Reference coding when requesting prior authorization or coverage review

See Coding section: CPT codes 0243U, 0247U, 0482U, and 0524U are listed as outpatient/lab services and may inform prior authorization or billing reviews; inclusion of a code in the coding table does not guarantee coverage—verify member benefit.

• CPT 0243U, 0247U, 0482U, 0524U are outpatient/lab codes referenced in the policy.
• Inclusion in the codes table is informational only; coverage is subject to member-specific benefit plan terms.

Do not use serum biomarker assays to select first‑trimester aspirin candidates

No maternal serum biomarker assays cleared by the FDA are indicated for selecting first‑trimester candidates for aspirin prophylaxis; sFlt‑1 and PlGF–based tests cleared in the US (KRYPTOR, Elecsys) are indicated for use later in pregnancy and thus not appropriate for first‑trimester aspirin selection.

• FDA‑cleared sFlt‑1/PlGF tests (KRYPTOR, Elecsys) are cleared for use at 23+0 to 34+6/7 weeks, not first trimester.
• No FDA‑cleared maternal serum biomarkers are indicated to select women for aspirin in the first trimester.

Prior authorization should reflect intended-use context (hospitalized, 23+0–34+6/7 wk HDP)

sFlt‑1/PlGF assays cleared in the US are intended as an adjunct to clinical assessment for hospitalized pregnant people with hypertensive disorders between 23+0 and 34+6/7 weeks; prior authorization (if required) should document hospitalization, gestational age, and hypertensive disorder indication.

• Cleared use: hospitalized pregnant people with hypertensive disorders, gestational age 23+0–34+6/7 weeks.
• If PA is required, include evidence of hospitalization, gestational age, and clinical indication (HDP).

Prior authorization may be required by plan terms or clinical context

The policy does not mandate a universal prior authorization requirement; however, prior authorization may be required by the member’s benefit plan or when the clinical utility is unestablished—verify plan requirements.

• No explicit PA code-level requirement is specified in the policy.
• Verify whether the member’s benefit plan requires prior authorization for these tests.

No universal prior authorization specified in policy text

The policy does not specify a universal prior authorization program or a single PA code—there is no explicit prior authorization requirement described in the cited policy text.

• Policy text notes uncertainty about clinical decisions and cutoffs and provides no explicit PA code-level rule.
• Do not assume a universal PA requirement from this policy alone.

Document test results and any management decisions taken after testing

If coverage is being requested for test-guided care, document the test result and the subsequent management decisions (for example, initiation of progesterone, low‑dose aspirin, nurse care management or surveillance) and the clinical rationale linking result to treatment.

• Record the exact test result and the specific interventions initiated because trials used prevention bundles after a positive PreTRM screen.
• Document rationale tying the test result to the chosen management steps.

Provide validation evidence (marketed algorithm, independent validation) for PA review

Prior authorization (when required) should include evidence of clinical validity: use of the marketed algorithm/version, an independent validation cohort, and clear patient/sample selection and characteristics as reported in validation studies.

• Provide data showing the marketed algorithm was used and that independent validation cohorts exist.
• Include patient/sample selection criteria and clinical characteristics as reported in validation studies.

Confirm assay and intended‑use population match validation criteria

If PA is requested, confirm that the tested population and assay match the validated intended‑use population (for example, Encompass: singleton, age ≥35, 17w4d–22w0d, exclusion of major pre‑existing risk factors) and that the marketed assay version was used.

• Confirm assay intended‑use population (e.g., Encompass validation: singleton pregnancies, age ≥35, 17w4d–22w0d).
• Document exclusions (diabetes, prior preeclampsia, chronic hypertension, renal disease, SLE, antiphospholipid syndrome) if applicable.

Expect PA for biomarker or cfRNA tests, especially non‑US‑cleared assays or unclear clinical decisions

Prior authorization may be required when maternal serum biomarker or cell‑free RNA testing is requested to predict preeclampsia or preterm birth—especially for tests not cleared in the US or when clinical utility is unestablished; include clinical justification in the PA request.

• Tests not cleared for US use or tests lacking clear intended clinical decisions are more likely to prompt PA or coverage denial.
• Provide clinical justification and patient‑specific medical necessity when submitting PA.

Use listed CPT codes for claims but verify coverage and PA per member benefit

CPT codes referenced in the policy (0243U, 0247U, 0482U, 0524U) are outpatient/lab services; coverage and PA requirements are determined per member benefit and the medical policy—verify coding on claims and member coverage prior to testing.

• CPT 0243U, 0247U, 0482U, 0524U are listed in the policy’s code table as outpatient/lab services.
• Inclusion of codes is informational; confirm coverage with member‑specific benefit plan.

Verify line‑of‑business exceptions and alternate coverage pathways

This policy may not apply to all lines of business (for example, FEP, Medicare Supplement, Medicare Advantage, Medicaid, and certain self‑insured groups); verify benefit exceptions and any alternate coverage pathways before ordering or seeking PA.

• Check whether the member’s line of business is excluded from this policy.
• Verify alternate coverage pathways for exception populations.

Perform guideline‑based risk assessment and BP monitoring before biomarker testing

Follow guideline‑recommended clinical risk assessment (USPSTF, ACOG) and routine prenatal monitoring (serial blood pressure and proteinuria screening); biomarker testing is adjunctive and does not replace standard guideline‑based assessment.

• USPSTF/ACOG risk assessment and BP monitoring remain standard of care.
• Biomarker testing should be considered only as an adjunct to history‑based screening.

Expect standard clinical management as the first step before biomarker assays

Payers may expect that standard clinical management (history, serial blood pressure, and proteinuria screening) is performed before ordering biomarker assays; trials used standard care as the comparator.

• Ensure standard assessment and documentation precede consideration of biomarker testing.
• Payers may require trial of guideline‑based management as the first step.

When using biomarkers with risk algorithms, document the algorithm and care changes

Some trials combined biomarker results with clinical risk algorithms (for example, fullPIERS) to guide escalation or de‑escalation of surveillance and admission; if applying such an approach, document the algorithm used and resulting care changes.

• Document which clinical risk algorithm (eg, fullPIERS) was used alongside biomarker results.
• Record how algorithm/biomarker integration altered surveillance, admission, or treatment decisions.

Document interventions delivered after a positive PreTRM screen

In trials using PreTRM, a positive screen commonly led to a prevention bundle (progesterone, low‑dose aspirin, nurse support); providers should document delivery of each bundle component and patient acceptance/refusal when claiming medical necessity.

• Document which prevention bundle components were initiated (progesterone, aspirin, care management).
• Record patient acceptance or refusal of the intervention bundle, as trials reported variable uptake.

Document acceptance and specifics of intervention bundles used after positive screens

Trials of prevention bundles reported variable uptake and outcomes; when asserting medical necessity for test‑guided interventions, document which bundle elements were offered and accepted, and link outcomes to the clinical decision pathway.

• Record uptake rates and which specific interventions were accepted by the patient.
• Link clinical outcomes and rationale to the specific interventions initiated after testing.

Use biomarkers only as adjuncts to guideline‑based screening and monitoring

Biomarker testing (including cfRNA) should be used as an adjunct to guideline‑based screening—not as a replacement for USPSTF/ACOG assessments and routine prenatal monitoring.

• Continue standard prenatal monitoring (blood pressure, proteinuria) even if biomarker testing is performed.
• Do not substitute biomarker testing for guideline‑recommended clinical risk assessment.

Verify member benefits and eligibility prior to testing or PA submission

Before ordering or requesting coverage, verify member eligibility and benefits with the member‑specific benefit plan—coverage determinations are subject to plan terms and may vary.

• Identify member eligibility and any plan‑specific coverage restrictions before testing.
• Coverage determinations depend on the member’s benefit document and additional terms.

Provide independent validation cohort and marketed‑version accuracy for PA

Validation evidence submitted for prior authorization should include an independent validation cohort separate from development, and report accuracy of the marketed/tested version (including any algorithm) as used in the clinical setting.

• Provide evidence that the marketed version and algorithm were validated in an independent cohort.
• Include reported accuracy metrics (sensitivity, specificity, AUROC) for the marketed version.

Document gestational age, hypertensive disorder status, hospitalization, platform, and numeric result

Include in the chart the clinical context: gestational age at sampling, presence or absence of a hypertensive disorder, whether the patient was hospitalized, the test platform used, and the numeric test result (for example, sFlt‑1/PlGF ratio and the cutoff applied).

• Document exact gestational age at blood draw and whether the patient had an HDP.
• Record the test platform (eg, KRYPTOR, Elecsys) and the numeric ratio/value and cutoff used.

Specify gestational age, hypertensive disorder diagnosis, ratio value, and platform in documentation

Chart documentation supporting a test claim should include gestational age at sampling, the hypertensive disorder diagnosis (if present), the reported sFlt‑1/PlGF ratio value and the assay platform used to generate it.

• Report the sFlt‑1/PlGF numeric value and specify the assay platform (KRYPTOR, Elecsys).
• Include clinical diagnosis (eg, gestational hypertension, preeclampsia) and gestational age at draw.

Include trial‑style documentation elements (GA, suspected criteria, assay used) when applicable

RCTs and validation studies included key elements such as gestational age at testing, suspected preeclampsia criteria, and the specific PlGF or sFlt‑1/PlGF assay used; include these elements when documenting test use and interpretation.

• Document the suspected preeclampsia criteria used in evaluation.
• List the assay name (eg, Triage, Elecsys) and the management recommendations linked to result ranges.

Show marketed‑version accuracy and independent validation in PA documentation

Validation studies used independent cohorts and reported accuracy for the marketed test version; prior authorization documentation should similarly report that the marketed version achieved the reported accuracy metrics.

• State that validation was performed on an independent cohort and provide reported performance metrics.
• Confirm the accuracy reported applies to the marketed/tested algorithm version.

Include patient/sample selection and exact gestational age at draw in documentation

Studies used for evaluation must report patient selection and sample characteristics and provide exact gestational age at blood draw; include these study‑level details in PA/supporting documentation to mirror validation evidence.

• Provide patient inclusion/exclusion criteria and exact gestational age windows used in validation studies.
• Ensure sample collection timing matches validated windows (eg, 17w4d–22w0d for Encompass; 19 weeks for PreTRM; 23+0–34+6/7 for sFlt‑1/PlGF).

Record assay, cutoff, US‑clearance status, gestational age, and intended clinical decision

Document which specific biomarker test and cutoff was used, whether the test is US‑cleared, the gestational age at testing, and the intended clinical decision the test informed when requesting coverage or recording in the chart.

• Specify the exact assay and numeric cutoff applied (eg, sFlt‑1/PlGF ≥40 per PRAECIS or >38 per Elecsys).
• Indicate US‑cleared status and the intended clinical action informed by the test.

Document medical necessity per member benefit and this policy for coverage requests

Document medical necessity consistent with the member’s benefit plan and this medical policy when requesting coverage for maternal serum biomarker testing.

• Tie the clinical rationale to the member‑specific benefit plan provisions.
• Provide supporting evidence and justification per policy when seeking coverage.

Investigational designation — tests may be denied as not medically necessary

Maternal serum biomarker tests (including maternal serum cell‑free RNA assays) for prediction of preeclampsia or spontaneous preterm birth are designated investigational per this policy and may be denied as not medically necessary.

• This policy states maternal serum biomarker and cfRNA tests for these predictions are investigational.
• Claims for these tests may be denied as not medically necessary under the policy.

Using tests to guide first‑trimester aspirin selection may trigger denial

Coverage denial risk may be triggered when tests are used to select first‑trimester candidates for aspirin prophylaxis, because no FDA‑cleared biomarkers are indicated for that use and no RCTs compare biomarker‑guided selection to guideline‑based care.

• Using biomarkers to choose first‑trimester aspirin candidates is not supported by FDA indications or RCT evidence.
• Such use may lead to coverage denial.

Use cleared tests only within their indicated gestational‑age window to reduce denial risk

FDA‑cleared sFlt‑1/PlGF tests (for example KRYPTOR, Elecsys) are indicated for use in hospitalized pregnant people between 23+0 and 34+6/7 weeks; use outside that gestational‑age window (for example, first‑trimester screening) may not align with cleared labeling and could risk denial.

• KRYPTOR/Elecsys cleared indication: hospitalized pregnant people 23+0–34+6/7 weeks for hypertensive disorders.
• Ordering these tests outside the cleared window may risk coverage denial.

Unclear intended clinical decision and variable cutoffs increase denial risk

Unclear clinical decisions and inconsistent cutoffs for sFlt‑1/PlGF testing create uncertainty in medical‑necessity determinations and may affect coverage outcomes.

• Policy notes variable cutoffs (eg, ≥40, >38, other values) and unclear intended clinical decisions.
• This uncertainty may influence medical necessity and coverage determinations.

Interventions guided by PreTRM without demonstrated outcome benefit may be denied

Testing or interventions driven by PreTRM results that lack demonstrated clinical utility in RCTs (or where benefits appear driven by bundled interventions) may be at risk for noncoverage; document direct evidence linking testing to improved outcomes when asserting necessity.

• PRIME and other trials had mixed results and methodological limitations; benefits may reflect bundled interventions rather than testing alone.
• Provide direct outcome evidence tying testing to improved patient outcomes when seeking coverage.

Do not use PreTRM for patients with known risk factors for spontaneous preterm birth

PreTRM is not indicated for use in women with known risk factors for spontaneous preterm birth; ordering the test for patients with such risk factors may not be consistent with intended use and could be denied.

• Policy explicitly states PreTRM is not indicated for women with known risk factors for spontaneous preterm birth.
• Avoid ordering PreTRM for patients with known risk factors if seeking coverage.

Lack of outcome evidence for cfRNA screening increases denial risk

Absence of RCT or observational evidence showing improved health outcomes with addition of serum cfRNA screening to guideline‑based assessment may prompt denial for claims asserting medical necessity for cfRNA screening.

• No RCTs compare cfRNA screening plus guideline assessment versus guideline assessment alone.
• Lack of outcome evidence supports potential denial for cfRNA claims.

Unsupported test use or non‑US‑cleared assays risk denial

Tests without clear clinical decision pathways or tests not cleared for US use (or using non‑validated cutoffs) may be considered unsupported by evidence and could be denied as not medically necessary.

• Clinical utility is uncertain for tests used outside validated populations, un‑cleared assays, or non‑prespecified cutoffs.
• Coverage determinations may deny unsupported test uses.

Coverage and reimbursement depend on member‑specific benefit plan terms

Coverage for these tests is subject to member‑specific benefit plan terms; inclusion of CPT codes in the policy does not guarantee coverage or reimbursement—verify plan terms before ordering.

• Inclusion of a code does not guarantee coverage.
• Verify member‑specific benefit plan details prior to ordering tests.