Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Leaking fluid
Treatment: 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative) 
The insurer denied the 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative). 
The denial is upheld.

The patient is a female G1P0 (one pregnancy, no births). She presented at 40.1 weeks gestation for a routine obstetric visit. She was complaining of some leaking from the vagina. She was nitrazine positive. She had an ultrasound that revealed an AFI (amniotic fluid index) of 8 cm (centimeters). She was sent to labor and delivery for evaluation. An Amnisure test was obtained.

No, the health plan should not cover the 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative). 

According to the American College of Obstetrics and Gynecology (ACOG), most cases of PROM (premature rupture of membranes) can be diagnosed on the basis of the patient's history and physical examination. Examination should be performed in a manner that minimizes the risk of introducing infection. Because digital cervical examinations increase the risk of infection and add little information to that available with speculum examination, digital examinations generally should be avoided unless the patient appears to be in active labor or delivery seems imminent. Sterile speculum examination provides an opportunity to inspect for cervicitis and umbilical cord prolapse or fetal prolapse, assess cervical dilatation and effacement, and obtain cultures as appropriate.

The diagnosis of membrane rupture typically is confirmed by the visualization of amniotic fluid passing from the cervical canal and pooling in the vagina, a basic pH (potential of hydrogen) test of vaginal fluid, or arborization (ferning) of dried vaginal fluid which is identified under microscopic evaluation. The normal pH of vaginal secretions is generally 4.56.0, whereas amniotic fluid usually has a pH (potential of hydrogen) of 7.17.3. False-positive test results may occur in the presence of blood or semen, alkaline antiseptics, or bacterial vaginosis. Alternatively, false-negative test results may occur with prolonged membrane rupture and minimal residual fluid.

In equivocal cases, additional tests may aid in the diagnosis. Ultrasonographic examination of amniotic fluid volume may be a useful adjunct, but is not diagnostic. Fetal fibronectin is a sensitive but nonspecific test for ruptured membranes; a negative test result is strongly suggestive of intact membranes, but a positive test result is not diagnostic of PROM. Several commercially available tests for amniotic proteins are currently on the market, with high reported sensitivity for PROM. However, false-positive test result rates of 19-30% have been reported in patients with clinically intact membranes and symptoms of labor. These test kits should be considered ancillary to standard methods of diagnosis. If the diagnosis remains unclear after a full evaluation, membrane rupture can be diagnosed unequivocally with ultrasonographically guided transabdominal instillation of indigo carmine dye, followed by the passage of blue-dyed fluid into the vagina, which is documented by a stained tampon or pad. It is important to note that the maternal urine also will turn blue and should not be confused with amniotic fluid.

The United States Food and Drug Administration (FDA) released a letter to health care providers in response to adverse events related to their use, including 13 fetal deaths and multiple reports of health complications in pregnant women. The FDA letter reminded health care providers that these tests should not be used without other clinical assessments because of concerns about "misuse, overreliance, and inaccurate interpretation of lab test results from rupture of membranes tests used to detect rupture of membranes in pregnant women. These can lead to serious adverse events, including fetal death, infection, and other health complications in pregnant women." At most, these test kits should be considered selectively relative to standard methods of diagnosis.

Abdelazim, et al did a study "designed to detect the accuracy of the placental alpha microglobulin-1 (PAMG-1) (AmniSure test) to diagnose premature rupture of the fetal membranes (PROM)." This comparative prospective study was carried out over two years in Al-Rashid Maternity Hospital, Kuwait. One hundred and fifty (150) pregnant women after 37 weeks gestation were included in this study for induction of labor and divided into two groups according to the presence or absence of PROM; 75 patients with PROM were included in group I and 75 patients without PROM were included in group II as controls. Patients with multiple pregnancies, fetal distress, vaginal bleeding, preterm labor, or chorioamnionitis were excluded from this study. Trans-abdominal ultrasound was done to detect the gestational age and the amniotic fluid index (AFI 5 cm in PROM) followed by sterile speculum examination to detect amniotic fluid pooling from the cervical canal and for the collection of samples.

In review of the medical record, the patient presented with contractions every 10 minutes and a concern for rupture of membranes. The literature above does support the sensitivity/specificity of AmniSure rupture of membranes test for detecting rupture of membranes. However, according to the literature, there is also a false-positive test result rates of 19-30% reported in patients with clinically intact membranes and symptoms of labor. ACOG also states that the use of traditional testing for the detection of ruptured membranes is recommended over protein testing. Protein testing can be used in cases where the standard diagnosis methods are equivocal.

Therefore, although there is literature supporting that the use of Amnisure for the detection of rupture of membranes, ACOG generates the guidelines for obstetricians and recommends that the gold standard for the diagnosis of rupture of membranes is a physical examination with visualization of pooling, pH testing, and ferning. Only if these tests are inconclusive would the protein based tests be recommended. The plan should not cover testing that is not considered the standard of care or medically appropriate.

No, the 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative) is not likely to be more beneficial.