Breast-fed infants have a lower risk of diarrhea and otitis media than bottle-fed infants during the first year of life. For premature infants, breast milk helps prevent infections, speeds recovery from respiratory distress syndrome, increases weight gain, protects against retinopathy, and facilitates cognitive and visual development.

Aetna considers breast pump rental medically necessary for infants while they are detained in the hospital. Breast pumps used in the hospital are specifically designed for reuse (sterilizable) and are not sold commercially.

By contrast, the manual and electric breast pumps that are available commercially are not designed for reuse, and are most commonly sold to mothers with normal infants who are working, traveling, or for other reasons not always home to breast-feed the baby. Standard electric breast pumps or manual breast pumps may be necessary to initiate breast feeding in the postpartum period, within the first eight weeks following delivery. Manual breast pumps are sufficient for continuation of breastfeeding following the postpartum period. Current recommendations from the American Academy of Pediatrics are to continue breastfeeding of infants through one year of age.

Women may be able to breastfeed adopted infants through induced lactation. The process involves nipple stimulation with use of an electric breast pump beginning about two months before the adoptive mother expects to begin breast-feeding. In addition, hormonal therapy, such as supplemental estrogen or progesterone, may be prescribed to mimic the effects of pregnancy. Typically, hormone therapy for induced lactation is discontinued shortly before breast-feeding begins. At that point, the infant's suckling is thought to stimulate and maintain milk production.

Authorized under provisions of the Patient Protection and Affordable Care Act, the U.S. Department of Health and Human Services (DHHS) released health plan coverage guidelines, developed by a committee of the Institute of Medicine, that require health insurance plans to cover breast pumps and certain other women's preventive services. New health plans and non-grandfathered plans and issuers are required to provide coverage consistent with these guidelines in the first plan year (in the individual market, policy year) that begins on or after August 1, 2012.

The Centers for Disease Control and Prevention (CDC, 2010) recommended that infected women in the United States refrain from breast-feeding to avoid post-natal transmission of HIV-1 to their infants through breast milk. These recommendations also should be followed by women receiving ant-iretroviral therapy. Passage of anti-retroviral drugs into breast milk has been evaluated for only a few anti-retroviral drugs; ZDV, 3TC, and nevirapine have been detected in the breast milk of women.

Qi and colleagues (2014) described breast pump-related problems and injuries and identified factors associated with these problems and injuries. Data were from the Infant Feeding Practices Study II; mothers were recruited from a nationally distributed consumer opinion panel. Mothers were asked about breast pump use, problems, and injuries at infant ages 2, 5, and 7 months. Survival analysis was used to identify factors associated with pump-related problems and injuries. The sample included 1,844 mothers. About 62 % and 15 % of mothers reported pump-related problems and injuries, respectively. The most commonly reported problem was that the pump did not extract enough milk and the most commonly reported injury was sore nipples. Using a battery-operated pump and intending to breast-feed less than 12 months were associated with higher risks of pump-related problems and injury. Learning from a friend to use the pump was associated with lower risk of pump-related problems, and using a manual pump and renting a pump were associated with a higher risk of problems. The authors concluded that these findings suggested that problems and injuries associated with breast pump use can happen to mothers of all socioeconomic characteristics. Breast-feeding mothers may reduce their risks of problems and injury by not using battery-operated pumps and may reduce breast pump problems by not using manual pumps and by learning breast pump skills from a person rather than following written or video instructions.

In a Cochrane review, Becker et al (2015) evaluated acceptability, effectiveness, safety, effect on milk composition, contamination and cost implications of methods of milk expression. These investigators searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2014), CINAHL (1982 to March 2014), conference proceedings, secondary references and contacted researchers. Randomized and quasi-randomized trials comparing methods at any time after birth were selected for analysis. Three authors independently assessed trials, extracted data and assessed risk of bias. This updated review included 34 studies involving 1,998 participants, with 17 trials involving 961 participants providing data for analysis. Eight studies compared 1 or more types of pump versus hand expression and 14 studies compared 1 type of pump versus another type of pump, with 3 of these studies comparing both hand expression and multiple pump types. Fifteen studies compared a specific protocol or adjunct behavior including sequential versus simultaneous pumping protocols (5 studies), pumping more than 4 times per day versus less than 3 times per day (1 study), provision of a milk expression education and support intervention to mothers of pre-term infants versus no provision (1 study), provision of audio/visual relaxation to mothers of pre-term infants versus no specific relaxation (2 studies), commencing pumping within 1 hour of delivery versus between 1 to 6 hours (1 study), breast massage before or during pumping versus no massage (2 studies, of which 1 also tested a second behavior), therapeutic touch versus none (1 study), warming breasts before pumping versus not warming breasts (1 study), combining hand expression with pumping versus pumping alone (1 study) and a breast cleansing protocol versus no protocol (1 study). There were insufficient comparable data on outcomes to undertake meta-analysis and data reported relates to evidence from single studies. Only 1 of the 17 studies examining maternal satisfaction/acceptability provided data in a way that could be analyzed, reporting that mothers assigned to the pumping group had more agreement with the statement “I don't want anyone to see me pumping” than mothers in the hand expression group and the statement “I don't want anyone to see me hand expressing” (n = 68, mean difference (MD) -0.70, 95 % confidence interval [CI]: -1.25 to -0.15, p = 0.01), and that mothers found instructions for hand expression were clearer than for pumping (n = 68, MD 0.40, 95 % CI: 0.05 to 0.75, p = 0.02). No evidence of a difference was found between methods related to adverse effects of milk contamination (1 study, n = 28, risk ratio (RR) 0.89, 95 % CI: 0.62 to 1.27, p = 0.51), (1 study, n = 142 milk samples, MD 0.20, 95 % CI: -0.18 to 0.58, p = 0.30), (1 study, n = 123 milk samples, MD 0.10, 95 % CI: -0.29 to 0.49, p = 0.61), (1 study, n = 141 milk samples, MD -0.10, 95 % CI: -0.46 to 0.26, p = 0.59 ); or level of maternal breast or nipple pain or damage (1 study, n = 68, MD 0.02, 95 % CI: -0.67 to 0.71, p = 0.96). For the secondary outcomes, greater volume was obtained when mothers with infants in a neonatal unit were provided with a relaxation tape or music-listening interventions to use while pumping, when the breasts was warmed before pumping or massaged while pumping. Initiation of milk pumping within 60 minutes of birth of a very low birth-weight infant obtained higher mean milk quantity in the first week than the group who initiated pumping later. No evidence of difference in volume was found with simultaneous or sequential pumping or between pumps studied. Differences between methods were found for sodium, potassium, protein and fat constituents; no evidence of difference was found for energy content. No consistent effect was found related to prolactin change or effect on oxytocin release with pump type or method. Economic aspects were not reported. Most studies were classified as unclear or low risk of bias. Most studies did not provide any information regarding blinding of outcome assessment; 15 of the 25 studies that evaluated pumps or products had support from the manufacturers. The authors concluded that the most suitable method for milk expression may depend on the time since birth, purpose of expression and the individual mother and infant. Low-cost interventions including early initiation when not feeding at the breast, listening to relaxation music, massage and warming of the breasts, hand expression and lower cost pumps may be as effective, or more effective, than large electric pumps for some outcomes. They stated that small sample sizes, large standard deviations, and the diversity of the interventions argue caution in applying these results beyond the specific method tested in the specific settings.

In a Cochrane review, Becker and colleagues (2016) evaluated acceptability, effectiveness, safety, effect on milk composition, contamination and costs of methods of milk expression. The authors concluded that the most suitable method for milk expression may depend on the time since birth, purpose of expression and the individual mother and infant. Low-cost interventions including initiation of milk expression sooner after birth when not feeding at the breast, relaxation, massage, warming the breasts, hand expression and lower cost pumps may be as effective, or more effective, than large electric pumps for some outcomes. Variation in nutrient content across methods may be relevant to some infants. These researchers noted that small sample sizes, large standard deviations, and the diversity of the interventions argued caution in applying these results beyond the specific method tested in the specific settings. Moreover, they stated that independently funded research is needed for more trials on hand expression, relaxation and other techniques that do not have a commercial potential.

Scope of Policy

This Clinical Policy Bulletin addresses breast pumps and associated supplies.

Medical Necessity

Breast Pump Rental

Aetna considers rental of a reusable breast pump medically necessary durable medical equipment (DME) when

of the following criteria is met:

Supplies

Aetna considers the following breast pump supplies medically necessary:

Policy Limitations and Exclusions

Other

The following policy applies to new health plans and non-grandfathered plans that are currently subject to DHHS requirements for coverage of breast pumps, with coverage beginning in the first plan year that begins on or after August 1, 2012 (please check benefit plan descriptions):