Breast Pumps - Clinical Medical Policy Bulletins (2023)

Number: 0421

Politics

Aetna considers renting a reusable breast pump, Durable Medical Equipment (DME), to be medically necessary ifanyone of the following criteria is met:

• For the duration of the newborn's hospitalization after the mother's discharge; Borrowing a breast pump is no longer considered medically necessary after the newborn is discharged;or
• For babies with birth defects that interfere with feeding, a breast pump is considered medically necessary up to 12 months of age.

Aetna does not cover the purchase of breast pumps under Aetna's standard benefit plans, which are not currently subject to the Department of Health and Human Services (DHHS) requirements for breast pump coverage. Non-reusable manual or electric breast pumps that are commercially available do not fall within the standard contractual definition of durable medical devices, Aetna believes, because they are typically used without illness or injury.

Up to 3 spare polycarbonate bottles; 3 replacement bottle tops, spouts or caps; and 3 replacement locking rings are considered medically necessary per pregnancy. Add toital. rReplacement accessories for comfort and convenience are not covered.

Aetna does not cover the following items related to breast pumps:

• baby scale
• Batteries, battery powered adapters and batteries
• Breast milk storage bags, ice packs, labels, label caps and other similar products
• Breast pump cleaning products including soap, sprays, wipes, steam cleaning bags and similar products
• Creams, ointments, and other products that soothe the breasts or nipples
• Power supplies for on the go
• Clothing or other products that allow hands-free pump operation
• Nursing bras, bra pads, breast pads, nipple pads and other similar products
• Suitcases and similar travel or transport accessories.

monitoring: The following policy applies to new health plans and currently unpurchased plans that are subject to DHHS requirements for breast pump coverage with coverage beginning in the first plan year beginning on or after August 1, 2012 (see benefit plan descriptions):

• Aetna believes it is medically necessary to purchase a standard manual or electric breast pump for breastfeeding during pregnancy or at any time after delivery.
• Aetna considers the purchase of a standard manual or electric breast pump medically necessary for women wishing to breastfeed an adopted baby if the criteria listed above are met.
• Aetna deems the rental of a high-capacity electric breast pump (hospital-grade) medically necessary for the newborn's hospitalization.
• For women who have used a breast pump in a previous pregnancy, a new set of breast pump accessories is deemed medically necessary for each subsequent pregnancy in order to initiate or continue breastfeeding during pregnancy or after delivery.
• A standard manual or electric pump is considered medically necessary for each subsequent pregnancy to initiate or continue breastfeeding during pregnancy or postpartum.
• Aetna does not consider the purchase of high-performance (hospital-grade) electric breast pumps to be medically necessary.

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Breastfed babies have a lower risk of diarrhea and otitis media during the first year of life than bottle-fed babies. In preterm infants, breast milk prevents infection, accelerates recovery from respiratory distress syndrome, increases weight gain, protects against retinopathy, and promotes cognitive and visual development.

Aetna believes it is medically necessary for babies to rent breast pumps during their hospital stay. The breast pumps used in the hospital are specially designed to be reused (sterilizable) and are not sold commercially.

On the other hand, commercially available hand and electric pumps are not designed to be reused and are more commonly sold to mothers with normal babies who work, travel, or are otherwise not always at home to breastfeed their baby. Standard electric breast pumps or manual breast pumps may be required to start breastfeeding in the postpartum period within the first eight weeks after birth. Manual breast pumps are sufficient for continued breastfeeding after confinement. Current recommendations from the American Academy of Pediatrics are to continue breastfeeding babies up to one year of age.

Women may be able to breastfeed adopted babies through induced lactation. The process involves nipple stimulation with an electric breast pump, beginning about two months before the adoptive mother is expected to start breastfeeding. In addition, hormone therapy such as estrogen or progesterone supplementation may be prescribed to simulate the effects of pregnancy. Typically, hormone therapy for induced lactation is stopped shortly before breastfeeding begins. At this point, it is believed that the baby's sucking stimulates and maintains milk production.

The U.S. Department of Health and Human Services (DHHS), authorized under the provisions of the Patient Protection and Affordable Care Act, has issued health insurance coverage guidelines developed by an Institute of Medicine committee that require health coverage for breast pumps and certain others women prevention services. New health insurance plans and vesting plans and issuers must provide coverage under these guidelines in the first plan year (in the individual market, the policy year) beginning on or after August 1, 2012.

The Centers for Disease Control and Prevention (CDC, 2010) recommended that infected women in the United States avoid breastfeeding to avoid postnatal transmission of HIV-1 to their babies through breast milk. These recommendations should also be followed by women receiving antiretroviral therapy. The passage of antiretroviral drugs into breast milk has only been studied for some antiretroviral drugs; ZDV, 3TC and nevirapine have been identified in human breast milk.

Qi and colleagues (2014) described problems and injuries associated with breast pumps and identified factors associated with these problems and injuries. The data came from the Study of Infant Feeding Practices II; Mothers were recruited from a nationwide consumer opinion panel. Mothers were asked about breast pump use, problems, and injuries at 2, 5, and 7 months of age. 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 the mothers, respectively, reported pump-related problems and injuries. The most commonly reported problem was the pump not getting enough milk and the most commonly reported injury was sore nipples. Using a battery pump and intending to breastfeed for less than 12 months was associated with an increased risk of pump-related problems and injuries. Learning to use a pump from a friend was associated with a lower risk of pump-related problems, and using a hand pump and renting a pump were associated with a higher risk of problems. The authors concluded that these results suggest that problems and injuries associated with breast pump use can occur among mothers of all socioeconomic characteristics. Breastfeeding mothers can reduce the risk of problems and injuries by not using battery pumps, and they can reduce breast pump problems by not using hand pumps and learning to pump individually rather than following written instructions or videos.

In a Cochrane review, Becker et al. (2015) the acceptability, efficacy, safety, impact on milk composition, contamination, and cost implications of milk extraction methods. These investigators searched the Cochrane Pregnancy and Childbirth Group trials registry (March 2014), CINAHL (1982 to March 2014), conference proceedings, secondary references, and contacted investigators. Randomized and quasi-randomized trials comparing methods at each time point after birth were selected for the analysis. Three authors independently analyzed the studies, extracted the data and assessed the risk of bias. This updated review included 34 studies with 1998 participants, with 17 studies with 961 participants providing data for analysis. Eight studies compared 1 or more pump types with hand expressions and 14 studies compared 1 pump type with another pump type, with 3 of these studies comparing hand expressions and multiple pump types. Fifteen studies compared a specific protocol or additional behavior, including sequential versus simultaneous pumping protocols (5 studies), pumping more than 4 times a day versus less than 3 times a day (1 study), pumping education, and supportive interventions for mothers of preterm infants versus no offer (1 study), audiovisual relaxation for mothers of preterm infants versus no specific relaxation (2 studies), starting extraction within 1 hour after delivery versus 1 to 6 hours (1 study), breast massage before or during extraction versus no massage (2 trials, 1 of which also tested a second behavior), therapeutic touch versus none (1 trial), pre-extraction breast warming versus no breast warming (1 trial), combination of hand expression with pumping versus pumping only (1 trial), and a breast cleansing protocol versus no protocol (1 study). There were insufficient comparable data on outcomes to perform a meta-analysis, and the data reported are based on evidence from individual studies. Only 1 of 17 studies examining mothers' satisfaction/acceptance provided data in a form that could be analyzed and reported that mothers assigned to the pumping group responded to the statement "I don't want anyone to pump me." sees" were more likely to agree than mothers assigned to the pumping group, the hand expression group, and the statement "I don't want anyone to see me doing the hand extraction" (n = 68, mean difference (MD) -0.70, 95 % confidence interval [CI]: -1.25 to -0.15, p=0.01) and that mothers found manual pumping instructions clearer than pumping instructions (n=68, MD 0.40, 95%- CI: 0.05 to 0.75, p=0.02). No evidence of a difference between the methods was found with regard 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 degree 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). In secondary outcomes, greater loudness was achieved when mothers with infants in a neonatal unit were given a relaxation band or interventions to listen to music during pumping, when the breasts were warmed before pumping, or when the breasts were massaged during pumping. The group that started pumping within 60 minutes of giving birth to a very low birth weight baby received a higher average amount of milk in the first week than the group that started pumping later. No evidence of a volume difference was found when pumping simultaneously or sequentially, or between the pumps studied. Differences between the methods were found for the components sodium, potassium, protein and fat; No evidence of a difference was found in 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 with a low risk of bias. Most studies did not provide information on the blinding of the results; 15 of the 25 studies evaluating pumps or products were supported by manufacturers. The authors concluded that the most appropriate method of pumping milk may depend on the time since birth, the purpose of pumping, and the individual mother and baby. Inexpensive interventions, including early initiation when not breastfeeding, listening to relaxing music, massaging and warming the breasts, pumping, and inexpensive pumps may be as or more effective than large electric pumps for some outcomes. They indicated that small sample sizes, large standard deviations, and the variety of interventions indicate caution in applying these results beyond the specific method tested in specific settings.

In a Cochrane review, Becker and colleagues (2016) evaluated the acceptability, efficacy, safety, impact on milk composition, contamination, and cost of milk extraction methods. The authors concluded that the most appropriate method of pumping milk may depend on the time since birth, the purpose of pumping, and the individual mother and baby. Inexpensive interventions, including starting pumps early after birth when not breastfeeding, relaxation, massage, breast warming, hand expression, and inexpensive pumps can be as effective or more effective than large electric pumps for some outcomes. Differences in nutrient levels between methods may be relevant to some infants. These researchers found that small sample sizes, large standard deviations, and the variety of interventions indicate caution in applying these results beyond the specific method tested in specific settings. Additionally, they stated that independently funded research is needed to further test hand expression, relaxation, and other techniques that have no commercial potential.

The above policy is based on the following references: