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View PDF of Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes, Effective 10/1/2026 in Medical
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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.
No material clinical/coverage changes.
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.
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
Coding
| 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.
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.
Revision History
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