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Date Printed: June 28, 2017: 11:55 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

05-86000-14

Original Effective Date: 04/15/97

Reviewed: 05/28/09

Revised: 11/01/15

Subject: Fetal Fibronectin Test

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Fetal fibronectin (FFN) is a high molecular weight glycoprotein that can be isolated from fetal connective tissue, placenta, and amniotic fluid. FFN may be detected between 21 and 37 weeks in association with preterm delivery. The purpose of FFN testing is to detect FFN in the cervicovaginal secretions of pregnant women.

The clinical importance of measuring FFN relates to the diagnosis and management of preterm labor (PTL).

Clinical symptoms of PTL are nonspecific and include vaginal spotting or bleeding, increased or changed vaginal discharge, intermittent abdominal cramping, backache, and inappropriate uterine contractions. Signs of PTL include cervical effacement and dilation, or a shortened cervix, as assessed by transvaginal ultrasound.

However, accurate diagnosis of PTL is extremely difficult; current methods of assessing risk result in overdiagnosis of PTL. FFN has been investigated as a method to more accurately diagnose PTL and thus eliminate unnecessary hospitalizations, tocolytic therapy, and corticosteroid treatment in women who do not truly have PTL. The use of FFN has been studied in several different categories of patients:

Approval by the U.S. Food and Drug Administration (FDA) of the fetal fibronectin test indicates it is used to rapidly assess the risk of preterm delivery in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes, and minimal cervical dilatation (<3 cm), sampled between 24 and 34 weeks, 6 days gestation or in conjunction with other clinical information obtained during a routine prenatal visit between 22 and 30 weeks, 6 days in women with a singleton pregnancy.

POSITION STATEMENT:

The use of FFN assays meets the definition of medical necessity for use in women with all of the following:

NOTE: Cervical effacement and dilatation is not required before the test is used.

The use of FFN assays is considered experimental or investigational, as there is insufficient clinical evidence to support the use of FFN assays for all other conditions, and specifically for the following indications:

For all other indications there is insufficient evidence to permit conclusions on efficacy and net health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

82731

Fetal fibronectin, cervicovaginal secretions, semi-quantitative

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

O60.00 – O60.03

Preterm labor without delivery

REIMBURSEMENT INFORMATION:

Fetal fibronectin testing meets the definition of medical necessity in patients whose symptoms of preterm labor prompt hospitalization (inpatient or out patient observation setting). See section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Amniotic membranes: the thin lining surrounding the baby in the uterus (womb).

Cervical dilation: near the time of birth, the cervix stretches open (dilates).

Cervix: connection opening of the wound, at the top of the vagina.

Cm: centimeters.

Effacement: thinning of the cervix, near the time of birth.

Fetal fibronectin: a test done on the cervix to test for certain features that might signal whether or not premature labor is occurring.

Gestation: the period of development.

Multiple gestations: twins, triplets, or more babies at once.

Preterm: birth occurring before 37 weeks of gestation.

Singleton: one baby in the womb.

Term: time when the baby is expected to be born, technically, after more than 37 weeks in the womb.

RELATED GUIDELINES:

Salivary Hormone Testing, 05-82000-14

OTHER:

Other name used to report fetal fibronectin:

Fetal Fibronectin Immunoassay
FFN
Rapid FFN Assay

REFERENCES:

  1. American College of Obstetricians & Gynecologists Committee Opinion, Number 187, September 1997.
  2. American College of Obstetricians and Gynecologists (ACOG), Assessment of Risk Factors for Preterm Birth, 10/01.
  3. Berghella V, Hayes E, Visintine J, Baxter J, Fetal Fibronectin Testing for Reducing the Risk of Preterm Birth, Cochrane Database of Systematic Reviews, October 2007.
  4. Blue Cross Blue Shield of Association Medical Policy. Fetal Fibronectin Enzyme Immunoassay (2.04.03), 11/01/97, 12/05.
  5. ClinicalTrials.gov. A Randomized Trial of Oral Nifedipine Versus Intravenous Magnesium Sulfate in the Acute Management of Preterm Labor in Women with Singleton Gestations, Intact Fetal Membranes, and Positive Vaginal Fetal Fibronectin, sponsored by Memorial Care, accessed 05/12/08.
  6. Hayes Medical Technology Directory, Fetal Fibronectin Test (FETA0803.01), 03/23/00.
  7. Hayes, Inc., Fetal Fibronectin Test in Asymptomatic Women, 01/07, update 01/29/08.
  8. Morgan MA, Goldenberg RL, Schulkin J, Obstetrician-Gynecologists’ Knowledge of Preterm Birth Frequency and Risk Factors, J Matern Fetal Neonatal Med. 2007 Dec; 20(12): 895-901.
  9. Stafford IP, Garite TJ, Dildy GA, et al, A Comparison of Speculum and Nonspeculum Collection of Cervicovaginal specimens for Fetal fibronectin Testing, Am J Obstet Gynecol. 2008 Mar 19.
  10. U.S. Food and Drug Administration (FDA), PMA Final Decisions Rendered for August 1998.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/28/09.

GUIDELINE UPDATE INFORMATION:

04/15/97

New Medical Coverage Guideline.

08/15/02

Annual review.

07/15/04

Scheduled review. Revised when services are covered and not covered. Guideline no longer scheduled for review.

08/19/04

Added “multiple” to When Services Are Covered.

08/15/07

Review, coverage statements maintained, Description section updated, guideline reformatted, references updated.

07/15/08

Annual review: position statements maintained, and updated the references.

06/15/09

Annual review: position statements maintained.

07/09/10

Billing/Coding Information section updated: added ICD-9 code 644.00.

10/15/10

Revision; related ICD-10 codes added.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: June 28, 2017: 11:55 PM