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CurrentAetnaPolicy 0464

Serum and Urine Marker Screening for Fetal Aneuploidy

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Aetna clinical policy bulletin defining medical necessity, investigational/experimental exclusions, and applicable CPT/HCPCS/ICD-10 codes for serum, urine, and cell-free DNA (NIPT) screening tests for fetal aneuploidy.

Policy Summary

PayerAetna

PolicySerum and Urine Marker Screening for Fetal Aneuploidy

Policy CodePolicy 0464

Change TypeNo material change

Effective DateJun 12, 2001

Last ReviewMay 5, 2023

Next Review DateMay 9, 2024

Key ActionOffer multiple serum marker testing only to pregnant women who have been adequately counseled and who desire information on their risk of having a Down syndrome fetus.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes reported in this update.

3Medically necessary categories

11Experimental/investigational items

20+Codes referenced

98.5%Reflex sgNIPT modeled sensitivity

9.4% vs 2.9%Twin failure rate example

Coverage Summary

Scope: Aetna clinical policy bulletin 0464 addresses serum, urine, and cell-free DNA (cfDNA/NIPT) screening for fetal aneuploidy and defines medical necessity, investigational exclusions, and applicable CPT/ICD-10 codes. Rationale: maternal serum marker testing (hCG, MSAFP, unconjugated estriol, and dimeric inhibin-A) identifies pregnancies at increased risk for Down syndrome and provides an alternative when invasive diagnostic testing is declined. cfDNA/NIPT measures cell-free fetal nucleic acids in maternal plasma to screen for common aneuploidies with higher sensitivity and specificity than conventional serum or ultrasound-based screening. Dates: Effective 06/12/2001; Last review 05/05/2023; Next review 05/09/2024.

Vanadis (RCR) ambient temp thresholdMaintain room temperature <25°C to reduce no-call rate (example: reduced overall no-call from 4.7% to 1.1% after relocation)

Unity/sgNIPT modeled sensitivityReflex sgNIPT sensitivity 98.5% (108/110) vs traditional carrier screening 41.5% per 100,000 births

cfDNA screening for 22q11.2 (Dar 2022)Sensitivity 75.0% overall (9/12); updated algorithm sensitivity 83.3% (10/12); specificity 99.84%

Minimum fetal fraction for NIPT-SGD (Mohan 2022)Minimum fetal fraction >= 4.5% required for interpretation