CurrentAetnaPolicy 0757

Non-Invasive Fetal Membranes Rupture Tests

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This policy governs Aetna's coverage stance on selected non-invasive tests to detect premature rupture of fetal membranes (PROM/PPROM) and applies to providers submitting claims to Aetna. It summarizes which tests and related imaging/assays are considered experimental/investigational for detection of ROM.

Policy Summary

PayerAetna

PolicyNon-Invasive Fetal Membranes Rupture Tests

Policy CodePolicy 0757

Change TypeNo material changes

Effective DateJun 6, 2008

Last ReviewOct 17, 2023

Next Review DateAug 22, 2024

Key ActionDocument clinical context and standard diagnostic findings (history, sterile speculum exam, nitrazine, ferning, ultrasound) when submitting tests for rupture of membranes.

SourceLink

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CurrentAetnaPolicy 0757

Non-Invasive Fetal Membranes Rupture Tests

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Sign up for Aetna Policy 0757 alerts

Get alerted when Policy 0757 changes without checking for updates manually.

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Policy Summary

PayerAetna

PolicyNon-Invasive Fetal Membranes Rupture Tests

Policy CodePolicy 0757

Change TypeNo material changes

Effective DateJun 6, 2008

Last ReviewOct 17, 2023

Next Review DateAug 22, 2024

Key ActionDocument clinical context and standard diagnostic findings (history, sterile speculum exam, nitrazine, ferning, ultrasound) when submitting tests for rupture of membranes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5experimental/interventional items

0066U, 84112example procedure codes

≈8%PROM prevalence

2%PPROM prevalence

10/17/2023last review

Coverage Criteria — Non‑invasive Tests for Rupture of Fetal Membranes

Covered when ALL of the following are met:

Non‑invasive fetal membrane rupture tests (Actim PROM, AmniSure ROM, Chorioquick, ROM Plus) and related imaging/elastography are considered experimental and investigational for detecting preterm rupture of membranes (PROM/PPROM) and for all other indications because effectiveness has not been established.

The evidence base includes diagnostic accuracy studies, systematic reviews, and technology assessments that show variable sensitivity/specificity and limited comparative effectiveness versus conventional methods; many studies excluded patients with vaginal bleeding, multiple pregnancy, fetal distress, or chorioamnionitis, limiting generalizability.

In settings where diagnosis is essential and conventional testing is equivocal, amniocentesis with injection of indigo carmine remains the definitive diagnostic procedure; non‑invasive tests should not replace definitive diagnostic procedures.

FDA communications have warned about misuse, over‑reliance, and inaccurate interpretation of ROM test results, noting associated serious adverse events and advising against using these tests as the sole basis for critical management decisions.

Functional placental MRI and fetal membrane imaging techniques (eg, magnetic resonance elastography, optical coherence elastography, shear wave elastography, ultrasound elastography) are considered investigational/pilot and unproven for routine clinical use in evaluation of ROM or infection/inflammation in PPROM.

Coding and Reimbursement

Covered/Listed CPT/PLA/Assay codes (examples shown in policy text)CPT

0066U	Placental alpha-micro globulin-1 (PAMG-1), immunoassay with direct optical observation, cervico-vaginal fluid, each specimen.
84112	Evaluation of cervicovaginal fluid for specific amniotic fluid protein(s) (eg, placental alpha microglobulin-1 [PAMG-1], placental protein 12 [PP12], alpha-fetoprotein), qualitative, each specimen.

Imaging and elastography codes mentionedCPT

76391	Magnetic resonance (eg, vibration) elastography.
74712	Magnetic resonance (eg, proton) imaging, fetal, including placental and maternal pelvic imaging when performed; single or first gestation.
76811	Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation plus detailed fetal anatomic examination, transabdominal approach; single or first gestation.
76981	Ultrasound, elastography; parenchyma (eg, organ).

ICD-10 codes referencedICD-10

O42.00 - O42.92

Premature rupture of membranes (ICD-10 range referenced as not covered for indications listed in the CPB).

Regulatory submissions referencedmixed

510(k)

FDA 510(k) summaries referenced for Actim ROM, AmniSure ROM, ROM Plus

Provider Actions — Documentation, Prior Authorization, and Risks

Prior Authorization

Prior Authorization — Possible for Listed Codes

Prior authorization may be required for certain listed procedure/test codes used to evaluate rupture of membranes (see coding lists in policy). Providers should verify plan-specific prior authorization requirements before ordering non-invasive ROM tests or related procedures.

Affected codes include CPT 0066U, 76391, 76811-76812, 76981-76983, 84112 and related HCPCS/ICD-10 codes listed in the policy.
Prior authorization applicability may vary by member benefit — check Aetna provider portal or member plan documents.

Denial Risk

Denial Risk for Non‑Invasive ROM Tests

Use of non-invasive ROM tests (Actim PROM, AmniSure ROM, Chorioquick, ROM Plus and similar) may be subject to denial because Aetna considers these tests experimental and investigational for detecting preterm ROM and other indications.

Background and Epidemiology

Fetal membranes enclose the amniotic cavity and protect the developing fetus and amniotic fluid. Premature rupture of membranes (PROM) is defined as membrane rupture before the onset of labor; preterm PROM (PPROM) occurs when rupture happens before 37 weeks’ gestation. PROM complicates approximately 8% of pregnancies, while PPROM accounts for roughly 2–3% of pregnancies and is a major contributor to preterm birth and its associated neonatal risks.

Definitions — Key Terms and Tests

PROM — Definition

DefinitionPremature rupture of membranes (PROM) is rupture of fetal membranes before the onset of labor.

Clinical relevancePROM complicates approximately 8% of pregnancies and is generally followed by spontaneous labor and delivery.

Primary risksMaternal risk: intra-uterine infection (risk increases with duration of membrane rupture). Fetal risks: umbilical cord compression and ascending infection.

PPROM — Definition

DefinitionPreterm premature rupture of membranes (PPROM) is rupture of fetal membranes before 37 weeks of gestation.

EpidemiologyPPROM complicates approximately 2% of pregnancies and is associated with ~40% of preterm deliveries.

Policy Dates and Revision History

2023-10-17last_reviewLatest

Policy was last reviewed.

2008-06-06effective_date

Policy became effective.

2024-08-22next_review

Next scheduled policy review date.

Policy Summary

PayerAetna

PolicyNon-Invasive Fetal Membranes Rupture Tests

Policy CodePolicy 0757

Change TypeNo material changes

Effective DateJun 6, 2008

Last ReviewOct 17, 2023

Next Review DateAug 22, 2024

Key ActionDocument clinical context and standard diagnostic findings (history, sterile speculum exam, nitrazine, ferning, ultrasound) when submitting tests for rupture of membranes.

SourceLink

On This Page

Policy labels non-invasive fetal membranes rupture tests (e.g., Actim PROM, AmniSure, Chorioquick, ROM Plus) as experimental/investigational.
Claims for these tests submitted for indications covered by this CPB may be denied as not medically necessary.

Denial Risk

Risk from Over‑Reliance on ROM Tests

The FDA has warned that misuse or over‑reliance on ROM test results can lead to serious adverse events. Providers must not base critical management decisions solely on these test results without clinical correlation.

FDA notified about adverse events (including fetal deaths) associated with over‑reliance and inaccurate interpretation of ROM tests.
ACOG guidance notes high false positive rates and recommends selective use relative to standard diagnostic methods.

Note

Regulatory Considerations May Affect Coverage

Regulatory communications and 510(k) summaries exist for several ROM tests; these documents and FDA safety communications may affect coverage determinations and clinical use.

FDA 510(k) summaries: Actim ROM (2007), AmniSure ROM (2009), ROM Plus (2011).
FDA letter to health care providers (2018) describing risks associated with use of ROM tests.

Documentation Required

Clinical Documentation Supporting PROM Diagnosis

Document the clinical history and physical examination that support a diagnosis of PROM before ordering non‑invasive ROM tests. Standard documentation should include patient report of fluid leakage, sterile speculum exam findings, and any relevant cultures or fetal/maternal assessments.

History: report of sudden gush or ongoing leakage of fluid.
Sterile speculum exam: visualization of pooling, cervicitis, cord/fetal prolapse, cervical dilation/effacement; avoid digital exam unless indicated.
Adjunct tests documented as performed: nitrazine, ferning, ultrasound, and cultures as appropriate.

Documentation Required

Clinical Context Documentation for Biochemical ROM Tests

When biochemical ROM tests are used, document the clinical context and reason for adjunct testing (eg, term vs preterm, equivocal speculum exam, presence of bleeding), since test performance and interpretation vary by setting.

Specify gestational age (term vs preterm), presence of bleeding or other complicating factors, and results of conventional tests (nitrazine, ferning, speculum findings).
Document why conventional methods were inconclusive and why a biochemical assay was ordered.

Documentation Required

Document Clinical Indication and Findings

For use of non‑invasive ROM tests, record the clinical indication and exam findings that justify testing (eg, equivocal membrane status on exam). Documentation should support the medical necessity of the test and include any follow-up actions based on results.

Indication: equivocal membrane status, diagnostic uncertainty after conventional testing, or other clearly stated clinical need.
Findings to document: speculum exam results, nitrazine/ferning outcomes, ultrasound findings, and planned management contingent on test result.

Step Therapy

Step Therapy / Preferred Initial Diagnostic Approach

No step‑therapy requirements for ROM testing are specified in this section; however, conventional diagnostic methods (history, speculum exam, nitrazine, ferning, ultrasound, indigo carmine when indicated) are considered the preferred initial approach and should generally be performed prior to biochemical assays.

Conventional methods remain important comparators and often suffice for diagnosis.
If biochemical tests are considered, document why initial, non‑invasive conventional methods were inconclusive.

Neonatal impactPPROM is associated with neonatal morbidity and mortality; primary causes of neonatal death include prematurity, sepsis, and pulmonary hypoplasia.

AmniSure (PAMG-1) — rapid immunochromatographic test detecting PAMG-1

Test typeAmniSure is a rapid immunochromatographic (non‑instrumented qualitative) test that detects placental alpha‑microglobulin‑1 (PAMG‑1) in vaginal secretions.

Intended useIntended to aid detection of rupture of membranes in pregnant women (AmniSure received FDA 510(k) clearance).

Clinical roleUsed as a noninvasive adjunct to history and physical exam to detect amniotic fluid in vaginal secretions when ROM is suspected.

PAMG‑1 (AmniSure) — point-of-care immunoassay detecting placental alpha microglobulin‑1

Assay targetPAMG‑1 (placental alpha‑microglobulin‑1) detected in vaginal secretions as a marker of membrane disruption.

LimitationsMany accuracy studies excluded patients with vaginal bleeding, multiple gestation, fetal distress, or chorioamnionitis, limiting generalizability.

IGFBP‑1 (Actim PROM / phIGFBP‑1) — test detecting insulin-like growth factor binding protein‑1

Analyte detectedIGFBP‑1 (insulin‑like growth factor binding protein‑1) in cervical/vaginal secretions.

Commercial exampleActim PROM (phIGFBP‑1) is a rapid strip test used to detect IGFBP‑1 as a biomarker for rupture of membranes.

Comparative evidenceSystematic reviews note variable sensitivity/specificity and, in equivocal cases, evidence is insufficient to recommend a single test as definitive.

Chorioquick — semi-quantitative rapid vaginal secretion test measuring IL‑6 and other biomarkers

Test descriptionChorioquick is a semi‑quantitative rapid vaginal secretion test measuring interleukin‑6 (IL‑6) and other biomarkers intended to detect chorioamnionitis in women with PROM.

Reported performanceIn a prospective cohort study (Eleje et al, 2020) Chorioquick showed sensitivity 97.5%, specificity 87.9%, and overall accuracy 93.2% for histologically confirmed chorioamnionitis (findings require further validation).

Intended use contextStudied in women with confirmed term and preterm PROM with or without suspected chorioamnionitis; authors note need for validation by well‑designed studies.

Functional placental MRI — MRI techniques assessing placental parameters presented as investigational

Definition/techniqueFunctional placental MRI encompasses MRI techniques assessing placental parameters (eg, T2, apparent diffusivity, fractional anisotropy) to identify placental changes associated with inflammation in women with PPROM.

Evidence statusPreliminary explorations suggest functional placental MRI may reveal placental changes related to inflammatory processes, but findings did not reach significance and heterogeneity was substantial.

Policy positionPresented as investigational/pilot evidence and considered unproven for routine clinical use to identify in‑vivo inflammation related to PPROM.

Placental alpha-microglobulin-1 (PAMG-1) test / AmniSure — rapid immunoassay on cervicovaginal fluid

Test descriptionThe placental alpha‑microglobulin‑1 (PAMG‑1) test (AmniSure) is a rapid immunoassay performed on cervicovaginal fluid to detect amniotic fluid and aid diagnosis of membrane rupture.

Regulatory noteAmniSure received FDA 510(k) marketing clearance; performance has been evaluated in multiple studies with high reported sensitivity and specificity in some series.

Practical considerationPositive results should be interpreted in clinical context; over‑reliance on test results without conventional examination may be inappropriate given study exclusions and FDA cautions regarding misuse.