CurrentCentenePolicy N/A

Noninvasive Prenatal Screening (NIPS) / Concert Genetic Testing

Coverage criteria for noninvasive prenatal screening (cell-free DNA testing) for common fetal aneuploidies, microdeletions, and single-gene disorders; governs use by providers ordering prenatal genetic screening for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyNoninvasive Prenatal Screening (NIPS) / Concert Genetic Testing

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionDocument that the member has a singleton or twin pregnancy and has received appropriate counseling about benefits and limitations prior to ordering NIPS.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1max cfDNA screens

T13,T18,T21,X,Yaneuploidies covered

not coveredmicrodeletions stance

not coveredsingle-gene stance

allowedtwins

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NIPS for Chromosome 13, 18, 21, X and Y Aneuploidies

NIPS for trisomy 13, 18, 21, X and Y aneuploidy may be considered medically necessary when ALL of the following are met:

Eligibility: Member has a singleton or twin pregnancy

Counseling: Member has received appropriate counseling about the benefits and limitations by a prenatal care provider, trained designee, or genetic counselor

Investigational / Not Medically Necessary

The following uses of NIPS are considered investigational and not medically necessary:

Investigational Indications: NIPS to predict twin zygosity (0060U); NIPS for multiple gestation pregnancies of triplets or higher; NIPS for microdeletions/microduplications; NIPS for single-gene disorders; NIPS for all other aneuploidies (other than trisomy 13, 18, and 21); NIPS performed simultaneously with maternal serum screening; use on a singleton pregnancy with a known vanishing twin; use for the sole purpose of fetal sex determination.

Maternal Serum Screening (MSS)

Maternal serum screening for aneuploidy using no more than one of the following one time per pregnancy is considered medically necessary:

MSS options: First trimester screening (free or total beta-hCG and PAPP-A) (81508); Second trimester screening (hCG, msAFP, uE3, and DIA) (81509, 81510, 81511, 81512); Integrated, stepwise, or contingent sequential screening (81508, 81509-81512); Penta screen (hCG, msAFP, uE3, DIA, ITA) (81512).

Only one maternal serum screen approach per pregnancy is covered.

Covered with criteria

Covered when criteria reflect guideline recommendations and limits:

General NIPS coverage: NIPS may be used to screen for fetal aneuploidies (trisomy 13, 18, 21 and sex chromosome aneuploidies) consistent with ACOG/SMFM and ACMG recommendations; patients should receive pretest counseling about limitations and false-positive risks, and post-test genetic counseling if results are increased-risk or indeterminate; NIPS is a screening test and positive results require confirmatory diagnostic testing (karyotype, FISH, or CMA).

Supported by ACOG/SMFM 2020 and ACMG positions

Test frequency limit: More than one cell-free DNA screen performed per pregnancy is not medically indicated (defined as no more than one paid test per pregnancy).1 test per pregnancy

Coverage limited to a single paid NIPS per pregnancy

Not recommended / limited validity

Microdeletion screening: Screening for limited microdeletions with cfDNA has not been clinically validated and is not recommended due to low positive predictive value; therefore not supported as routine screening.

ACOG/SMFM 2020

Not recommended

Single-gene cfDNA screening: cfDNA screening for single-gene disorders lacks sufficient data on accuracy and predictive values and is not currently recommended in pregnancy.

ACOG practice advisory Feb 2019 (reaffirmed Mar 2020)

The policy considers several expanded uses of noninvasive prenatal screening (NIPS) to be investigational and not medically necessary. Specifically, NIPS for microdeletions/microduplications (e.g., CPT 81422 and related proprietary codes) and NIPS for single‑gene disorders (e.g., CPT 81302, 81404, 81406, 81407, 81408, 81442) are classified as investigational. In addition, NIPS to predict twin zygosity (0060U), NIPS in triplets or higher‑order multiple gestations, NIPS for aneuploidies other than trisomy 13/18/21, simultaneous NIPS with maternal serum screening, use in a singleton pregnancy with a known vanishing twin, and testing solely for fetal sex determination are considered investigational and excluded from coverage.

Rationale: these indications represent expanded applications of cfDNA technology for which clinical validation, performance data, and demonstrated clinical utility are limited or lacking. The policy therefore treats these uses as investigational pending sufficient evidence of analytic and clinical validity and clear clinical benefit.

Major professional societies have cautioned against routine use of cfDNA screening for microdeletions and single‑gene disorders. ACOG and SMFM (2020) note that screening for a limited number of microdeletions using cfDNA has not been clinically validated, includes only a few rare targets, and has a much lower positive predictive value (PPV) than screening for common trisomies; therefore microdeletion panels are not recommended. Likewise, ACOG’s practice advisory (Feb 2019; reaffirmed Mar 2020) states that although single‑gene cfDNA assays are available clinically, there are insufficient data on accuracy and predictive values in the general pregnant population, and single‑gene cfDNA screening is not currently recommended in pregnancy

When submitting requests or claims for investigational uses of NIPS, include the specific procedure or proprietary laboratory code that corresponds to the test performed. Examples of codes referenced in the policy for investigational cfDNA applications include 81422 (microdeletions), 0060U (proprietary code referenced for twin zygosity/microdeletion panels), and single‑gene NIPT codes such as 81302, 81404, 81406, 81407, 81408, and 81442. Requests for these codes will be reviewed as investigational and may be denied.

The policy does not support repeat routine NIPS during a single pregnancy; no more than one paid cell‑free DNA screen per pregnancy is considered medically indicated. Repeat testing or ordering NIPS for investigational indications (microdeletions, single‑gene disorders, twin zygosity, higher‑order multiples, simultaneous MSS/NIPS, vanishing twin scenarios, or fetal sex determination alone) is not supported by the policy and may be denied. Positive or indeterminate NIPS results should be followed by genetic counseling and offered diagnostic confirmation rather than repeated screening.

Covered Indications

Screening for trisomy 13, 18, 21, and sex chromosome aneuploidies in singleton or twin pregnancies — documentation and counseling required

Screening for trisomy 13, 18, 21, and sex chromosome aneuploidies in singleton or twin pregnancies is covered when documentation and counseling requirements are met:

Pregnancy type documented: Documentation that the member has a singleton or twin pregnancy is provided.

Pretest counseling documented: Documentation that the member received counseling about benefits, limitations, and potential false-positive/false-negative results from a prenatal care provider, trained designee, or genetic counselor prior to testing.

Pretest counseling should include discussion of false-positive risk and limitations of NIPS.

Posttest follow-up: Patients with increased-risk or indeterminate/no-call NIPS results should be referred for genetic counseling and offered diagnostic testing and ultrasound evaluation.

Refer to ACOG/SMFM guidance for management of no-call results.

Maternal serum screening (MSS) using a single approach once per pregnancy — first/second/integrated/sequential/penta options

Maternal serum screening (MSS) may be performed using a single approach one time per pregnancy (choose one of the following):

MSS approach options: First trimester screening (free or total beta-hCG and PAPP-A) (81508); Second trimester screening panels (81509, 81510, 81511, 81512); Integrated, stepwise sequential, or contingent sequential screening combining first- and second-trimester markers (81508 and 81509-81512); Penta screen (81512).

Only one maternal serum screen approach per pregnancy is covered.

Screening for common fetal aneuploidies in singleton and twin pregnancies — guideline recommendations and performance notes

Guideline-supported recommendations and performance notes for screening common fetal aneuploidies in singleton and twin pregnancies:

Guideline recommendation: ACOG/SMFM and ACMG recommend that NIPS is the most sensitive screening option for traditionally screened aneuploidies (trisomy 21, 18, 13) and recommend offering NIPS for singleton and twin gestations; providers should inform patients that NIPS is a screening—not diagnostic—test.

References: ACOG Practice Bulletin No. 226 (2020), ACMG guidance

Twin gestation performance note: Performance of NIPS in twin pregnancies is acceptable for trisomy 21 but detection rates for trisomy 18 and 13 are less certain due to small numbers of affected cases; providers should consider this when counseling patients with twin gestations.

ACOG/SMFM practice bulletin notes limited data for higher-order or rarer trisomies.

Coding

Referenced procedure / test codesmixed

81420	Cell-free DNA screening for common aneuploidies (example code referenced for NIPS)
81507	Proprietary/other code referenced for NIPS (example: Harmony)
0327U	Proprietary lab code referenced for specific NIPS tests
0060U	Proprietary lab code referenced for twin zygosity or other proprietary tests
81422	NIPS for microdeletions/microduplications (referenced)
81302	Test codes referenced for single-gene NIPT
81404	Test codes referenced for single-gene NIPT
81406	Test codes referenced for single-gene NIPT
81407	Test codes referenced for single-gene NIPT
81408	Test codes referenced for single-gene NIPT

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Common ICD codes referencedICD-10

O09	Supervision of high-risk pregnancy; common ICD codes referenced for testing
O28	Encounter for supervision of pregnancy with history of other conditions
O30	Multiple gestation
O35	Maternal care for known or suspected fetal abnormality
Q90-Q99	Chromosomal abnormalities (examples Q90 through Q99 referenced)
Z34	Encounter for supervision of normal pregnancy
Z36.0	Encounter for antenatal screening for chromosomal anomalies
Q90	Trisomy 21 (Down syndrome) (example within referenced range)

Maximum NIPS per pregnancy

Policy limitNo more than one paid cell-free DNA (NIPS) screen per pregnancy.

Definition of limitMore than one cell-free DNA screen performed per pregnancy is not medically indicated (defined as no more than one paid test per pregnancy).

Implication for claimsClaims for additional NIPS tests in the same pregnancy may be denied as not medically indicated.

Provider Actions & Documentation

Billing Rule
Billing & Code Usage
Use the referenced procedure codes when requesting coverage and for billing. Submit appropriate CPT/HCPCS codes that reflect the specific test ordered (eg, 81420, 81422, 0327U, 0060U, 81404, 81406–81408, 81442, 81302, 81507).
Include relevant ICD-10 diagnosis codes (eg, O09, O28, O30, O35, Q90–Q99, Z34, Z36.0).
One paid cfDNA/NIPS per pregnancy — multiple paid screens for the same pregnancy are not medically indicated.

Prior Authorization
One Paid NIPS per Pregnancy
Only one cfDNA/NIPS test will be paid per pregnancy; more than one cell-free DNA screen performed per pregnancy is not medically indicated and may be denied.
Operational note: duplicate or repeated cfDNA claims for the same pregnancy should be reviewed for medical necessity before payment.

Documentation Required
Complementary Testing — NTD Screening
NIPS does not assess neural tube defects (NTDs). Continue recommended complementary screening for NTDs (eg, maternal serum alpha-fetoprotein or ultrasound) as clinically indicated.
Do not substitute NIPS for standard NTD screening protocols.
Document that complementary NTD screening was discussed or offered when relevant.

Denial Risk
Investigational Indications — Do Not Order for These Uses
Ordering NIPS for investigational indications listed in the policy is not supported and may be denied. Examples include NIPS for microdeletions/microduplications, single-gene disorders, predictions of zygosity (0060U), triplet-or-higher gestations, simultaneous use with maternal serum screening, use for vanishing twin cases, or solely for fetal sex determination.
If ordered for an investigational indication, include documentation supporting medical necessity; expect claim review and possible denial.
Providers should order only indicated tests per policy criteria (eg, 81420/81507 for trisomy 13/18/21 in singleton or twin pregnancies with counseling).

Documentation Required
Counseling, Pregnancy Type & Genetic Counseling Documentation
Providers must document that the patient received appropriate counseling about NIPS benefits and limitations, and that the pregnancy type (singleton vs twin) was assessed. Referral to genetic counseling is recommended for increased-risk, indeterminate, or no-call results.
Document who provided counseling (prenatal care provider, trained designee, or genetic counselor) and that counseling occurred prior to testing.
Document pregnancy type (singleton or twin) on the order or in the medical record.
Refer patients with increased-risk or no-call results to a genetic counselor and document the referral.

Definitions

Singleton pregnancy definition

DefinitionSingleton pregnancy is a pregnancy with one fetus.

ContextUsed to determine eligibility for NIPS coverage (policy allows screening in singleton or twin pregnancies).

DocumentationProvider documentation should confirm singleton pregnancy status prior to testing.

Twin zygosity definition and clinical implications

DefinitionTwin zygosity testing predicts whether twins are monozygotic (identical) or dizygotic (fraternal).

Clinical implicationMonozygotic twins have higher risk for complications such as twin–twin transfusion syndrome (TTTS).

Coverage stanceNIPS to predict twin zygosity is considered investigational and not medically necessary (policy excludes twin zygosity testing).

Noninvasive prenatal screening (NIPS) definition

DefinitionNoninvasive prenatal screening (NIPS) is a sequencing-based screening test performed on placental cell-free DNA (cfDNA) in maternal serum to assess risk for fetal genetic disorders.

PurposeCommonly used to screen for fetal aneuploidies including trisomy 21, trisomy 13, trisomy 18, and sex chromosome aneuploidies (X and Y).

LimitationsNIPS is a screening—not diagnostic—test; positive results require confirmatory diagnostic testing (eg, karyotype, FISH, or CMA).

No-call / indeterminate result definition

DefinitionNo-call (indeterminate) result refers to an uninterpretable or indeterminate cfDNA/NIPS test outcome where the test fails to provide a definitive screen result.

Clinical significanceNo-call results have been associated with an increased risk of aneuploidy and warrant referral for genetic counseling and offer of diagnostic testing.

Recommended actionsGuidelines recommend posttest genetic counseling, ultrasound evaluation, and consideration of diagnostic testing when NIPS yields a no-call result.

OpenPayer

Noninvasive Prenatal Screening (NIPS) / Concert Genetic Testing

Coverage Criteria

Covered Indications

Coding

Provider Actions & Documentation

Eligibility Requirements

Definitions

Background

Not Covered / Investigational Services