HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
L-30-017
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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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
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    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

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    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.




    Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

    Discrimination is Against the Law
    The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.