ModifiedPremera BluecrossPolicy 2.04.152

Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes

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This policy addresses maternal serum biomarker, cell-free RNA, and algorithmic testing used to predict preeclampsia or spontaneous preterm birth. These tests are considered investigational because evidence is insufficient to demonstrate improved health outcomes.

Policy Summary

PayerPremera Bluecross

PolicyMaternal Serum Testing for Prediction of Adverse Obstetric Outcomes

Policy CodePolicy 2.04.152

Change TypeModified

Effective DateOctober 1, 2026

Last ReviewJul 13, 2026

Next Review DateN/A

Key ActionTreat maternal serum tests, including cell-free RNA tests with or without algorithmic analysis, as investigational when used to predict preeclampsia or spontaneous preterm birth.

SourceLink

POLICY UPDATE CHANGES

Policy statements were updated to include testing of maternal serum cell-free RNA as investigational.

The policy title was changed from Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes to Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes.

The description for CPT code 0247U was revised during the August 2026 coding update and again in the October 2026 coding update.

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ModifiedPremera BluecrossPolicy 2.04.152

Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes

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Policy Summary

PayerPremera Bluecross

PolicyMaternal Serum Testing for Prediction of Adverse Obstetric Outcomes

Policy CodePolicy 2.04.152

Change TypeModified

Effective DateOctober 1, 2026

Last ReviewJul 13, 2026

Next Review DateN/A

Key ActionTreat maternal serum tests, including cell-free RNA tests with or without algorithmic analysis, as investigational when used to predict preeclampsia or spontaneous preterm birth.

SourceLink

POLICY UPDATE CHANGES

Policy statements were updated to include testing of maternal serum cell-free RNA as investigational.

The policy title was changed from Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes to Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes.

The description for CPT code 0247U was revised during the August 2026 coding update and again in the October 2026 coding update.

Investigational Coverage Criteria

Prediction of preeclampsia

The following use is considered investigational; no covered medical-necessity criteria are provided.

Investigational preeclampsia prediction testing: Maternal serum testing, including maternal serum cell-free RNA testing, with or without additional algorithmic analysis, is used to predict preeclampsia.

Investigational; claims may be denied as unproven.

Prediction of spontaneous preterm birth

The following use is considered investigational; no covered medical-necessity criteria are provided.

Investigational spontaneous preterm birth prediction testing: Maternal serum testing with or without additional algorithmic analysis is used to predict spontaneous preterm birth.

Investigational; claims may be denied as unproven.

The August 2026 annual review updated the policy to identify maternal serum cell-free RNA testing as investigational, in addition to maternal serum biomarker testing. The policy statements also removed biomarker nomenclature, and the policy title was revised to Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes.

Coding and Test Thresholds

Investigational maternal serum biomarker testingCPTExperimental

0243U	Obstetrics (preeclampsia), biochemical assay of placental-growth factor, time-resolved fluorescence immunoassay, maternal serum, predictive algorithm reported as a risk score for preeclampsia (use to report: PGIF Preeclampsia Screen by PerkinElmer Genetics, Inc., Brahms sFlt-1/ PlGF KRYPTOR Test System)
0247U	Obstetrics (preterm birth), insulin-like growth factor-binding protein 4 (IGFBP4), sex hormone-binding globulin (SHBG), quantitative measurement by LC-MS/MS, utilizing maternal serum, combined with clinical data, reported as predictive-risk stratification for spontaneous preterm birth (use to report: PreTRM test by Sera Prognostics, Inc.).
0482U	Obstetrics (preeclampsia), biochemical assay of soluble fms-like tyrosine kinase 1 (sFlt- 1) and placental growth factor (PlGF), serum, ratio reported for sFlt-1/PlGF, with risk of progression for preeclampsia with severe features within 2 weeks.
0524U	Obstetrics (preeclampsia), sFlt-1/PlGF ratio, immunoassay, utilizing serum or plasma, reported as a value

Codes identified in policy historyCPT

0390U	New CPT code effective 7/1/2023; subsequently removed from the policy coding information.
0482U	New CPT code added in the October 2024 coding update; descriptor not provided in this document window.
0524U	New CPT code added in the January 2025 coding update; descriptor later updated in January 2026, but the descriptor is not provided in this document window.
0247U	CPT code whose description was revised in the August 2026 and October 2026 coding updates; revised descriptor not provided in this document window.

KRYPTOR sFlt-1/PlGF Ratio

Test systemBRAHMS sFlt-1/PlGF KRYPTOR

Proposed cutoff≥40

Evidence statusPRAECIS proposed this cutoff; other publications have proposed various cutoffs.

Elecsys sFlt-1/PlGF Ratio

AssayElecsys sFlt-1/PlGF

Proposed cutoff>38

Evidence statusPRAECIS proposed this cutoff; other publications have proposed various cutoffs.

Provider Action Required

Denial Risk

Investigational Maternal Serum Testing

Maternal serum tests, including maternal serum cell-free RNA tests, with or without additional algorithmic analysis, are considered investigational for prediction of preeclampsia and spontaneous preterm birth.

Note

Policy History: Maternal Serum Testing Update

The policy history records an 08/01/26 annual review update adding maternal serum cell-free RNA testing to the investigational policy statements. Biomarker nomenclature was removed, and the policy title was changed to Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes.

Clinical Background

Preeclampsia is a pregnancy complication characterized by new-onset hypertension after 20 weeks of gestation, together with proteinuria or significant end-organ dysfunction. Maternal serum biomarkers—including placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFlt-1), PAPP-A, IGFBP4, and SHBG—have been studied to improve prediction of preeclampsia and related adverse obstetric outcomes. Although some tests demonstrate predictive validity, the available evidence is insufficient to show improved net health outcomes; standard assessment remains based on medical and obstetric history, clinical risk factors, and routine prenatal evaluation.

Key Definitions and Test Systems

Preeclampsia

HypertensionNew-onset maternal hypertension after the 20th week of gestation.

ProteinuriaNew-onset hypertension with proteinuria, or hypertension with significant end-organ dysfunction with or without proteinuria.

End-organ dysfunctionSignificant end-organ dysfunction may establish the definition when present with new-onset hypertension, whether or not proteinuria is present.

Preterm Birth

Gestational ageBirth occurring between the 20th and 37th week of pregnancy.

Spontaneous birthMay follow preterm labor and rupture of membranes.