ModifiedPremera BluecrossPolicy 15.01.031

ROUTINE TEST MANAGEMENT POLICY - Celiac Disease Testing

Defines reimbursable and non-reimbursable laboratory tests for diagnosis, follow-up, and risk assessment of celiac disease for Premera Bluecross members.

Policy Summary

PayerPremera Bluecross

PolicyROUTINE TEST MANAGEMENT POLICY - Celiac Disease Testing

Policy CodePolicy 15.01.031

Change TypeAdded reimbursement criteria and exclusionscoding update

Effective DateFeb 6, 2026

Next Review Date

Key ActionOrder IgA anti-TTG and total IgA for symptomatic or at-risk individuals and document IgA status when submitting claims.

SourceLink

POLICY UPDATE CHANGES

New policy approved October 14, 2025 and effective for dates of service on or after February 6, 2026 following 90-day provider notification.

Policy statement that rapid point-of-care anti-tissue transglutaminase testing, multi-analyte panels, testing of asymptomatic individuals without risk factors, and non-standard methods such as stool or saliva testing are not reimbursable due to insufficient evidence.

Coding update removing CPT codes 81376, 81377, 81382, 81383, 83516, 86255, 86256, 86258.

2026-02-06Policy effective date (on or after)

8CPT codes removed (count)

3-6 moFirst follow-up interval

Every 6 mo

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Interval until normalization

12-24 moOngoing surveillance

Not reimbursableRapid POC anti-TTG

Coverage Criteria for Celiac Disease Testing

Denial Risk

Denial Risk / Provider Actions

Claims for the following test methods are at risk for denial. Providers should order only reimbursable tests listed in this policy and document clinical indication in the chart. Tests that are not reimbursable include rapid antigen point-of-care anti-TTG testing, panel/multiplex or multi-analyte testing for more than two analytes, testing of asymptomatic individuals who are not at increased risk for celiac disease, stool- or saliva-based celiac testing, anti-reticulin antibody testing, and HLA-DQ–gluten tetramer–based assays (including flow cytometry–based tetramer assays). If these methods are billed, expect denial unless prior authorization or an exception is documented and approved.

Do not use rapid point-of-care anti-TTG (qualitative antigen) tests for diagnosis or monitoring — these are not reimbursable.
Avoid ordering multi-analyte panels or multiplex panels that include more than two analytes for celiac evaluation; these are not reimbursable.
Do not bill for stool- or saliva-based celiac tests or anti-reticulin antibody tests — these methods are not reimbursable.
HLA-DQ–gluten tetramer–based assays (including flow cytometry tetramer assays) are not reimbursable.
Testing asymptomatic individuals who are not at increased risk for celiac disease is not reimbursable.
If a non-reimbursable test is clinically necessary, document the medical rationale and obtain prior authorization or an exception when allowed by the plan.

Documentation Required

Ordering & Documentation

Covered diagnostic and monitoring tests must follow the clinical criteria and guideline-based indications in this policy. Ordering clinicians should follow guideline recommendations regarding use of quantitative IgA anti-TTG with total IgA, confirmatory EMA when using a no-biopsy pathway in children, and appropriate use of IgG-based tests for IgA-deficient patients.

Document clinical signs/symptoms or specific risk factors when ordering serologic or genetic testing for celiac disease.
For monitoring, document prior diagnosis of celiac disease and the date of diagnosis; follow recommended intervals (first follow-up 3–6 months, every 6 months until normalization, then every 12–24 months).
When using a no-biopsy diagnostic approach in children, document TGA-IgA ≥10× ULN, positive EMA-IgA on a second sample, and shared decision-making with family per guideline criteria.
If HLA DQ2/DQ8 testing is ordered, document the specific diagnostic dilemma or rationale (e.g., seronegative with histologic changes, gluten-free diet initiated before testing).

Coding and Test Identifiers

CPT codes referencedCPT

82784	Gammaglobulin (immunoglobulin); IgA, IgD, IgG, IgM, each
86231	Endomysial antibody (EMA), each immunoglobulin (Ig) class
86364	Tissue transglutaminase, each immunoglobulin (Ig) class

Removed CPT CodesCPTNot Covered

81376
81377
81382
81383
83516
86255
86256
86258

FDA device referencemixed

FDA K193604

Aptiva Celiac Disease IgA Reagent clearance reference

inv-21: TTG-IgA threshold for probable/no-biopsy diagnosis

Threshold>= 10× upper limit of normal (ULN)

ContextUsed as criterion for probable/no-biopsy diagnosis in children when combined with confirmatory EMA-IgA on a second blood sample and shared decision-making

Assay requirementsOnly antibody tests with proper calibrator curve-based calculation and having the 10× ULN value within their measurement range should be used

inv-22: Follow-up interval after diagnosis

First follow-upSchedule first visit 3–6 months after diagnosis

Until antibody normalization

Provider Actions, Documentation, and Billing Risks

Note

Coding referenced — prior auth not specified

The policy excerpt does not specify any payer prior authorization (PA) requirements; CPT codes listed in the coding section are provided for billing reference only.

Referenced CPT codes: 82784, 86231, 86364 (billing references).

Prior Authorization

Prior authorization

The document does not state any specific prior authorization requirements for celiac disease serologic or genetic testing in the provided sections.

Note

Assay approvals — no PA specified

FDA clearances for multiple assays (including Aptiva) are listed, but the policy does not impose or describe payer prior authorization requirements tied to specific assays in these sections.

Background and Context

Celiac disease is an autoimmune disorder triggered by gluten ingestion that damages small intestinal villi and impairs nutrient absorption. Diagnosis relies primarily on serologic testing—particularly tTG-IgA combined with total IgA to detect IgA deficiency—and, when indicated, duodenal biopsy and/or HLA testing. Management is a gluten-free diet, and serology is used for diagnosis and for ongoing monitoring as outlined in this policy.

Definitions and Test Terminology

inv-46: TTG / tTG — Tissue transglutaminase; assays detect IgA antibodies against transglutaminase 2 (see TTG/ TGA-IgA in terminology).

TTG / tTGTissue transglutaminase; assays detect IgA antibodies against transglutaminase 2 (primary first-line serologic test)

EMA / AEAAnti-endomysium antibodies (typically IgA); used as a highly specific confirmatory test

DGPDeamidated gliadin peptide antibodies (IgA or IgG); useful alternative, especially IgG-DGP in IgA-deficient individuals

inv-47: EMA / AEA — Anti-endomysium antibodies (EMA/AEA), typically IgA class, used in celiac serology.

EMA / AEAAnti-endomysium antibodies; typically IgA class and highly specific for celiac disease; used as confirmatory test

Method

Policy Revision History

2026-02-06coding_updateLatest

Coding update removed CPT codes 81376, 81377, 81382, 81383, 83516, 86255, 86256, and 86258.

2025-10-14policy_approval

New Routine Test Management policy approved adding a section specifying reimbursable diagnostic and monitoring indications for serologic and genetic testing for celiac disease and operational reimbursement exclusions for rapid point-of-care anti-TTG testing, multi-analyte panels, testing asymptomatic low-risk individuals, and non-standard methods such as stool or saliva testing.

Policy Summary

PayerPremera Bluecross

PolicyROUTINE TEST MANAGEMENT POLICY - Celiac Disease Testing

Policy CodePolicy 15.01.031

Change TypeAdded reimbursement criteria and exclusionscoding update

Effective DateFeb 6, 2026

Next Review Date

Key ActionOrder IgA anti-TTG and total IgA for symptomatic or at-risk individuals and document IgA status when submitting claims.

SourceLink

On This Page

Subsequent visits every 6 months until IgA-TGA (using same assay) normalizes

Ongoing surveillanceAfter normalization, follow-up every 12–24 months

inv-23: TG2 titer for non-biopsy diagnosis in children

TG2 titer threshold>10 times ULN

Use caseIn symptomatic children, TG2 >10× ULN plus positive EMA (and HLA-DQ2/8 when indicated) may permit diagnosis without duodenal biopsy

Confirmation adviceDiagnosis without biopsy should be confirmed by antibody decline and preferably clinical response to a gluten-free diet

inv-24: IgA deficiency definition (NICE)

IgA deficiency cutoff (NICE)Total IgA < 0.07 g per litre

ImplicationIf IgA deficient, use IgG-based testing such as IgG EMA, IgG DGP, or IgG tTG

Testing recommendationMeasure total IgA concurrently with serology to detect IgA deficiency

inv-25: Gluten challenge after self-initiated GFD (NASSCD)

Gluten challenge after self-initiated GFD (NASSCD)>3 g gluten per day for at least 2 weeks (approx. 1–2 slices of bread/day)

PurposeTo restore diagnostic sensitivity of serology when patient started a gluten-free diet before evaluation

AlternativeConsider combined IgA and IgG-based testing or HLA testing when appropriate to avoid or limit challenge

inv-26: FDA approval dates — Aptiva IgA cleared 2021-06-16

Device/assayAptiva Celiac Disease IgA Reagent (Inova Diagnostics)

FDA clearance dateCleared June 16, 2021

Intended analytesSemi-quantitative determination of anti-tTG IgA and anti-DGP IgA antibodies in human serum

Examples of FDA-cleared assays are enumerated (multiple clearances listed across years).
Aptiva Celiac Disease IgA Reagent clearance (Inova) is referenced.

Prior Authorization

Prior authorization not specified

No prior authorization requirements are specified for the reimbursable serologic or genetic tests in the policy excerpt; coverage guidance and exclusions are provided but PA is not described.

Step Therapy

Step therapy — not applicable

The policy does not define a step‑therapy sequence for testing; test selection and timing are determined by IgA status, age, symptoms, and risk rather than by a formal step‑therapy algorithm.

Initial testing: total IgA and tTG‑IgA for symptomatic or at‑risk patients.
If IgA deficient, use IgG‑based alternatives (IgG EMA, IgG DGP, IgG tTG).
Follow-up intervals are time‑based (3–6 months, then every 6 months until normalization, then every 12–24 months).

Step Therapy

Step therapy

The provided document contains no stated step‑therapy requirements for celiac testing; clinicians should follow the diagnostic/monitoring algorithms and timing in the policy rather than a step‑therapy ladder.

Step Therapy

No step therapy requirements specified

No step‑therapy requirements are specified in the policy excerpt for ordering serologic or genetic testing for celiac disease.

Documentation Required

Required documentation — clinical rationale and IgA status

Documentation must support the patient’s IgA status, the clinical signs/symptoms or risk factors prompting testing, the timing relative to diagnosis or follow‑up (for example first follow‑up at 3–6 months), and the rationale when ordering IgG‑based tests in IgA deficiency.

Record total IgA result to demonstrate IgA sufficiency or deficiency.
Document clinical signs/symptoms or risk status (see Note 1) that justify testing.
Document timing of tests relative to diagnosis and follow‑up schedule (3–6 months, then every 6 months until normalization).

Documentation Required

Required diagnostic documentation — serology and biopsy details

When used for diagnosis or confirmation, document serologic test results including total IgA and specific antibody titers, duodenal biopsy findings with histologic classification (e.g., Marsh) and villous:crypt ratio, and when applying the pediatric no‑biopsy pathway, document confirmatory EMA‑IgA on a second blood sample.

Include numeric serology values (e.g., TTG‑IgA level and total IgA).
Document biopsy specimen details and histologic assessment (Marsh classification, villous:crypt ratio).
For pediatric no‑biopsy diagnosis, include TTG‑IgA ≥10× ULN and positive EMA‑IgA on second sample plus shared decision‑making documentation.

Documentation Required

Biopsy specimen documentation — number and site of biopsies

If endoscopy/biopsy is performed for suspected celiac disease, obtain and document at least four distal duodenal biopsies plus duodenal bulb biopsies per guideline recommendations, and record specimen orientation and histopathology findings.

Obtain at least four distal duodenal biopsies and at least one duodenal bulb biopsy.
Document biopsy handling, orientation, and histologic interpretation.

Documentation Required

IgA level documentation — test concurrently and act if deficient

Document total serum IgA level concurrently with serologic testing to detect IgA deficiency; if IgA deficiency is present, document use of IgG‑based testing (eg, IgG EMA, IgG DGP, or IgG tTG).

Total IgA <0.07 g per litre identifies IgA deficiency per NICE.
If deficient, order and document IgG‑class serologic testing as indicated.

Billing Rule

Member benefit verification — check plan limits

Coverage and reimbursement are subject to member benefit plan limits and conditions; providers should verify member benefits and any applicable limits or exclusions in the member benefit booklet or via customer service before billing.

Policy guidance may not apply to all member contracts (consult benefit booklet).
Contact member services for plan‑specific coverage limits.

Denial Risk

Biopsy when indicated — avoid missed diagnosis in type 1 diabetes

Failure to obtain duodenal biopsies at the time of upper endoscopy in patients with type 1 diabetes who have not had prior celiac testing may result in missed diagnosis; perform and document biopsies per guideline recommendations when indicated.

For patients with type 1 diabetes undergoing upper endoscopy, perform duodenal biopsies if prior CD testing has not been done.

Documentation Required

Testing timing and diet — ensure gluten exposure during testing

Do not perform serologic testing while the patient is not consuming a gluten‑containing diet; advise patients not to start a gluten‑free diet before diagnostic testing because test accuracy requires gluten exposure during the diagnostic process.

Advise patients to remain on a gluten‑containing diet until diagnostic evaluation is complete.
If patient started a GFD already, consider HLA testing or a gluten challenge per guidelines.

Denial Risk

Biopsy requirement for adults — biopsy generally required

Adults generally require duodenal biopsy for diagnosis; diagnosing adult patients without biopsy may be considered inappropriate per BSG guidance, so perform and document biopsy when diagnosing adults on a gluten‑containing diet.

Document that biopsy was performed while patient on a gluten‑containing diet.
Record histology and number/site of biopsies per adult guidance.

Denial Risk

Denial risk for non‑reimbursable test methods

Claims for rapid point‑of‑care anti‑tissue transglutaminase tests, multi‑analyte panels, testing asymptomatic low‑risk individuals, and non‑standard sample types (stool, saliva) may be denied as not reimbursable due to insufficient evidence of clinical benefit.

Rapid point‑of‑care TTG tests are not recommended and are not reimbursable.
Multi‑analyte panels and non‑standard specimen testing (stool, saliva) are listed as exclusions.

Typically detected by immunofluorescence assays

RoleRecommended when tTG is weakly positive or when serology alone is used for diagnosis without biopsy

inv-48: DGP — Deamidated gliadin peptides; antibodies (IgA or IgG) used in celiac testing, especially in young children or IgA-deficient individuals.

DGP definitionAntibodies to deamidated gliadin peptides (IgA or IgG)

Clinical useUseful alternative test, particularly IgG-DGP in IgA-deficient patients and in some infants; slightly lower sensitivity/specificity than anti-tTG IgA

LimitationsHigher false-positive rates reported in infants; performance varies by assay

inv-53: DGP (deamidated gliadin peptide antibodies) — Antibodies against deamidated gliadin peptides; useful alternative especially IgG-DGP in IgA deficiency; lower sensitivity/specificity th...

DGP (deamidated gliadin peptide antibodies)Antibodies against deamidated gliadin peptides; useful alternative especially IgG-DGP in IgA deficiency

PerformanceGenerally slightly lower sensitivity than anti-tTG IgA; IgG-DGP can be very good in IgA-deficient patients

CaveatsHigher false-positive rates reported in infants; interpret in clinical context

inv-54: HLA DQ2/DQ8 testing — Genetic testing that has high negative predictive value; not recommended for routine initial screening but useful to exclude disease or r...

HLA DQ2/DQ8 testingGenetic testing with high negative predictive value; useful to exclude CD or resolve diagnostic dilemmas

Not routineNot recommended for routine initial screening; reserve for specific diagnostic problems or patients already on GFD

Use casesHelpful to exclude CD when negative; consider when serology and histology are discordant or for patients on GFD prior to testing

inv-51: tTG IgA / tTG IgG — Autoantibodies against tissue transglutaminase; first-line serologic marker (IgA) and alternative (IgG) in IgA deficiency; high sensitivi...

tTG IgA / tTG IgGAutoantibodies against tissue transglutaminase; IgA is first-line serologic marker and IgG an alternative in IgA deficiency

Use in IgA deficiencyPerform IgG-based tests (tTG-IgG or DGP-IgG) when total IgA is low

Testing considerationsCombine with total IgA measurement to detect IgA deficiency; specificity of IgG tTG is lower in IgA-competent patients

inv-52: EMA (endomysial antibodies) — Highly specific immunofluorescence-based antibody test; used as confirmatory test and when serology alone is used without biopsy.

EMA (endomysial antibodies)Highly specific immunofluorescence-based antibody test; used as confirmatory test and when serology alone is used without biopsy

Role in no-biopsy pathwayRequired confirmatory test (positive EMA-IgA on second sample) when considering no-biopsy diagnosis in children with high TG2/TGA

InterpretationPositive EMA combined with high TG2 yields very high PPV for celiac disease

inv-55: Laboratory-developed tests (LDTs) — Tests developed and validated in-house by laboratories; regulated by CMS under CLIA as high-complexity tests and not FDA-cleared or -appr...

Laboratory-developed tests (LDTs)Tests developed and validated in-house by laboratories and regulated by CMS under CLIA as high-complexity tests

FDA statusLDTs are not FDA-cleared or -approved; FDA clearance is not required for clinical use currently

Clinical implicationMany labs perform LDTs for celiac-related antibodies; verify assay validation and performance when used clinically