DESCRIPTION
Fetal fibronectin (fFN) is a high-molecular-weight glycoprotein isolated from fetal connective tissue, placenta, and amniotic fluid. Fetal fibronectin can be measured in cervicovaginal secretions early in pregnancy. The presence of fFN greater than or equal to 50ng/ml is a positive indication of impending preterm delivery.
According to ACOG, fFN testing may be useful in women with symptoms of preterm labor to identify those with negative values and a reduced risk of preterm birth, thereby avoiding unnecessary intervention.
POLICY
Fetal fibronectin testing to predict preterm labor is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Fetal fibronectin testing to predict preterm labor, including, but not limited to, the following is considered investigational:
Routine pregnancy monitoring
Standard clinical monitoring of asymptomatic high risk pregnant women
Term gestation considered for induction, without symptoms of preterm lab
Multiple gestations or other high risk characteristics for preterm birth, with symptoms suggestive of preterm labor
MEDICAL APPROPRIATENESS
Fetal fibronectin to predict preterm labor is considered medically appropriate when ALL of the following criteria are met:
Singleton or twin gestations
Intact membranes
Cervical dilation less than 3 cm
Symptoms suggestive of preterm labor
Gestational age between 24 and less than 35 weeks
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Originally, fFN immunoassays were available only at specialized reference laboratories. Because the tests were sent to a reference lab, there was a minimum of a 24-hour delay between sampling and receipt of the results. In 1999, a rapid FFN test became available, permitting results within 20 minutes of testing. This assay produces qualitative results, reported as positive, negative, or indeterminate.
There is inadequate published data in peer-reviewed scientific journals to support the investigational applications of the FFN assay as listed above. Specifically, in asymptomatic patients both with and without additional risk factors (including multiple gestations) for preterm birth, the positive predictive value is inadequate to identify women who require preventive treatment based upon the FFN result alone. Although the FFN assay is a risk predictor for preterm delivery among asymptomatic women, there is no proven effective treatment for asymptomatic women at risk of preterm birth that is known to improve maternal or fetal outcomes. Finally, the evidence is insufficient to support the use of the FFN assay to identify women at term being considered for induction who are likely to deliver within 24–48 hours and, therefore, do not require induction. Although many studies show an association between FFN levels and imminent term delivery, there is no evidence that the predictive values are sufficiently high to alter management.
SOURCES
Agency for Healthcare Research & Quality. (2002, May). Evidence report/technology assessment No. 53: Management of prolonged pregnancy (AHRQ Publication No. 02-E018). Retrieved July 19, 2006 from http://www.ahrq.gov/downloads/pub/evidence/pdf/prolpreg/prolpreg.pdf. (over 300 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2005). Fetal fibronectin enzyme immunoassay (2.04.03). Retrieved June 23, 2009 from BlueWeb. (7 articles and/or guidelines reviewed)
British Columbia Reproductive Care Program. (2004). Fetal fibronectin. Retrieved July 14, 2006 from http://www.rcp.gov.bc.ca/whatsnew_pdfs/fibronectin.pdf.
Giles, W., Bisits, A., Knox, M., Madsen, G., & Smith, R. (2000). The effect of fetal fibronectin testing on admissions to a tertiary maternal-fetal medicine unit and cost savings. American Journal of Obstetrics and Gynecology, 182 (2), 439-442. Abstract retrieved July 20, 2006 from PubMed database.
Gomez, R., Romero, R., Medina, L., Nien, J. K., Chaiworapongsa, T., Carstens, M., et al. (2005). Cervicovaginal fibronectin improves the prediction of preterm delivery based on sonographic cervical length in patients with preterm uterine contractions and intact membranes. American Journal of Obstetrics and Gynecology, 193 (1), 308-309. Abstract retrieved July 20, 2006 from PubMed database.
Institute for Clinical Systems Improvement. (2008, August). Health care guideline: Routine prenatal care. Retrieved June 23, 2009 from http://www.icsi.org/guidelines_and_more/gl_os_prot/womens_health/prenatal_care_4/prenatal_care__routine__3.html. (28 articles and/or guidelines reviewed)
Lopez, R. L., Francis, J. A., Garite, T. J., & Dubyak, J. M. (2000). Fetal fibronectin detection as a predictor of preterm birth in actual clinical practice. American Journal of Obstetrics and Gynecology, 182 (5), 1103-1106. Abstract retrieved July 20, 2006 from PubMed database.
March of Dimes Birth Defects Foundation. (2006). Fetal fibronectin (fFN): A test for preterm delivery. Retrieved July 14, 2006 from http://www.marchofdimes.com/professionals/14332_1149.asp.
National Guideline Clearinghouse. American College of Obstetricians and Gynecologists. (2001, October). Assessment of risk factors for preterm birth. Retrieved July 19 2006 from http://www.guidelines.gov/summary/summary.aspx?doc_id=3980&nbr=003119&string=fibronectin.
National Guideline Clearinghouse. American College of Obstetricians and Gynecologists. (2003, May). Management of preterm labor. Retrieved July 19, 2006 from http://www.guidelines.gov/summary/summary.aspx?doc_id=3993&nbr=003130&string=fibronectin.
Plaut, M. M., Smith, W., & Kennedy, K. (2003). Fetal fibronectin: The impact of a rapid test on the treatment of women with preterm labor symptoms. American Journal of Obstetrics and Gynecology, 188 (6), 1588-1593. Abstract retrieved July 14, 2006 from PubMed database.
Ramsey, P. S., & Andrews, W. W. (2003). Biochemical predictors of preterm labor: Fetal fibronectin and salivary estriol. Clinics in Perinatology, 30 (4), 701-733.
Ressel, G. (2002). ACOG issues recommendations on assessment of risk factors for preterm birth. American Family Physician, 65 (3), 509-510.
ORIGINAL EFFECTIVE DATE: 10/1998
MOST RECENT REVIEW DATE: 8/13/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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