Home Uterine Activity Monitoring

Number: 0127

Policy

Aetna considers home uterine activity monitoring (HUAM) experimental and investigational.  In its discretion, Aetna may consider HUAM medically necessary upon review of each circumstance and consideration of any of the following criteria:

1. Women with complicated pregnancies who cannot feel their contractions. HUAM may be considered medically necessary on an individual case exception basis for pregnant women with gestational age greater than 18 weeks who cannot feel their contractions and have any of the following complications:
   1. Incompetent cervix (as documented by need for cerclage or signs of cervical incompetence (funneling on valsalva, silent shortening); or
   2. Presence of risk factors that increase risk of preterm birth: placenta previa with hemorrhage; history of classical caesarean section or deep myomectomy with contractions/cervical change in index pregnancy, such that woman is not able to safely tolerate contractions; or
   3. Presence of physiologic or anatomic factors (eg, paralysis, neuromuscular disorders such as muscular dystrophy) which limit the ability to self-detect contractions; or
   4. Triplets, quadruplets, or greater multiple gestations (however, HUAM is not considered medically necessary in twin gestations unless other extenuating circumstances exist); or
      

2. Women with preterm labor, where conventional methods to arrest progression of preterm labor have failed; or

3. Women with a positive fetal fibronectin test, gestational age is 20 weeks or greater and less than 36 weeks, and progressive cervical changes (with cervical length less than 2.5 cm documented by vaginal probe ultrasound) despite treatment with multiple tocolytics.

Background

Large randomized controlled trials have demonstrated that the use of a home uterine monitor is not associated with a decrease in the incidence of preterm birth.  This analysis is supported by policy statements by the American College of Obstetricians and Gynecologists (1997; 2001; 2003) and the U.S. Preventive Services Taskforce (1996).  An evidence report prepared for the Agency for Healthcare Research and Quality (AHRQ) (2000) concluded that "home uterine activity monitoring was found to confer no maternal or fetal/neonatal benefits".

Reichmann (2008) stated that the current paradigm in obstetrics has shifted toward evidence-based medicine, and yet in clinical practice physicians continue to use interventions for which there exists no credible evidence.  The author examined the United States Food and Drug Administration (FDA) status of home uterine activity monitoring (HUAM) and the published clinical trials examining HUAM for the management of current preterm labor.  The use of HUAM was introduced into clinical practice and heavily marketed without benefit of scientific rigor.  Gradually, HUAM use migrated primarily for patients diagnosed (or mis-diagnosed) with preterm labor in the current pregnancy who are stabilized and sent home with or without a tocolytic.  This clinical intervention has not been cleared by the FDA, has virtually no scientific support, and constitutes a gross deviation from evidence-based medicine.  As obstetricians accept the role of medical evidence steering clinical practice, HUAM clearly has no clinical value and therefore should not be used to manage patients outside of a randomized controlled clinical trial.

In a Cochrane review, Urquhart et al (2012) examined if HUAM is effective in improving the outcomes for women and their infants considered to be at high-risk of preterm birth, when compared with conventional or other care packages that do not include HUAM.  These investigators searched the Cochrane Pregnancy and Childbirth Group's Trials Register (November 30, 2011), CENTRAL (The Cochrane Library 2011, Issue 4 of 4), MEDLINE (1966 to November 30, 2011), EMBASE (1974 to November 30, 2011), CINAHL (1982 to November 30, 2011) and scanned reference lists of retrieved studies.  Randomized control trials of HUAM, with or without patient education programs, for women at risk for preterm birth, in comparison to the same care package without HUAM were selected for analysis.  Two review authors independently assessed trials for inclusion, extracted data and assessed risk of bias.  Data were checked for accuracy.  These researchers did not attempt to contact authors to resolve queries.  There were 15 included studies (total number of enrolled participants 6,008); 13 studies contributed data.  Women using HUAM were less likely to experience preterm birth at less than 34 weeks (risk ratio (RR) 0.78; 95 % confidence interval (CI): 0.62 to 0.99; 3 studies, n = 1,596; fixed-effect analysis).  However, this significant difference was not evident when the authors carried out a sensitivity analysis, restricting the analysis to studies at low-risk of bias based on study quality (RR 0.75; 95 % CI: 0.57 to 1.00, 1 study, 1,292 women).  There was no significant difference in the rate of perinatal mortality (RR 1.22; 95 % CI: 0.86 to 1.72; 2 studies, n = 2,589).  There was no significant difference in the number of preterm births at less than 37 weeks (average RR 0.85; CI: 0.72 to 1.01; 8 studies, n = 4,834; random effects, T(2) = 0.03, I(2) = 68 %).  Infants born to women using HUAM were less likely to be admitted to neonatal intensive care unit (average RR 0.77; 95 % CI: 0.62 to 0.96; 5 studies, n = 2,367; random-effects, T(2) = 0.02, I(2) = 32 %).  Although this difference was not statistically significant when only high-quality studies were included (RR 0.86; 95 % CI: 0.74 to 1.01; 1 study, n = 1,292).  Women using HUAM made more unscheduled antenatal visits (mean difference (MD) 0.49; 95 % CI: 0.39 to 0.62; 2 studies, n = 2,807).  Women using HUAM were also more likely to have prophylactic tocolytic drug therapy (average RR 1.21; 95 % CI: 1.01 to 1.45; 7 studies, n = 4,316; random-effects. T(2) = 0.03, I(2) = 62 %); but this difference was no longer significant when the analysis was restricted to high-quality studies (average RR 1.22; 95 % CI: 0.90 to 1.65, 3 studies, n = 3,749,random effects, T(2) = 0.05, I(2) = 76 %).  One small study reported that the HUAM group spent fewer days in hospital antenatally.  No data on maternal anxiety or acceptability were found.  The authors concluded that HUAM may result in fewer admissions to a neonatal intensive care unit but more unscheduled antenatal visits and tocolytic treatment. There is no impact on maternal and perinatal outcomes such as perinatal mortality or incidence of preterm birth.

An UpToDate review on "Management of pregnant women after inhibition of acute preterm labor" (Caritis and Simhan, 2015) states that "Home uterine activity monitoring – We agree with the American College of Obstetricians and Gynecologists and other expert organizations that recommend not using home uterine activity monitors to monitor women at risk for pre-term labor (PTL) or recurrent PTL.  In a 2015 systematic review and meta-analysis of trials of standard care with versus without home uterine activity monitoring, the intervention had no impact on maternal and perinatal outcomes such as perinatal mortality or incidence of preterm birth".

Table: CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
CPT codes not covered for indications listed in the CPB:
99500	Home visit for prenatal monitoring and assessment to include fetal heart rate, non-stress test, uterine monitoring and gestational diabetes monitoring
Other CPT codes related to the CPB:
82731	Fetal fibronectin, cervicovaginal secretions, semi-quantitative
HCPCS codes not covered for indications listed in the CPB:
S9001	Home uterine monitor with or without associated nursing services
Other HCPCS codes related to the CPB:
S9208 - S9214	Home management of preterm labor, preterm rupture of membranes (PROM), gestational hypertension, postpartum hypertension, preeclampsia, or gestational diabetes, including administrative services, professional pharmacy services, care coordination, and all necessary supplies or equipment (drugs and nursing visits coded separately), per diem (do not use this code with any home infusion per diem code)
ICD-10 codes covered for indications listed in the CPB (not all-inclusive):
G11.4	Hereditary spastic paraplegia [Troyer Syndrome]
G12.20 - G12.29	Motor neuron disease [Monomelic Amyothrophy] [Primary Lateral Sclerosis]
G70.2	Congenital and developmental myasthenia
G70.80 - G70.81	Other specified myoneural disorders [Lambert-Eaton myasthenic syndrome]
G71.11	Myontonic muscular dystrophy [Isaac’s Syndrome]
G71.12	Myontonia congenita [Myotonia]
G71.2	Congenital myopathies
G71.3	Mitochandrial myopathy, not elsewhere classified
G81.00 - G81.94	Hemiplegia and hemiparesis
G82.2 - G82.54	Paraplegia (paraparesis) and quadriplegia (quadriparesis)
G83.0 - G83.9	Other paralytic syndrome
H49.811 - H49.819	Kearns-Sayre syndrome
P94.1	Congenital hypertonia
R48.2	Apraxia
Z3A.18	18 Weeks gestation of pregnancy
Z3A.19	19 Weeks gestation of pregnancy
Z3A.20 - Z3A.49	Weeks of gestation of pregnancy, weeks 20 - 49
ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):
O09.211 - O09.219	Supervision of pregnancy with history of pre-term labor
O30.101 - O30.199	Triplet pregnancy, antepartum condition or complication
O30.201 - O30.299	Quadruplet pregnancy, antepartum condition or complication
O31.10x+ - O31.13x+	Continuing pregnancy after spontaneous abortion of one fetus or more
O34.211 - O34.219	Maternal care for scar from previous cesarean delivery
O34.30 - O34.33	Maternal care for cervical incompetence
O44.10 - O44.13	Placenta previa with hemorrhage
O60.00 - O60.03	Premature labor without delivery
O30.001 - O30.099	Twin gestation placenta status
O30.101 - O30.199	Triplet gestation placenta status
O30.201 - O30.299	Quadruplet gestation placenta status
O30.801 - O30.899	Other specified multiple gestation placenta status

The above policy is based on the following references: