DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

View PDF of Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes, Effective 10/1/2026 in Medical

Defines Blue Cross Blue Shield - Rhode Island's coverage stance for specific maternal serum biomarker tests (PlGF Preeclampsia Screen CPT 0243U; PreTRM CPT 0247U; PreClara sFlt-1/PlGF CPT 0524U) for prediction of preeclampsia and spontaneous preterm birth for Medicare Advantage and Commercial Products, including prior authorization and laboratory participation rules.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyView PDF of Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes, Effective 10/1/2026 in Medical

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2026

Next Review Date

Key ActionOnly the ordering physician may be involved in authorization, appeal, or other administrative processes related to prior authorization/medical necessity; labs and third parties must not obtain authorization on behalf of the ordering physician.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

3Specific CPT codes listed as not covered / not medically necessary

Medicare Advantage & CommercialPlans affected

DRAFTPolicy status

Coverage Summary

This DRAFT policy defines Blue Cross Blue Shield – Rhode Island's coverage stance for specific maternal serum biomarker tests for prediction of preeclampsia and spontaneous preterm birth (including CPT 0243U, 0247U, and 0524U).

Policy status: DRAFT. Effective date: 2026-10-01. Last review: 2026-06-03.

Policy attributes

PayerBlue Cross Blue Shield - Rhode Island

Policy titleMaternal serum biomarker testing for prediction of preeclampsia and spontaneous preterm birth

Plans affectedMedicare Advantage & Commercial

Policy statusDRAFT

Effective date2026-10-01

Last review2026-06-03

Medical-Necessity Criteria

Coverage Determinations

Coverage determinations for maternal serum biomarker tests:

ALL of the following

For Medicare Advantage Plans: Maternal serum biomarker tests (including maternal serum cell-free RNA tests), with or without additional algorithmic analysis, for prediction of preeclampsia are considered not covered.
Applies to listed CPT codes and similar tests
For Commercial Products: Maternal serum biomarker tests (including maternal serum cell-free RNA tests), with or without additional algorithmic analysis, for prediction of preeclampsia are considered not medically necessary.
Applies to listed CPT codes and similar tests
For Medicare Advantage Plans: Maternal serum biomarker tests, with or without additional algorithmic analysis, for prediction of spontaneous preterm birth are considered not covered.
For Commercial Products: Maternal serum biomarker tests, with or without additional algorithmic analysis, for prediction of spontaneous preterm birth are considered not medically necessary.
Benefits may vary by group/contract; refer to Evidence of Coverage or Subscriber Agreement for specific not medically necessary / not covered laboratory benefits.
Some self-funded groups may have contract exclusions per the Biomarker Testing Mandate policy

Prior Authorization & Operational Rules

Prior Authorization

Operational prior authorization rules and laboratory participation constraints:

ALL of the following

Prior authorization: Not applicable.
Policy states 'Not applicable' for prior authorization generally
Only the ordering physician shall be involved in the authorization, appeal or other administrative processes related to prior authorization/medical necessity; laboratories and third parties are prohibited from obtaining authorization or participating on behalf of the ordering physician.
Violations may result in termination from BCBSRI provider network and laboratory financial liability for unauthorized services

Documentation Required

Ordering physician must handle authorization/appeals

Only the ordering physician may be involved in authorization, appeal, or other administrative processes related to prior authorization/medical necessity; labs and third parties must not obtain authorization on behalf of the ordering physician.

Denial Risk

Unauthorized laboratory services will be denied and financially liable

If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member.

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 (PlGF Preeclampsia Screen)
0247U	Obstetrics (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 (PreTRM)
0524U	Obstetrics (preeclampsia), sFlt-1/PlGF ratio, immunoassay, utilizing serum or plasma, reported as a value (PreClara Ratio) (Test Name Revision Effective 1/1/2026)

Background & Evidence Summary

Maternal serum biomarker tests are proposed as adjuncts to standard screening to identify pregnant people at risk for preeclampsia and spontaneous preterm birth, with the goal of improving early identification and guiding interventions.

Some sFlt-1/PlGF ratio assays (KRYPTOR and Elecsys) have FDA clearances for specific inpatient prognostic use among hospitalized women with hypertensive disorders of pregnancy (gestational age ~23+0 to 34+6/7 weeks) to aid risk assessment for progression to severe preeclampsia within 2 weeks of presentation.

Overall, observational studies, systematic reviews, and randomized trials to date are considered insufficient to demonstrate improved net health outcomes for broader predictive or screening use across evaluated populations.

Key evidence items

PRAECIS cutoff proposedKRYPTOR >40; Elecsys <38 (cutoffs reported but variable across studies)

Regulatory clearances notedKRYPTOR De Novo DEN220027 (May 2023); Elecsys cleared Feb 2025

RCTs for PreTRM / biomarker-guided interventionsMixed results; PRIME RCT showed reduced neonatal morbidity but overall evidence insufficient

Preeclampsia: New onset maternal hypertension and proteinuria or new onset hypertension and significant end-organ dysfunction (with or without proteinuria) after 20 weeks' gestation.

Preterm birth: Birth occurring between 20 and 37 weeks of pregnancy; spontaneous or iatrogenic.

Not Covered / Not Medically Necessary

For Medicare Advantage Plans: maternal serum biomarker tests (including maternal serum cell-free RNA tests), with or without additional algorithmic analysis, for prediction of preeclampsia and for prediction of spontaneous preterm birth are considered not covered because the evidence is insufficient to show improved net health outcomes.

For Commercial Products: these tests are considered not medically necessary for prediction of preeclampsia and spontaneous preterm birth for the same reason.

Although some sFlt-1/PlGF ratio assays (KRYPTOR, Elecsys) have FDA clearance for specific inpatient prognostic use in hospitalized women with hypertensive disorders of pregnancy, broader outpatient screening or predictive use across populations lacks sufficient evidence and is not covered/not medically necessary.

Definitions

Preeclampsia: New onset maternal hypertension and proteinuria or new onset hypertension and significant end-organ dysfunction (with or without proteinuria) after 20 weeks' gestation.

Preterm birth: Birth occurring between 20 and 37 weeks of pregnancy; spontaneous or iatrogenic.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyView PDF of Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes, Effective 10/1/2026 in Medical

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2026

Next Review Date

SourceLink

On This Page

OpenPayer

View PDF of Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes, Effective 10/1/2026 in Medical

Coverage Summary

Medical-Necessity Criteria

Prior Authorization & Operational Rules

Coding

Background & Evidence Summary

Not Covered / Not Medically Necessary

Definitions

Revision History