HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
L-30-016
Topic:
Fetal Fibronectin Enzyme Immunoassay
Section:
Laboratory
Effective Date:
October 1, 2017
Issued Date:
January 28, 2019
Last Revision Date:
January 2019
Annual Review:
January 2019
 
 

Assessment of fetal fibronectin (FFN) is proposed for use in the diagnosis and management of preterm labor (PTL) and in the management of women at term being considered for induction. FFN testing has been considered for several categories of patients including women who are experiencing symptoms of PTL, asymptomatic women at increased risk of PTL, and asymptomatic women as part of routine pregnancy care.

The ELISA Fetal fibronectin (FFN) immunoassay test is designed to detect FFN in cervicovaginal secretions. When detected between the weeks of 21 and 37 weeks gestation, the probability of preterm delivery within the next 7-14 days is reportedly increased.

Policy Position

The ELISA FFN immunoassay and the rapid FFN assay may be considered medically necessary for women who meet ALL of the following indications:

  • Intact amniotic membranes; and
  • Cervical dilation < 3cm; and
  • Experiencing symptoms suggestive of preterm labor severe enough to potentially warrant hospital admission for tocolysis; and
  • Cervical effacement and dilation or shortened cervix; and
  • Lab results can be provided in order to make timely treatment determinations (i.e., rapid test results provided in less than an hour); and
  • The test is performed for singleton or twin gestations between  24 and 35 weeks; and
  • The individual does not have cervical cerclage.

All other applications of the ELISA FFN immunoassay are considered experimental/investigational, including but not limited to, the following:

  • As part of routine pregnancy monitoring in women with singleton gestations, no risk factors for preterm birth, and without symptoms of PTL.

NOTE: The positive predictive value of the FFN is inadequate to identify women who require preventive treatment based on the FFN result alone. Effective treatment in an asymptomatic population has not been established.

  • As part of clinical monitoring of high-risk women with multiple gestations or other high-risk characteristics for preterm birth (e.g., history of preterm birth, uterine malformation, cervical incompetence, history of two or more spontaneous second trimester abortions) without symptoms of PTL.

NOTE: The positive predictive value of the FFN is inadequate to identify women who require preventive treatment based on the FFN result alone. Effective treatment in an asymptomatic population has not been established, and the monitoring frequency for high-risk women with multiple gestations is already high.

  • Women at term being considered for induction who are likely to deliver within 24-48 hours and therefore do not require induction.

NOTE: There is insufficient evidence in literature to support the use of the FFN in these women.

  • Women with multiple gestations or other high-risk characteristics for preterm birth, with symptoms suggestive of PTL.

NOTE: There is insufficient evidence to suggest that the results of the FFN alter the standard aggressive management of these symptomatic high-risk women.

82731




 Covered Diagnosis Codes for Procedure Code 82731

O60.02

O60.03

 

 

 

 

 



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Fetal fibronectin enzyme immunoassay is typically an outpatient procedure which is only eligible or coverage as an inpatient procedure in special circumstances including, but not limited to the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.



The policy position applies to all commercial lines of business



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