed under CPTs 81479, 82397, 83520, 86140, 88346, 88350) and prognostic algorithmic tests (examples listed under CPTs 81401, 83520, 88346, 88350).

Evidence reviews cited in the policy specifically concluded that Prometheus IBD sgi Diagnostic and Prometheus Crohn's Prognostic tests have insufficient evidence in peer‑reviewed publications to demonstrate improved health outcomes compared with standard care, and guideline statements recommend against routine serologic algorithmic testing for IBD diagnosis.

Sections of testing represented by codes removed from the Policy Reference Table may be considered not meeting policy criteria. The revision notice documents removal of example tests and codes (including CPT 88342, PLA 0203U, CPT 81356, and CPT 86671), and states that these removals affect the Reference Table and criteria.

Where a code or example test has been removed, providers should assume the corresponding test no longer meets the policy criteria unless an alternative covered code or explicit criterion is listed; confirm acceptable billing codes and authorization requirements with the Health Plan before ordering.

Coding and Policy Reference Table

HLA-DQ Genotyping CPT CodesCPTCovered

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

HFE Targeted Variant GenotypingCPTCovered

81256

HFE C282Y and H63D genotyping

Hereditary Pancreatitis Multigene Panel CodesCPTCovered

81222	Sequence analysis for hereditary pancreatitis genes (panel)
81223	Deletion/duplication analysis for hereditary pancreatitis genes (panel)
81404	Targeted gene panel (multigene) sequencing
81405	Targeted gene panel sequencing (larger)
81479	Unlisted molecular pathology procedure (used for some panels)

Inflammatory Bowel Disease Algorithmic/Related CodesCPTNot Covered

81479	Unlisted molecular pathology procedure (used for algorithmic and panel tests)
82397	Algorithmic immunoassay or special chemistry (listed with IBD algorithmic tests)
83520	Enzyme assay, other (listed with IBD/prognostic algorithmic tests)
86140	Antibody detection by immunoassay (listed with IBD algorithmic tests)
88346	Immunohistochemistry or special staining (listed with IBD tests)
88350	Tissue examination procedure code (listed with IBD tests)

Hereditary IBD / Crohn's Disease Panel CodesCPTCovered

81321	Targeted genotyping (listed with hereditary IBD panel)
81406	Targeted gene panel (another panel code)
81407	Targeted gene panel

Hereditary IBD / Crohn's Disease Panel CodesCPTExperimental

No codes listed

Non-invasive Liver Fibrosis Serum Test CodesCPT | HCPCSCovered

0002M	Non-invasive liver fibrosis serum test (example)
0003M	Non-invasive liver fibrosis serum test (example)
84450	AST
84460	ALT
85049	Platelet count
81517	Enhanced Liver Fibrosis (ELF) test

Policy reference updatesCPT

81256

Not specified in excerpt — replaced 81479 with 81256 in Policy Reference Table

Removed/updated example codesmixed

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

IBD/diagnostic test examplesCPT

86140	Serologic/antibody test code referenced in IBD diagnostic algorithmic tests (example)
88342	Pathology/microscopy code previously in reference table (removed from table in update)

Removed from Policy Reference TablemixedNot Covered

88342	CPT code removed from Policy Reference Table and criteria
0203U	PLA code removed from Policy Reference Table and criteria
81356	CPT code removed from Policy Reference Table and criteria
86671	CPT code removed from Policy Reference Table and criteria

FIB-4 index — threshold value used in fibrosis criteria

FIB-4 index threshold> 1.3

Use as triggerFIB-4 > 1.3 is the prior testing threshold required before ordering non-invasive liver fibrosis serum tests (per policy).

Preferred initial assessmentFIB-4 is recommended as the preferred first-line noninvasive test due to simplicity and low cost.

Recurrent acute pancreatitis — definition used in hereditary pancreatitis criteria

Definition of recurrent acute pancreatitis

Provider Actions, Prior Authorization, and Documentation Requirements

Billing Rule

Code alignment required

Prior authorization and medical necessity reviews should align with the current Policy Reference Table and claims submitted. Verify that all CPT/PLA codes used on authorization requests and claims match the updated reference table to avoid processing delays.

Verify Policy Reference Table codes before submission.
Confirm any removed codes are not billed on authorization or claims.

Prior Authorization

Code list changes affecting prior authorization

Changes to the code list may affect whether prior authorization is required or whether previously authorized services remain valid. Providers must review the updated code lists and resubmit or amend authorizations when codes have been added, removed, or replaced.

Background and Scope

Genetic testing can confirm and clarify diagnoses for a range of non‑cancerous gastrointestinal disorders and guide management when used according to evidence‑based criteria. Examples in this policy include HLA‑DQA1/DQB1 genotyping to help rule out celiac disease when serology or histology is inconclusive or when a gluten‑free diet was started before testing, targeted HFE C282Y/H63D genotyping when biochemical iron indices (e.g., transferrin saturation) are consistent with iron overload or there is an affected first‑degree relative, and hereditary pancreatitis or hereditary IBD multigene panels when strict age, clinical, and family criteria are met.

Algorithmic IBD diagnostic and prognostic tests (including Prometheus IBD sgi Diagnostic and Prometheus Crohn's Prognostic) currently lack sufficient peer‑reviewed evidence of clinical benefit and are categorized as investigational. Non‑invasive liver fibrosis serum tests are useful in risk stratification for NAFLD/MASLD when patients have listed risk factors and prior FIB‑4 > 1.3, with FIB‑4 recommended as a preferred initial assessment before proprietary biomarkers or advanced imaging.

Definitions and Key Terms

Close relatives — definition of first-, second-, third-degree 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

Infantile-onset IBD (Infantile-IBD) — defined as diagnosis younger than 2 years

Infantile-IBD definitionClinical manifestations and/or diagnosis when younger than 2 years of age.

Testing implicationInfants diagnosed before age 2 should be referred for genomic/panel/exome testing consideration per guidance.

Policy Summary

PayerCentene

PolicyGenetic Testing: Gastroenterologic (Non‑Cancerous) Disorders

Policy CodePolicy N/A

Change TypeCriteria additions, code removals, and new non-invasive fibrosis criteria

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Genomic/panel testing recommended for infants and children under age 2, and for children under age 6 with additional clinical/family/immunologic criteria (eg, family history, consanguinity, recurrent infections, hemophagocytic features, autoimmunity, early malignancy, congenital intestinal atresias).

onset <2 years strongly recommended; <6 years with criteria

Per UpToDate and European Society guidance

IBD Algorithmic Tests (Diagnostic/Prognostic): Prometheus IBD sgi Diagnostic and Prometheus Crohn's Prognostic tests currently have insufficient peer‑reviewed evidence to demonstrate improved health outcomes compared to standard care; routine serologic algorithmic testing for IBD is not recommended by ACG.insufficient evidence

Policy treats these algorithmic tests as not supported by evidence for improved outcomes

Non-Invasive Liver Fibrosis Serum Tests: NITs (including FIB-4 as preferred initial test) recommended for risk stratification of NAFLD; use combination of >=2 NITs or imaging when FIB-4 >1.3; reserve proprietary biomarkers for second-line evaluation or when imaging is unavailable.FIB-4 >1.3 triggers further testing

Aligned with AGA/AASLD guidance

Two or more separate, documented acute attacks of pancreatitis for which there is no explanation (eg, not due to anatomical anomalies, stones, alcohol, drugs, hyperlipidemia, trauma, viral infection).

Context in criteriaRecurrent attacks listed as one qualifying feature for hereditary pancreatitis multigene panel testing.

Documentation requirementEpisodes must be documented and unexplained by common causes to meet the criterion.

Age thresholds for panel testing — Infantile-IBD <2 years; VEO-IBD <6 years

Infantile-IBD age thresholdDiagnosis younger than 2 years of age

VEO-IBD age thresholdDiagnosis younger than 6 years of age

Testing recommendation contextPanel testing recommended for infants <2 and for children <6 when additional clinical/features present.

Transferrin saturation (TS) — lab threshold reference

Transferrin saturation (TS) threshold>= 45%

Role in HFE testing algorithmACG algorithm indicates HFE genotyping when TS is 45% or greater and/or serum ferritin is elevated.

Required antecedent labsDocumentation of TS and serum ferritin is indicated prior to HFE genotyping per policy guidance.

FIB-4 — reminder of threshold to proceed to further testing/imaging

FIB-4 action threshold> 1.3 (use as threshold to proceed to further testing or imaging)

Preferred roleFIB-4 recommended as preferred initial noninvasive fibrosis assessment before proprietary biomarkers or imaging.

Clinical guidanceWhen FIB-4 >1.3, consider combination of 2 or more NITs or confirmatory imaging (eg, TE, MRE) or proprietary biomarkers if imaging unavailable.

Removed CPT codes (e.g., 81356, 86671) and PLA codes (e.g., 0203U) may no longer be recognized for prior authorization.
If a code used for an approved authorization is removed, contact the Health Plan to determine required actions.

Billing Rule

Coding/reference table mismatches

If a claim or authorization uses a code that no longer appears in the Policy Reference Table, the claim may be denied or pend for additional review. Providers should not rely on legacy codes; update billing to current codes.

Do not submit removed CPT/PLA codes on claims or authorizations.
Check the Concert Platform or Plan resources for the comprehensive, current list of registered tests and codes.

Denial Risk

Denial triggers from removed codes

Billing with CPT or PLA codes that have been removed from the Policy Reference Table can trigger denials or claim rejections. To reduce denial risk, update billing systems and test catalogs to reflect removed and replacement codes before submission.

Removed codes may result in automatic denials if submitted.
If a removed code must be billed, include clinical documentation and contact the Health Plan for prior clarification.

Documentation Required

Required supporting clinical documentation

Provide supporting clinical documentation with authorization requests to demonstrate medical necessity. Examples include inconclusive serology or histology for celiac evaluation, prior genotyping status, or elevated iron indices for HFE testing.

Document inconclusive serology or biopsy results when requesting HLA-DQ genotyping.
Indicate if genotyping has not been previously performed as required by criteria.
Include prior test dates and results when available.

Documentation Required

HFE testing antecedent labs

For HFE C282Y and H63D genotyping requests, document antecedent serum iron studies. The Plan may require transferrin saturation (TS) and serum ferritin (SF) values; genotyping is typically considered when TS ≥ 45% and/or SF is elevated.

Include recent TS and SF laboratory results with the authorization request.
If family history of hereditary hemochromatosis is present, include details of the affected relative.

Documentation Required

Required documentation

When prior genotyping or other prerequisite testing is required by the clinical criteria, document previous test results and dates. If prior testing was not performed, explicitly state this in the request.

Attach prior genotype reports when available.
If prior testing is absent, include a statement that genotyping has not been previously performed.

Note

Preferred initial fibrosis assessment

For evaluation of liver fibrosis, use Fibrosis‑4 index (FIB-4) as the preferred initial, low-cost assessment before ordering proprietary serum fibrosis tests or advanced imaging. Proprietary biomarkers or imaging are recommended as confirmatory or second-line tests when FIB-4 is >1.3 or results are indeterminate/discordant.

Order FIB-4 as first-line fibrosis risk stratification.
Reserve proprietary fibrosis biomarkers (e.g., ELF) or imaging (TE, MRE) for confirmatory testing when FIB-4 >1.3 or clinical suspicion persists.

Guideline supportUpToDate and society guidelines recommend testing for infants with these features.

Very early onset IBD (VEO-IBD) — defined as diagnosis younger than 6 years

VEO-IBD definitionClinical manifestations and/or diagnosis when younger than 6 years of age.

Testing implicationChildren with onset under age 6, especially under age 2, warrant consideration of genomic/panel/exome testing when additional criteria present.

Guideline noteBritish Society and UpToDate recommend considering monogenic causes in this age group.

Fibrosis-4 index (FIB-4) — description of test and inputs

Test descriptionFIB-4 is a blood test estimating the probability of advanced liver fibrosis using AST, ALT, platelet count, and patient age.

InputsRequires AST, ALT, platelet count, and age to calculate the index.

Clinical useUsed as a noninvasive initial assessment to risk stratify for advanced fibrosis in NAFLD/MASLD.

Very‑early‑onset IBD — reiteration that onset under age 6 (esp <2) warrants genomic testing consideration

Policy reiterationOnset under age 6, especially under age 2, should prompt consideration of genomic/panel/exome testing.

Infant emphasisInfantile onset (<2 years) particularly indicates testing per guideline recommendations.

Additional criteriaTesting for VEO-IBD under age 6 is recommended when additional clinical/family/immunologic features are present.

Noninvasive liver fibrosis tests (NITs) — definition and examples (serum or imaging-based biomarkers)

Definition of NITsNoninvasive liver fibrosis tests (NITs) are serum or imaging-based biomarkers used to risk stratify NAFLD/MASLD patients and guide need for biopsy or further imaging.

ExamplesExamples include FIB-4, ELF (Enhanced Liver Fibrosis), and proprietary biomarkers such as FibroTest/FibroSure, FIBROSpect, Hepamet, Pro-C3 based scores, and FibroMeter.

Clinical roleCombine 2 or more NITs when FIB-4 >1.3; reserve specialized/proprietary blood tests for second-line evaluation or when imaging unavailable.

metabolic dysfunction-associated steatotic liver disease (MASLD) — alternate name for NAFLD referenced in policy

Alternate nameMetabolic dysfunction-associated steatotic liver disease (MASLD)

Relation to NAFLDMASLD is presented in the policy as an alternate name for nonalcoholic fatty liver disease (NAFLD) in fibrosis test criteria.

Use in criteriaPresence of NAFLD/MASLD is one qualifying risk factor for ordering noninvasive liver fibrosis serum tests.

HLA-DQA1 and HLA-DQB1 genotyping analysis — genotyping requirement for celiac testing

Required genotyping for celiac testingHLA-DQA1 and HLA-DQB1 genotyping analysis must not have been previously performed (i.e., prior HLA-DQA1/DQB1 genotyping absent) to meet the celiac HLA criterion.

PurposeHLA-DQ genotyping (HLA-DQA1/DQB1) is used to help rule out celiac disease when serology or histology is inconclusive or when gluten-free diet started prior to evaluation.

Related CPT codesCovered CPT codes for HLA-DQ genotyping include 81375, 81376, 81377, 81382, 81383 per the policy coding section.