Serum Tests for Preeclampsia Risk Assessment
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Defines Select Health of South Carolina's coverage stance for serum sFlt‑1/PlGF ratio assays (BRAHMS KRYPTOR and Elecsys) used as adjuncts to clinical assessment for predicting progression to preeclampsia with severe features in pregnancy.
No material clinical or coverage changes in this revision.
Coverage Determinations
Investigational / Not Medically Necessary — sFlt‑1/PlGF ratio assays
Tests measuring the sFlt‑1/PlGF ratio (specific platforms listed) are considered investigational / not medically necessary as adjuncts to current clinical criteria for diagnosing or predicting preeclampsia:
Policy cites lack of demonstrated benefit to maternal or neonatal outcomes and absence of proven clinical utility despite diagnostic performance in trial populations (PRAECIS and related trials).
The U.S. Food and Drug Administration has cleared two Class II prognostic sFlt‑1/PlGF ratio immunoassays for a specific FDA‑labeled intended use: hospitalized pregnant women with singleton pregnancies between 23+0 and 34+6/7 weeks gestation who have a hypertensive disorder of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension). These intended uses are limited to predicting short‑term progression to preeclampsia with severe features within two weeks of presentation and apply when the assays are used in conjunction with clinical assessment and routine laboratory testing.
This policy addresses two specific sFlt‑1/PlGF ratio assays: the BRAHMS sFlt‑1/PlGF KRYPTOR Test System (Thermo Fisher Scientific) and the Elecsys sFlt‑1 and Elecsys PlGF tests (Roche Diagnostics). Although both immunoassays quantify circulating sFlt‑1 and PlGF and report a ratio, Select Health considers use of these tests as adjuncts to current clinical criteria (not as replacements for clinical assessment) when applied to diagnosis or prediction of preeclampsia.
Clinical guidelines and the evidence base emphasize that these assays are intended to be used in conjunction with, and not to supplant, guideline‑directed clinical risk assessment and management decisions. Randomized trials and systematic reviews indicate diagnostic performance for predicting short‑term progression in trial‑eligible, hospitalized women, but they do not demonstrate improved maternal or neonatal outcomes; therefore the tests are classified here as investigational / not medically necessary when used as adjunctive tests to current clinical criteria.
Coding and Test Thresholds
Provider Requirements and Billing Guidance
Prior authorization required — affected codes may be denied
Tests listed as investigational / not medically necessary (including CPT/Codes 0524U and 0482U) are subject to denial; obtain prior authorization where required by the plan, but note that this policy does not support coverage for these assays.
Preferred initial management: guideline-directed clinical risk assessment
Use guideline-directed clinical risk assessment as the covered initial management strategy; the policy lists this clinical assessment as the alternative service to investigational biomarker testing.
- Perform standard clinical evaluation and routine laboratory testing for hypertensive disorders of pregnancy prior to considering sFlt‑1/PlGF ratio assays.
Include assay code and hospitalization/clinical context with submissions
When submitting claims or prior-authorization requests, include the specific assay code (e.g., 0524U or 0482U) and clinical documentation that the woman was hospitalized for a hypertensive disorder of pregnancy when applicable; FDA indications apply to hospitalized singleton pregnancies 23+0 to 34+6/7 weeks.
Denial risk for BRAHMS KRYPTOR and Elecsys when used as adjuncts
Claims for BRAHMS KRYPTOR (0524U) and Elecsys (0482U) tests used as adjuncts to current clinical criteria are considered investigational / not medically necessary and may be denied when submitted for that purpose.
- The policy names the BRAHMS sFlt‑1/PlGF KRYPTOR Test System and the Elecsys sFlt‑1 and Elecsys PlGF test as investigational/not medically necessary when used as adjuncts to clinical criteria.
- Denials may be issued for claims relying on these assays to supplement clinical diagnosis or risk prediction.
Clinical Background
Preeclampsia is a hypertensive disorder of pregnancy typically arising after 20 weeks' gestation and can progress rapidly to severe disease with multi‑organ involvement. Pathophysiology involves placental dysfunction leading to release of antiangiogenic factors such as soluble fms‑like tyrosine kinase‑1 (sFlt‑1) and relative deficiency of proangiogenic factors like placental growth factor (PlGF).
Immunoassays that measure circulating sFlt‑1 and PlGF and report their ratio have been developed as prognostic biomarkers to help identify hospitalized pregnant women at higher short‑term risk of progression to preeclampsia with severe features. While trials (including the PRAECIS‑enrolled population) demonstrate the assays’ diagnostic performance in selected hospitalized, singleton pregnancies between 23+0 and 34+6/7 weeks, randomized studies and systematic reviews have not shown that use of sFlt‑1/PlGF ratio testing improves maternal or neonatal outcomes or reduces unnecessary admissions.
Definitions and Diagnostic Criteria
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