CurrentArizona Complete HealthPolicy N/A

Concert Genetic Testing: Endocrinology — Monogenic Diabetes (MODY) Panels

Defines medical necessity criteria for genetic testing panels used to diagnose monogenic diabetes (including MODY) and related endocrine genetic tests for members of Arizona Complete Health. Applies to providers ordering Concert genetic tests for endocrine indications.

Policy Summary

PayerArizona Complete Health

PolicyConcert Genetic Testing: Endocrinology — Monogenic Diabetes (MODY) Panels

Policy CodePolicy N/A

Change TypeCriteria revisions and age-threshold updates

Effective Date

Next Review Date

Key ActionObtain prior authorization when the policy criteria for multigene panel testing for monogenic diabetes are met.

SourceLink

POLICY UPDATE CHANGES

Changed requirement from diabetes diagnosis within first 6 months of life to within the first 12 months of life for neonatal testing.

Changed age cutoff for testing from diagnosis before age 35 years to diagnosis before age 30 years.

Removed requirement for specific gene inclusion in panels and reworded antibody and C-peptide criteria to be less prescriptive.

New policy created to separate endocrine genetic testing from prior metabolic/endocrine/mitochondrial policy.

1Distinct criteria sets

≥12mNeonatal age threshold

30Upper age cutoff

Policy Summary

PayerArizona Complete Health

PolicyConcert Genetic Testing: Endocrinology — Monogenic Diabetes (MODY) Panels

Policy CodePolicy N/A

Change TypeCriteria revisions and age-threshold updates

Effective Date

Next Review Date

Key ActionObtain prior authorization when the policy criteria for multigene panel testing for monogenic diabetes are met.

SourceLink

On This Page

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Coverage Criteria — Monogenic Diabetes and Related Panels

Monogenic Diabetes (Including MODY) Panels

Multigene panel analysis to establish or confirm a diagnosis of monogenic diabetes (including MODY) is considered medically necessary when:

Primary indications: A. Diagnosis of diabetes within the first 12 months of lifeage <= 12 months

neonatal diabetes indication

Younger-onset pathway

At least one of: a) Autoantibody negative
At least one of: b) Retained C-peptide levels

Atypical diabetes with family history: C. Diagnosis of diabetes not characteristic of type 1 or type 2 diabetes AND family history consistent with an autosomal dominant pattern of inheritanceclinical phenotype and family history

MODY suspicion with autosomal dominant pattern

Unsupported / investigational uses

Not supported indications

Other indications: Current evidence does not support multigene panel analysis to establish or confirm a diagnosis of monogenic diabetes (MODY) for all other indicationsN/A

investigational/unproven for unspecified indications

This policy addresses the scope and limits for use of multigene panel analysis to diagnose monogenic forms of diabetes (including MODY). Multigene panels are considered medically necessary only when they are used to establish or confirm a diagnosis in patients who meet the specific criteria listed in the policy — for example, a diabetes diagnosis within the first 12 months of life; a diagnosis before 30 years of age combined with supportive features such as autoantibody negativity or retained C‑peptide; or a diabetes phenotype not characteristic of type 1 or type 2 diabetes with an autosomal dominant family history. The policy does not require panels to include predefined gene lists and intentionally removes prescriptive numeric laboratory cutoffs to align with current evidence and guideline updates.

Routine or reflex use of multigene panels for monogenic diabetes outside the defined criteria is not supported by current evidence. The policy explicitly states that multigene panel analysis is not supported for all other indications beyond the specific criteria described, and such testing should not be performed routinely when the listed clinical thresholds and indications are not met.

Coding and Key Clinical Thresholds

Referenced CPT and ICD-10 Codesmixed

81403	tiered molecular multigene panel (as referenced in policy)
81405	tiered molecular multigene panel (as referenced in policy)
81406	tiered molecular multigene panel (as referenced in policy)
81407	tiered molecular multigene panel (as referenced in policy)
81479	unlisted molecular pathology procedure (as referenced in policy)
E10	Type 1 diabetes mellitus (ICD-10 listed in table)
E11	Type 2 diabetes mellitus (ICD-10 listed in table)
E16.1	Other hypoglycemia (ICD-10 listed in table)
E16.2	Hypoglycemia, unspecified (ICD-10 listed in table)

Age at diabetes diagnosis for neonatal testing

ThresholdDiagnosis of diabetes within the first 12 months of life

PurposeQualifies the member for immediate consideration of multigene panel testing for neonatal monogenic diabetes

Policy changePreviously required diagnosis within first 6 months; updated to first 12 months (Revision Date 01/24)

Upper age for one testing pathway

ThresholdDiagnosis of diabetes before 30 years of age

Associated requirementsPlus at least one of: autoantibody negative OR retained C-peptide levels (per policy criteria)

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed CPT multigene panel codes when medical necessity criteria are met. Submit prior authorization requests with relevant clinical information that demonstrates how the member meets the policy criteria (for example: age at diagnosis, antibody status, C‑peptide results, family history, and indication). Authorization is actionable only when the submitted documentation supports the policy's medical necessity requirements.

Affected tests: multigene panel CPT codes referenced in this policy (see code table or Concert Platform).
Authorization must be obtained prior to claim submission for services requiring PA.

Billing Rule

Coding and Coverage Caveat

Providers must ensure appropriate coding and understand that listing a CPT code in this policy does not guarantee coverage. Verify coding and coverage with the most current professional coding resources and the payer prior to claim submission. Use the Concert Platform or payer-specific guidance for up-to-date test registries and coverage status.

Background and Scope

This policy covers genetic testing to evaluate monogenic causes of diabetes, including neonatal diabetes and maturity‑onset diabetes of the young (MODY). The rationale reflects recent updates to align with guideline and evidence reviews: age thresholds were revised to require diagnosis within the first 12 months for neonatal testing and diagnosis before 30 years for one younger‑onset pathway; antibody and C‑peptide language was clarified rather than using strict numeric cutoffs; and panel composition is no longer prescriptive. Pre‑test and post‑test genetic counseling and clinical documentation of age at diagnosis, antibody status, C‑peptide, family history, and atypical phenotype are strongly advised.

Definitions

Monogenic diabetes / MODY — definition and typical clinical presentation

DefinitionDiabetes caused by a pathogenic single-gene variant, including maturity-onset diabetes of the young (MODY)

Typical presentationOften presents early in life and may show an autosomal dominant family history across successive generations

Clinical cluesFeatures suggesting monogenic diabetes include diagnosis in infancy or early adulthood, absence of typical T1D/T2D features, autoantibody negativity, or retained C-peptide

Guideline supportADA and ISPAD recommend genetic testing for infants diagnosed very early and for those with family histories or atypical presentations