CurrentMedStar Family Choice, MarylandPolicy 1427

Non-Invasive Prenatal Aneuploidy and Other Prenatal Genetic Testing

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This policy governs coverage and authorization requirements for non-invasive prenatal screening for fetal aneuploidy and other prenatal genetic testing in Maryland. Routine screening for trisomies 13, 18, and 21 is available without prior authorization under specified conditions; testing beyond those screens requires prior authorization.

Policy Summary

PayerMedStar Family Choice, Maryland

PolicyNon-Invasive Prenatal Aneuploidy and Other Prenatal Genetic Testing

Policy CodePolicy N/A

Change TypeMaterial coverage and authorization updates

Effective DateJuly 2025

Next Review DateJuly 2026

Key ActionOrder routine screening through LabCorp or Myriad using the specified test configuration to avoid prior authorization.

SourceLink

POLICY UPDATE CHANGES

Whole exome sequencing was added as an exclusion from coverage in the July 2024 revision.

Additional exclusions from coverage were added in the July 2023 revision.

The July 2023 revision clarified when advanced prenatal genetic testing will be considered.

The Myriad order form was added as Attachment A in July 2022.

The July 2026 review recorded no changes.

3Routine aneuploidies screened without prior authorization

10 weeks

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CurrentMedStar Family Choice, MarylandPolicy 1427

Non-Invasive Prenatal Aneuploidy and Other Prenatal Genetic Testing

Customize your policy alerts

Sign up for medstarfamilychoicemaryland Policy 1427 alerts

Get alerted when Policy 1427 changes without checking for updates manually.

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Policy Summary

PayerMedStar Family Choice, Maryland

PolicyNon-Invasive Prenatal Aneuploidy and Other Prenatal Genetic Testing

Policy CodePolicy N/A

Change TypeMaterial coverage and authorization updates

Effective DateJuly 2025

Next Review DateJuly 2026

Key ActionOrder routine screening through LabCorp or Myriad using the specified test configuration to avoid prior authorization.

SourceLink

POLICY UPDATE CHANGES

Whole exome sequencing was added as an exclusion from coverage in the July 2024 revision.

Additional exclusions from coverage were added in the July 2023 revision.

The July 2023 revision clarified when advanced prenatal genetic testing will be considered.

The Myriad order form was added as Attachment A in July 2022.

The July 2026 review recorded no changes.

3Routine aneuploidies screened without prior authorization

10 weeks

Earliest gestational age for routine screening

Singleton onlyPregnancy type eligible for basic screening

2Contracted laboratories

8Explicitly excluded testing or indications

4CPT codes specifically addressed

Coverage Criteria

Basic Screening

Basic prenatal aneuploidy screening is available without prior authorization when all applicable conditions are met.

Basic screening eligibility

Timing and pregnancy type: Testing is performed at or after 10 weeks gestational age in a singleton pregnancy10 weeks; singleton only
First-trimester screening approach: Use ultrasound with aneuploidy screening, preferably ultrasound with NIPT, OR use traditional Quad screening, but do not use bothOne approach only
Covered screening target and configuration: Screening is limited to trisomies 13, 18, and 21 and uses the specified contracted-laboratory configurationTrisomies 13, 18, and 21; LabCorp or Myriad

Advanced Testing

Further prenatal genetic testing will be considered when all applicable requirements are met.

Advanced testing criteria

Authorization: Prior authorization is obtainedRequired
Qualified ordering pathway: The test is ordered by a Maternal Fetal Medicine Specialist OR ordered after consultation with a Genetic CounselorMaternal Fetal Medicine Specialist or Genetic Counselor
Clinical trigger: Fetal ultrasound findings show anatomic abnormalitiesAnatomic abnormality on fetal ultrasound

Out-of-Network Testing

Out-of-network laboratory testing may be approved only when all requirements are met.

Out-of-network laboratory criteria

Prior authorization is obtainedRequired for all out-of-network laboratory requests
Laboratory availability: The requested testing is not available from an in-network laboratoryUnavailable in network
Medical necessity: The requested testing is determined to be medically necessaryMedically necessary

Testing performed as a follow-up to an abnormal first- or second-trimester screening is excluded from coverage.

Testing for low fetal fraction on the initial NIPT is excluded from coverage. Counseling and diagnostic testing are recommended in this situation.

Testing in cases of a known co-twin demise, also referred to as vanishing twin syndrome, is excluded from coverage.

Screening for trisomies other than 21, 18, and 13 is excluded from coverage.

Screening for single-gene disorders is excluded from coverage.

Whole-genome NIPT is excluded from coverage.

Whole exome sequencing is excluded from coverage.

Testing used to determine the genetic cause of miscarriage or fetal demise is excluded from coverage, including testing associated with missed abortion or incomplete abortion.

For advanced testing through LabCorp, the specified covered configuration is MaterniT21 Genome Add On, test #452104 or #452114 when a redraw is needed. Any other version of LabCorp MaterniT21 duplicates the original screening test and is not medically necessary.

Coding and Test Specifications

Prenatal testing without prior authorizationCPTCovered

81420	Fetal chromosomal aneuploidy (e.g., trisomy 21, monosomy X) genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18, and 21
81507	Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy

Prenatal testing requiring prior authorizationCPTCovered

81422	Fetal chromosomal microdeletion(s) genomic sequence analysis (e.g., DiGeorge syndrome, Cri-du-chat syndrome), circulating cell-free fetal DNA in maternal blood
81479	Unlisted molecular pathology procedure

Specified LabCorp basic screening testmixedCovered

451927

LabCorp MaterniT21 PLUS Core + SCA

Specified LabCorp advanced testingmixedCovered

452104	LabCorp MaterniT21 Genome Add On
452114	LabCorp MaterniT21 Genome Add On if redraw is needed

Gestational Age for Basic Screening

Minimum gestational ageStarting at 10 weeks gestational age

Screening typePrenatal screening for fetal aneuploidy

Authorization status when eligibleAvailable without prior authorization when applicable basic-screening requirements are met

Pregnancy Type for Basic Screening

Eligible pregnancy typeSingleton pregnancy only

Contracted laboratoriesLabCorp and Myriad

Provider Actions and Authorization Guidance

Note

Routine Trisomy Screening: No Prior Authorization

Routine non-invasive prenatal screening for trisomies 13, 18, and 21 is available without prior authorization for pregnant women beginning at 10 weeks' gestation when the pregnancy is singleton. Ultrasound with NIPT is preferred; first-trimester screening should include ultrasound plus aneuploidy screening or traditional quad screening, but not both.

Routine screening is limited to singleton pregnancies beginning at 10 weeks' gestational age.
CPT 81420 and CPT 81507 require no prior authorization for prenatal testing when used for trisomies 13, 18, and 21.

Billing Rule

LabCorp Routine Test Configuration

For LabCorp routine screening, order the exact MaterniT21 PLUS Core + SCA configuration. This configuration reports trisomies 21, 18, and 13, sex chromosome aneuploidy, and fetal sex; any other LabCorp test requires prior authorization.

Policy Background

This policy addresses non-invasive prenatal screening using cell-free fetal DNA in maternal blood for common fetal aneuploidies. Routine screening focuses on trisomies 13, 18, and 21; additional genomic or microdeletion testing is limited to cases with relevant fetal ultrasound findings and requires specialist or genetic counselor involvement. Testing categories and indications specifically excluded from coverage are also identified.

Definitions

First Trimester Screening

DefinitionA prenatal screening approach using an ultrasound and aneuploidy screening or traditional Quad screening

Sequencing limitationUse ultrasound with aneuploidy screening OR traditional Quad screening, but not both

Preferred methodUltrasound with NIPT is the preferred method

Advanced Testing

DefinitionTesting beyond basic non-invasive screening for trisomies 13, 18, and 21

When consideredWhen fetal ultrasound findings show anatomic abnormalities

Authorization requirement

Covered Indications

Prenatal Non-Invasive Screening for Trisomies 13, 18, and 21

Covered without prior authorization when the pregnancy, timing, screening approach, and test configuration requirements are all met.

Covered basic prenatal screening

Pregnancy and timing: The pregnancy is singleton and testing is performed at or after 10 weeks gestational ageSingleton pregnancy; at least 10 weeks gestational age
Permitted screening approach: First-trimester screening uses ultrasound with aneuploidy screening, preferably ultrasound with NIPT, OR uses traditional Quad screening, but not bothOne approach only
Permitted contracted-laboratory configuration:

Eligibility Requirements

For routine prenatal screening, testing must be performed at or after 10 weeks’ gestational age in a singleton pregnancy. First-trimester screening should use either ultrasound with aneuploidy screening—preferably ultrasound with NIPT—or traditional Quad screening, but not both. Second-trimester screening should include a detailed anatomic ultrasound and an alpha-fetoprotein level. Advanced testing is considered when fetal ultrasound findings show anatomic abnormalities and requires the applicable prior authorization, ordering, consultation, and documentation requirements.

Not Covered

The following testing categories are not covered: screening for trisomies other than 13, 18, and 21; screening for single-gene disorders; whole-genome NIPT; whole exome sequencing; testing after an abnormal first- or second-trimester screen; testing for low fetal fraction on initial NIPT; testing in a known co-twin demise or vanishing twin syndrome; and testing to determine the genetic cause of miscarriage or fetal demise. Any LabCorp MaterniT21 version other than the specified Genome Add On is not medically necessary because it duplicates the original screening test.

Policy Summary

PayerMedStar Family Choice, Maryland

PolicyNon-Invasive Prenatal Aneuploidy and Other Prenatal Genetic Testing

Policy CodePolicy N/A

Change TypeMaterial coverage and authorization updates

Effective DateJuly 2025

Next Review DateJuly 2026

Key ActionOrder routine screening through LabCorp or Myriad using the specified test configuration to avoid prior authorization.

SourceLink

On This Page

Required documentation: The request documents the reason for testing, the condition suspected, and the anticipated actions or change in clinical management based on the outcome of testingComplete clinical rationale and management plan

Routine screening targetFetal aneuploidy screening for chromosomes 13, 18, and 21

LabCorp Advanced Testing Resolution

Qualifying LabCorp testMaterniT21 Genome Add On, LabCorp test #452104, or #452114 if redraw is needed

Chromosome-material analysisDeletions or duplications of chromosome material 7 Mb or larger, including comprehensive chromosome copy number analysis and unbalanced derivatives

Microdeletion analysisAnalysis of seven clinically relevant microdeletions less than 7 Mb in size

LabCorp test #451927
Do not substitute another MaterniT21 configuration for routine screening.

Billing Rule

Myriad Prequel Routine Test Configuration

For Myriad Prequel routine screening, select both required options on the order form: Common aneuploidy, chromosome 13, 18, 21 and Include sex chromosome analysis. When both selections are made, prior authorization is not required; any other configuration requires prior authorization.

Use the Myriad Prequel Prenatal Screen—Noninvasive prenatal screen order form.
The common-aneuploidy and sex-chromosome selections must both be checked.

Prior Authorization

Advanced Testing Requires Prior Authorization

Advanced prenatal genetic testing requires prior authorization and must be ordered by a Maternal Fetal Medicine specialist or performed after consultation with a Genetic Counselor. Requests should generally be supported by fetal ultrasound findings showing anatomic abnormalities and must include the required clinical documentation.

LabCorp qualifying configuration: MaterniT21 Genome Add On, test #452104, or #452114 if a redraw is needed.
The LabCorp Genome Add On provides comprehensive chromosome copy-number analysis, including unbalanced derivatives, deletions or duplications of chromosome material 7 Mb or larger, and seven clinically relevant microdeletions smaller than 7 Mb.
For Myriad, check only the microdeletions box for a singleton pregnancy.
CPT 81422 and CPT 81479 require prior authorization; CPT 81479 may be used only for NIPT testing.
Any other MaterniT21 version duplicates the original screening test and is not medically necessary.

Prior Authorization

Out-of-Network Laboratory Testing

Requests for testing at an out-of-network laboratory require prior authorization. Approval is limited to cases in which the requested testing is unavailable from an in-network laboratory and is determined to be medically necessary.

LabCorp and Myriad are the contracted in-network laboratories.

Unsupported block type: documentation},{

Documentation Required

Clinical Rationale and Management Impact

The submitted medical record must explain why the test is being requested, identify the condition suspected, and state the anticipated action or change in clinical management that will result from the test outcome.

Document the clinical rationale for testing.
Document how the result will affect treatment, surveillance, delivery planning, referral, or other clinical management.

Documentation Required

Out-of-Network Medical Necessity

For out-of-network laboratory requests, document both that the requested test is unavailable through an in-network laboratory and that the test is medically necessary for the member's clinical circumstances.

Both availability and medical-necessity documentation are required for approval.

Unsupported block type: denial_risk

Denial Risk

Excluded Testing and Indications

The following circumstances are excluded from coverage under the MDH NIPT clinical criteria.

Testing as follow-up to an abnormal first- or second-trimester screening.
Low fetal fraction on initial NIPT testing.
Known co-twin demise or vanishing twin syndrome.
Screening for trisomies other than 21, 18, and 13.
Screening for single-gene disorders.
Whole-genome NIPTs.
Whole-exome sequencing.
Testing to determine the genetic cause of miscarriage or fetal demise, including missed or incomplete abortion.

Prior Authorization

Out-of-Network Laboratory Limitation

Out-of-network laboratory approval is available only when the requested testing is not available from an in-network laboratory and the testing is medically necessary. Prior authorization is required for every out-of-network laboratory request.

Route testing to LabCorp or Myriad whenever the needed service is available there.
Submit documentation of in-network unavailability and medical necessity.

Denial Risk

Duplicate MaterniT21 Testing

Unspecified or alternative MaterniT21 versions beyond the approved LabCorp routine configuration are not medically necessary when they duplicate the original screening test. Advanced LabCorp testing must use the qualifying Genome Add On configuration.

Routine: MaterniT21 PLUS Core + SCA, test #451927.
Advanced: MaterniT21 Genome Add On, test #452104, or #452114 if redraw is needed.
Any other MaterniT21 version is considered duplicative of the original screening test.

Documentation Required

Provider Actions: Consultation and Low Fetal Fraction

For advanced testing, obtain and retain evidence of Maternal Fetal Medicine or Genetic Counselor consultation, document the suspected condition and management impact, and counsel members that low fetal fraction on an initial NIPT is excluded from coverage.

Counseling and diagnostic testing are recommended when initial NIPT has low fetal fraction.
Do not submit low-fetal-fraction redraws as covered routine screening without addressing the exclusion and applicable clinical pathway.

Prior Authorization

Provider Actions: Routing and Ordering

OB/GYN providers must route prenatal samples to MedStar Family Choice's contracted laboratories, LabCorp or Myriad, and select the exact approved configuration for the clinical indication. Obtain prior authorization before ordering advanced, nonstandard, or out-of-network testing.

Routine LabCorp: MaterniT21 PLUS Core + SCA, test #451927.
Routine Myriad: select common aneuploidy for chromosomes 13, 18, and 21 plus include sex chromosome analysis.
Advanced LabCorp: MaterniT21 Genome Add On, test #452104 or #452114 if redraw is needed.
Advanced Myriad: select only microdeletions for a singleton pregnancy.
Submit consultation, suspected-condition, clinical-rationale, and management-impact documentation with advanced-testing requests.

Requires prior authorization and must be ordered by a Maternal Fetal Medicine Specialist or after consultation with a Genetic Counselor

Documentation requirementRecords must state the reason for testing, suspected condition, and anticipated actions or change in clinical management based on the result

Known Co-Twin Demise

Known co-twin demiseA case in which one co-twin has died and is no longer developing

Alternate termVanishing twin syndrome

Coverage statusTesting in cases with a known co-twin demise or vanishing twin syndrome is excluded from coverage

For LabCorp, the exact test ordered is MaterniT21 PLUS Core + SCA, test #451927 OR, for Myriad Prequel, the Common aneuploidy boxes for chromosomes 13, 18, and 21 and Include sex chromosome analysis are selected

LabCorp #451927 or specified Myriad Prequel configuration

Contracted laboratory: The sample is sent to LabCorp or MyriadIn-network laboratory

Advanced Prenatal Genetic Testing for Fetal Ultrasound Anatomic Abnormalities

Advanced prenatal genetic testing may be considered when all authorization, clinical, consultation, and documentation requirements are met.

Advanced testing for fetal anatomic abnormalities

Prior authorization is obtainedRequired
Qualified specialist involvement: The testing is ordered by a Maternal Fetal Medicine Specialist OR is ordered after consultation with a Genetic CounselorMaternal Fetal Medicine Specialist or Genetic Counselor
Consultation evidence: The request includes evidence of consultation with a Maternal Fetal Medicine Specialist or Genetic Counselor
Clinical documentation: The medical records state the reason for testing and the condition suspected
Management impact: The medical records describe the anticipated actions or change in clinical management based on the testing outcome