ModifiedBlue Cross Blue Shield - MassachusettsPolicy 163

Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes

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This policy governs coverage and authorization for maternal serum biomarker tests, including tests with algorithmic analysis, used to predict preeclampsia or spontaneous preterm birth in commercial and Medicare Advantage members. The policy considers these predictive tests investigational.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyMaternal Serum Testing for Prediction of Adverse Obstetric Outcomes

Policy CodePolicy 163

Change TypeModified

Effective DateOctober 1, 2026

Last ReviewOct 1, 2026

Next Review DateNot specified

Key ActionObtain precertification or preauthorization for all products when a service described in this policy is performed inpatient.

SourceLink

POLICY UPDATE CHANGES

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

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

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ModifiedBlue Cross Blue Shield - MassachusettsPolicy 163

Maternal Serum Testing for Prediction of Adverse Obstetric Outcomes

Customize your policy alerts

Sign up for Blue Cross Blue Shield - Massachusetts Policy 163 alerts

Get alerted when Policy 163 changes without checking for updates manually.

Monitor payer policy activity

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Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyMaternal Serum Testing for Prediction of Adverse Obstetric Outcomes

Policy CodePolicy 163

Change TypeModified

Effective DateOctober 1, 2026

Last ReviewOct 1, 2026

Next Review DateNot specified

Key ActionObtain precertification or preauthorization for all products when a service described in this policy is performed inpatient.

SourceLink

POLICY UPDATE CHANGES

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

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

Coverage Criteria

Preeclampsia Prediction

Maternal serum testing for prediction of preeclampsia is considered investigational.

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

No covered medical-necessity pathway is provided for this service.

Spontaneous Preterm Birth Prediction

Maternal serum testing for prediction of spontaneous preterm birth is considered investigational.

Investigational spontaneous preterm birth prediction testing: Maternal serum testing, with or without additional algorithmic analysis, is used for prediction of spontaneous preterm birth.

No covered medical-necessity pathway is provided for this service.

Maternal serum testing, including maternal serum cell-free RNA testing, performed with or without additional algorithmic analysis to predict preeclampsia is considered investigational. The policy does not provide a covered clinical-necessity pathway for this predictive use.

Maternal serum testing performed with or without additional algorithmic analysis to predict spontaneous preterm birth is considered investigational. The policy does not provide a covered clinical-necessity pathway for this predictive use.

Coding and Test Details

Investigational CPT-described maternal serum testsCPTExperimental

	Obstetric (preeclampsia), biochemical assay of placental growth factor using time-resolved fluorescence immunoassay, maternal serum, with predictive algorithm reported as a risk score for preeclampsia.
	Obstetric (preterm birth), insulin-like growth factor-binding protein 4 (IBP4), 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.
	Obstetric (preeclampsia), kinase insert domain receptor (KDR), Endoglin (ENG), and retinol-binding protein 4 (RBP4), by immunoassay, serum, algorithm reported as a risk score.
	Obstetric (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.
	Obstetric (preeclampsia), sFlt-1/PlGF ratio, immunoassay, utilizing serum or plasma, reported as a value

KRYPTOR sFlt-1/PlGF Ratio

TestKRYPTOR sFlt-1/PlGF ratio

Proposed cutoff≥ 40

StudyPRAECIS prospective observational study

Elecsys sFlt-1/PlGF Ratio

TestElecsys sFlt-1/PlGF ratio

Proposed cutoff> 38

StudyPRAECIS study, using archived samples from the PRAECIS cohort

Provider and Authorization Actions

Prior Authorization

Inpatient Authorization Required

Precertification/preauthorization is required for all products when a service described in this policy is performed in the inpatient setting.

Denial Risk

Investigational Predictive Testing

Maternal serum testing used to predict adverse obstetric outcomes is considered investigational, including cell-free RNA testing with or without additional algorithmic analysis.

Prediction of preeclampsia
Prediction of spontaneous preterm birth

Denial Risk

Outpatient Service Not Covered

Clinical Background

Preeclampsia is defined as new-onset maternal hypertension with proteinuria, or new-onset hypertension with significant end-organ dysfunction, with or without proteinuria, after the 20th week of gestation. Preterm birth occurs between the 20th and 37th week of pregnancy and may follow spontaneous preterm labor or rupture of membranes, or may be initiated for maternal or fetal medical indications.

Spontaneous preterm birth is preterm birth that follows spontaneous preterm labor or spontaneous rupture of membranes rather than a delivery initiated for a maternal or fetal medical indication. Maternal serum biomarkers and algorithmic analyses have been proposed to improve prediction beyond standard clinical risk assessment; however, the reviewed evidence was insufficient to establish improvement in net health outcomes.

Definitions

Preeclampsia

TimingAfter the 20th week of gestation

Blood pressure findingNew-onset maternal hypertension

Additional findingProteinuria or significant end-organ dysfunction; proteinuria may be absent when significant end-organ dysfunction is present

Preterm Birth

Gestational-age rangeBirth occurring between the 20th and 37th week of pregnancy

Spontaneous pathwayMay follow preterm labor and rupture of membranes

Medically initiated pathway