Humana Immunoassay Testing for Rupture of Membranes in Pregnancy Form

Description

During pregnancy, the fetal membrane protects the developing fetus and surrounding amniotic fluid from infection. Tearing or rupture of membranes (ROM) normally occurs during labor. Premature rupture of membranes (PROM) is the rupture of membranes before the onset of labor. In most situations, ROM can be diagnosed on the basis of the individual’s history and physical examination.¹

Noninvasive, rapid immunoassay tests have been developed to determine ROM in pregnancy. These tests purportedly detect specific proteins found in amniotic fluid through collection and analysis of vaginal secretions. Examples of ROM tests include, but may not be limited to, the following:

• Actim PROM – Detects insulin-like growth factor binding protein (IGFBP-1) in cervicovaginal secretions
• AmniSure ROM Test and PartoSure – Detects placental alpha microglobulin-1 (PAMG-1) in vaginal secretions
• ROM Plus Rupture of Membranes Test – Detects alpha-fetoprotein (AFP) and placental protein 12 (PP12) or insulin growth factor binding protein-1 (IGFBP-1) in vaginal secretions

Coverage Determination

Humana members may NOT be eligible under the Plan for immunoassay testing for ROM in pregnancy. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

The American College of Obstetricians and Gynecologists (ACOG) does not currently recommend immunoassay testing for amniotic proteins as the primary method for ruling out rupture of membranes. These tests are associated with high false positive rates of 19 to 30% in individuals with clinically intact membranes and symptoms of labor. According to ACOG, at most these test kits should be considered selectively relative to standard methods of diagnosis.¹

Additional information about rupture of membranes in pregnancy may be found from the following websites:

• American College of Obstetricians and Gynecologists
• National Library of Medicine

Medical Alternatives

Alternatives to immunoassay testing for ROM in pregnancy include, but may not be limited to, the following:

• Arborization (ferning) of dried vaginal fluid, identified under a microscope
• Nitrazine test to evaluate the pH of vaginal secretions
• Physical examination using a sterile speculum
• Ultrasound to measure amniotic fluid levels

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes.

Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Immunoassay Testing for Rupture of Membranes in Pregnancy

Effective Date: 10/27/2022
Revision Date: 10/27/2022
Review Date: 10/27/2022
Policy Number: HUM-0528-009
Page: 4 of 5

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

References

1. American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin. Prelabor rupture of membranes. www.acog.org. Published March 2020. Updated 2022. Accessed October 3, 2022.
2. ClinicalKey. Nuss EE, Sciscione A. Prelabor rupture of membranes. In: Ferri, FF. Ferri’s Clinical Advisor 2023. Elsevier; 2023:1258.e2-1258.e3. www.clinicalkey.com. Accessed September 29, 2022.
3. ECRI Institute. Clinical Evidence Assessment. AmniSure ROM Test (AmniSure International, LLC) for detecting ruptured fetal membranes. www.ecri.org. Published March 17, 2014. Updated August 10, 2022. Accessed August 25, 2022.
4. ECRI Institute. Product Brief (ARCHIVED). Actim PROM Test (Medix Biomedica) for detecting ruptured fetal membranes. www.ecri.org. Published March 9, 2017. Accessed August 25, 2022.
5. ECRI Institute. Product Brief (ARCHIVED). PartoSure Test (Parsagen Diagnostics, Inc.) for predicting the risk of preterm labor. www.ecri.org. Published April 27, 2017. Accessed August 25, 2022.
6. ECRI Institute. Product Brief (ARCHIVED). ROM Plus Test (Clinical Innovations, LLC) for detecting ruptured fetal membranes. www.ecri.org. Published March 1, 2017. Accessed August 25, 2022.
7. Hayes, Inc. Molecular Test Assessment. AmniSure ROM Test for detection of fetal membrane rupture. evidence.hayesinc.com. Published March 20, 2018. Updated June 13, 2022. Accessed August 25, 2022.
8. UpToDate, Inc. Prelabor rupture of membranes before and after the limit of viability. www.uptodate.com. Updated August 2022. Accessed September 29, 2022.
9. UpToDate, Inc. Preterm prelabor rupture of membranes: clinical manifestations and diagnosis. www.uptodate.com. Updated August 2022. Accessed September 29, 2022.
10. US Food and Drug Administration (FDA). FDA News Release. FDA alerts healthcare providers, women about risks associated with use of rupture of membranes tests. www.fda.gov. Published August 8, 2018. Updated August 9, 2018. Accessed July 30, 2019.