CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes

This policy governs coverage and medical necessity determinations for maternal serum biomarker tests (including algorithmic analyses) used to predict preeclampsia and spontaneous preterm birth for BCBSRI Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMaternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateJul 1, 2025

Next Review DateMar 19, 2025

Key ActionVerify member benefits and any prior authorization requirements for proprietary lab tests before ordering.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredPreeclampsia stance

Not coveredPreterm birth stance

3Named tests

0524UCoding update

07/01/2025Effective

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Preeclampsia prediction

Covered when ALL of the following are met:

policy_stance: Considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome

Basis: insufficient evidence across studies and uncertainty in clinical decision impact

Spontaneous preterm birth prediction

Covered when ALL of the following are met:

Includes tests such as PreTRM and IBP4/SHBG-based algorithms

Some genetic testing services may be excluded for self-funded groups when those groups have contract-level exclusions for expanded biomarker coverage. For plan-specific determinations, consult the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies and the member's Benefit Booklet to confirm which genetic testing services require authorization, are not medically necessary, or are contract exclusions.

Benefits and eligibility are governed by the member's subscriber agreement or the employer agreement, and those documents supersede the provisions of this medical policy. For member-specific benefits and coverage determinations, contact the provider call center.

Maternal serum biomarker tests, with or without algorithmic analysis, used to predict preeclampsia or spontaneous preterm birth are considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products due to insufficient evidence demonstrating improved net health outcomes.

Services determined to be not medically necessary or otherwise non-covered may not be billed to the member. Providers must not charge members for such services unless the member has been informed in advance and has agreed in writing to accept financial responsibility.

Coding

Not covered / Not medically necessary CPT codesCPTNot Covered

0243U	Obstetrics (preeclampsia), biochemical assay of placental-growth factor, time-resolved fluorescence immunoassay, maternal serum, predictive algorithm reported as a risk score for preeclampsia
0247U	Obstetrics (preterm birth), insulin-like globulin (SHBG), quantitative measurementby LC-MS/MS, utilizing maternal serum, combined with clinical data, reported as predictive-risk stratification for spontaneous preterm birth growth
0524U	Obstetrics (preeclampsia), sFlt-1/PIGF ratio, immunoassay, utilizing serum or plasma, reported as value (New Code Effective 1/1/2025)

Proprietary / PLA code - PreTRMCPT

0247U

Obstetrics (preterm birth), insulin-like globulin (SHBG), quantitative measurementby LC-MS/MS, utilizing maternal serum, combined with clinical data, reported as predictive-risk stratification for spontaneous preterm birth growth

Proprietary / PLA code - sFlt-1/PlGFCPT

0524U

Obstetrics (preeclampsia), sFlt-1/PIGF ratio, immunoassay, utilizing serum or plasma, reported as value (New Code Effective 1/1/2025)

Provider Actions and Billing Guidance

Prior Authorization

Prior Authorization / Benefit Verification Required

Prior authorization / benefit verification: Providers must verify member-specific benefits and obtain any required prior authorization before ordering proprietary laboratory tests (including CPT® codes 0247U and 0524U). Contact the provider call center for member eligibility, benefit coverage, and authorization requirements.

Affected codes: 0247U (PreTRMO) and 0524U (sFlt-1/PlGF)
Verify eligibility and authorization with BCBSRI provider call center prior to testing
Failure to obtain required authorization may result in claim denial and financial liability for the ordering provider or performing laboratory.

Billing Rule

Ordering Physician Must Be Sole Participant in Authorization Process

Background

Preeclampsia and spontaneous preterm birth are major contributors to maternal and neonatal morbidity and mortality. Preeclampsia is new-onset maternal hypertension with proteinuria or significant end-organ dysfunction and can lead to eclampsia, placental abruption, HELLP syndrome, fetal growth restriction, or intrauterine fetal death. Preterm birth is delivery between 20 and 37 weeks and is associated with increased infant morbidity and mortality.

Traditional risk stratification for these conditions relies on clinical history and objective measures such as blood pressure and cervical length. Maternal serum biomarkers (for example, placental growth factor, sFlt-1, IBP4/SHBG and proprietary proteomic panels) have been proposed to augment risk prediction, but current evidence has not demonstrated that use of these biomarker tests results in improved net health outcomes or clear changes in clinical management that benefit patients.

Definitions

Preeclampsia — definition

TermPreeclampsia

DefinitionNew-onset maternal hypertension with proteinuria or new-onset hypertension with significant end-organ dysfunction (with or without proteinuria)

Related complicationsMay lead to eclampsia, placental abruption, HELLP syndrome, fetal growth restriction, or intrauterine fetal death

At-risk groupsIncreased prevalence among older maternal age, chronic illnesses (eg, diabetes, chronic hypertension, chronic kidney disease, systemic lupus erythematosus), obesity, multiple gestation, and prior preeclampsia

Preterm birth — definition

TermPreterm birth

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMaternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateJul 1, 2025

Next Review DateMar 19, 2025

Key ActionVerify member benefits and any prior authorization requirements for proprietary lab tests before ordering.

SourceLink

On This Page

Laboratories and third parties may NOT obtain prior authorization or otherwise participate in the authorization, appeal, or documentation process on behalf of the ordering physician. Only the ordering physician may be involved in obtaining authorizations, submitting appeals, or preparing clinical documentation for authorization/medical necessity determinations. If a laboratory or third party supports any portion of the authorization process on behalf of the ordering physician, BCBSRI will consider this a violation and may take severe action up to termination from the BCBSRI provider network.

Labs are prohibited from obtaining authorizations for the ordering physician
Any unauthorized support of the authorization or appeal process is a policy violation subject to sanctions

Denial Risk

Denial and Billing Risk

Services provided without required authorization will be denied and the financial responsibility will rest with the performing laboratory or ordering provider per policy. Providers may not balance-bill members for services that are denied as not medically necessary or non-covered unless the member was informed and provided written agreement in advance to accept financial responsibility.

Unauthorized lab services will be denied and may not be billed to the member
If services are determined not medically necessary or non-covered, providers may not charge the member unless written advance agreement exists

Note

Provider Action — Verify Benefits and Contact Call Center

Provider procedural note: For member-specific benefits, coverage determinations, and authorization instructions, contact the BCBSRI provider call center. This policy is informational and does not guarantee payment; member certificates and employer agreements govern benefits.

Call provider call center for benefit verification and authorization procedures
Policy is informational and benefits are governed by subscriber/member documents

Birth occurring between 20 and 37 weeks of pregnancy; can be spontaneous (preterm labor or rupture of membranes) or iatrogenic (clinical intervention)

EpidemiologyEstimated ~10% preterm birth rate in the U.S. (2020); rates vary by race/ethnicity

Clinical significanceAssociated with increased infant morbidity and mortality and long-term morbidity into adulthood

PreTRM — definition

Test namePreTRM

CPT/PLA code0247U

DescriptionObstetrics (preterm birth), insulin-like globulin (SHBG), quantitative measurement by LC-MS/MS, utilizing maternal serum combined with clinical data, reported as predictive-risk stratification for spontaneous preterm birth

PurposeReports predictive risk stratification for spontaneous preterm birth

sFlt-1/PlGF ratio — definition

AnalytesFlt-1/PlGF ratio

CPT/PLA code0524U

DescriptionObstetrics (preeclampsia), sFlt-1/PlGF ratio, immunoassay utilizing serum or plasma, reported as a value

Effective date noteNew code effective 1/1/2025