Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Fetal Fibronectin Enzyme (fFN) Immunoassay

Policy #:06.02.04d

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

The fetal fibronectin (fFN) immunoassay is considered medically necessary and, therefore, covered for women who meet all of the following indications:
  • Their symptoms are suggestive of current preterm labor severe enough to potentially warrant hospital admission for tocolysis.
  • Lab results can be provided in order to make timely treatment determinations (i.e., rapid test results should be provided in less than an hour).
  • Singleton or twin gestation between 24 weeks and less than 35 weeks.
  • Intact amniotic membranes.
  • Cervical dilation less than 3 cm.

EXPERIMENTAL/INVESTIGATIONAL

The fFN immunoassay is considered experimental/investigational for all other indications including, but not limited to:
  • As part of routine clinical monitoring in asymptomatic pregnant women with singleton gestation and no risk factors for PTL.
  • As part of routine clinical monitoring in asymptomatic pregnant women at risk for PTL, including those with a history of multiple gestations, preterm birth, uterine malformation, cervical incompetence, or a history of two or more spontaneous second-trimester abortions.
  • As part of routine clinical monitoring in women with triplet or higher-order gestations, intact membranes, cervical dilation less than 3 cm, and who are experiencing symptoms suggestive of PTL.
  • As a test to identify women at term being considered for induction who are likely to deliver within 24 to 48 hours and, therefore, do not require induction.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

Testing for fetal fibronectin (fFN) should only be performed by laboratories that are capable of performing the "rapid" fFN immunoassay in order to allow for timely treatment determinations.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, an fFN immunoassay is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The Fetal Fibronectin Rapid System (Adeza Biomedical Corp.; Sunnyvale, CA) was approved by the US Food and Drug Administration (FDA) on August 14, 1998, for detecting the presence of fFN in cervicovaginal secretions.

Manufacturers of the Rapid fFN test have listed the following CONTRAINDICATIONS:

The Rapid fFN test should not be used for symptomatic women with one or more of the following conditions:
  • advanced cervical dilatation (≥ 3 centimeters)
  • rupture of amniotic membranes
  • cervical cerclage
  • moderate or gross vaginal bleeding

The Rapid fFN test should not be used for asymptomatic women with one or more of the following conditions:
  • multiple gestations, e.g., twins
  • cervical cerclage
  • placenta previa (partial or complete)
  • sexual intercourse in the preceding 24 hours

Description

Fetal fibronectin (fFN) is a high-molecular-weight glycoprotein that can be isolated from the fetal connective tissue, placenta, and amniotic fluid. This biochemical marker can be measured in cervicovaginal secretions to evaluate the risk of preterm labor (PTL) and delivery in women with symptoms of PTL. The absence of fFN is a strong indicator that PTL and delivery will not occur within the ensuing 14 days.

PTL is defined as regular contractions associated with a cervical change before 37 completed gestational weeks. Clinical symptoms of PTL include vaginal spotting or bleeding, increased or changed vaginal discharge, intermittent abdominal cramping, backache, and intermittent uterine contractions. Signs of PTL include cervical effacement and dilation (ie, shortening of the uterine cervix), as assessed by transvaginal ultrasound. Accurate diagnosis of PTL is extremely difficult. Many methods of assessing the risk of PTL result in overdiagnosis, which can lead to unnecessary hospitalization, tocolytic therapy, and/or corticosteroid use for women who do not truly have PTL.

Fetal fibronectin (fFN) is usually detected in cervicovaginal secretions early in pregnancy and at term. In a normal pregnancy, it is rarely detectable between gestational weeks 21 to 37. The presence of fFN within that timeframe signals the separation of the placental uterine junction; therefore, fFN may be a useful indicator in diagnosing early PTL.

The fFN immunoassay has been studied as a method to more accurately rule out PTL. When the fFN enzyme is not detected between gestational week 24 and week 35, the probability of PTL within the next 14 days decreases significantly. The immunoassay's negative predictive value of greater than 95 percent renders it a useful adjunct to clinical findings in the management of PTL symptoms. Prospective and observational studies have been reported on the use of the fFN immunoassay in relation to the rate of hospitalization for PTL. The study results were compared to a baseline time period of one year prior, when fFN immunoassays had not been performed, and this comparison revealed that there were fewer hospital admissions for PTL during the year when fFN immunoassays were performed. In addition, the PTL and delivery rates for each year were similar.

The Fetal Fibronectin Rapid System (Adeza Biomedical Corp.; Sunnyvale, CA) was approved by the US Food and Drug Administration (FDA) in 1998 for fFN immunoassay testing between gestational weeks 24 and less than 35 weeks gestation. Test results can be provided in as few as 20 minutes and are reported as positive, negative, or indeterminate. A negative result may eliminate unnecessary hospitalization and treatment. The fFN immunoassay is performed primarily by hospital facilities capable of providing the immediate results required to make timely treatment determinations. An fFN level of 50 ng/mL or higher is considered positive.

PRACTICE GUIDELINES AND POSITION STATEMENTS

The American College of Obstetricians and Gynecologists (ACOG) reached the following recommendations regarding fFN testing:
  1. FFN or ultrasonography to determine cervical length may be useful in determining women at high risk for preterm labor. However, their clinical usefulness may rest primarily with their negative predictive value given the lack of proven treatment options to prevent preterm birth.
  2. 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.

According to the ACOG Committee on Obstetric Practice, the fFN test is only appropriate for use in symptomatic pregnant women with all of the following characteristics:
  • Amniotic membranes intact; and
  • Cervical dilatation is minimal (less than 3 cm); and
  • Sampling is performed no earlier than 24 weeks, 0 days and no later than 34 weeks, 6 days of gestation.

Although a negative test appears to be useful in ruling out imminent preterm delivery (i.e., within 2 weeks), the clinical implications of a positive result have not been fully evaluated.

If the test is to be clinically useful, the results must be available from the laboratory in a timely manner (generally considered to be under 4 hours) so that the test can effect decisions concerning the immediate care of the patient. This is in accordance with the ACOG Committee Opinion, which states that “[i]f the test is to be clinically useful, the results must be available from the laboratory in a timely manner.”

ACOG does not recommend the fFN test for screening asymptomatic women to determine risk of preterm delivery. ACOG's Division of Practice Activities concluded that "this test is not recommended as a routine screening procedure for the general prenatal population". A recent clinical trial of the fFN test in 108 women at low risk of preterm delivery concluded that bi-weekly fFN determinations in asymptomatic women between 24 and 34 weeks' gestation “are of limited clinical value for the prediction of preterm birth”.
References


American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 127: Management of preterm labor.Obstet Gynecol.2012;119.6:1308.

American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 130: Prediction and Prevention of Preterm Birth.Obstet Gynecol. 2012;120(4):964-973.

Berghella V, Hayes E, Visintine J, Baxter JK. Fetal fibronectin testing for reducing the risk of preterm birth. Cochrane Database of Systematic Reviews 2008;4:CD006843.

Bolt L, Chandriamani M, Greeff A, et al. The value of combined cervical length measurement and fetal fibronectin testing to predict spontaneous preterm birth in asymptomatic high-risk women. J Maternal-Fetal Neonatal Med. 2011; 24(7):928-932.

Conde-Agudelo A, Romero R. Cervicovaginal fetal fibronectin for the prediction of spontaneous preterm birth in multiple pregnancies: a systematic review and meta-analysis. J Maternal-Fetal Neonatal Med. 2010:23(12):1365-1376.

Gomez R, Romero R, Medina L, et al. Cervicovaginal fibronectin improves the prediction of preterm delivery based on sonographic cervical length in patients with preterm uterine contractions and intact membranes. Am J Obstet Gynecol. 2005;192:350-359.

Grobman WA, Welshman EE, Calhoun EA. Does fetal fibronectin use in the diagnosis of preterm labor affect physician behavior and health care costs? A randomized trial. Am J Obstet Gynecol. 2004;191(1):235-240.

Joffe GM, Jacques D, Bemis-Heys R, et al. Impact of the fetal fibronectin assay on admissions for preterm labor. Am J Obstet Gynecol. 1999;180(3 Pt 1):581-586.

Kurtzman J, Chandriamani M, Briley A, et al. Quantitative fetal fibronectin screening in asymptomatic high-risk patients and the spectrum of risk for recurrent preterm delivery. Am J Obstet Gynecol. 2009:200(3): 263.e1-6.

Leitich H, Kaider A. Fetal fibronectin--how useful is it in the prediction of preterm birth? Br J Obstet Gynaecol. 2003;110(Suppl 20):66-70.

Plaut MM, Smith W, Kennedy K. Fetal fibronectin: the impact of a rapid test on the treatment of women with preterm labor symptoms. Am J Obstet Gynecol. 2003;188(6):1588-1595.

Rapid fFN™ Cassette Kit. Available at: http://www.ffntest.com/pdfs/rapid_ffn_cassettekit_ifu.pdf Accessed October 10th, 2016.

Roberts WE, Morrison JC. Has the use of home monitors, fetal fibronectin, and measurement of cervical length helped predict labor and/or prevent preterm delivery in twins? Clin Obstet Gynecol. 1998;41(1):94-102.

Shennan A, Crawshaw S, Briley A, et al. A randomized controlled trial of metronidazole for the prevention of preterm birth in women positive for cervicovaginal fetal fibronectin: the PREMET study. Br J Obstet Gynaecol. 2006:113(1):65-74.

Terrone DA, Rinehart BK, Kraeden U, Morrison JC. Fetal fibronectin in symptomatic twin gestations. Primary Care Update for OBGYNs. 1998;5(4):179.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Enzyme immunoassay, fetal fibronectin. Premarket Approval (PMA) Database. [FDA Web site]. 09/21/1995. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?start_search=1&applicant=&tradename=&productcode=&pmanumber=P920048&supplementnumber=&advisorycommittee=&docketnumber=&supplementtype=&expeditedreview=&ivdproducts=off&combinationproducts=off&decisiondatefrom=&decisiondateto=&noticedatefrom=&noticedateto=&PAGENUM=500&sortcolumn=pn_asc_sn_asc. Accessed October 10th, 2016.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

82731


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

O60.02 Preterm labor without delivery, second trimester

O60.03 Preterm labor without delivery, third trimester



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

Revisions from 06.02.04d
09/12/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Fetal Fibronectin Enzyme (fFN) Immunoassay.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 12/04/2015
Version Issued Date: 12/04/2015
Version Reissued Date: 09/12/2018

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2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.