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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.
No material clinical or coverage changes in this revision.
Coverage Criteria — Non‑invasive Tests for Rupture of Fetal Membranes
Coverage Criteria — Non‑invasive Tests for Rupture of Fetal Membranes
Covered when ALL of the following are met:
Coding and Reimbursement
| 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. |
| 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). |
| O42.00 - O42.92 | Premature rupture of membranes (ICD-10 range referenced as not covered for indications listed in the CPB). |
| 510(k) | FDA 510(k) summaries referenced for Actim ROM, AmniSure ROM, ROM Plus |
Provider Actions — Documentation, Prior Authorization, and Risks
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.
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.
- 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.
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.
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.
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.
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.
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 / 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.
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
Policy Dates and Revision History
Policy was last reviewed.
Policy became effective.
Next scheduled policy review date.
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