ModifiedPremera BluecrossPolicy 2.04.152

Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes

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This policy addresses maternal serum biomarker and cell-free RNA testing, with or without algorithmic analysis, 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 ActionMaternal serum biomarker testing, including maternal serum cell-free RNA testing, with or without algorithmic analysis, is considered investigational when used to predict preeclampsia or spontaneous preterm birth and may be denied on that basis.

SourceLink

POLICY UPDATE CHANGES

The policy was updated to classify 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 descriptor for CPT code 0247U was revised in the 2026 coding update.

HCPCS code 0390U was removed during the May 2024 policy update.

CPT codes 0482U and 0524U were added through coding updates.

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ModifiedPremera BluecrossPolicy 2.04.152

Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes

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Sign up for Premera Bluecross Policy 2.04.152 alerts

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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

SourceLink

POLICY UPDATE CHANGES

The policy was updated to classify 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 descriptor for CPT code 0247U was revised in the 2026 coding update.

HCPCS code 0390U was removed during the May 2024 policy update.

CPT codes 0482U and 0524U were added through coding updates.

Coverage Criteria

Maternal Serum Testing for Obstetric Risk Prediction

The following maternal serum testing uses are considered investigational:

ALL of the following

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

Investigational Testing — Policy History

Policy history classifies maternal serum testing as investigational. The policy was subsequently updated to expressly include maternal serum cell-free RNA testing.

Policy history

07/01/23 — New policy, approved June 13, 2023; literature review through December 21, 2022. Maternal serum biomarker testing was classified as investigational. CPT code 0390U was added, effective 07/01/23.
05/01/24 — Annual review, approved April 8, 2024; literature review through January 2, 2024 and references added. Policy statements were unchanged. Wording was changed from "women" to "pregnant individuals" throughout the policy, and HCPCS code 0390U was removed.
10/01/24 — Coding update; CPT code 0482U was added.
01/01/25 — Coding update; CPT code 0524U was added.
05/01/25 — Annual review, approved April 7, 2025; literature review through December 9, 2024 and references added. Policy statements were unchanged.
01/01/26 — Coding update; the code descriptor for HCPCS code 0524U was updated.
08/01/26 — Annual review, approved July 13, 2026; literature review through April 6, 2026 and references added. Policy statements were updated to include maternal serum cell-free RNA testing as investigational. Biomarker nomenclature was removed from the policy statements, and the title changed from "2.04.152 Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes" to "2.04.152 Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes." CPT code 0247U description was revised.
10/01/26 — Coding update; CPT code 0247U description was revised.

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

Coding and Test Thresholds

Investigational maternal serum testing codesCPTExperimental

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

Historical HCPCS Coding UpdateHCPCS

0390U

New code effective 7/1/2023; later removed as an HCPCS code

Historical CPT Coding UpdatesCPT

0482U	New CPT code added 10/01/24
0524U	New CPT code added 01/01/25; code descriptor updated 01/01/26
0247U	CPT code description revised in the 08/01/26 and 10/01/26 coding updates

KRYPTOR sFlt-1/PlGF Ratio

Published cutoff≥40

Test systemB·R·A·H·M·S sFlt-1/PlGF KRYPTOR Test System

Use described in evidence reviewThe cutoff was proposed for the sFlt-1/PlGF ratio; other publications have proposed various cutoffs.

Elecsys sFlt-1/PlGF Ratio

Published cutoff>38

Test systemElecsys sFlt-1/PlGF test

Use described in evidence review

Provider and Billing Actions

Denial Risk

Investigational predictive testing

Maternal serum biomarker testing, including maternal serum cell-free RNA testing, is considered investigational when used—with or without additional algorithmic analysis—to predict preeclampsia or spontaneous preterm birth. Claims for this use may be denied on that basis.

Applies to CPT codes 0243U, 0247U, 0482U, and 0524U.
Maternal serum tests are not established as proven predictive tests for these indications.

Clinical Background

Preeclampsia is a pregnancy-related hypertensive disorder involving new-onset hypertension after 20 weeks of gestation, with proteinuria or significant end-organ dysfunction. Spontaneous preterm birth occurs between the 20th and 37th weeks of pregnancy and may follow preterm labor or rupture of membranes. Maternal serum biomarkers—including PlGF, sFlt-1, PAPP-A, IGFBP4, and SHBG—and cell-free RNA have been studied as adjuncts to standard clinical risk assessment; however, evidence is insufficient to establish improved net health outcomes.

Definitions and Test Descriptions

Preeclampsia

TimingNew onset after the 20th week of gestation

Core diagnostic featuresNew-onset maternal hypertension and proteinuria

Alternative diagnostic featureNew-onset hypertension with significant end-organ dysfunction, with or without proteinuria

Preterm Birth

DefinitionBirth occurring between the 20th and 37th week of pregnancy

Spontaneous categoryMay follow preterm labor or rupture of membranes

Iatrogenic category