CurrentUnitedHealthcarePolicy CS151KY.07

Carrier Testing Panels for Genetic Diseases (for Kentucky Only)

Defines medical policy for carrier genetic screening panels for reproductive purposes in Kentucky, including which panel sizes/indications are considered medically necessary versus not medically necessary, recommendations for pre-test counseling, and lists applicable procedure codes for reference.

Policy Summary

PayerUnitedHealthcare

PolicyCarrier Testing Panels for Genetic Diseases (for Kentucky Only)

Policy CodePolicy CS151KY.07

Change TypeRevised definition and supporting information (07/01/2025)

Effective DateJul 1, 2025

Next Review Date

Key ActionPre-test genetic counseling is strongly recommended to inform persons about advantages and limitations of testing prior to carrier screening.

SourceLink

POLICY UPDATE CHANGES

Updated definition of 'Gene Panel' and supporting sections (Clinical Evidence, FDA, References) on 07/01/2025; previous policy version CS151KY.06 archived.

6Unrestricted Covered Panel Size (genes)

15Conditional Covered Panel Size (genes)

16+Not Medically Necessary Panel Size (genes)

CF/SMA/HemoglobinopathyKey ACOG Recommendations

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Coverage Summary

This policy (Policy Number CS151KY.07) is effective July 1, 2025 and defines UnitedHealthcare’s coverage approach for reproductive carrier genetic screening panels for Kentucky members. The policy applies only within the state of Kentucky and establishes which panel sizes and indications are considered medically necessary versus not medically necessary, and it lists referenced procedure codes for informational purposes.

Coverage is structured by panel size: panels of up to 6 genes are considered proven and medically necessary; panels of up to 15 genes are conditionally covered when the individual or their reproductive partner meets at least one qualifying criterion (documented Ashkenazi Jewish ancestry or an affected First- or Second-Degree Relative for a condition on the panel); and panels comprised of 16 or more genes are considered unproven and not medically necessary. The policy strongly recommends pre-test genetic counseling to inform persons about advantages and limitations of testing and ties provider requirements (e.g., prior authorization or documentation) to these panel-size rules.

Key thresholds and guidance

Unrestricted Covered Panel Size (genes)6

Conditional Covered Panel Size (genes)15 (requires Ashkenazi Jewish ancestry OR an affected first- or second-degree relative)

Not Medically Necessary Panel Size (genes)16+

Carrier frequency thresholdsACOG suggests disorders with carrier frequency > 1/100; ACMG tiering uses ≥1/200 and ≥1/100 thresholds

ACOG guidance (highlight)Offer CF, SMA, and hemoglobinopathy screening to all pregnant/planning individuals; consider ECS for disorders with carrier frequency >1/100 and well-defined early-onset severe phenotypes

ACMG guidance (highlight)Tiered approach (Tier 1: CF+SMA; Tier 2: ≥1/100; Tier 3: ≥1/200 incl. X-linked; Tier 4: <1/200 reserved for consanguinity/family history)

NSGC summary (highlight)Conditional recommendation to offer ECS to all individuals considering reproduction, with shared decision-making; recommendation is conditional based on balance of benefits/harms

Medical Necessity Criteria

Reproductive Carrier Screening Coverage

Covered when ALL of the following are met:

ALL of the following

Panel size - covered options
- Reproductive Carrier Screening Panels of up to six genes are proven and medically necessary
- ANY of the following
  - Eligibility for up to 15-gene panel
    Ashkenazi Jewish ancestry (individual/reproductive partner has at least one parent or grandparent of Ashkenazi Jewish descent)
    A biological First- or Second-Degree Relative has been affected by one or more of the conditions evaluated by the Panel

Guideline-based Recommendations & Rationale

Guideline-based Recommendations for Offering Carrier Screening

Professional societies' recommendations summarized; these inform coverage stance and criteria:

ALL of the following

ACOG recommendations
- Offer hemoglobinopathy testing to all individuals planning a pregnancy or at the first prenatal visit if no prior testing has been performed (hemoglobin electrophoresis or molecular genetic testing).
- Offer carrier screening for cystic fibrosis (CF), spinal muscular atrophy (SMA), and complete blood count and screening for thalassemias and hemoglobinopathies to all individuals who are pregnant or considering pregnancy.
- If ECS is considered, consensus-driven criteria should be met: disorder carrier frequency > 1/100; well-defined phenotype with detrimental effect on quality of life and early onset; diagnosable prenatally with potential antenatal interventions; panels should not include adult-onset conditions.

Coding

Referenced Procedure Codesmixed

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 genomic sequence analysis panel, must include sequencing of at least 9 genes (e.g., ASPA, BLM, CFTR, FANCC, GBA, HEXA, IKBKAP, MCOLN1, SMPD1).
81443	Genetic testing for severe inherited conditions genomic sequence analysis panel, must include sequencing of at least 15 genes (examples listed).
81479	Unlisted molecular pathology procedure

Provider Actions & Billing Impact

Prior Authorization

Prior Authorization / Coverage Limits for Panel Size

Panels up to 6 genes: coverage is allowed as proven and medically necessary. Panels of 7–15 genes: coverage is allowed only when there is documented Ashkenazi Jewish (AJ) ancestry for the individual or their reproductive partner, or when a biological first- or second-degree relative is known to be affected by one or more of the conditions on the panel. Panels of 16 or more genes: not medically necessary and not covered.

Affected codes: 0400U, 81412, 81443, 81479
Coverage: up to 6 genes generally covered
7–15 genes: covered only with documented AJ ancestry or affected 1st/2nd-degree relative
16+ genes: not medically necessary / not covered

Documentation Required

Pre-test Genetic Counseling Recommended

Pre-test genetic counseling is strongly recommended prior to carrier screening. Document that counseling occurred in the medical record, including discussion of test purpose, limitations, potential outcomes (including variants of uncertain significance), and reproductive implications.

Definitions & Evidence Summary

Definitions provided in the policy include: Carrier Screening — genetic testing performed on an asymptomatic individual to determine whether they may have a variant that could be passed to biological children; First-Degree Relative — parents, siblings, and children; Second-Degree Relative — half siblings, aunts, uncles, grandparents, grandchildren, and nieces/nephews.

Gene Panel — a testing panel that looks for genetic changes/variants in more than one gene in the same test. Note: the definition of 'Gene Panel' was updated in the Summary of Changes dated 07/01/2025.

Expanded Carrier Screening (ECS) — screening panels that test multiple autosomal recessive and X-linked conditions across populations rather than ethnicity-based targeted panels; and Tiered carrier screening (ACMG) — ACMG’s categorization of panels by carrier frequency thresholds (Tiers 1–4) to guide condition inclusion and offering.

Evidence highlights

Study sample sizes referencedExamples include 346,790 individuals screened (Haque et al. 2016) and 9,138 participants (Shraga et al. 2017); other large cohorts: 381,014 (Westemeyer et al. 2020), 460,608 (Johansen Taber et al. 2022)

Genome sequencing reportingGenome sequencing arm reported on 728 conditions (NextGen study); 78% of participants had at least one finding; median genetic counselor prep time 64 minutes

Revision History

2025-07-01Summary of ChangesLatest

Updated definition of 'Gene Panel' and supporting sections (Clinical Evidence, FDA, References) on 07/01/2025; previous policy version CS151KY.06 archived.

Policy Metadata

Status & Scope

Policy Summary

PayerUnitedHealthcare

PolicyCarrier Testing Panels for Genetic Diseases (for Kentucky Only)

Policy CodePolicy CS151KY.07

Change TypeRevised definition and supporting information (07/01/2025)

Effective DateJul 1, 2025

Next Review Date

Key ActionPre-test genetic counseling is strongly recommended to inform persons about advantages and limitations of testing prior to carrier screening.

SourceLink

On This Page

Pre-test genetic counseling is strongly recommended to inform persons being tested about advantages and limitations of the test

Not Medically Necessary / Unproven

The following are unproven and not medically necessary:

ALL of the following

ALL of the following
- Reproductive Carrier Screening Panels comprised of 16 or more genes
- Carrier Screening for all other indications

For Ashkenazi Jewish descent individuals, offer screening for Canavan disease, CF, Familial Dysautonomia, Tay-Sachs; consider more comprehensive AJ panels per expert guidance.

ACMG recommendations

Use a tiered approach: Tier 1: CF + SMA + risk-based screening; Tier 2: >=1/100 carrier frequency (includes Tier 1); Tier 3: >=1/200 carrier frequency (includes Tier 2 and X-linked); Tier 4: <1/200 carrier frequency (include only for consanguinity or family history).
Promote ethnic/population neutral paradigms; recommend Tier 3 for all pregnant patients and those planning pregnancy.

NSGC recommendation

Offer ECS to all individuals considering reproduction, pregnant individuals, their partners and contributors to pregnancy; decision via shared decision-making; recommendation is conditional based on balance of benefits/harms.

RCOG position

Insufficient evidence to recommend routine testing of all prospective parents; targeted screening appropriate for high-risk individuals; lack of standardization across ECS panels and need for clinician genetics expertise for interpretation.

Carrier screening is used to identify individuals or reproductive partners at risk of having a child with autosomal recessive or X-linked conditions and may impact reproductive decision-making; modern molecular methods such as next-generation sequencing (NGS) enable multigene panel testing. Professional societies (ACOG, ACMG, NSGC, RCOG) inform the policy’s stance by recommending routine screening for specific conditions (notably cystic fibrosis, spinal muscular atrophy, and hemoglobinopathies) while offering differing guidance on the scope of expanded carrier screening (ECS) and the thresholds for condition inclusion.

Provider guidance in the policy emphasizes the importance of genetics expertise and counseling: genetic counseling is strongly recommended prior to testing, providers should understand the specific ECS panel being used and ensure appropriate interpretation by clinicians with genetics knowledge, and laboratories are regulated under CLIA. The policy clarifies that FDA clearances are provided for informational purposes only and that FDA approval alone is not a basis for coverage determinations.

This Medical Policy applies only to Kentucky (Kentucky community plan) and coverage decisions must also reference applicable federal, state, or contractual plan requirements which govern in the event of conflict.

Document counseling in the medical record
Recommended before ordering carrier panels

Documentation Required

Genetic Counseling and Shared Decision‑Making

Genetic counseling should be offered to all individuals undergoing carrier screening as part of shared decision-making. Document counseling, informed consent discussion, and any patient decisions (including declines) in the medical record.

Shared decision-making with documented counseling for all individuals undergoing carrier screening
Record whether counseling was provided by a genetics professional or other qualified clinician

Documentation Required

Panel Results: Interpretation and Follow‑Up

Ensure that clinicians interpreting expanded carrier screening (ECS) results have appropriate genetics expertise. Providers are responsible for obtaining specialist interpretation or referral when needed and for documenting interpretation and follow-up recommendations.

Results interpretation should involve clinicians with genetics expertise as appropriate
Document interpretation and recommended follow-up in the record

Billing Rule

Laboratory Regulation Requirement

Laboratory testing must be performed in a CLIA-certified laboratory. FDA clearance or approval of a test is informational only and is not a substitute for CLIA regulation when making coverage determinations.

CLIA certification is required for covered testing
FDA clearance is informational only for coverage decisions

Prior Authorization

Refer to State/Federal Contractual Requirements

State and federal contractual requirements may affect coverage and prior authorization requirements. Verify benefits, medical necessity rules, and prior authorization policies per the member’s plan and applicable state/federal mandates before ordering testing.

Follow state/federal contractual requirements and plan-specific prior authorization rules
Coverage determinations may vary by contract and regulatory requirements