Serum Tests for Preeclampsia Risk Assessment
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Defines AmeriHealth Caritas coverage stance for serum immunoassays that measure the soluble fms-like tyrosine kinase-1 (sFlt-1) to placental growth factor (PlGF) ratio to predict progression to preeclampsia in pregnancy; applies to providers submitting claims to AmeriHealth Caritas.
No material clinical or coverage changes in this revision.
Coverage Determination
Not medically necessary — named sFlt-1/PlGF assays
Tests considered investigational / not medically necessary as adjuncts to clinical criteria:
Policy lists these specific named tests as not medically necessary.
No additional limitations were identified in this policy beyond the specific coverage stance for named sFlt-1/PlGF ratio assays.
The policy lists two named serum immunoassays as investigational/not clinically proven and therefore not medically necessary when used as an adjunct to current clinical criteria for diagnosing or predicting risk of preeclampsia: the BRAHMS sFlt-1/PlGF KRYPTOR Test System (Thermo Fisher/Brahms) and the Elecsys sFlt-1 and Elecsys PlGF tests (Roche). The supporting rationale in the source states these specific assays are not established as medically necessary adjuncts to standard clinical assessment for preeclampsia risk.
Coding and Test Characteristics
| 0524U | Obstetrics (preeclampsia), sFlt-1/PlGF ratio, immunoassay, utilizing serum or plasma, reported as a value. Includes PreClara ™ Ratio (sFlt-1/PlGF), Thermo Fisher Scientific. |
| 0482U | Obstetrics (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 two weeks. Includes Preeclampsia sFlt-1/PlGF Ratio (PERA), Mayo Clinic, Laboratory Developed Test. |
Provider Requirements and Impact
Prior authorization / coverage requirement — investigational assays
The BRAHMS sFlt-1/PlGF KRYPTOR Test System and the Elecsys sFlt-1 and Elecsys PlGF tests are listed as investigational/not medically necessary as adjuncts to current clinical criteria; because these named assays are not medically necessary, claims may be denied and providers should obtain pre-service confirmation of coverage where applicable.
- Named assays: BRAHMS sFlt-1/PlGF KRYPTOR Test System; Elecsys sFlt-1 and Elecsys PlGF tests.
- Subject to denial when billed as adjuncts to current clinical criteria for diagnosing or predicting risk of preeclampsia.
Alternative covered service required before biomarker testing
Before ordering biomarker testing, use guideline-directed clinical risk assessment as the covered alternative service.
- Clinical risk assessment is the recommended first-line approach per the policy's alternative covered services.
Documentation expectations when ordering/billing sFlt-1/PlGF assays
If ordering or billing these sFlt-1/PlGF ratio assays, include the specific test name and the clinical indication in the record; expect clinical review because these specific assays are listed as investigational/not medically necessary.
- Document the exact assay ordered (e.g., BRAHMS KRYPTOR or Elecsys sFlt-1/PlGF) and the reason for testing in the patient record and claim documentation.
- Be prepared for utilization review given the policy's not medically necessary designation for these named tests.
Denial risk for named investigational sFlt-1/PlGF tests
The policy explicitly states the BRAHMS KRYPTOR and Elecsys sFlt-1/PlGF tests are investigational/not clinically proven and therefore not medically necessary; claims for these tests may be denied when billed as adjuncts to current clinical criteria.
- Denial risk applies specifically to BRAHMS sFlt-1/PlGF KRYPTOR Test System and Elecsys sFlt-1 and Elecsys PlGF tests.
- Denials are likely when these assays are used as adjuncts to standard clinical diagnostic or prognostic criteria for preeclampsia.
Clinical Background
Preeclampsia is a hypertensive disorder of pregnancy that typically arises after 20 weeks' gestation and is characterized by new-onset hypertension with signs of maternal end-organ dysfunction and increased perinatal risk. Angiogenic biomarkers—soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF)—and their ratio have been developed to stratify short-term risk of progression to preeclampsia with severe features, but evidence has not shown that adding these tests to guideline-directed clinical assessment improves maternal or neonatal outcomes.
Definitions and Clinical Terms
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