CurrentAloha CarePolicy MP-06

Cell-Free Fetal DNA Testing

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Defines medical necessity, coverage criteria, coding guidance, and limitations for cffDNA/NIPT to screen for fetal trisomy (13, 18, 21) in pregnancy for Aloha Care members.

Policy Summary

PayerAloha Care

PolicyCell-Free Fetal DNA Testing

Policy CodePolicy MP-06

Change TypeNo material changes

Effective Date04/26/2022

Last ReviewApr 26, 2024

Next Review Date04/26/2024

Key ActionObtain prior authorization with supporting documentation to determine medical necessity for cffDNA testing in eligible singleton high-risk pregnancies.

SourceLink

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CurrentAloha CarePolicy MP-06

Cell-Free Fetal DNA Testing

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Defines medical necessity, coverage criteria, coding guidance, and limitations for cffDNA/NIPT to screen for fetal trisomy (13, 18, 21) in pregnancy for Aloha Care members.

Policy Summary

PayerAloha Care

PolicyCell-Free Fetal DNA Testing

Policy CodePolicy MP-06

Change TypeNo material changes

Effective Date04/26/2022

Last ReviewApr 26, 2024

Next Review Date04/26/2024

Key ActionObtain prior authorization with supporting documentation to determine medical necessity for cffDNA testing in eligible singleton high-risk pregnancies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

T21/T18/T13Targeted aneuploidies

>=35Maternal age threshold

>99%/>97%/>95%Sensitivity (T21/T18/T13)

~99.9%/~99.9%/~99.8%Specificity (T21/T18/T13)

Prior authAuthorization

2024Last revised

Coverage and Medical Necessity Criteria

Medically Necessary Coverage Criteria

Cell-free fetal DNA testing for trisomy 21, 18, and 13 is covered in singleton pregnancies who meet ANY of the following high‑risk criteria and after prior authorization:

High‑risk qualifying indications: One or more of the following: maternal age >= 35 years at estimated date of delivery; fetus with one or more major structural abnormalities identified on ultrasound; prior pregnancy with a trisomy; positive standard serum screening test for aneuploidy; either parent has a balanced Robertsonian translocation increasing risk for fetal trisomy 13 or trisomy 21.

Prior authorization with documentation is required to determine medical necessity.

This policy covers cell-free fetal DNA (cffDNA) noninvasive prenatal testing (NIPT) for detection of fetal trisomies 21, 18, and 13 in singleton pregnancies when prior authorization has been obtained and the pregnancy meets one or more qualifying high-risk indications (see coverage criteria). The policy explicitly excludes scenarios where NIPT is being used in place of conventional diagnostic testing; when a fetal structural anomaly has been identified on ultrasound; for multiple gestations (e.g., twins, triplets); for low-risk or average-risk pregnancies; for evaluation of sex chromosome abnormalities or to determine biologic sex; and for evaluation of microdeletions or micro-duplication syndromes, neural tube defects, or ventral wall defects. Abnormal NIPT results require confirmatory invasive diagnostic testing (amniocentesis or CVS) prior to being considered diagnostic.

This section of the source document contains bibliographic citations and references related to NIPT and cfDNA testing (for example, Norton ME et al., Sparks AB et al., and Genetics Home Reference). No explicit coverage exclusions are introduced in this bibliographic excerpt.

These pages reproduce literature citations and reference entries for studies and resources on cfDNA/NIPT. There are no additional explicit coverage exclusions stated in this excerpt.

This bibliographic excerpt lists repeated references concerning analysis of cell-free fetal DNA for trisomy detection. It does not provide further coverage exclusions or policy statements.

These referenced pages continue to list citations related to cfDNA/NIPT literature. No explicit coverage exclusions are present in this excerpt.

The document includes a review/revision line dated 04/26/2024 followed by a Retired designation. This indicates the policy document or this version may have been retired as of that date.

The policy explicitly lists the following scenarios as not medically necessary and not covered: (a) NIPT performed in place of conventional diagnostic testing without confirmatory testing; (b) patients with multiple gestations; (c) low-risk or average-risk pregnancies; (d) evaluation of sex chromosome abnormalities; (e) NIPT to determine biologic sex; (f) evaluation of microdeletions or micro-duplication syndromes; (g) evaluation of neural tube or ventral wall defects; and (h) when a fetal structural anomaly has been identified on ultrasound examination. Additionally, the policy reiterates that abnormal cffDNA results must be confirmed by amniocentesis or CVS.

The cited excerpt is bibliographic in nature and does not contain any statements declaring services as not medically necessary.

This portion of the document lists literature references and does not include any explicit 'not medically necessary' statements.

Billing and Diagnosis Codes

Covered HCPCS/CPT CodesCPTCovered

81420	Fetal chromosomal aneuploidy (e.g., trisomy 21) 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.

Not Covered HCPCS/CPT CodesCPTNot Covered

0060U

Twin zygosity, genomic targeted sequence analysis of chromosome 2, using circulating cell-free DNA in maternal blood

ICD-10-CM Covered / Relevant Diagnosis CodesICD-10

O09.291-O09.299	Supervision of pregnancy with other poor reproductive or obstetric history.
O09.511-O09.519	Supervision of elderly primigravida.
O09.521-O09.529	Supervision of elderly multigravida; Maternal care for (suspected) chromosomal abnormality in fetus [aneuploidy].
O35.1XX0	Maternal care for (suspected) chromosomal abnormality in fetus.
Q95.0-Q95.9	Balanced rearrangements and structural markers, not elsewhere classified.

ICD-10-CM Not Covered / Informational CodesICD-10Not Covered

O28.0-O28.9	Abnormal finding on antenatal screening of mother.
Q92.0-Q92.9	Other trisomies and partial trisomies of the autosomes, not elsewhere classified.
Q93.88	Other microdeletions [micro-deletion syndrome].
Z13.228	Encounter for screening for other metabolic disorders [not covered for use of urinary markers (measurement of cell free DNA and metabolomic profiling) for testing for fetal].
Z13.71-Z13.79	Encounter for screening for genetic and chromosomal anomalies.
Z31.438	Encounter for other genetic testing of female for procreative management.
Z34.80-Z34.93	Encounter for supervision of normal pregnancy [low risk women].

inv-15: Maternal age threshold used as a qualifying risk factor

Maternal age threshold>= 35 years (at estimated date of delivery)

ContextQualifies as a high‑risk indication for covered cffDNA testing in singleton pregnancies

RequirementPrior authorization with documentation is required to determine medical necessity when this threshold is the indication

Provider Requirements, Authorization, and Denial Triggers

Prior Authorization

Prior authorization required for covered cffDNA testing

Prior authorization with supporting documentation is required to determine medical necessity for cell-free fetal DNA (cffDNA) testing for trisomy 21, 18, and 13 in singleton pregnancies that meet any qualifying high‑risk indication (e.g., maternal age ≥35 at estimated date of delivery; fetal structural abnormality on ultrasound; prior pregnancy with a trisomy; positive standard serum screen; either parent with a balanced Robertsonian translocation). Submit prior authorization requests with documentation of the qualifying indication listed above.

Covered CPT codes: 81420, 81507 (see coding section).
Prior authorization applies only for singleton pregnancies meeting the listed high‑risk indications.

Note

Prior authorization — not specified in this section

No prior authorization requirements are specified in the bibliographic or citation-only sections of the document excerpt; these chunks contain references and do not define authorization procedures.

Clinical Background and Rationale

Noninvasive prenatal testing using circulating cell-free fetal DNA (cffDNA) in maternal blood is a screening method to assess risk for fetal trisomies 21, 18, and 13. NIPT offers higher sensitivity and specificity than conventional screening in high-risk pregnancies but is not diagnostic; therefore, positive or abnormal results require confirmatory diagnostic testing by amniocentesis or chorionic villus sampling (CVS). Comprehensive pretest and posttest genetic counseling and documentation of the indication supporting high‑risk status are required when seeking coverage.

Definitions and Terminology

inv-37: cffDNA — Cell-Free Fetal DNA testing definition/term

TermCell‑Free Fetal DNA testing (cffDNA)

DefinitionA prenatal test in which fetal DNA fragments are collected from maternal blood for evaluation of certain fetal genetic conditions (e.g., trisomy 21, 18, 13)

Role in policyUsed as a noninvasive screening method; covered for specified high‑risk singleton pregnancies with prior authorization

inv-38: NIPT — Non-invasive Prenatal Testing definition/term

TermNon‑invasive Prenatal Testing (NIPT)

DefinitionA screening method where a sample of maternal blood is collected to evaluate or detect genetic abnormalities of a fetus

Policy Summary

PayerAloha Care

PolicyCell-Free Fetal DNA Testing

Policy CodePolicy MP-06

Change TypeNo material changes

Effective Date04/26/2022

Last ReviewApr 26, 2024

Next Review Date04/26/2024

Key ActionObtain prior authorization with supporting documentation to determine medical necessity for cffDNA testing in eligible singleton high-risk pregnancies.

SourceLink

On This Page

Note

Prior authorization not addressed in this section

Prior authorization is not addressed in this bibliographic excerpt; the text consists of literature citations and does not provide authorization instructions.

Note

Prior authorization — no requirements stated in provided pages

No explicit prior authorization requirements are stated on the provided pages that are primarily citation text; providers should rely on the procedure section for authorization rules.

Note

Prior authorization (not specified)

The document lists literature references and a review/revision date but does not include explicit prior authorization instructions in this segment.

Step Therapy

Confirmatory diagnostic testing required for abnormal cffDNA results

An abnormal or positive cffDNA screening result is not diagnostic; confirmatory invasive diagnostic testing (amniocentesis or chorionic villus sampling) must be performed before a diagnosis is established.

Perform amniocentesis or CVS for diagnostic confirmation of abnormal cffDNA results prior to reporting a definitive diagnosis.

Note

Step therapy — not present in this excerpt

No step therapy requirements (sequenced treatments or tests) are described in the cited bibliographic sections of the policy.

Note

Step therapy — not specified in this excerpt

No step therapy requirements are specified in the bibliographic citation excerpts; the policy does not impose step therapy sequencing in these sections.

Note

Step therapy — no requirements present

No step therapy requirements are present in the citation-focused document chunks provided.

Documentation Required

Required documentation and evidence of pretest counseling

Document and retain evidence that the patient meets a qualifying high‑risk indication and that comprehensive pretest counseling was provided. Prior authorization requests must include documentation of the qualifying indication and evidence of pretest counseling to support medical necessity.

Document the specific qualifying indication (e.g., maternal age ≥35, ultrasound-detected structural anomaly, prior pregnancy with trisomy, positive standard serum screen, parental Robertsonian translocation).
Document that comprehensive pretest genetic counseling was provided (benefits, limitations, and implications of cffDNA screening).

Note

No documentation requirements stated in this citation list

No documentation requirements are specified in these bibliographic or citation-only chunks.

Note

No documentation requirements specified in this bibliographic excerpt

No documentation requirements are specified in this excerpt of bibliographic material.

Note

No documentation requirements present in these chunks

No documentation requirements are present in these document chunks focused on references.

Note

References for cfDNA testing

The policy cites multiple studies and resources on cffDNA/NIPT (e.g., Norton ME et al., Sparks AB et al., NIH Genetics Home Reference) in the references section.

Denial Risk

Not medically necessary triggers for denial

Testing will be denied (considered not medically necessary) when used in low‑ or average‑risk pregnancies, multiple gestations, to evaluate sex chromosome abnormalities, to assess microdeletions/micro‑duplications, to determine biologic sex, in place of conventional diagnostic testing, for neural tube or ventral wall defects, or when a fetal structural anomaly has been identified on ultrasound.

NIPT performed in place of conventional diagnostic testing (without confirmatory diagnostic testing) is not covered.
Patients with multiple gestations are not eligible for coverage under this policy.
Low/average‑risk pregnancies and use for sex chromosome or microdeletion/microduplication evaluation are not covered.

Note

No authorization or denial criteria are present in these bibliographic chunks; they contain literature citations only.

Note

This excerpt contains only bibliographic citations and does not state authorization or denial criteria.

Note

No authorization or denial rules are present in these reference-focused chunks.

Denial Risk

Retirement/Denial risk note

The policy review/revision line for this document indicates: Review/Revision Date: 04/26/2024 - Retired. Treat this as a retirement note for this version of the policy.

Relationship to cffDNANIPT commonly refers to analysis of circulating cell‑free fetal DNA in maternal plasma

inv-39: Amniocentesis / CVS — definitions and timing for invasive diagnostic tests

AmniocentesisAn invasive diagnostic prenatal test performed between 15 and 20 weeks gestation in which amniotic fluid is removed via needle through the abdomen; provides definitive diagnosis for certain fetal genetic conditions

Chorionic Villus Sampling (CVS)An invasive diagnostic prenatal test performed between 10 and 13 weeks gestation in which a placental (chorionic villus) sample is obtained via abdomen or cervix; provides definitive diagnosis

PurposeBoth tests are diagnostic and required to confirm abnormal cffDNA/NIPT screening results prior to considering a diagnosis

inv-40: Trisomy (general) — referenced Genetics Home Reference material

TopicTrisomy (general)

Reference sourceNational Institutes of Health, National Library of Medicine — Genetics Home Reference (Trisomy)

Context in policyTrisomy is the class of chromosomal aneuploidies (e.g., extra chromosome 21, 18, 13) targeted by cffDNA/NIPT screening

inv-41: Trisomy — NIH Genetics Home Reference entries (e.g., Trisomy 13)

ExamplesTrisomy 13 (Patau), Trisomy 18 (Edwards), Trisomy 21 (Down syndrome)

Trisomy 13 descriptionAn aneuploidy with an extra copy of chromosome 13 associated with heart defects, brain or spinal cord abnormalities, microphthalmia, polydactyly, cleft lip/palate, and hypotonia (policy definitions)

Source citationNIH Genetics Home Reference entry for Trisomy 13 (reviewed Nov 2013) cited in policy references

inv-42: cfDNA testing references — citations to key studies and resources (Norton ME et al., Sparks AB et al.)

Key studies citedNorton ME et al., N Engl J Med 2015;372(17):1589-97

Additional citationSparks AB, Wang ET, et al., Prenatal Diagnosis 2012; selective analysis of cell‑free DNA for evaluation of fetal trisomy

ResourceNIH/NLM Genetics Home Reference (Trisomy entries) cited for background information