ModifiedUnitedHealthcarePolicy CS151KY.08

Carrier Testing Panels for Genetic Diseases (for Kentucky Only)

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This policy governs coverage of reproductive carrier screening and carrier testing panels for UnitedHealthcare Community Plan members in Kentucky, with medical necessity determined by panel size, reproductive context, ancestry, family history, and applicable Kentucky statutory criteria.

Policy Summary

PayerUnitedHealthcare

PolicyCarrier Testing Panels for Genetic Diseases (for Kentucky Only)

Policy CodePolicy CS151KY.08

Change TypeModified

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionDocument relevant medical history, physical examination findings, and pertinent diagnostic results to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

The policy added instruction to refer to Kentucky Revised Statutes § 304.17A-263 for medical-necessity clinical coverage criteria.

The policy added medical-record documentation requirements for evaluating medical necessity.

The policy updated its description of services, clinical evidence, and references to reflect current information.

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ModifiedUnitedHealthcarePolicy CS151KY.08

Carrier Testing Panels for Genetic Diseases (for Kentucky Only)

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Sign up for UnitedHealthcare Policy CS151KY.08 alerts

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Policy Summary

PayerUnitedHealthcare

PolicyCarrier Testing Panels for Genetic Diseases (for Kentucky Only)

Policy CodePolicy CS151KY.08

Change TypeModified

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionDocument relevant medical history, physical examination findings, and pertinent diagnostic results to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

The policy added instruction to refer to Kentucky Revised Statutes § 304.17A-263 for medical-necessity clinical coverage criteria.

The policy added medical-record documentation requirements for evaluating medical necessity.

The policy updated its description of services, clinical evidence, and references to reflect current information.

KentuckyApplicable state

Up to 6 genesCovered panel size without additional qualifying risk criteria

Up to 15 genesCovered panel size with qualifying ancestry or family history

16+ genesPanel size considered unproven and not medically necessary

§ 304.17A-263Kentucky biomarker-testing statute

Medical Necessity and Coverage Criteria

State-Specific Criteria

For medical necessity clinical coverage criteria, refer first to Kentucky Revised Statutes (KRS) § 304.17A-263, Coverage Under Health Benefit Plan for Biomarker Testing. When medical necessity cannot be determined using those criteria, refer to the criteria listed below.

Medical necessity is determined in accordance with KRS § 304.17A-263.

Reproductive Carrier Screening Panels Up to 6 Genes

Reproductive Carrier Screening panels of up to six genes are covered when the following criterion is met:

The requested Reproductive Carrier Screening panel comprises no more than six genes.

Reproductive Carrier Screening Panels Up to 15 Genes

Reproductive Carrier Screening panels of up to 15 genes are covered when all of the following criteria are met:

ALL of the following

The requested Reproductive Carrier Screening panel comprises no more than 15 genes.
At least ONE of the following
- The individual and/or their reproductive partner has Ashkenazi Jewish ancestry, defined as having at least one parent or grandparent of Ashkenazi Jewish descent.
- A biological first-degree relative or second-degree relative of the individual and/or their reproductive partner has been affected by one or more conditions evaluated by the panel.

Kentucky State-Specific Medical Necessity Criteria

Kentucky-specific medical necessity criteria apply before the policy criteria. When medical necessity cannot be determined using the Kentucky statutory criteria, apply the policy criteria listed in this section.

Apply KRS § 304.17A-263 first. If the statutory criteria do not determine medical necessity, apply the applicable UnitedHealthcare policy criteria.

Carrier screening for indications other than the covered Reproductive Carrier Screening indications is unproven and not medically necessary due to insufficient evidence of efficacy.

FDA approval or clearance alone is not a basis for coverage.

Reproductive Carrier Screening panels comprising 16 or more genes are unproven and not medically necessary due to insufficient evidence of efficacy.

Carrier Screening for all other indications is unproven and not medically necessary due to insufficient evidence of efficacy.

Covered Reproductive and Prenatal Screening Indications

Reproductive Carrier Screening Using a Panel of Up to Six Genes

Considered proven and medically necessary when the following criterion is met.

Panel-size requirement: The requested service is reproductive carrier screening using a panel containing no more than six genes.Up to 6 genes

Reproductive Carrier Screening Using a Panel of Up to 15 Genes With Qualifying Ashkenazi Jewish Ancestry

Considered proven and medically necessary when all of the following are met.

Ashkenazi Jewish ancestry criterion

Panel size: The requested service is reproductive carrier screening using a panel containing no more than 15 genes.Up to 15 genes

Eligibility Requirements

For reproductive carrier screening panels containing up to 15 genes, eligibility may be established when a biological first-degree or second-degree relative has been affected by one or more conditions evaluated by the panel. The affected relative must be biological and within the specified degree of relationship.

ACOG recommends hemoglobinopathy testing at the first prenatal visit or when planning pregnancy if the individual has not had prior hemoglobinopathy testing. Testing may use hemoglobin electrophoresis or molecular genetic testing.

Procedure Codes and Panel Parameters

Applicable procedure codesCPT

0400U	Obstetrics (expanded carrier screening), 145 genes by next generation sequencing, fragment analysis and multiplex ligation dependent probe amplification, DNA, reported as carrier positive or negative.
81412	Ashkenazi Jewish associated disorders (e.g., Bloom syndrome, Canavan disease, cystic fibrosis, familial dysautonomia, Fanconi anemia group C, Gaucher disease, Tay-Sachs disease), genomic sequence analysis panel, must include sequencing of at least 9 genes, including ASPA, BLM, CFTR, FANCC, GBA, HEXA, IKBKAP, MCOLN1, and SMPD1.
81443	Genetic testing for severe inherited conditions (e.g., cystic fibrosis, Ashkenazi Jewish-associated disorders [e.g., Bloom syndrome, Canavan disease, cystic fibrosis, Fanconi anemia type C, mucol ความidosis type VI, Gaucher disease, Tay-Sachs disease], beta hemoglobinopathies, phenylketonuria, galactosemia), genomic sequence analysis panel, must include sequencing of at least 15 genes (e.g., ACADM, ARSA, ASPA, ATP7B, BCKDHA, BCKDHB, BLM, CFTR, DHCR7, FANCC, G6PC, GAA, GALT, GBA, GBE1, HBB, HEXA, IKBKAP, MCOLN1, PAH).
81479	Unlisted molecular pathology procedure.

Reproductive carrier screening threshold

Panel sizeUp to 6 genes

ServiceReproductive carrier screening

Coverage statusProven and medically necessary

Expanded reproductive carrier screening threshold

Panel sizeUp to 15 genes

Qualifying criteriaAshkenazi Jewish ancestry or an affected biological first-degree or second-degree relative

Coverage status

Documentation and Provider Requirements

Documentation Required

Medical Necessity Documentation Required

Submit relevant medical history, physical examination findings, and pertinent diagnostic test or procedure results that support the medical necessity of the requested service.

Documentation must be maintained in the patient's medical record and made available upon request.

Documentation Required

Document Qualifying Ancestry or Family History

For a reproductive Carrier Screening panel of up to 15 genes, document qualifying Ashkenazi Jewish ancestry or an affected biological First-Degree Relative or Second-Degree Relative for one or more conditions evaluated by the panel.

Ashkenazi Jewish ancestry means the individual or reproductive partner has at least one parent or grandparent of Ashkenazi Jewish descent.

Noncovered and Unproven Services

The following are not covered under these criteria: reproductive carrier screening panels comprising 16 or more genes; carrier screening for other indications; and services supported solely by FDA approval or clearance.

Policy Background

Carrier screening is genetic testing performed in an asymptomatic individual to determine whether the person carries a genetic variant associated with a disorder that could be passed to biological children. Results may inform reproductive decision-making, with coverage for reproductive carrier screening determined primarily by the number of genes tested and qualifying ancestry or family-history risk.

Definitions and Screening Frameworks

Carrier Screening

Who is testedAn individual who does not have symptoms of a genetic disorder

What is assessedWhether the individual may have a genetic variant associated with a disorder

Reproductive relevanceThe disorder could be passed to biological children

First-Degree Relative

ParentIncluded as a first-degree relative

SiblingIncluded as a first-degree relative

ChildIncluded as a first-degree relative

Policy Summary

PayerUnitedHealthcare

PolicyCarrier Testing Panels for Genetic Diseases (for Kentucky Only)

Policy CodePolicy CS151KY.08

Change TypeModified

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionDocument relevant medical history, physical examination findings, and pertinent diagnostic results to support medical necessity.

SourceLink

On This Page

Qualifying ancestry: The individual or reproductive partner has at least one parent or grandparent of Ashkenazi Jewish descent.At least 1 parent or grandparent

Reproductive Carrier Screening Using a Panel of Up to 15 Genes With an Affected Biological Relative

Considered proven and medically necessary when all of the following are met.

Family-history criterion

Panel size: The requested service is reproductive carrier screening using a panel containing no more than 15 genes.Up to 15 genes
Affected biological relative: A biological first-degree or second-degree relative has been affected by one or more conditions evaluated by the panel.First-degree or second-degree relative

Hemoglobinopathy Testing Before or at the First Prenatal Visit

ACOG recommends offering hemoglobinopathy testing when the following conditions apply.

Hemoglobinopathy testing indication

ONE of the following reproductive-care settings
- The individual is planning a pregnancy.
- The individual is presenting for a first prenatal visit.
No prior testing for hemoglobinopathies has been performed.
Testing may be performed using hemoglobin electrophoresis or molecular genetic testing.

Carrier and Hematologic Screening During Pregnancy or When Considering Pregnancy

ACOG states that the following screening should be offered to individuals who are pregnant or considering pregnancy.

Pregnancy-related carrier and hematologic screening

ONE of the following populations
- The individual is pregnant.
- The individual is considering pregnancy.
Screening includes the applicable recommended services: Screening includes cystic fibrosis, spinal muscular atrophy, and a complete blood count, together with screening for thalassemias and hemoglobinopathies.

ACMG Tier 3 Autosomal Recessive and X-Linked Carrier Screening

ACMG recommends offering Tier 3 screening when the following population criterion is met.

ACMG Tier 3 carrier screening

ONE of the following populations
- The individual is pregnant.
- The individual is planning a pregnancy.
The requested screening evaluates Tier 3 autosomal recessive and X-linked conditions.Carrier frequency at least 1 in 200 for Tier 3 conditions
Tier 3 autosomal recessive screening may also be offered to a reproductive partner when performed simultaneously with the pregnant individual or individual planning pregnancy.

Proven and medically necessary when at least one qualifying criterion is met

Unproven reproductive carrier screening threshold

Panel size16 or more genes

Evidence statusUnproven due to insufficient evidence of efficacy

Medical necessityNot medically necessary

ACOG expanded screening threshold

Suggested carrier frequencyGreater than 1 in 100

Screening contextACOG consensus-driven criterion for conditions considered for expanded carrier screening

Additional condition characteristicThe disorder should have a well-defined phenotype and early-life onset

ACMG Tier 2 threshold

Carrier frequencyAt least 1 in 100

Tier relationshipTier 2 includes Tier 1

Tier 1 contentCystic fibrosis, spinal muscular atrophy, and risk-based screening

ACMG Tier 3 threshold

Carrier frequencyAt least 1 in 200

Tier relationshipTier 3 includes Tier 2

Conditions includedAutosomal recessive and X-linked conditions

ACMG Tier 4 threshold

Carrier frequencyLess than 1 in 200

Tier relationshipTier 4 includes Tier 3

When to considerA known or possible consanguineous relationship, such as second cousins or closer, or a relevant family or personal medical history

Documentation Required

Medical Records Must Support the Request

Legible medical records must fully support the medical necessity of the requested service. Records should be maintained in the patient's medical record and provided upon request.

Include relevant medical history, physical examination findings, and pertinent diagnostic results.

Denial Risk

Unproven Panel Size or Indication

Reproductive Carrier Screening panels comprising 16 or more genes, and Carrier Screening for other indications, are unproven and not medically necessary because of insufficient evidence of efficacy.

Coverage may be denied when the requested panel size or indication is not supported by the policy.

Denial Risk

Qualifying Criteria Required for Panels Up to 15 Genes

Panels of up to 15 genes require qualifying criteria. Document Ashkenazi Jewish ancestry or an affected biological First-Degree Relative or Second-Degree Relative with one or more conditions evaluated by the panel.

Panels of up to six genes are proven and medically necessary without these additional criteria.

Denial Risk

Insufficient Medical Records

Requests may be denied or delayed when the submitted medical records are incomplete, illegible, unavailable, or do not support medical necessity. Documentation must be maintained in the patient's medical record and made available upon request.

Note

FDA Status Alone Does Not Establish Coverage

FDA approval or clearance alone does not establish coverage for a genetic test. Coverage remains subject to the applicable benefit requirements and policy criteria.

Billing Rule

Applicable Benefit Requirements Control

Federal, state, or contractual benefit requirements and applicable laws control coverage when they require coverage for a specific service or differ from the standard benefit plan. Before applying this policy, check the applicable benefit requirements; in the event of a conflict, those requirements govern.

Medical records documentation may be required to assess clinical criteria but does not guarantee coverage.

Note

Recommend Pretest Genetic Counseling

Pretest genetic counseling is strongly recommended so individuals and reproductive partners understand the advantages, limitations, and implications of reproductive Carrier Screening.

Note

Qualified Provider Referral or Ordering

Carrier screening may be referred or ordered by a qualified health care provider. Providers should select and interpret testing in accordance with applicable clinical judgment and benefit requirements.

Gene Panel

Test scopeLooks for genetic changes or variants in more than one gene

Testing formatMultiple genes are evaluated in the same test

Use in policyCarrier screening panels are gene panels

Second-Degree Relative

Half siblingIncluded as a second-degree relative

Aunt, uncle, or grandparentIncluded as a second-degree relative

Grandchild, niece, or nephewIncluded as a second-degree relative

Expanded Carrier Screening (ECS)

Who is testedParents

Test scopeVariants in many genes

Conditions assessedA variety of recessive disorders

Reproductive Carrier Screening (RCS)

PurposeScreening for multiple genetic conditions

Population focusIndividuals or couples at reproductive risk

Clinical contextUsed to inform reproductive decision-making

High-Risk Couple

PopulationA reproductive couple

FindingThe couple has carrier findings

RiskThe findings place the couple at risk for an affected pregnancy

Autosomal Recessive Couple (ARC)

PopulationA reproductive couple

Variant statusBoth partners carry pathogenic or likely pathogenic variants in the same gene

Condition typeThe gene is associated with an autosomal recessive condition

ACMG Tiered Carrier Screening

FrameworkA tiered carrier-screening approach

Tier 1Cystic fibrosis, spinal muscular atrophy, and risk-based screening

Tier 2 through Tier 4Tier 2: at least 1 in 100; Tier 3: at least 1 in 200 and X-linked conditions; Tier 4: less than 1 in 200

Genomics-Based Carrier Screening

Testing approachReproductive carrier screening using genomic sequencing or broad genomic panels

AssessmentAssesses carrier status across many conditions

Conditions assessedMay include autosomal recessive and X-linked disorders

Pan-Ethnic Expanded Carrier Screening

Population scopeAssesses carrier status across populations

Ethnicity selectionDoes not rely on a person's self-reported ethnicity to select the testing panel

PurposeProvides a comprehensive approach to carrier screening across populations